JP2022046074A - Electronic patient reporting outcome patient diary acquisition method, clinical-test information acquisition method and electronic patient reporting outcome patient diary acquisition system - Google Patents

Abstract

To provide an electronic patient reporting outcome patient diary acquisition method capable of efficiently advancing a clinical test etc., while suppressing communication costs from increasing.SOLUTION: There is provided an electronic patient reporting outcome patient diary acquisition method including the processes of: communicating, by a medical institution server, examinee information related to an examinee expected to use a predetermined communication device mounted with a SIM having been invalidated to an EDC system and information related to use start registration of the SIM to a management server; receiving, by the management server, the information related to the use start registration and performing communication related to an application for validation of the SIM receiving, by a communication company system, the communication related to the application for validation and validating the SIM; communicating, by a communication device, patient report outcome etc., that the examinee inputs to the EDC system; and receiving and storing, by the EDC system, the patient report outcome etc., associatively with the examinee information.SELECTED DRAWING: Figure 1

Description

The present invention relates to an electronic patient report outcome / patient diary acquisition method for acquiring electronic patient report outcomes, medication records, etc., an information acquisition method in clinical trials, and an electronic patient report outcome / patient diary acquisition system.

In the development process of new drugs and new treatment methods, various clinical trials and clinical trials are conducted for the purpose of confirming the efficacy and safety of drugs and treatment methods. In recent years, with the background of the development of communication networks and the shift to advanced information equipment for medical devices, materials such as texts and images related to clinical trials and clinical trials tend to be managed as electronic data. In clinical trials and clinical trials, not only pharmaceutical companies, medical facilities, and medical research organizations, but also CROs (Contract Research Organizations) are involved in the conversion of clinical trials and clinical trials into electronic data. The materials have been managed (see Patent Document 1 etc.).

In recent years, the importance of PRO (Patient Reported Outcome) and patient diary including medication records has been attracting attention in the development process of new drugs and new treatment methods. In other words, not only on the development side of pharmaceutical companies, but also by introducing the perspective of patients who ultimately use drugs and pay for them into the development process of drugs, etc., the reliability of clinical trials is improved and the reliability of clinical trials is improved. It is expected to collect high quality information. In addition, by using the technology to acquire PRO electronically using a communication device such as a smartphone (ePRO (electronic patient report outcome)), even if the subject is not an inpatient but a home-based patient, the quality is high. It is expected to get a high PRO. Furthermore, data acquired from wearable devices and IoT devices is also attracting attention as a PRO.

When acquiring the PRO electronically using a communication device such as a smartphone, it is preferable to use a specific communication device prepared by the CRO or the like instead of the communication device owned by the individual patient. This is because differences in input and communication devices can affect the validation of the acquired PRO.

Japanese Unexamined Patent Publication No. 2016-126637

However, when preparing communication devices that acquire PRO electronically, it becomes necessary to prepare a large number of communication devices at medical provision facilities and medical research institutes (hereinafter collectively referred to as "medical institutions"). Therefore, there are problems of increased communication cost and waste of communication infrastructure. On the other hand, limiting the number of communication devices prepared in a medical institution causes problems such as a longer period required for clinical trials.

The present invention has been made to solve such a problem, and is capable of efficiently advancing clinical trials and the like while suppressing an increase in communication costs. Electronic patient report outcomes, patient diary acquisition method, etc. Regarding.

The method for obtaining an electronic patient report outcome / patient diary according to the present invention is as follows.
The process by which the medical institution server communicates to the EDC system subject information about a subject who will use a given communication device with a disabled SIM.
A process in which the medical institution server or the applicant server communicates information regarding the SIM usage start registration to the management server.
The process by which the EDC system receives and stores the subject information,
A process in which the management server receives information regarding the usage start registration and communicates with the communication company system regarding the SIM activation application.
The process by which the telecommunications company system receives the communication regarding the activation application and activates the SIM.
A process in which the communication device communicates at least one of the patient-reported outcomes and medication records entered or obtained from the subject to the EDC system after the carrier system has enabled the SIM.
The EDC system has a process of receiving at least one of the patient-reported outcome and the medication record and storing at least one of the patient-reported outcome and the medication record in association with the subject information.

