WO2009138521A1

WO2009138521A1 - Novel methods and means for clinical investigations

Info

Publication number: WO2009138521A1
Application number: PCT/EP2009/056028
Authority: WO
Inventors: Richard Geert Albertus Bult; Jan Johan Adriaan Tuiten
Original assignee: Mobile Drug Research B.V.
Priority date: 2008-05-16
Filing date: 2009-05-18
Publication date: 2009-11-19
Also published as: CA2762145A1; EP2296533A1

Abstract

The present invention discloses a method for testing at least one effect of a pharmaceutical substance in a subject, comprising administering a pharmaceutical substance to a subject, measuring with at least one sensor contained within a mobile sensor system, at the subject or in close proximity to said subject, at least one parameter value indicative of a body function of said subject, transmitting at least one sensor system signal associated with the at least one parameter value to a receiver contained within a mobile base unit, said receiver being provided with a means for wireless transmission, and wirelessly transmitting a mobile base unit signal associated with the at least one sensor system signal from said receiver to a back-end system, whereby at least said back-end system correlates the at least one parameter value with and/or displays a representation of the at least one effect of said pharmaceutical substance.

Description

Novel methods and means for clinical investigations

The invention relates to the field of medicine, in particular to the field of clinical trials (or clinical experiments in live subjects) for the development of substances and/or devices useful for diagnosing, preventing, ameliorating and/or treating undesired (pathological) conditions. The invention combines knowledge from two distant fields: (1) the field of clinical development and (2) the field of mobile data capture and data transmission technology. An important feature of the invention is this combination of these two distant fields. As described in the following introduction the inventors have realized that the combination of these fields provides inter alia more accurate and/or more reliable data for (clinical) testing of a pharmaceutical substance and/or medical devices. In its broadest sense the invention thus provides the application of mobile data capture and data transmission technology in the field of clinical (drug) development.

Introduction of the invention

There are numerous instances where circumstances dictate or at least influence outcome. Easy calculus that one can answer from the top of one's head may present an insurmountable problem under stress conditions (e.g. exams, television shows). The reverse is also true. Tasks that seem insurmountable under "normal" conditions can be accomplished if the need is extremely high (life threatening situations). There is undoubtedly a strong interaction between body and mind. This is also true for our health. "Mens sana in corpore sanum". Herpes simplex clinical episodes (cold sores) are strongly correlated with stress. In medicine the so-called "placebo -effect" is clear evidence of the strength of the mind in influencing outcome of a treatment.

Thus, it seems clear that the mind plays an important role in the efficacy of drugs. Yet when drugs are tested for their clinical efficacy, the mind is not just ignored as a factor, it is in fact set in an artificial, typically stressful environment. When drugs are tested in human subjects (as part of the clinical development; see below) such tests are typically carried out in a "hospitalized" setting, which for most people is associated with negative emotions. Whereas these "hospitalized" circumstances do not significantly affect the efficacy of e.g. antibiotics, one may expect that there are numerous classes of drugs of which the efficacy is influenced by the state of mind of the user. Examples are psychotropic drugs, hormones, and drugs for metabolic diseases such as insulin.

More specific embodiments of the invention

The invention provides a method and means for testing at least one effect of at least one pharmaceutical substance in at least one subject, comprising measuring with at least one measuring device, at the subject or in close proximity to said subject, at least one parameter indicative of a body function of said at least one subject, transmitting said measurement to at least one receiving device, said receiving device being provided with a means for wireless transmission, and transmitting said measurement from said receiving device to a computer (back-end system), whereby at least said computer correlates the at least one parameter with and/or displays a representation of the at least one effect of said at least one pharmaceutical substance. The present invention further provides a monitoring system for testing an effect of a pharmaceutical substance in a subject comprising a mobile body area network and a remote user network, wherein the mobile body area network comprises a sensor system and a mobile base unit and the remote user network comprises a back-end system, wherein the sensor system is suitable for determining a parameter value of a subject, the parameter value being associated with the effect of the pharmaceutical substance, and for transmitting a sensor signal to the mobile base unit, the sensor signal being associated with the parameter value, and the mobile base unit is suitable for receiving the sensor signal and for wirelessly transmitting a mobile base unit signal associated with the sensor signal to the back-end system, characterized in that the back-end system comprises a service controller, an on-line service centre and an interface to a digital vault, the service controller being arranged for automatically preparing an exact and secured copy of the at least one mobile base unit signal associated with the received sensor signal and transmitting said copy to the digital vault, and the on-line service centre being arranged for correlating the at least one sensor signal with at least one effect of said pharmaceutical substance.

According to the invention a pharmaceutical substance is defined as any substance having an effect on a subject which is considered useful in the amelioration, prevention and/or treatment of an undesired (pathological) condition of said subject.

According to the invention a substance is defined as a chemical compound, preferably an organic chemical compound including but not limited to proteins, steroids, polysaccharides, nucleotides, combinations of the aforementioned compounds or compositions comprising the aforementioned compounds or combinations thereof.

According to the invention a subject is defined as a human or animal or a model representing (a part of) said human or animal. A subject thus is to be understood as a subject to be monitored, not necessarily having a disorder. It will be appreciated that it is also possible to monitor healthy people, for instance healthy people who require special attention, such as sportsmen, elderly or infants.

According to the invention a measuring device is defined as a means arranged to determine at least one value of a parameter of the subject through the translation of physical and/or chemical parameters into an electromagnetic signal.

Parameters indicative of a body function may be any parameters that can be measured through a sensor which may be used at or near a subject. It is also possible to use parameters that are measured inside a subject's body, although non-invasive sensors are preferred. The parameters that can be measured include but are not limited to heart rate, blood pressure, blood flow, blood oxygenation, body temperature, glucose levels, levels of other chemicals and/or biological s, conductivity (of skin), etc. Typically a sensor will measure a parameter and convert it into an electrical current, which can be relayed and/or converted into digital data. Conversion into digital data may be accomplished by methods known in the art. The meaning and scope of the term digital data is considered to be well known in the art. The important feature here is that the signal, which correlates to an effect on a parameter measured at or near the subject, is converted into transferable, storable and interpretable digital data that still correlate to the same effect. A sensor may be reusable or disposable. A sensor may be connected to a measuring device or it may be an integral part of a measuring device. The measuring device may communicate (wireless) with a receiving device or it may be an integral part of a receiving device. According to the invention preferably multiple (at least two) parameters are measured at or near the same subject, preferably simultaneously. The different sensors needed for these measurements may be connected to one or more measuring/receiving devices. Preferably the measurements for one subject are relayed through a single receiving device. Measurements may be made continuously or at certain intervals. Signals from the measurements may be relayed immediately or they may be stored in a storage device before being relayed. The storage device may be separate or integrated into one of the other devices. Signals may also be analysed by the measuring device. When such an analysis is made, measurements may be relayed upon a certain event in the measurements, or for a certain interval of time surrounding a certain event in the measurements. In this way a large bulk of signals and/or data containing less relevant data (or less immediately relevant data) needs not be relayed, or may be relayed at a later moment in time. As an example, when measuring heart rate, it may not be necessary to relay measurements as long as the heart rate remains within a certain range. Once it is outside said range signals/data of the heart rate sensor and/ or measuring device may be relayed to the receiving device or if the analysis takes place at the receiving device from the receiving device onward. The signals and/or data relayed at that time may be originating from the sensor making the heart rate measurement, but also from other sensors/devices measuring parameters at or near the same subject. It may be relevant to determine what caused the event (in this case change in heart rate), therefore the measuring device and/or receiving device may retrieve some of its stored historical data/signals and relay these onward in the system together with or preceding/following the data at the time of the event that triggered the relay. Sensors and/or measuring devices may also be provided which measure parameters from the environment of the subject. For instance the temperature of the surroundings of the subject may be relevant for certain parameters measured from the subject.

According to the invention a receiving device is defined as a means arranged for receiving (directly or indirectly) a signal from at least one measuring device and for wirelessly transmitting a signal correlated with the signal received from said measuring device. The receiving device may be a separate or integrated device. It may be integrated with the measuring device (s) (which in itself may be integrated with the sensor(s), and/ or it may be integrated (or part of) a storage/computing/analyzing device. It may be connected (hard-wired or wireless) to a separate storage/computing/analyzing device. It may be a pda or a mobile phone. It may have a user interface. It may be connected to, or have a monitor and/or a printing device. The important part is that in a system according to the invention, there may be provided for a user interface at or near the site where the sensors are measuring. This may be a unidirectional, or two way or multidirectional interface. This interface connects the subject or a person near the subject (user) with a person (responsible) at the back-end of the system (directly or indirectly). The responsible may be able to direct, question and/or instruct the user (subject). The user (and/or subject) may be able to ask questions or send messages to the responsible.

According to the invention the term computer has its usual meaning, including a system comprising several connected CPU's and/or several connected storage facilities. Typically a computer includes a display and input devices such as a keyboard and a mouse.

A sensor may measure chemical and/or physical parameters. To be useful these measurements have to be converted into electric (electromagnetic) signals and/or digital data. The electric signals may be filtered, amplified and/or modified in any manner considered necessary and/or useful. The signals may be converted into digital data at any stage of the processes according tot the invention. This may be done in the measuring device, the receiving device, or the back-end computer. The digital data can be further processed (filtered, analyzed) also at any stage. They may be partially stored and partially relayed, completely stored for later transmission, etc. The methods and means disclosed above inter alia provide the following advantages in the field of clinical development. Pharmaceutical substances (hereinafter also referred to as drugs) under clinical development can now be tested under conditions resembling their eventual "circumstance of use" more closely, instead of restricting the clinical testing of drugs to hospital-like environments wherein subjects are limited in their behavior. This limit may bias the outcome of the clinical tests. For example, the clinical efficacy of statins is known to be dependent on behavioral components and/or environmental influences, such as the amount of physical exertion, stress, and food intake. In a hospital-like setting these components and or influences will typically deviate from routine behavior.

According to the invention data can be collected anywhere and anytime (including real time), thereby allowing for any type of circumstances (behavioral and/or environmental) considered to be useful and/or relevant for the analysis of a drug/device under clinical testing. Such circumstances, optionally including behavioral and/or dietary instructions, include but are not limited to a home-setting, a less-restricted hospitalized-setting (e.g. more freedom of movement in and around the hospital), free-roaming (e.g. essentially unrestricted movement), testing under exertion, the natural and/or regular habitat of the subject, or combinations thereof, .thereby allowing the support of the development of more "personalized medicine".

Personalized medicine is a relatively new term, that is based on the emerging knowledge that the effect of medicines as measured on the basis of large groups of subjects (by statistical analysis) may be different than the effects on smaller groups or individual subjects. In large groups treated as one group, there may actually be two subgroups, one of which has no real benefit of a drug and a second group that has a strong benefit of the drug. By treating these two groups as one, the effects of the drug are underestimated for the group in need of the drug (if the group is smaller, it may even be not significant) or overestimated for the other group. Improved subgrouping of patients allows for more tailored drug treatment and better solutions. The availability of tailor-designed clinical studies will support the improved clinical development of new and also exisiting drugs to the right patient at the right time. The present invention provides means and methods suitable to be combined with other (innovative) systems that are used for screening for the presence of subgroups within a larger group. Since all data may be made available without human interference (and interpretation) such analyses become more feasible and more reliable.

According to the invention integrity of data can be increased. Collected data may be relayed immediately to a (central) data storage facility without the possibility of any human interference. Such a data storage facility may be at or under control of the end-user (e.g. a pharmaceutical company) and/or at or under control of an escrow-like body and/or at or under control of a regulatory body such as the FDA or EMEA.

Paper-free information may be instantly and constantly compiled as part of a real time growing database; Clinical trial subjects can be continuously monitored by a remote clinical research centre while continuing normal mobility under normal life circumstances; Drug efficacy and safety profiles can be tested in an individualized home-like setting enabling the collection of physical and mental measures under conditions more closely representing conditions under which drugs are actually being used;

Individualized dialogues with clinical subjects is possible and in real time; A strong commitment to completing post-marketing studies can be accomplished; an increased public commitment to drug safety and surveillance can be expected; The corporate governance of drug developing companies is supported; Clinical trial subject compliance and persistency clinical trial is supported; The public's perception of the value of medicines becomes more apparent.

Although the instant invention is explained in more detail regarding human clinical trials, it is clear that the same invention also applies to veterinary medicine and the field trials therein, but it also applies in animal experiments preceding or supporting human clinical trials. As explained herein before, the invention is not limited to pharmaceuticals per se, but can also be applied for testing diagnostic devices, medical devices and other devices for which behavior of the subject interacting with it may be relevant. Especially objects and/or devices related to well being are good candidates for testing according to the invention. Recently a new kind of alarm clock was introduced by Philips, which wakes a person up in what is stated to be a more pleasant way. The present invention could show whether this is actually the case or not by measuring relevant parameters of subjects waking up under their normal "home" conditions. In situations where animals are subjected to tests (either as target subjects or as prestage for human testing) it may be very well feasible to use transmission systems which are wireless, but function only within a short distance or within in a confined space ( for instance provided with signalling triggers, such as wiring in floors, walls and/or ceilings). In certain circumstances, such a set-up may also be useful for human trials. The present invention enables trials in subjects (both human and other) under circumstances that can be chosen by the investigator. Depending on the risks associated with the test, the subjects involved, the need to have contact with the subjects, etc, a test set-up may be chosen ranging from a confined situation to a completely free roaming subject test and everything in between. There are of course certain constraints associated with every different set-up. In a free roaming set-up a subject may be out of reach of mobile networks for a certain period of time. This more or less excludes high risk tests to be carried out under such conditions. It also means that storage capacity is needed at or near the subject. It also means that certain measurements will need to be assigned to a certain moment in time or a certain event. This calls in the case that different measurements are made for a means for synchronization of measurement. The present invention provides a means to achieve synchronization without actually having to synchronize. The detailed description explains this process in more detail.

Detailed description of a preferred mobile monitoring system, the use of which is preferred according to the invention

According to the invention, the use of a mobile monitoring system is provided, said system comprising at least one mobile sensor system arranged for detecting a parameter value and wirelessly transmitting a sensor signal associated with said parameter value, a mobile base unit arranged for receiving the sensor signal from the at least one mobile sensor system and for wirelessly transmitting a mobile base unit signal associated with the received sensor signal, wherein the at least one mobile sensor system and the mobile base unit are arranged to be carried by a movable object or movable organism, wherein the mobile monitoring system further comprises a back-end system arranged for receiving the mobile base unit signal, thus allowing a wireless communications link between the mobile base unit and the back-end system, and making data associated with the mobile base unit signal available to a user.

It will be appreciated that herein a signal, such as the sensor signal, may have data associated therewith, e.g. data associated with the parameter value, preferably in digital form. Hence, the mobile base unit can be wirelessly connected to, one or a plurality of mobile sensor systems. This provides the advantage that the mobile sensor system(s) can be easily applied to the movable object or movable organism, e.g. subject, while the mobile base unit can separately be applied to the subject, e.g. worn on the clothing or carried in a pocket of a person's clothing, without the need of any physical connection between the mobile sensor system(s) and the mobile base unit. Further, a user, such as a physician, may monitor the data associated with the mobile base unit signal, which may comprise data relating to the detected parameter value, via the wireless communications link and via the back-end system.

Preferably, the back-end system is further arranged for transmitting a back-end system signal and the mobile base unit is further arranged for receiving the user unit signal from the user unit. Hence, it is possible to communicate data from the mobile base unit towards the back-end system and vice versa. It is for instance possible for the physician using the back-end system, e.g. via a user terminal and an interface, such as a web- application, to transmit commands, such as feedback, e.g. tactile, audio, and/or visual feedback signals, to the subject carrying the mobile base unit.

In a preferred embodiment, the back-end system comprises a service controller arranged for automatically preparing an exact and secured copy of the mobile base unit signal associated with the at least one received sensor signal and transmitting said copy to a digital vault. The digital vault may only be accessible to regulatory authorities, like FDA or EMEA. The service controller may further transmit the mobile base unit signal associated with the at least one received sensor signal to an on-line service centre for correlating the at least one sensor signal with at least one effect of said pharmaceutical substance. The on-line service controller preferably prepares a representation of the at least one sensor signal with the at least one effect of said pharmaceutical substance automatically and/or on-demand for visualisation on an external data display.

Preferably, the mobile base unit is provided with an actuator, e.g. a loudspeaker or a vibratory element, and is arranged for actuating the actuator on the basis of the received back-end system signal.

Preferably, the mobile base unit is further arranged for wirelessly transmitting a mobile-base-unit-to-sensor-system signal, e.g. associated with the received back-end system signal, and the at least one mobile sensor system is arranged for receiving the mobile-base-unit-to-sensor-system signal. Preferably, the at least one mobile sensor systems is provided with an actuator. Hence, it is possible to activate the actuator by receiving a command from the mobile base unit or from the back-end system via the mobile base unit. Thus, it is for instance possible for the physician using the back-end system, e.g. via a user terminal and an interface, such as a web-application, to transmit commands, such as feedback, e.g. tactile, audio, and/or visual feedback signals, to the sensor system, via the mobile base unit. Also, it is possible for the subject using the mobile base unit, to transmit commands, e.g. to actuate the actuator, to the sensor system.

In a preferred embodiment, the mobile base unit is arranged such that it can be wirelessly connected to different mobile sensor systems, e.g. determining values of different parameters, transmitting sensor signal using different wireless communications protocols, transmitting sensor signals in different (data) formats and/or manufactured by different manufacturers. Thus, a very versatile system is provided.

Preferably, the mobile base unit is arranged for filtering and/or processing data associated with the received sensor signal. Thus, e.g. noise may be removed from the data associated with the received sensor signal, or signal processing operations, such as averaging, (Fourier) transformation, etc. may be performed.

Preferably, the mobile base unit is arranged for compressing and/or prioritizing data associated with the received sensor signal. Thus, it is possible to reduce the amount of data transmitted via the wireless communications link to the back-end system.

According to an additional aspect of the invention, at least one of the at least one mobile sensor systems is arranged for detecting a first parameter value and a second parameter value and for transmitting a composite sensor signal associated with the first and the second parameter values, wherein the mobile base unit is arranged for decomposing the received composite sensor signal into a first sensor signal representative of the first parameter value and a second sensor signal representative of the second parameter value or for decomposing composite sensor data associated with the received composite sensor signal into first sensor data representative of the first parameter value and second sensor data representative of the second parameter value. This provides the advantage that if the mobile base unit is associated with a mobile sensor system transmitting a composite sensor signal, this composite sensor signal (or the composite sensor data) is decomposed in the mobile base unit. Thus, the mobile base unit comprises separate data associated with the separately determined parameters, which were combined in the composite sensor signal. Thus, it is possible to separately process the separate data associated with the separately determined parameters.

According to a further additional aspect of the invention, the mobile base unit is arranged for converting first sensor data associated with a first sensor signal that is transmitted in a first data format and second sensor data associated with a second sensor signal that is transmitted in a second data format, differing from the first data format, into a first and second converted sensor data, respectively, of identical data format. Hence, it is possible to perform identical or similar operations to the first and second converted sensor data, irrespective of the nature of the associated first and second sensor signals.