In the electronic patient report outcome / patient diary acquisition method according to the present invention, the SIM is disabled when the communication device is stored in the medical institution, and the SIM is enabled at the timing when the subject starts the clinical trial to communicate. Allows communication between the device and the EDC system. Therefore, according to such a patient report outcome / patient diary acquisition method, it is possible to efficiently acquire patient report outcomes and the like and proceed with clinical trials while suppressing an increase in communication costs. In addition, medical institutions can prepare communication devices with sufficient margin in the number of units without worrying about communication costs, so that clinical trials can be carried out efficiently. Furthermore, according to such an electronic patient report outcome / patient diary acquisition method, an application for SIM activation is made via a management server, so that the state of the subject's communication device is determined by an organization that manages clinical trials such as CRO. Can be surely grasped.

Further, for example, in the electronic patient report outcome / patient diary acquisition method according to the present invention, the EDC system may also serve as the management server.

When the EDC system also serves as a management server, the EDC system can comprehensively control the SIM and store patient report outcomes and the like. If the EDC system and the management server are separated, for example, the CRO manages the EDC system, and an organization other than the CRO manages the activation / invalidation of the SIM of the communication device. Is easy to manage.

Further, for example, in the electronic patient report outcome / patient diary acquisition method according to the present invention, at least a part of the subject information, the patient report outcome, and the medication record stored by the EDC system is stored in the medical institution server. It may further have a process of communicating with it.

In such an electronic patient report outcome / patient diary acquisition method, for example, a medical institution can obtain patient report outcomes during a clinical trial without having the subject visit the hospital or contact the subject by telephone. Can be confirmed and the state of the subject can be known.

Further, for example, in the electronic patient report outcome / patient diary acquisition method according to the present invention, at least a part of the subject information, the patient report outcome, and the medication record stored by the EDC system is stored in a predetermined monitoring server. It may further have a process of communicating with it.

In such an electronic patient report outcome / patient diary acquisition method, a monitoring server such as a CRO communicates with the EDC system to check whether the patient report outcome is properly communicated from the communication device to the EDC system. The status of ongoing clinical trials can be easily checked by CROs and the like.

Further, for example, in the electronic patient report outcome / patient diary acquisition method according to the present invention, the telecommunications company system may further have a process of invalidating the SIM.

The SIM of the communication device is preferably disabled by the telecommunications company system at the end of the clinical trial. For example, the telecommunications company system may invalidate the SIM after a predetermined period of time has passed from the activation of the SIM, or may invalidate the SIM in response to the communication related to the SIM invalidation request from the management server. ..

Further, for example, in the information acquisition method in the clinical trial according to the present invention, the information acquisition method in the clinical trial using any of the above-mentioned electronic patient report outcomes / patient diary acquisition methods and the information acquisition method.
A process in which the medical institution server communicates the case data of the subject to the EDC system.
The EDC system further comprises a process of receiving the case data from the medical institution server and storing the case data in association with the subject information.

In the information acquisition method in the clinical trial according to the present invention, the EDC system receives the case data from the medical institution server and stores the case data in association with the subject information to form highly reliable clinical trial data. ..

In addition, the electronic patient report outcome / patient diary acquisition system according to the present invention is
An EDC system that receives and stores subject information about the subject and at least one of the patient report outcomes and medication records.
Equipped with a SIM that can switch between disabled and enabled states, the subject can enter at least one of the patient-reported outcome and the medication record or obtain at least one of the patient-reported outcome and the medication record from the subject. With a communication device that communicates at least one of the patient report outcome and the medication record to the EDC system after the SIM is activated.
With the telecommunications company system that receives the communication regarding the SIM activation application and activates the SIM.
A management server that receives information related to usage start registration and communicates with the telecommunications company system regarding the activation application.
It has a medical institution server that communicates subject information about the subject using the communication device to the EDC system and also communicates information about the usage start registration of the SIM to the management server.
Further, for example, the EDC system may also serve as the management server.
Further, for example, the medical institution server may also serve as the applicant server.

According to such an electronic patient report outcome / patient diary acquisition system, clinical trials and the like can be efficiently advanced while suppressing an increase in communication costs.

FIG. 1 is a conceptual diagram showing an electronic patient report outcome / patient diary acquisition method and an information acquisition method in a clinical trial according to an embodiment of the present invention. FIG. 2 is a conceptual diagram showing a hardware configuration of an electronic patient report outcome / patient diary acquisition system that realizes the electronic patient report outcome / patient diary acquisition method shown in FIG. FIG. 3 is a conceptual diagram showing an electronic patient report outcome / patient diary acquisition method and an information acquisition method in a clinical trial according to a modified example.

FIG. 1 is a conceptual diagram showing an electronic patient report outcome / patient diary acquisition method and an information acquisition method in a clinical trial according to an embodiment of the present invention. Further, FIG. 2 is a conceptual diagram showing the hardware configuration of the electronic patient report outcome / patient diary acquisition system 10 that realizes the electronic patient report outcome / patient diary acquisition method shown in FIG. 1. Hereinafter, the electronic patient report outcome / patient diary acquisition method and the electronic patient report outcome / patient diary acquisition system 10 according to the embodiment will be described with reference to FIGS. 1 and 2.

As shown in FIG. 1, the electronic patient report outcome / patient diary acquisition system 10 includes a medical institution server 20, a communication device 30, an EDC integrated system 40, a communication company system 70, a monitoring server 80, and the like. As shown in FIG. 2, the EDC integrated system 40 is a system having an EDC system 50 and a management server 60, which will be described later, but the configuration of the electronic patient report outcome / patient diary acquisition system 10 is not limited to this. As in the electronic patient report outcome / patient diary acquisition system 110 shown in FIG. 2, the EDC system 50 and the management server 60 may be independent servers, and the EDC system 50 may be the management server 60. May also serve as.

The medical institution server 20 shown in FIG. 1 is a server managed by a medical institution 92 such as a hospital. The medical institution server 20 is installed in a medical institution 92 or the like, and a doctor, a nurse, a CRC (Clinical Research Coordinator), or the like input data. As shown in FIG. 2, the medical institution server 20 includes a calculation unit 21, a communication unit 22, a storage unit 23, an input unit 24, a display unit 25, and the like.

The arithmetic unit 21 has a microprocessor and the like, and performs various arithmetic processes on the medical institution server 20. The communication unit 22 has a modem or the like, realizes a connection to a network environment such as the Internet, and realizes communication with another server, a system, or the like. The storage unit 23 has a hard disk, a flash memory, or the like, and stores various information input from the input unit 24, received by the communication unit 22, and calculated by the calculation unit 21.

The input unit 24 has a keyboard, a mouse, and the like, and together with the display unit 25 and the like, constitutes a user interface of the medical institution server 20. The display unit 25 has a display device such as a liquid crystal display, and is controlled by the calculation unit 21 to display image information, character information, and the like.

In the electronic patient report outcome / patient diary acquisition method shown in FIG. 1, the medical institution 92 sends and stores the communication device 30 lent to the subject from the CRO (Contract Research Organization) 93 or the like. While stored in the medical institution 92, the SIM 36 (see FIG. 2) of the communication device 30 is disabled, as will be described later.

When the subject 91 to be the subject of the clinical trial is determined, the medical institution 92 lends the stored communication device 30 to the subject 91 and inputs the patient reported outcome (PRO) 37 via the communication device 30. Ask to do. Further, in the medical institution 92, the subject information 26, which is the information of the subject 91, is input to the medical institution server 20 to perform the participant registration information, and the information 27 regarding the use start registration of the SIM 36 is input.

As shown in FIG. 1, the medical institution server 20 provides subject information 26 regarding the subject 91 who participates in the clinical trial and uses the communication device 30 to the EDC integrated system 40 (particularly the EDC system 50 (see FIG. 2)). To communicate. At the same time, the medical institution server 20 communicates the information 27 regarding the use start registration of the SIM 36 to the EDC integrated system 40 (particularly, the management server 60 (see FIG. 2)).