Preferably, the mobile base unit comprises a first plug-in software module for converting the first sensor data into the first converted sensor data and/or a second plug-in software module for converting the second sensor data into the second converted sensor data. Thus, it is possible to allow any type of sensor signal to be converted into a properly formatted converted sensor signal, preferably uniform for all converted sensor signals, by providing the correct plug-in software module. According to yet a further additional aspect of the invention, the mobile base unit is arranged for gathering data associated with received sensor signals into a data record, and for processing the data record. Here processing may e.g. comprise transmitting of the data record. Thus, a well- defined data structure may be provided. Preferably, the mobile base unit is arranged for gathering the sensor data associated with received sensor signals into a data record such that sensor data associated with each particular sensor device of the at least one mobile sensor system is comprised in a respective data-channel of the data record. Thus, the data record comprises a single data-channel for each sensor device. Hence, retrieving data from the data record is made particularly easy. Optionally, the data record comprises for each data-channel a relative priority of that data-channel.

According to another additional aspect of the invention, the mobile base unit is arranged for, during consecutive predetermined time intervals, for each predetermined time interval adding to a single data record all first sensor data associated with the first sensor signal received during that predetermined time interval and all second sensor data associated with the second sensor signal received during that predetermined time interval, and subsequently processing the data record. Here processing may e.g. comprise transmitting said data record. This provides the advantage that the first and second sensor signal are synchronised upon reception by the mobile base unit. Thus, the first and second sensor signal need not be synchronised at a later time, e.g. upon transmitting the mobile base unit signal, which proves to be difficult when receiving the first and second sensor signal via a wireless communications connection. Since, however, the first and second sensor signals received during one predetermined time interval are grouped into the same data record, the data associated with the first and second sensor signal and comprised in that data record is synchronised in time.

According to a further additional aspect of the invention, the mobile base unit is arranged for, during consecutive predetermined storage intervals, for each predetermined storage interval accumulating the sensor signal or all data associated with that sensor signal received during that predetermined storage interval, and transmitting the mobile base unit signal associated with the accumulated sensor signal or data associated with the received sensor signal after lapse of that storage interval. Herein, a plurality of data records may be accumulated during that predetermined storage interval. This provides the advantage that data may be transmitted from the mobile base unit to the back-end system in batches, which may e.g. reduce power consumption of the mobile base unit. In a generally applicable embodiment, the mobile base unit comprises an indicator for indicating data associated with the received sensor signal and/or data associated with the received back-end system signal to the user and/or movable organism. Preferably, the indicator comprises a display, and the data associated with the received sensor signal and/or associated with the received back-end system signal is indicated to the user and/or movable organism via a user interface.

According to an additional aspect of the invention, the mobile base unit is arranged for making the data associated with the received sensor signal, and/or the back-end system signal, available to the user interface or third party software components, e.g. a human machine interface, using an Application Programming Interface (API). This provides the advantage, that the user interface may be modified, or be tailor made, to the needs of a specific subject or user, without the need to modify software, running on the mobile base unit, relating to receiving and processing the sensor signals and/or back- end system signal and transmission of the base unit signal. Preferably, the data associated with the received sensor signal and/or the data associated with the received back-end system signal is communicated to the user interface using the Internet Protocol (IP). In an embodiment, the mobile base unit comprises a, preferably non-volatile, memory for storing the data associated with the received sensor signal. Thus, in addition to transmitting data associated with the received sensor signals to the back-end system, such data may also be stored into the memory. Preferably, all data associated with all received sensor signals is stored into the memory. This provides the possibility of retrieving any data, e.g. in case of loss of data due to malfunction or transmission errors in the wireless communication to the back-end system.

According to a further aspect of the invention, the mobile base unit is arranged to transmit historical data stored in the memory of the mobile base unit, e.g. data not previously transmitted, upon request by the back-end system or when triggered by a special event. Thus, it is possible to selectively omit transmission of data associated with, certain or certain parts of, received sensor signals and transmit previously non-transmitted data when needed. This may e.g. be useful in case of a medical episode, in which a user of the back-end system is interested in data predating the onset of the medical episode by a certain amount of time.

In one embodiment, the mobile base unit is arranged for transmitting status information of the mobile base unit. Such status information may comprise proper operation or malfunction information, free memory amount, remaining battery power, periodic acknowledgement of proper operation of the mobile base unit (mobile base unit "heartbeat"), etc.

According to an additional aspect of the invention, the data record comprises a system status channel comprising data indicating the status information of the mobile base unit and/or mobile sensor system(s). This provides the advantage that the data record comprises both data associated with received sensor signals and status information of the mobile base unit and/or mobile sensor system(s) in a (time-) synchronised way. Preferably, the system status channel is awarded a higher priority than the data channels comprising data associated with sensor signals.

According to an additional aspect of the invention, the mobile base unit is arranged for transmitting data for remote management of the mobile base unit towards the back-end system. Preferably, the back-end system is arranged for transmitting data for remote management of the mobile base unit towards the mobile base unit. The back-end system may transmit a system management signal comprising data relating to instructions and/or parameters concerning operation of the mobile base unit towards the mobile base unit. The mobile base unit may transmit a system management response, e.g. comprising acknowledgement of receipt of the system management signal and/or a new mobile base unit configuration, towards the back-end system. Preferably, the system management signal and the system management response is transmitted over a system management channel, which forms a second wireless communications link between the mobile base unit and the back-end system, separate of the wireless communications link (hence also referred to as data records channel) used for transmitting the mobile base unit signal and the back-end system signal.

Preferably, the system management channel is awarded top priority over the data records channel comprising data associated with sensor signals and the system status channel. Hence, operation of the system is safeguarded, even in situations where the system has to communicate high volumes of data associated with received sensor signals from the mobile base unit to the user unit.

According to yet another additional aspect of the invention, the mobile base unit is arranged to modify the content of the data record to be transmitted based on a measured characteristic of the wireless communications link, such as a measured bandwidth, delay and/or delay variation of the wireless communications link. This provides the advantage that the mobile base unit may utilise the available bandwidth of the wireless communications link as desired, e.g. to the most optimal level from a communications link perspective, or the mobile base unit may decide to switch to an alternative wireless communications link based on a policy based mechanism. Such policy based mechanism allows the mobile base unit to assess parameters (e.g. power consumption, communication costs and/or communications speed) of available wireless communications links and determine which of the available links to use based on a policy, such as minimum required transmission time (e.g. in view of power consumption), maximum allowable transmission costs or the like.

Preferably, the mobile base unit is arranged to modify the content of the data record to be transmitted on the basis of the relative priority of the channels of the data record. Thus, one or more channels of the data channels comprising data associated with received sensor signals and the system status channel which are deemed more important than other channels may be spared when modifying the content of the data record. Alternatively, or additionally, those data channels among the data channels which are deemed more important than other data channels may be spared when modifying the content of the data record.

In a certain embodiment, the mobile base unit is arranged for determining the characteristic, such as bandwidth, of the wireless communications link on the basis of a filling degree of a transmission buffer of the mobile base unit. It will be appreciated that when the filling degree of the transmission buffer increases, e.g. the bandwidth of the wireless communications link is decreasing, as evidently a decreased amount of data can be transmitted per unit of time.

It is possible that the mobile base unit is arranged to remove a channel from the data record to be transmitted if the measured characteristic of the wireless communications link fulfils a predetermined criterion, e.g. if the bandwidth of the wireless communications link is lower than a predetermined threshold bandwidth, if a time delay in the wireless communications link is more than a predetermined threshold time delay, and/or if a variation in the time delay in the wireless communications link is more than a predetermined threshold variation.

Alternatively, or additionally, it is possible that the mobile base unit is arranged to increase an amount of filtering of data in a channel in the data record to be transmitted if the measured characteristic of the wireless communications link fulfils a predetermined criterion, e.g. with respect to bandwidth, delay or variation in delay.

Alternatively, or additionally, it is possible that the mobile base unit is arranged to increase an amount of data compression, or apply stronger filtering of data associated with a sensor signal, of data in a channel in the data record to be transmitted if the bandwidth of the wireless communications link is lower than a predetermined threshold bandwidth.

According to a further aspect of the invention, the back-end system is arranged to provide a surrogate object representing the mobile base unit, e.g. utilizing the Jini Surrogate Architecture. This provides the advantage that the mobile base unit only interacts with the back-end system (i.e. the surrogate object) and the back-end system emulates and handles all mobile base unit interactions with a plurality of (mobile base unit data) users, while the mobile base unit need not communicate with each user or a the plurality of users separately.

In general it may be preferred that the at least one mobile sensor system is connected or connectable to the mobile base unit via a, preferably short-range, wireless communications connection, such as Bluetooth or ZigBee. It will be appreciated that if a plurality of mobile sensor system is communicatively connected to the mobile base unit, different wireless communication connections, e.g. of different types, may be used side by side.

In general, it may be preferred that the mobile base unit is connected or connectable to the back-end system via a wireless communications link, such as GSM, GPRS, UMTS, HSDPA, EDGE, WLAN and/or WiMax.

In one embodiment, at least one of the mobile sensor systems comprises an event button and is arranged for transmitting a sensor signal associated with a status of the event button.

It will be appreciated that it is possible that a data channel associated with the event button sensor signal may be awarded a higher priority than other data channels associated with other sensor signals. Upon receiving the mobile base unit data record, the back-end system interprets the data record and may search for event related data. If this data is available, the back-end system may create an event message (e.g. text, audio, visual) and may forward this message to a third party service provider: text to SMS or email service provider, audio/visual to MMS or phone service provider or internet application provider.

The invention also relates to a method for mobile monitoring, comprising: detecting at least one parameter value and wirelessly transmitting a sensor signal associated with said at least one parameter value using at least one mobile sensor system carried by a movable object or movable organism; receiving the sensor signal from the at least one mobile sensor system and wirelessly transmitting a mobile base unit signal associated with the received sensor signal using a mobile base unit carried by the movable object or movable organism; receiving the mobile base unit signal using a back-end system, thus establishing a wireless communications link between the mobile base unit and the back-end system; and making data associated with the mobile base unit signal available to a user.