Further, after starting the clinical trial, the medical institution server 20 communicates the case data 28 of the subject 91 input by the doctor or the like to the EDC system 50. The information 27 regarding the registration to start using the SIM 36 is input to the applicant server managed by the subject 91 and the like instead of the medical institution server 20, and is communicated from the applicant server to the management server 60 (see FIG. 2). You may. Examples of the applicant server include a smartphone of an individual subject and a personal computer. Further, the communication device 30 may be the applicant server. In this case, since the SIM 36 of the communication device 30 is invalidated, the information 27 regarding the registration to start using the SIM 36 is communicated by another communication method such as wifi.

As shown in FIG. 2, the EDC integrated system 40 shown in FIG. 1 has an EDC system 50 and a management server 60. The EDC (Electronic Data Capture) system 50 electronically collects and stores clinical data using the Internet. As shown in FIG. 2, the EDC system 50 includes a calculation unit 51, a communication unit 52, a storage unit 53, and the like.

The specific configuration of the calculation unit 51, communication unit 52, and storage unit 53 of the EDC system 50 is not particularly limited, but is, for example, the same configuration as the calculation unit 21, communication unit 22, and storage unit 23 of the medical institution server 20. Can be.

As shown in FIG. 2, when the subject 91 is determined in the medical institution 92, the EDC system 50 receives and stores the subject information 26, which is the information of the subject 91, from the medical institution server 20 and inputs the subject 91 to the clinical trial. Complete participant registration. Further, the EDC system 50 receives the case data 28 of the subject 91 from the medical institution server 20 during the clinical trial, associates it with the subject information 26, and stores it in the storage unit 53. Further, the EDC system 50 receives the patient report outcome 37 and the medication record 38 from the communication device 30 after the SIM 36 is activated, associates them with the subject information 26, and stores them in the storage unit 53.

As shown in FIG. 1, during a clinical trial, the medical institution 92 or CRO93 can communicate with the EDC system 50 to monitor case data 28, patient report outcomes 37, and the like. That is, as shown in FIG. 2, the EDC system 50 communicates at least a part of the subject information 26, the patient report outcome 37, the medication record 38, and the case data 28 stored in the storage unit 53 with the medical institution server 20. can do. Further, as shown in FIG. 2, the EDC system 50 uses the monitoring server 80 managed by the CRO 93 to manage at least a part of the subject information 26, the patient report outcome 37, the medication record 38, and the case data 28 stored in the storage unit 53. Can communicate with.

The management server 60 in the EDC integrated system 40 shown in FIGS. 1 and 2 performs at least a part of a series of communications performed when the SIM 36 provided in the communication device 30 is enabled. As shown in FIG. 2, the management server 60 has a calculation unit 61, a communication unit 62, and a storage unit 63. The specific configuration of the calculation unit 61, the communication unit 62, and the storage unit 63 of the management server 60 is not particularly limited, but is, for example, the same configuration as the calculation unit 21, the communication unit 22, and the storage unit 23 of the medical institution server 20. Can be.

The management server 60 receives information 27 regarding the use start registration of the SIM 36 provided in the communication device 30 from the medical institution server 20. Further, the management server 60, which has received the information 27 regarding the usage start registration, performs the communication 64 regarding the activation application of the SIM 36 to the communication company system 70. When the management server 60 receives the information 27 regarding the registration to start using the SIM 36 from the medical institution server 20 by using the API (Application Programming Interface) provided by the communication company 94 or the like, the management server 60 automatically or simply performs an input operation. This makes it possible to perform communication 64 regarding the application for activation of SIM 36 to the communication company system 70.

The management server 60 can store in the storage unit 63 the information 27 regarding the usage start registration received and the information of the SIM 36 related to the communication 64 regarding the transmitted activation application, if necessary. Thereby, the management server 60 can manage the valid and invalid SIMs 36 prepared for the clinical trial. Although the EDC system 50 and the management server 60 are described as a system and a server having a separate arithmetic unit or the like in FIG. 2, the EDC system 50 and the management server 60 are realized by the same arithmetic unit or the like. For example, the EDC system 50 and the management server 60 may be integrated.

The communication company 94 shown in FIG. 1 sells or provides the communication device 30, the SIM 36 used in the communication device 30, and the communication device 30 uses the SIM 36 (for example, using a telephone communication network) to the Internet or the like. Provide a connection environment to connect.

As shown in FIG. 2, the communication company system 70 managed by the communication company 94 has a calculation unit 71, a communication unit 72, a storage unit 73, and the like. The specific configuration of the calculation unit 71, the communication unit 72, and the storage unit 73 of the communication company system 70 is not particularly limited, but is the same as, for example, the calculation unit 21, the communication unit 22, and the storage unit 23 of the medical institution server 20. It can be configured.

As shown in FIGS. 1 and 2, the communication company system 70 receives communication 64 relating to an activation application of SIM 36 provided in the communication device 30 from the management server 60 of the EDC integrated system 40. The telecommunications company system 70 activates the SIM 36 corresponding to the activation application received, which enables the communication device 30 to connect to the Internet or the like using the SIM 36.

Further, the telecommunications company system 70 can invalidate the SIM 36 in the enabled state. The communication company system 70 invalidates the SIM 36, for example, when a communication regarding an invalidation application for the SIM 36 is received from the management server 60, or when the activation period specified at the time of the activation application has elapsed. By disabling the SIM 36, the communication device 30 cannot connect to the Internet or the like using the SIM 36.

The communication company 94 shown in FIG. 1 charges the CRO 93 who purchased the communication device 30 only while the SIM 36 is enabled, and charges the communication fee for the communication device 30 during the period when the SIM 36 is disabled. It is possible not to charge the communication fee for the communication device 30 to the CRO93. Further, the telecommunications company 94 does not necessarily have to perform provisioning corresponding to the number of issued SIM36s, and may provision a number smaller than the number of issued SIM36s and appropriately allocate them at the time of activation. This allows the carrier 94 to reduce the infrastructure and costs required for provisioning.

The communication device 30 shown in FIG. 1 is purchased by, for example, a communication company 94 by CRO93 and sent to the medical institution 92, and is stored in the medical institution 92 before the subject 91 is lent. The communication device 30 is lent to the subject 91 of the clinical trial by the medical institution 92 at the start of the test of the subject 91. The communication device 30 is equipped with a SIM 36 that can switch between an invalid state and a valid state, and the subject 91 can input the patient report outcome 37 and the medication record 38, or the subject 91 can input the patient report outcome 37 and the medication record 38. The communication device 30 is not particularly limited as long as it can acquire the above. As the communication device 30, for example, a smartphone in which the subject 91 inputs a patient report outcome 37, a wearable device capable of acquiring the state of the subject 91 such as vital signs, a medication record 38 of the subject 91, an action record, and the like can be acquired. Examples include IoT devices, wearable devices, or sets of IoT devices and smartphones. The medication record 38 and the like communicated from the communication device 30 are included in the patient diary.

As shown in FIG. 2, the communication device 30 includes a calculation unit 31, a communication unit 32, a storage unit 33, an input unit 34, a display unit 35, a SIM 36, and the like. The specific configuration of the calculation unit 31, communication unit 32, and storage unit 33 of the communication device 30 is not particularly limited, but is, for example, the same configuration as the calculation unit 21, communication unit 22, and storage unit 23 of the medical institution server 20. Can be. The input unit 34 and the display unit 35 of the communication device 30 are composed of an input / display device that can be operated by directly touching a screen such as a touch panel, but the present invention is not limited to this.

The SIM 36 is typically a SIM card provided in a smartphone or the like, but is stored in a so-called eSIM (a module that may be incorporated in a device), a so-called softSIM or a virtual SIM (a module of a device such as a communication module). A software SIM that may optionally include a software SIM) that may be downloaded wirelessly, or a so-called secure element. The SIM 36 can include a SIM other than a SIM card, and may include, for example, a SIM embodied in a UICC (universal integrated circuit card), eUICC, iUICC, or the like.

The SIM 36 can switch between an invalid state and a valid state from the communication company system 70. In particular, it is preferable that the SIM 36 can be switched from the invalid state to the valid state by the communication company system 70 without operating the communication device 30 incorporating the SIM 36.