The invention will now be further elucidated by means of a, non- limiting, embodiment, referring to the drawings, in which

Fig. 1 shows a schematic representation of a first embodiment of a mobile monitoring system according to the invention;

Fig. 2 shows a part of the system of Fig. 1 in more detail; Fig. 3 shows an example of a data record according to the invention;

Fig. 4 shows an example of user network functionality using a surrogate object representing a mobile base unit;

Fig.5 shows the set-up of a monitoring system for use in a clinical test setting, whereby data are stored without the necessity of human interference.

Fig. 6 shows an overview of a study design. The administration of medication X and placebo is described in a fixed order, but in reality administration is randomized. Fig. 1 shows a schematic representation of a first embodiment of a mobile monitoring system 1 to be used according to the invention. In this example, the monitoring system is arranged for monitoring physical parameters, for instance blood pressure, saturation level of blood, skin temperature, heart rate, etc, of a subject. The parameters can for instance be monitored by a user of the system, such as a physician.

In the example of Fig. 1, the system 1 comprises a Body Area Network (BAN) 2 which is communicatively connected or connectable to a user unit, in this example embodied as a user network (UN) 4. In this example, the BAN 2 is connected to the UN 4 via a wireless communications link, such as GSM (Global System for Mobile communications), GPRS (General Packet Radio Service), UMTS (Universal Mobile Telecommunications System), HSDPA (High Speed Downlink Packet Access), EDGE (Enhances Data rates for GSM Evolution), WLAN (Wireless Local Area Network), WiMax (Worldwide Interoperability for Microwave Access) etc.

In Fig. 1 the Body Area Network 2 comprises a plurality of mobile sensor systems 6.i (i=l,2,3,...). These mobile sensor systems 6.i are carried by the subject. Thereto, the mobile sensor systems 6.i may e.g. be connected to the body or clothing of the subject. Each mobile sensor system 6.i comprises at least one mobile sensor device 8.j (j=l,2,3,...) for detecting a parameter of the subject. In this example, the first mobile sensor system 6.1 comprises two mobile sensor devices 8.1 and 8.2. In this example, the second mobile sensor system 6.2 comprises a single mobile sensor device 8.3. In this example, the third mobile senor system 6.3 comprises a single mobile sensor device 8.4. In this example, the first mobile sensor device 8.1 is a heart rate sensor for measuring the heart rate of the subject, and the second mobile sensor device 8.2 is a pulse oximeter (SpO2) sensor for measuring the amount of oxygen in the blood (saturation) of the subject. In this example, the third mobile sensor device 8.3 is a temperature sensor for measuring skin temperature of the subject. In this example, the fourth mobile sensor device 8.4 is an event button that can be activated by the subject, e.g. when the subject starts to feel unwell.

In Fig. 1, each mobile sensor system 6.i comprises a transmitter 10. i for transmitting a sensor signal associated with the detected parameter. Hence, the first transmitter 10.1 may transmit a first sensor signal associated with the measured heart rate and amount of oxygen in the blood. It will be appreciated that the first sensor signal may be a composite signal wherein two parameters detected by the first mobile sensor system 6.1, here the heart rate and the amount of oxygen in the blood, are combined, e.g. interleaved, encoded and/or encrypted. The second transmitter 10.2 may transmit a second sensor signal associated with the measured skin temperature. The third transmitter 10.3 may transmit a third sensor signal associated with a status (activated or non-activated) of the event button. The third transmitter may e.g. be arranged to only transmit the third sensor signal when the event button is activated, and refrain from transmitting the third sensor signal when the event button is not activated.

In the example of Fig. 1 the first, second and third sensor signals comprise sensor data associated with the respective detected parameters. In this example, the sensor signals comprise the sensor data in the form of digital data. In Fig. 1, the Body Area Network 2 further comprises a mobile base unit 12. The mobile base unit 12 is carried by the subject. Thereto, the mobile base unit 12 may e.g. connected to the body or clothing of the subject. In this example, a general-purpose computer, such as a Personal Digital Assistant (PDA) is used as a (hardware) platform for the mobile base unit 12. The mobile base unit 12 comprises a receiver 14 for receiving the respective sensor signals from the sensor systems 6.i. In this example, the transmitters 10. i and the receiver 14 are arranged for, e.g. short range, wireless communication of the sensor signals, for instance via Bluetooth or ZigBee. Thus, the BAN 2 forms a wireless network comprising mobile sensor systems 6.i and a mobile base unit 12 carried by the subject.

In Fig. 1, the mobile base unit 12 further comprises a transmitter 18 for transmitting a mobile base unit signal. The mobile base unit signal may be associated with the sensor signals received by the receiver 14 as described herein below. In this example, the mobile base unit signal comprises mobile base unit data associated with the sensor data. In the example of Fig. 1, the mobile base unit 12 further comprises data processing means 16 for processing the received sensor signals (e.g. for processing the sensor data), if so desired, and generating the mobile base unit signal on the basis of the sensor signals. It will be appreciated that the mobile base unit may be arranged to run a software portion for receiving and processing the sensor signals and transmission of the mobile base unit signal. Such software portion is herein also referred to as BAN application framework.

In the example of Fig. 1, the user network 4 comprises a back-end system 20, in this example a server, e.g. an internet server. The back-end system 20 comprises or is connected or connectable to a service receiver 22 for receiving the mobile base unit signal from the transmitter 18 of the BAN 2. In this example, the BAN 2 is connected to the UN 4 via a wireless communications link, such as GSM, GPRS, UMTS, HSDPA, EDGE, WLAN, WiMax etc. The user network 4 further comprises computing means 24 for handling, processing and making available data associated with the mobile base unit signal to a user or users. The user network 4 in this example comprises a user group 26. In this example, the user group comprises a plurality of user terminals 28.k (k=l,2,...). A first user terminal 28.1 may e.g. belong to a medical specialist, and a second user terminal 28.2 may e.g. belong to a general practitioner. A third user terminal 28.3 may e.g. belong to a system administrator for remotely (initially) setting and or modifying a configuration of the mobile base unit 12. The user terminal may e.g. be a general -purpose computer such as a desktop computer, laptop computer, PDA, etc., a communications device, such as a mobile telephone, or a dedicated device. In this example, the user terminals 28.k are communicatively connected to the back-end system 20 via the internet using wired or wireless telecommunications connections. It will be appreciated that at least one of the user terminals may also be communicatively connected to the back-end system 20 via an intranet or using wired or wireless telecommunications connections. Alternatively, at least one of the user terminals may be integral with the back- end system, e.g. the server 20, or comprise the functionality of the back-end system 20.

Up to this point, communication of data from the mobile sensor system 6.i towards the user terminal 28.k has been described. According to an aspect of the invention, it may also be possible to send data from the user terminal 28.k towards the sensor system 6.i. Thereto, the back-end system 20 may comprise or be connected or connectable to a transmitter, or the receiver 22 may be designed as a transceiver 22, for transmitting a back-end system signal. The mobile base unit 12 may comprise a receiver, or the transmitter 18 may be designed as a transceiver 18, for receiving the back-end system signal. The mobile base unit 12 may comprise a transmitter, or the receiver 14 may be designed as a transceiver 14, for transmitting a mobile-base-unit-to-sensor- system signal. At least one of the mobile sensor systems 6.i may comprise a receiver, or the associated transmitter 10. i may be designed as a transceiver 10. i, for receiving the mobile-base-unit-to-sensor-system signal.

In the example of Fig. 1, the third mobile sensor system 6.3 comprises an actuator 30 for making information associated with a secondary mobile-base-unit-to-sensor-system signal received by the transceiver 10.3 known to the subject. The actuator 30 may comprise visual signalling means, such as a light and/or a readable and/or graphic display, auditory signalling means, such as a loudspeaker, and/or tactile signalling means, such as a vibratory element.

It will be appreciated that the actuator may also perform an action in reaction to a certain mobile-base-unit-to-sensor-system signal received by the transceiver 10.3, wherein this action may be noticeable or not noticeable to the subject. It is for instance possible that the actuator actuates an insulin pump implanted in the subject in reaction to receiving a certain mobile-base- unit-to-sensor-system signal. It will be appreciated that transmission of a signal in the direction from the user network 4 towards the Body Area Network 2 may be initiated at any stage of the system. It is for instance possible that the user enters a command into the user terminal 28. k which command is translated into a particular user command signal, which is transmitted towards the transceiver 18 of the BAN 2. It is also possible that the back-end system 20 initiates the back-end system signal, e.g. a back-end system command signal, being transmitted towards the transceiver 18, e.g. in response to certain data being received from the BAN 2. It is also possible that the data processor 16 initiates a data processor command signal being transmitted towards the actuator 30, e.g. in response to certain data being received from at least one of the mobile sensor devices 8.j, or in response to an action or input of the subject with respect to the mobile base unit. Thus, the monitoring system 1 allows diverse feedback loops to be created and/or operated within the system.

According to an aspect of the invention, in the example of Fig. 1, the mobile base unit 12 is arranged to receive sensor signals from different types of mobile sensor systems 6.i (this may also entail mobile sensor systems 6.i of different manufacturers and/or employing different data formats) and to process the data associated with the different sensor signals in a similar, or same, manner. Thereto, the mobile base unit 12 is arranged to convert the received sensor signals, or the sensor data contained in these sensor signals, into sensor channels with a preferably uniform format.