The communication device 30 is a patient report outcome 37 and medication input or obtained from the subject 91 via a telephone communication network, the Internet, or the like after the SIM 36 built in by the communication company system 70 is activated. Communicate at least one of the records 38 to the EDC system 50. Patient-reported outcomes 37 include, but are not limited to, subjective indicators of subject 91, such as information on treatment satisfaction, degree of subjective symptoms and physical function, health-related quality of life, and degree of adherence to treatment. Further, the communication device 30 may communicate information other than the patient report outcome 37, for example, the medication record 38, to the EDC system 50.

CRO93 (Contract Research Organization) shown in FIG. 1 is an external organization that outsources or supports clinical trial-related work at the request of pharmaceutical companies 96 and the like. The monitoring server 80 shown in FIGS. 1 and 2 is under the control of CRO93 and can monitor the EDC integrated system 40.

As shown in FIG. 2, the monitoring server 80 includes a calculation unit 81, a communication unit 82, a storage unit 83, an input unit 84, a display unit 85, and the like. The specific configuration of the calculation unit 81, the communication unit 82, the storage unit 83, the input unit 84, and the display unit 85 of the monitoring server 80 is not particularly limited, but for example, the calculation unit 21 and the communication unit 22 of the medical institution server 20. , The storage unit 23, the input unit 24, and the display unit 25 can be configured in the same manner.

As shown in FIGS. 1 and 2, the monitoring server 80 can communicate with the EDC system 50 of the EDC integrated system 40 to monitor the case data 28 and the patient report outcome 37. Further, the monitoring server 80 can communicate with the management server 60 of the EDC integrated system 40 and confirm the activation application status of the SIM 36. As a result, the CRO 93 confirms that the required number of communication devices 30 are secured in the hospital, and the information 27 regarding the registration for starting use from the medical institution server 20 and the communication 64 regarding the activation application by the monitoring server 80 are sent. You can check that it is done properly.

A part of the medical institution server 20, the EDC system 50, the management server 60, the communication company system 70, and the monitoring server 80 described above may be realized by a predetermined physical server, such as cloud computing. It may be realized by a virtual server by. Further, for communication via the Internet between the EDC integrated system 40 and the medical institution server 20, the communication device 30, the monitoring server 80, etc., a highly confidential communication method using a VPN (Virtual Private Network) or the like is adopted. It is also preferable.

Hereinafter, an example of an information acquisition method in a clinical trial using the electronic patient report outcome / patient diary acquisition system 10 shown in FIGS. 1 and 2 will be described.

As shown in FIG. 1, CRO93, which has been entrusted with clinical trials from the client pharmaceutical company 96, first purchases the required number of SIM36s (communication device main body as necessary) from the telecommunications company 94 as a preparatory stage for clinical trials. (Or rent) (Fig. 1 [A]) and send it to the medical institution 92 that will be the medical institution where the clinical trial is conducted (Fig. 1 [B]). At this stage, the SIM 36 (see FIG. 6) built in the communication device 30 is in an invalid state. In addition, CRO93 prepares the EDC integrated system 40 and the like. The communication device main body, which is a part of the communication device 30 other than the SIM 36, may be procured from the communication company 94 in the same manner as the SIM 36, but may be procured by a route separate from the SIM 36.

Next, the medical institution 92 determines the subject 91 to participate in the clinical trial, and lends the communication device 30 to the subject 91 (FIG. 1 [C]). At this time, the medical institution 92 requests the subject 91 to input the PRO using the communication device 30. For example, a dedicated application for PRO input is installed in the communication device 30, and the responsible doctor or CRC explains to the subject 91 the PRO input method or the like.

When the medical institution 92 determines the subject 91, the medical institution 92 inputs the subject information 26 to the medical institution server 20 to register the participant information, and also inputs the information 27 regarding the registration to start using the SIM 36. The medical institution server 20 communicates the subject information 26 regarding the subject 91 who is planning to use the communication device 30 equipped with the disabled SIM 36 to the EDC system 50 (FIGS. 1 and 2 [D]). Further, the medical institution server 20 communicates the information 27 regarding the invalidation start use registration of the SIM 36 to the management server 60 (FIGS. 1 and 2 [E]).