The mobile base unit 12 is arranged to receive the first sensor signal from the first mobile sensor system 6.1 and to decompose the first sensor signal, or the sensor data associated with the first sensor signal, into sensor channels, such that each sensor channel is associated with data measured by one of the mobile sensor devices 8.1, 8.2 of the first mobile sensor system 6.1. This is diagrammatically shown in Fig. 2. In the example shown in Fig. 2, the mobile base unit 12 receives the wireless sensor signal in the form of a composite sensor signal S_c from the first mobile sensor system 6.1. It will be appreciated that the composite sensor signal S₁ may be formed by the first sensor signal comprising composite sensor data. The transceiver 14 forwards the received composite sensor signal S_c to the data processing means 16. In the example of Fig. 2, the data processing means 16 comprises a conversion module 32 that is arranged to decompose the composite sensor signal S_c received from the first mobile sensor system 6.1 into separate sensor signals S₁ and S₂ of the mobile sensor devices 8.1 and 8.2, respectively. It will be appreciated that it is also possible that the conversion module 32 is arranged to decompose the composite sensor data d_c associated with the composite sensor signal S_c into separate sensor data sets d_u d₂ each associated with a respective one of the mobile sensor devices 8.1 and 8.2, respectively. The separate sensor signals S₁ and S₂ (or separate sensor data sets d_x, d₂) are forwarded to data sorter 34. In this example, the conversion module 32 converts the sensor signals S₁ and S₂ (or separate sensor data sets d_1; d₂) in a uniform data format that is readily processable by the data sorter 34. It will be appreciated that the data processing means may comprise similar data conversion modules 32', 32" for converting sensor signals (or data associated with these sensor signals) from further mobile sensor systems, such as the mobile sensor systems 6.2 and 6.3, respectively, in Fig. 2, into sensor signals S₃,S₄ (or data sets d₃, d₄) having the same (uniform) data format as the sensor signals S₁ and S₂ (or data sets d_1; d₂). The sensor signals S₁-S₄ are herein referred to as converted sensor signals. The data sets d_x-d₄ are herein referred to as converted sensor data. It will be appreciated that each data conversion module 32, 32', 32" may be implemented as a software module. Further, each data conversion module 32, 32', 32" may be arranged specifically to convert sensor signals (or sensor data) from a specific make and type of mobile sensor system. Such conversion modules may be arranged as plug-in modules in the software of the mobile base unit 12 (BAN application framework). In general it is known in the art how to implement plug-in modules.

The data sorter 34 arranges data associated with the converted sensor signals (i.e. the converted sensor data) in a data record. An example of such data record is shown in Fig. 3. For convenience of reading, the data record is shown as comprising a plurality of columns, each starting with a header. It will be appreciated that internally in a computer memory of the data processing means 16 the data record may be written in a different structure (such as a linear array of memory locations, or a plurality of partial arrays) which will not affect the function and purpose of the data record.

In Fig. 3 it can be seen that the data record comprises sensor channels CH_m (m=l,2,3,...) (first column), wherein each sensor channel is associated with a separate mobile sensor device 8.j (third column) of a mobile sensor system (second column). In Fig. 3 the first mobile sensor system, e.g. mobile sensor system 6.1 in Figs. 1 and 2, is indicated by Dl, the second mobile sensor system, e.g. mobile sensor system 6.2 in Figs. 1 and 2, is indicated by D2, etc. In Fig. 3 the first mobile sensor device of the first mobile sensor system, e.g. mobile sensor device 8.1 in Figs. 1 and 2, is indicated by Dl.1, the second mobile sensor device of the first mobile sensor system, e.g. mobile sensor system 8.2 in Figs. 1 and 2, is indicated by Dl.2, etc. The fourth column of the data record of Fig. 3 comprises the converted sensor data associated with the actual converted sensor signals associated with the separate mobile sensor devices. Thus, the data processing means 16 acts as a multiplexer that multiplexes a plurality of composite sensor signals (data) and/or separate sensor signals (data) into a single data record of converted sensor data.

It will be appreciated that having the data record, wherein sensor data of possibly different origin are combined in a uniform data format that is readily processable by the data sorter 34, also provides the possibility to filter, or otherwise process, the converted sensor data within the mobile base unit 12. This may reduce the amount of data to be transmitted towards the user network 4.

It will be appreciated that the data record may also comprise one or a plurality of channels which are not associated with a mobile sensor system, but which are associated with a data source present in the mobile base unit 12. One channel, herein referred to as system status channel, may e.g. comprise a 'system ok' (e.g. battery) signal given by the mobile base unit 12 to signal to the back-end system 20 that the mobile base unit, for example the battery of the mobile base unit 12 and/or at least one of the mobile sensor systems 6.i, and/or BAN 2, is working properly. Such 'system ok' signal may e.g. be generated at predetermined time intervals by the mobile base unit. Alternatively, or additionally, a channel of the data record may be associated with a subject action performed in relation to the mobile base unit, e.g. activating a button on the mobile base unit 12.

According to an aspect of the invention, a system management channel is specified comprising data for remote management of the mobile base unit 12. The system management channel is a separate wireless communications link between the mobile base unit 12 and the back-end system 20, independent of the wireless communications link (also referred to as data records channel) used for transmitting the data records. The system management channel may be awarded top priority over the data records channel. Hence, system management of the system is safeguarded, even in situations where the system has to communicate high volumes of data associated with received sensor signals from the mobile base unit to the user unit. The back-end system 20 may transmit a system management signal (e.g. in response to input at a user terminal 28.3) comprising data relating to instructions and/or parameters concerning operation of the mobile base unit 12 towards the mobile base unit 12 using the system management channel. The mobile base unit 12 may transmit a system management response, e.g. comprising acknowledgement of receipt of the system management signal and/or a new mobile base unit configuration, towards the back-end system 20 using the system management channel. In this example, the system management signal is also transmitted by the transceiver 22 and received by the transceiver 18, and the system management response is also transmitted by the transceiver 18 and received by the transceiver 22. It will be appreciated that the mobile base unit 12 and/or back-end system 20 may also be provided with a separate transceiver for the system management channel.

Returning to Fig. 2, the data record, or a part of the data record may be forwarded to the transceiver 18 of the mobile base unit 12 and transmitted to the transceiver 22 of the back-end system 20.

Further, in Fig. 2, the mobile base unit 12 comprises a non-volatile memory 36. This may e.g. be an internal non-volatile memory of the mobile base unit 12, or e.g. a removable non-volatile memory such as a memory card, for instance of the type USB, SD, miniSD, microSD, MMC, CompactFlash type I (CF I), CompactFlash type II (CF II), Memory Stick PRO, MultiMediaCard, SmartMedia Card, Memory Stick Duo, xD-Picture Card, or Memory Stick PRO Duo. In the example of Fig. 2, the data record is integrally stored in the nonvolatile memory 36. This provides the advantage, that the data associated with the converted sensor signals may be retrieved from the memory 36, e.g. if transmission errors have occurred.

As can be seen in Fig. 1 the back-end system 20 may comprise or be connected or connectable to the transceiver 22. The transceiver 22 receives the data records transmitted by the transceiver 18 of the BAN 2. The back-end system 20 may forward the data comprised in the data records to the user terminals 28.k in the user group 26, e.g. via email, SMS, MMS, or the like. It is also possible that the back-end system makes the data comprised in the data records available for the user terminals 28.k of the user group 26, for instance on a (secure) internet web-page or in a user accessible database. It is also possible that a user terminal 28,k achieves direct communication with the transceiver 18 of the BAN 2, The user terminal 28. k may e.g. be a general purpose computer such as a desk top computer, laptop computer, PDA, etc., a communications device, such as a mobile telephone, or a dedicated device, which is provided with the transceiver 22. It this case, the user terminal may act as a display device. The mobile base unit 12 may advertise itself via transceiver 18 to the user terminal 28.k (e.g. direct communication via short range wireless communication technology). Once the user terminal 28.k discovers the mobile base unit 12, it may visualise the mobile base unit data on its own display. However, all communications involved to obtain the mobile base unit data is preferably provided by the back-end system 20.

It is also possible that the user terminal 28.k achieves communication with the transceiver 18 of the BAN 2, via the back-end system 20 as depicted in Fig. 1.

It is also possible that a plurality of user terminals 28.k achieves communication with a single BAN 2. If, however, such plurality of user terminals 28.k achieves direct communication with that BAN 2, the main actions taken by the BAN 2 may be in handling communication with each of the plurality of user terminals 28.k. Hence, actions relating to data processing may be delayed or terminated due to insufficient computing power of the data processing means 16.

According to an aspect of the invention, to cope with the plurality of user terminals 28.k (and optionally a plurality of mobile base units 12), the user network 4 may be arranged as a network of service providers and service consumers with a service discovery mechanism, wherein a mobile base unit broker 38 (or a plurality of such brokers) act as a service provider whose services are discovered and consumed by the service consumers, here the user terminals 28.k, e.g. utilizing Jini Network Technology (as developed by Sun Microsystems, Inc.) which is known per se. Such a configuration is shown in Fig. 4. In the Jini model each service provider, in this case the mobile base unit broker 38, registers a Service Proxy 40 into a Jini LookUp Service 42 of a Jini network community 44, which may then be discovered and consumed by the service consumers, in this case the user terminals 28.k. Additionally, to cope with the volatile nature of the connection between mobile base units 12 and their brokers 38, a model such as the Jini Surrogate Architecture (also developed by Sun Microsystems, Inc. and known per se) can be applied, wherein the mobile base unit broker 38 takes the role of a surrogate object, a representative of a resource-constrained mobile base unit 12 on a more powerful computing platform (in this case the server 20), which monitors mobile base unit 12 liveness and hides transient failures from the users 28.k. In the example of Figs. 1 and 2 the transmitters 10.1, 10.2, 10.3 are arranged to continuously transmit their respective sensor signals. This may pose a problem with time synchronisation of sensor signals associated with the parameters detected by the mobile sensor devices 6.1, 6.2, 6.3. According to an aspect of the invention, the data sorter 34 is arranged to add data associated with the converted sensor signals, i.e. converted sensor data, into a first data record during a first predetermined period of time, for instance one second. After expiry of the first predetermined period of time, the first data record is closed, a unique timestamp, preferably associated with a time of generating or closing the data record, may be added, and the first data record is forwarded to the transceiver 18 for transmission. Data associated with subsequently received converted sensor signals is added into a second data record during a second predetermined period of time, preferably equally long (e.g. one second). After expiry of the second predetermined period of time the second data record is closed, a unique timestamp may be added, and the second data record is forwarded to the transceiver 18 for transmission, and subsequent data added into a third data record etc. Thus, sensor signals from different mobile sensor devices 6.i, but received by the mobile base unit 12 within the same predetermined period of time, are bundled in a data record, e.g. with the unique timestamp, and transmitted to the back-end system 20 simultaneously. Hence, the non- synchronised sensor signals, and the associated sensor data, are synchronised in the data records. It will be appreciated that the time duration of the predetermined period can be varied to achieve a desired accuracy of time synchronisation.

In Fig. 3, the amount of data associated with the respective converted sensor signals is schematically shown in the fourth column. A larger number of crosses denote a larger amount of data. It can be seen that not each mobile sensor device 8.j may deliver the same amount of data during the predetermined period of time. It will be appreciated that the differing amount of data per channel does not affect the synchronisation of the channels within the accuracy of the predetermined period of time.

Up to this point, it has been assumed that the transceiver 18 of the BAN 2 continuously transmits data records associated with sensor signals. Hence, the system 1 can be operated real-time, i.e. any given sensor signal' is received by the back-end system 20 approximately at the time it is generated by the associated mobile sensor device 8.j, allowing some time delay due to processing of the signals and/or associated data, formatting of the data records etc. It has also been explained that the data records are stored in the non-volatile memory 36 of the mobile base unit 12. Hence, it will be appreciated that the system 1 can also be operated off-line, i.e. the data record history may be accessed at will in the non-volatile memory 36. According to an aspect of the invention it is also possible to operate the system near-line; i.e. predetermined time delayed operation. In this near- line mode of operation, the data records are stored in the memory 36 of the mobile base unit 12, and at predetermined time intervals, e.g. chosen between 300-900 seconds, a collection of data records, aggregated during the last predetermined time interval, is sent to the back-end system 20 in a single batch. This may reduce average overall transmitting time, hence improving battery life, of the mobile base unit 12, and may reduce costs associated with transmitting data via the wireless communications link to the back-end system 20, e.g. costs associated with a subscription to such a wireless communications link.

According to an aspect of the invention it is also possible to prioritise data comprised in the data records. It is for instance possible to rank channels in the data record according to their relevance for the user. In the example of Fig. 3 the fifth column displays such priorities P_m, wherein Pl denotes a higher priority than P2, which in turn denotes a higher priority than P3, etc. This allows for selective transmission of parts of the data record. This may be useful e.g. to minimise the amount of data to be transmitted.

It is possible to refrain from transmitting a certain channel CH₁₁₁ if it is not required that the associated converted sensor data is available real- time or near-line. It may suffice that that sensor data may be retrieved from the memory 36 off-line. Hence, the transmitted data record transmitted by the transceiver 18 may differ from the stored data record stored into the memory 36.

According to an aspect of the invention, the data processing means 16 may be arranged to automatically modify the content of the data record to be transmitted (preferably without affecting the content of the data record to be stored into the memory 36) e.g. based on the perceived bandwidth of the wireless communications link. A decrease in bandwidth may e.g. be perceived by the mobile base unit 12 by an increase of a filling degree of a transmission buffer comprising data records to be transmitted by the transceiver 18. Conversely, an increase in bandwidth may e.g. be perceived by the mobile base unit 12 by a decrease of the filling degree of the transmission buffer. In this example, the transmission buffer is a buffer of the mobile base unit 12 that is located downstream of the multiplexer which multiplexes the plurality of composite sensor signals (or composite sensor data) and/or separate sensor signals (or separate sensor data) into the single data record of converted sensor data. Alternatively, or additionally, wireless communications link characteristics, such as a bandwidth, or change in these characteristics may be communicated to the mobile base unit 12 by the back-end system 20 via the data records channel and/or the system management channel.

Thus, when e.g. high bandwidth is perceived, a data record may be transmitted comprising more channels than a data record transmitted when low bandwidth is perceived. The data processing means 16 modifies the content of the data record using the priorities P_m. Hence, channels being awarded a low priority may be removed from the data record to be transmitted in order to reduce the size of the data record to be transmitted, to allow more data records per unit time to be transmitted in case of lower bandwidth.

Alternatively, or additionally an amount of filtering or data compression applied to converted sensor data of a channel may be modified on the basis of the perceived wireless communications link characteristics, e.g. bandwidth. It is for instance possible to increase data filtering when lower bandwidth is perceived.

It will be appreciated that it is also possible that the amount of filtering applied to converted sensor data of a channel may be modified on the basis of the perceived wireless communications link characteristics and the priority P_m of a channel. Thus, increased data filtering may be applied to ^• channels of lower priority.

It will be appreciated that a predetermined filling degree of the transmission buffer may initiate modification of the content of data records, e.g. by omission of certain channels and/or modification of the degree of filtering. It will also be appreciated that a plurality of threshold level filling degrees may be defined, wherein each threshold defines a certain level of modification of the content of the data records.

It may be noted here, that the system management channel may be given a higher priority than the data records channel, so that in case of highly limited bandwidth, at least the correct system management and functioning of the BAN 2 is safeguarded. This may e.g. be used to prevent detaching of BAN 2 as the service provider from the Jini network community if the Jini surrogate architecture is used. Preferably, the rules determining how to modify the content of the data record (in the data records channel) to be transmitted based on the filling degree of the buffer can be configured.

According to an aspect of the invention, it is possible to transmit (sensor) data not previously transmitted upon request or when triggered by a special event. Such data may e.g. comprise data channels not previously transmitted, e.g. due to low bandwidth and/or low priority. Such event may e.g. be a clinical episode of a subject carrying the BAN 2. When the subject has such clinical episode, for instance recognised by at least one of the mobile sensor devices 8.j, or recognised by the subject himself and indicated by pressing the event button 8.4, the mobile base unit may continue to transmit data records comprising real-time measurement data generated by the mobile sensor devices 8.j. In case of the clinical episode, the user, in this example the physician, may want to possess historical data, not previously transmitted to the back-end system 20, of e.g. the last five minutes before the onset of the episode. The mobile base unit 12 is thereto arranged to transmit the historical data, for instance interleaved or transmitted prior to the data records of the real-time measurement data transmitted during the episode. Alternatively, or additionally, the historical data may be transmitted after the end of the episode.

It is possible that the processing means 16 of the mobile base unit 12 comprise software portions arranged for performing actions on the basis of the converted sensor data. It is for instance possible that software portions are present for making at least one of the converted sensor data known to the subject or user. It is for instance possible that such sensor data is shown, e.g. on the display of the mobile base unit 12, e.g. in the form of a numerical value, a histogram, a graph, a time line etc.

According to an aspect of the invention, the converted sensor signals, or the converted sensor data associated with the converted sensor signals are made available to a user interface using an Application Programming Interface (API). Thus, the user interface of the mobile base unit may be designed as a software portion that is separate from the BAN application framework. Using the API allows the user interface to be tailor made to the needs of a specific subject or user, without having to modify the BAN application framework. This also allows user interfaces to be manufactured by third party manufacturers. It will be appreciated that input from the user interface to the BAN application framework may also be made available using an Application Programming Interface. In a preferred embodiment, communication between the BAN application framework and the user interface makes use of Internet Protocol (IP). Hence, IP communication is used within the mobile base unit 12, between the BAN application framework and the user interface.

The invention is by no means limited to the above example. It will be appreciated that various modifications may be made without diverting from the invention.

It is for instance possible that BAN 2 is carried by an animal, in order to remotely monitor parameters of the animal.

It is also possible that the body area network is carried by a device, such as a vehicle, e.g. an automobile. In this case, the mobile sensor devices may sense parameters of certain components of the vehicle, such as tire pressure, oil pressure, engine temperature, battery voltage etc. In Fig.5 the set-up of a monitoring system for use in a clinical test setting is shown, whereby data are stored without the necessity of human interference. Physiological data from at least one sensor are received by a mobile sensor system wherein conditioning of the sensor signals occurs. A digital flow of physiological data (one channel per sensor) is wirelessly transmitted to the mobile base unit. More than one sensor system may wirelessly communicate with one mobile base unit. In the mobile base unit, data conversion to a system-internal data format as well as time synchronisation of all physiological data streams from all sensor systems occurs. The results may be shown on the display of the mobile base unit. According to the preferred embodiment of the invention shown in

Fig. 5, the mobile base unit wirelessly transmits all physiological data to the back-end system. The back-end system as shown in Fig. 5 comprises a service controller and an on-line service centre. The service controller automatically prepares an exact and secured copy of the original physiological data, and transmits this copy to a digital vault. In this way, human intervention does not occur, and data tampering is prevented. The digital vault may only be accessible to regulatory authorities, like FDA or EMEA. In addition, the service controller transmits the original physiological data to the on-line service centre. In the on-line service centre, the data may be (automatically) processed by the authority responsible for conducting the pharmaceutical investigation, for instance into a suitable format for analysis, e.g. correlation of physiological data with the effect of a pharmaceutical substance, and presentation. The data may be displayed, preferably on-line, on a data display device, for instance a personal computer with visualisation software. From the data display device, a signal for. controlling the process of the measurement of physiological data, e.g. controlling measurement interval, start time, stop time, may transmitted to the mobile base unit without the original physiological data from the sensor system being processed.

Example 1

Efficacy of Medicine X on the subjective and vaginal sexual response to erotic stimuli in women with hypoactive sexual desire disorder

In a double-blind, randomly assigned placebo controlled cross-over design, a group of 32 women with hypoactive sexual desire disorder (HSDD) are tested under condition of Medicine X and of placebo.

Medication

Medication X = on demand medication for HSDD with maximum efficacy 1-3 hours after intake.

Placebo = a compound with the same shape, colour, odour, taste, route of administration etc as Medicine X, but without the active ingredient.

Measurements 1. Vaginal pulse amplitude (VPA) and subjective rating of erotic stimuli are measured in response to erotic film clips in the institutional laboratory, under condition of Medicine X and Placebo.