Next, the EDC system 50 of the EDC integrated system 40 receives and stores the subject information 26, secures an area for storing the case data 28 of the subject 91 and the patient report outcome 37, and completes the participant information registration. .. Further, the management server 60 of the EDC integrated system 40 receives the information 27 regarding the usage start registration, and performs the communication 64 regarding the activation application of the SIM 36 mounted on the communication device 30 to the communication company system 70 (FIG. 1). And FIG. 2 [F]).

Next, the telecommunications company system 70 receives the communication 64 related to the activation application from the management server 60, and activates the SIM 36 provided in the communication device 30 of the subject 91 (FIGS. 1 and 2 [G]).

The communication device 30 then communicates the patient report outcome 37 or medication record 38 entered by or obtained from the subject 91 to the EDC system 50 using the activated SIM 36 (FIGS. 1 and 2). [H]). The subject 91 inputs the patient report outcome 37 and the medication record 38 to the communication device 30 according to the explanation in the medical institution 92.

The EDC integrated system 40 receives the patient report outcome 37 and the medication record 38 from the communication device 30, and stores the patient report outcome 37 and the medication record 38 in association with the subject information 26. During the clinical trial, the medical institution 92 stores the case data 28 of the subject 91 in the EDC system 50 through the communication between the medical institution server 20 and the EDC system 50, and the patient report outcome 37 and the medication record of the subject 91. The contents of 38 can be confirmed ([I] in FIGS. 1 and 2).

In addition, CRO93 can confirm the contents of the case data 28 of the subject 91, the patient report outcome 37 of the subject 91, and the medication record 38 via the communication between the monitoring server 80 and the EDC system 50 during the clinical trial. Yes ([J] in FIGS. 1 and 2). The data monitored by the medical institution 92 shown in FIG. 1 is only the patients of the medical institution 92 among the subjects participating in the clinical trial, but the CRO93 monitors the data of all the subjects participating in the clinical trial. Can be done.

Finally, CRO93 summarizes the contents of the case data 28 and the patient report outcome 37 in the clinical trial, and delivers the data of the clinical trial result in which the subject 91 and the like are anonymized to the pharmaceutical company 96 ([K] in FIG. 1). ..

According to the information acquisition method including the patient report outcome 37 in such a clinical trial, the SIM 36 is disabled when the communication device 30 is stored in the medical institution 92, and the subject 91 starts the clinical trial at the timing. SIM36 can be activated. Therefore, according to such a patient report outcome / patient diary acquisition method, it is possible to efficiently acquire the patient report outcome 37 from the subject 91 or the like at home while suppressing the increase in communication cost. Such an information acquisition method including the patient-reported outcome 37 can improve the efficiency of drug development by enabling the efficient and high-quality acquisition of the patient-reported outcome 37.

In addition, according to the electronic patient report outcome / patient diary acquisition system 10, it is possible to avoid the problem of storing a large number of communication devices having an activated SIM in the medical institution 92, thus wasting the infrastructure related to the telephone communication network. Can be avoided. Further, since the CRO 93 can store the communication device 30 in the medical institution 92 with a sufficient margin in the number of units without worrying about the communication cost, the clinical trial can be efficiently advanced. Further, according to the electronic patient report outcome / patient diary acquisition system 10, the communication cost required for clinical trials can be suppressed, so that the pharmaceutical company 96 can suppress the development cost of the drug. Furthermore, according to such an electronic patient report outcome / patient diary acquisition method, an application for activation of SIM36 is made via the management server 60, so that the CRO93 can check the status of all communication devices 30 used in clinical trials. It can be surely grasped.

The above-mentioned information acquisition method including the patient report outcome 37 is not only suitably used in clinical trials conducted to obtain approval for new drugs, but also in clinical trials other than clinical trials such as confirmation of the efficacy of approved drugs. It can be suitably used. Further, it goes without saying that the electronic patient report outcome / patient diary acquisition system 10 described above is only one embodiment of the present invention, and many other embodiments and modifications are included in the technical scope of the present invention. stomach. In the example shown in FIG. 1, CRO93 led the collection of case data 28 and patient-reported outcomes 37, whereas pharmaceutical company 96 may also lead the collection of case data 28 and patient-reported outcomes 37. It is possible.