2. VPA and subjective rating of erotic stimuli are measured in response to erotic film clips in the homes of the subjects with a mobile laboratory, under condition of Medicine X and Placebo. 3. Sexual functioning in general (e.g. regarding experiences of sexual encounters with spouse) are measured by a diary and a monthly questionnaire (e.g. Female Sexual Functioning Questionnaire; FSFI).

Screening

The experiment are preceded by a screening visit. In this screening visit subjects are interviewed and examined by a gynaecologist to diagnose for FSD and to determine eligibility for study participation. Subjects are asked to fill out a questionnaire; the Female Sexual Function Index (FSFI). Subjects are screened to exclude pregnancy or breast feeding, vaginal infections, major operations to the vagina and/or vulva, undetected major gynaecological illnesses or unexplained gynaecological complaints. Weight, height, blood pressure (supine and standing) are measured. Cardiovascular condition are tested and ECG checked for significant abnormalities. Subjects with a history of endocrinological, neurological or psychiatric illness and/or treatment.

Standard blood chemistry and haematology tests are performed. Participants are required not to use alcohol or psychoactive drugs the evening before and the day of experimentation. During period of menstruation, subjects will not be tested.

Laboratory measurement (institutional lab & mobile lab)

The vaginal pulse amplitude is measured in response to neutral and erotic film excerpts, 1 hour after drug administration. The two experimental days are separated by (at least) a three-day period. On the two experimental days, subjects receive one capsule consisting of either Medicine X, or Placebo.

During the experimental sessions in the laboratory, subjects take Medication X or placebo, and after one hour, the subject must insert a tampon- shaped vaginal probe (a photoplethysmograph) in order to measure the VPA. Then subjects will view a 10 minute neutral fragment, followed by a 5 minute erotic film fragment. Blood pressure (supine and standing), heart rate, respiration rate, and body temperature are monitored throughout on the experimental days. Measurements & drug administration at home (Sexual function diary & questionnaires)

One hour before a sexual encounter at home (coitus, masturbation etc) medication is taken. After each sexual encounter subjects write down their experiences in a diary. In this diary, the amount of arousal, desire, pain, orgasm intensity etc is described. Each month subjects fill out the FSFI. This questionnaire measures experienced arousal, desire, pain, orgasm intensity etc. over the past month.

VPA and subjective sexual arousal to erotic film clips is measured four times in the institutional laboratory and four times at home (see Figure 6). After the first two institutional measurements and the first two mobile lab measurements at home, subjects receive 3 months medication X or placebo to take home for use in sexual encounters. After the first 3 months, subjects take home 3 months of medication of the second type. Then, two mobile lab measurements at home and two institutional measurements follow.

Claims

1. A method for testing at least one effect of a pharmaceutical substance in a subject, comprising administering a pharmaceutical substance to a subject, measuring with at least one sensor contained within a mobile sensor system, at the subject or in close proximity to said subject, at least one parameter value indicative of a body function of said subject, transmitting at least one sensor system signal associated with the at least one parameter value to a receiver contained within a mobile base unit, said receiver being provided with a means for wireless transmission, and wirelessly transmitting a mobile base unit signal associated with the at least one sensor system signal from said receiver to a back-end system, whereby at least said back-end system correlates the at least one parameter value with and/or displays a representation of the at least one effect of said pharmaceutical substance.

2. A method according to claim 1, further comprising transmitting a back-end system signal using the back-end system and receiving the back-end system signal using the mobile base unit.

3. A method according to claim 2, further comprising actuating an actuator of the mobile base unit on the basis of the received back-end system signal.

4. A method according to any one of claims 1-3, further comprising wirelessly transmitting a mobile base unit- to- sensor- system signal, e.g. associated with the received back-end system signal, using the mobile base unit, and receiving the mobile-base-unit-to-sensor-system signal using the at least one mobile sensor system.

5. A method according to claim 4, further comprising actuating an actuator of at least one of the at least one mobile sensor system on the basis of the received mobile-base-unit-to- sensor signal.

6. A method according to any one of claims 1-5, comprising detecting a first parameter value and a second parameter value and transmitting a composite sensor signal associated with the first and the second parameter values using at least one of the at least one mobile sensor systems, and decomposing the received composite sensor signal into a first sensor signal representative of the first parameter value and a second sensor signal representative of the second parameter value or decomposing composite sensor data associated with the received composite sensor signal into first sensor data representative of the first parameter value and second sensor data representative of the second parameter value.

6. A method according to any one of claims 1-5, comprising converting first sensor data associated with a first sensor signal that is transmitted in a first data format and second sensor data associated with a second sensor signal that is transmitted in a second data format into a first and second converted sensor data, respectively, of identical data format.

7. A method according to any one of claims 1-6, comprising gathering data associated with received sensor signals into a data record.

8. A method according to claim 7, wherein the data associated with received sensor signals is gathered into the data record such that data associated with each single sensor device of the at least one sensor system is comprised in a respective channel.

9. A method according to claim 7 or 8, comprising adding into a single data record first sensor data associated with the first sensor signal received during a predetermined time interval and second sensor data associated with the second sensor signal received during that predetermined time interval, optionally adding a time -stamp to the data-record, and subsequently processing, e.g. transmitting, the data record.

10. A method according to claim 9, comprising, during consecutive predetermined time intervals, for each predetermined time interval adding to a single data record the first sensor data associated with the first sensor signal received during that predetermined time interval and the second sensor data associated with the second sensor signal received during that predetermined time interval, optionally adding a time-stamp to the respective data record, and¹ subsequently processing, e.g. transmitting, the respective data record.

11. A method according to any one of claims 1-8, comprising, during consecutive storage intervals, for each storage interval accumulating the sensor signal or data associated with the sensor signal received during that storage interval, and transmitting the mobile base unit signal associated with the accumulated sensor signals or accumulated sensor data associated with the received sensor signals after lapse of that storage interval.

12. A method according to any one of claims 1-11, comprising making the data associated with the received sensor signal and/or the received back-end system signal available to a user interface of the mobile base unit using an Application Programming Interface (API).

13. A method according claim 12, wherein the data associated with the received sensor signal and/or the received back-end system signal in communicated to the user interface using Internet Protocol (IP).

14. A method according to any one of claims 1-13, preferably at least claim 7, comprising transmitting historical data stored in a memory of the mobile base unit, e.g. data not previously transmitted, upon request by the back-end system or when triggered by a special event.

15. A method according to claim 14, wherein the mobile base unit is arranged for interleaving the historical data between data records of real-time measurement data.

16. A method according to any one of claims 1-15, comprising transmitting status information of the mobile base unit.

17. A method according to any one of claims 1-16, preferably at least claims 7 and 16, wherein the data record comprises a system status channel comprising data indicating a status of the mobile base unit and/or at least one of the at least one mobile sensor system(s).

18. A method according to any one of claims 1-17, preferably at least claim 6, further comprising wirelessly transmitting a system management signal towards the mobile base unit comprising data for remote management of the mobile base unit, wherein the system management signal is transmitted using a further wireless communications link between the mobile base unit and the back-end system separate of the wireless communications link for transmitting the mobile base unit signal.

19. A method according to any one of claims 1-18, preferably at least claim 7, comprising modifying the content of the data record to be transmitted on the basis of a measured characteristic, such as bandwidth, delay or delay variation, of the wireless communications link.

20. A method according to any one of claims 1-19, preferably at least claim 8, comprising modifying the content of the data record to be transmitted on the basis of a relative priority of the channels of the data record.

21. A method according to any one of claims 1-20, comprising determining the characteristics, such as bandwidth, of the wireless communications link on the basis of a filling degree of a transmission buffer of the mobile base unit.

22. A method according to any one of claims 1-21, preferably at least claim 8 and 19, comprising removing a channel from the data record to be transmitted if the measured characteristic of the wireless communications link fulfils a predetermined criterion, e.g. if the bandwidth is lower than a predetermined threshold bandwidth.

23. A method according to any one of claims 1-22, preferably at least claim 8 and 19, comprising increasing an amount of filtering of data in a channel in the data record to be transmitted if the measured characteristic of the wireless communications link fulfils a predetermined criterion, e.g. if the bandwidth is lower than a predetermined threshold bandwidth.

24. A method according to any one of claims 1-23, preferably at least claim 5, comprising increasing an amount of data compression of the data record to be transmitted if the bandwidth of the wireless communications link is lower than a predetermined threshold bandwidth.

25. A method according to any one of claims 1-24, comprising providing a surrogate object representing the mobile base unit, e.g. utilizing Jini technology.

26. A method according to any one of claims 1-25, wherein said at least one sensor system signal is transmitted to said receiver of the mobile base unit by wireless transmission.

27. A method according to claim 26, wherein said transmission is made through bluetooth technology.

28 A method according to any one of claims 1-27, wherein said at least one sensor system is integrated with said mobile base unit.

29. A method according to any one of the claims 1-28, wherein measurements are made continuously or at regular time intervals.

30. A method according to any one of the claims 1-29, wherein said measurements axe transmitted to said receiver of the mobile base system continuously or at regular time intervals.

31. A method according to any one of the claims 1-30, wherein said measurements are transmitted to said back-end system continuously or at regular time intervals.

32. A method according to any one of the claims 1-31, wherein a selection of data from said measurement is transmitted.

33. A method according to claim 32, wherein said selection is a selection of a certain time interval of measurement.

34. Use of a mobile monitoring system, comprising at least one mobile sensor system arranged for detecting a parameter value and transmitting a sensor signal associated with said parameter value; a mobile base unit arranged for receiving the sensor signal from the at least one mobile sensor system and for wirelessly transmitting a mobile base unit signal associated with the received sensor signal; wherein the at least one mobile sensor system and the mobile base unit are arranged to be carried by a movable object or movable organism; wherein the mobile monitoring system further comprises a back-end system arranged for receiving the mobile base unit signal, thus allowing a wireless communications link between the mobile base unit and the back-end system, and making data associated with the mobile base unit signal available to a user, for testing at least one effect of a pharmaceutical substance in a subject to which said pharmaceutical substance is administered.

35. Use of a mobile monitoring system according to claim 34, wherein the back-end system is further arranged for transmitting a back-end system signal and wherein the mobile base unit is further arranged for receiving the back-end system signal from the back-end system.

36. Use of a mobile monitoring system according to any one of claims 35, wherein the mobile base unit is further arranged for wirelessly transmitting a mobile-base-unit-to-sensor-system signal, e.g. associated with the received back-end system signal, and wherein the at least one mobile sensor system is arranged for receiving the mobile-base-unit-to-sensor-system signal.

37. Use of a mobile monitoring system according to any one of claims 34-36, wherein at least one of the at least one mobile sensor systems is arranged for detecting a first parameter value and a second parameter value and for transmitting a composite sensor signal associated with the first and the second parameter values, wherein the mobile base unit is arranged for decomposing the received composite sensor signal into a first sensor signal representative of the first parameter value and a second sensor signal representative of the second parameter value or for decomposing composite sensor data associated with the received composite sensor signal into first sensor data representative of the first parameter value and second sensor data representative of the second parameter value.

38. Use of a mobile monitoring system according to any one of claims 34-37, wherein the mobile base unit is arranged for converting first sensor data associated with a first sensor signal that is transmitted in a first data format and second sensor data associated with a second sensor signal that is transmitted in a second data format into a first and second converted sensor data, respectively, of identical data format.

39. Use of a mobile monitoring system according to claim 38, wherein the mobile base unit comprises a plug-in software module for converting the first sensor data into the first converted sensor data.

40. Use of a mobile monitoring system according to any one of claims 34-39, wherein the mobile base unit is arranged for filtering data associated with the received sensor signal.

41. Use of a mobile monitoring system according to any one of claims 34-40, wherein the mobile base unit is arranged for compressing data associated with the received sensor signal.

42. Use of a mobile monitoring system according to any one of claims 34-41, wherein the mobile base unit is arranged for gathering data associated with received sensor signals into a data record, and for processing the data record.

43. Use of a mobile monitoring system according to claim 42, wherein the mobile base unit is arranged for gathering the sensor data associated with received sensor signals into a data record such that sensor data associated with each single sensor device of the at least one sensor system is comprised in a respective data channel of the data record.

44. Use of a mobile monitoring system according to claim 43, wherein the data record comprises for each data channel a relative priority of that data channel.

45. Use of a mobile monitoring system according to any one of claims 42-44, wherein the mobile base unit is arranged for adding into the data record first sensor data associated with a first sensor signal from a first mobile sensor system received during a predetermined time interval and second sensor data associated with a second sensor signal from a second mobile sensor system received during that predetermined time interval, and subsequently processing, e.g. transmitting, the data record.

46. Use of a mobile monitoring system according to claim 45, wherein the mobile base unit is arranged for, during consecutive predetermined time intervals, for each predetermined time interval adding to a single data record the first sensor data associated with the first sensor signal received during that predetermined time interval and the second sensor data associated with the second sensor signal received during that predetermined time interval, and subsequently processing, e.g. transmitting, the respective data record.

47. Use of a mobile monitoring system according to any one of claims 34-46, wherein the mobile base unit is arranged to accumulate the received sensor signal and/or sensor data associated with the received sensor signal during a predetermined storage interval, and transmitting the mobile base unit signal associated with the accumulated sensor signal and/or accumulated data associated with the received sensor signal after lapse of the predetermined storage interval.

48. Use of a mobile monitoring system according to claim 47, wherein the mobile base unit is arranged for, during consecutive predetermined storage intervals, for each predetermined storage interval accumulating the sensor signals or data associated with the sensor signals received during that predetermined storage interval, and transmitting the mobile base unit signals associated with the accumulated sensor signals or data associated with the received sensor signals after lapse of that predetermined storage interval.

49. Use of a mobile monitoring system according to any one of claims 34-48, wherein the mobile base unit comprises an indicator for indicating data associated with the received sensor signal and/or the received back-end system signal to the user and/or movable organism.

50. Use of a mobile monitoring system according to claim 49, wherein the indicator comprises a display, and the data associated with the received sensor signal and/or the received back-end system signal is indicated to the user and/or movable organism via a user interface.

51. Use of a mobile monitoring system according to claim 50, wherein the mobile base unit is arranged for making the data associated with the received sensor signal and/or the received back-end system signal available to the user interface using an Application Programming Interface (API).

52. Use of a mobile monitoring system according claim 51, wherein the data associated with the received sensor signal is communicated to the user interface using Internet Protocol (IP).

53. Use of a mobile monitoring system according to any one of claims 34-52, comprising a, preferably non-volatile, memory for storing the data associated with the received sensor signal.

54. Use of a mobile monitoring system according to claim 42 and 53, wherein the mobile base unit is arranged to transmit historical data stored in the memory of the mobile base unit, e.g. data not previously transmitted, upon request by the back-tend system or when triggered by a special event.

55. Use of a mobile monitoring system according to claim 54, wherein the mobile base unit is arranged for interleaving the historical data between data records of real-time measurement data.

56. Use of a mobile monitoring system according to any one of claims 34-55, wherein the mobile base unit is arranged for transmitting status information of the mobile base unit.

57. Use of a mobile monitoring system according to any one of claims 1-56, preferably at least claims 43 and 56, wherein the data record comprises a system status channel comprising data indicating a status of the mobile base unit and/or at least one of the at least one mobile sensor systems.

58. Use of a mobile monitoring system according to claim 57, wherein the system status channel is awarded higher priority than channels comprising sensor data associated with sensor signals.

59. Use of a mobile monitoring system according any one of claims 34-58, wherein the back-end system is arranged for wirelessly transmitting a system management signal towards the mobile base unit comprising data for remote management of the mobile base unit.

60. Use of a mobile monitoring system according to claim 59 wherein the system management signal is transmitted using a further wireless communications link between the mobile base unit and the back-end system separate of the wireless communications link for transmitting the mobile base unit signal.

61. Use of a mobile monitoring system according to claim 60, wherein the further wireless communications link is awarded top priority over the wireless communications link for transmitting the mobile base unit signal.

62. Use of a mobile monitoring system according to any one of claims 1-61, preferably at least claim 42, wherein the mobile base unit is arranged to modify the content of the data record to be transmitted on the basis of a measured characteristic, such as bandwidth, delay or delay variation, of the wireless communications link.

63. Use of a mobile monitoring system according to any one of claims 1-62, preferably at least claim 43, wherein the mobile base unit is arranged to modify the content of the data record to be transmitted on the basis of the relative priority of the channels of the data record.

64. Use of a mobile monitoring system according to any one of claims 34-63, wherein the mobile base unit is arranged for determining a characteristic, such as bandwidth, of the wireless communications link on the basis of a filling degree of a transmission buffer of the mobile base unit.

65. Use of a mobile monitoring system according to any one of claims 1-64, preferably at least claim 43 and 62, wherein the mobile base unit is arranged to remove a channel from the data record to be transmitted if the measured characteristic of the wireless communications link fulfils a predetermined criterion, e.g. if the bandwidth is lower than a predetermined threshold bandwidth.

66. Use of a mobile monitoring system according to any one of claims 1-65, preferably at least claim 43 and 62, wherein the mobile base unit is arranged to increase an amount of filtering of data in a channel in the data record to be transmitted if the measured characteristic fulfils a predetermined criterion, e.g. if the bandwidth of the wireless communications link is lower than a predetermined threshold bandwidth.

67. Use of a mobile monitoring system according to any one of claims 1-66, preferably at least claim 42, wherein the mobile base unit is arranged to increase an amount of data compression and/or filtering of data in a channel in the data record to be transmitted if the bandwidth of the wireless communications link is lower than a predetermined threshold bandwidth.

68. Use of a mobile monitoring system according to any one of claims 34-67, wherein the back-end system is arranged to provide a surrogate object representing the mobile base unit, e.g. utilizing Jini technology.

69. Use of a mobile monitoring system according to any one of claims 34-68, wherein the at least one mobile sensor system is connected or connectable to the mobile base unit via a, preferably short-range, wireless communications connection, such as Bluetooth or ZigBee.

70. Use of a mobile monitoring system according to any one of claims 34-69, wherein the mobile base unit is connected or connectable to the back-end system via a wireless communications link, such as GSM, GPRS, UMTS, HSDPA, EDGE, WLAN and/or WiMax.

71. Use of a mobile monitoring system according to any one of claims 34-70, wherein the user unit comprises a transceiver sei'vice and computing means and at least one user terminal communicatively coupled to the back-end system.

72. Use of a mobile monitoring system according to any one of claims 34-71, wherein at least one of the mobile sensor systems comprises an event button and is arranged for transmitting a sensor signal associated with a status of the event button.

73. Use of a mobile monitoring system according to any one of claims 34-72, wherein the mobile base unit and the back-end system are arranged for real-time data communication via the wireless communications link.

74. A monitoring system (1) for testing an effect of a pharmaceutical substance in a subject comprising a mobile body area network (2) and a remote user network (4), wherein the mobile body area network comprises a sensor system (6) and a mobile base unit (12) and the remote user network comprises a back-end system (20), wherein the sensor system is suitable for determining a parameter value of a subject, the parameter value being associated with the effect of the pharmaceutical substance, and for transmitting a sensor signal to the mobile base unit, the sensor signal being associated with the parameter value, and the mobile base unit is suitable for receiving the sensor signal and for wirelessly transmitting a mobile base unit signal associated with the sensor signal to the back-end system, characterized in that the back-end system comprises a service controller, an on-line service centre and an interface to a digital vault, the service controller being arranged for automatically preparing an exact and secured copy of the at least one mobile base unit signal associated with the received sensor signal and transmitting said copy to the digital vault, and the on-line service centre being arranged for correlating the at least one sensor signal with at least one effect of said pharmaceutical substance.