Further, FIG. 3 is a conceptual diagram illustrating an electronic patient report outcome / patient diary acquisition system 110 according to a modified example. As shown in FIG. 3, the EDC system 50 and the management server 60 may be configured as independent servers that do not cooperate with each other or communicate with each other. In the electronic patient report outcome / patient diary acquisition system 110 shown in FIG. 3, the CRO193 that monitors the data of the EDC system 50 does not procure the communication device 30, but a support organization 97 different from the CRO193 shows in FIG. The communication device 30 will be procured on behalf of the CRO93. The support organization 97 can monitor the management server 60, but does not access the EDC system 50.

In the electronic patient report outcome / patient diary acquisition system 110 shown in FIG. 3, the support organization 97 that procures the communication device 30 is a separate organization from the CRO 93, and the support organization 97 acquires the patient report outcome. It can be suitably adopted when only the preparation of 30 is performed. The electronic patient report outcome / patient diary acquisition system 110 is different from the electronic patient report outcome / patient diary acquisition system 10 shown in FIG. 1, except that the EDC system 50 and the management server 60 are separated so as not to cooperate with each other. The same is true, and the common part has the same effect as the electronic patient report outcome / patient diary acquisition system 10.

Further, as a modification of the electronic patient report outcome / patient diary acquisition systems 10 and 110 shown in FIGS. 1 and 3, the management server 60 may be stored under the CRO 93 or the support company 97. In this case, the information 27 regarding the registration to start using the SIM 36 is received by the management server 60 under the CRO 93 or the support company 97, and the communication 64 regarding the application for activation of the SIM 36 is received from the management server 60 to the communication company system 70. Is done. Further, the information 27 regarding the use start registration of the SIM 36 communicated from the applicant server may be transmitted to the communication company system 30 in addition to the management server 60. Further, the applicant server may directly apply to the communication company system 30 for activation of the SIM 36, in which case the applicant server also serves as the management server 60.

10 ... Electronic patient report outcome / patient diary acquisition system 20 ... Medical institution server 26 ... Subject information 27 ... Information on registration to start use 28 ... Case data 30 ... Communication device 36 ... SIM
37 ... Patient report outcome 38 ... Medication record 40 ... EDC integrated system 50 ... EDC system 60 ... Management server 64 ... Communication related to activation application 70 ... Communication company system 80 ... Monitoring server 21, 31, 51, 61, 71, 81 ... Calculation unit 22, 32, 52, 62, 72, 82 ... Communication unit 23, 33, 53, 63, 73, 83 ... Storage unit 24, 34, 84 ... Input unit 25, 35, 85 ... Display unit 91 ... Subject 92 … Medical institutions 93, 193… CRO
94 ... Telecommunications company 96 ... Pharmaceutical company 97 ... Support agency

Claims (9)

The process by which the medical institution server communicates to the EDC system subject information about a subject who will use a given communication device with a disabled SIM.
A process in which the medical institution server or the applicant server communicates information regarding the SIM usage start registration to the management server.
The process by which the EDC system receives and stores the subject information,
A process in which the management server receives information regarding the usage start registration and communicates with the communication company system regarding the SIM activation application.
The process by which the telecommunications company system receives the communication regarding the activation application and activates the SIM.
A process in which the communication device communicates at least one of the patient-reported outcomes and medication records entered or obtained from the subject to the EDC system after the carrier system has enabled the SIM.
An electronic patient-reported outcome having a process in which the EDC system receives at least one of the patient-reported outcome and the medication record and stores at least one of the patient-reported outcome and the medication record in association with the subject information.・ How to get a patient diary. The electronic patient report outcome / patient diary acquisition method according to claim 1, wherein the EDC system also serves as the management server. The electronic according to claim 1 or 2, wherein the EDC system further comprises a process of communicating at least a portion of the subject information, the patient report outcome and the medication record to be stored with the medical institution server. How to obtain patient report outcomes and patient diary. 1. How to obtain the electronic patient report outcomes and patient diary described. The electronic patient report outcome / patient diary acquisition method according to any one of claims 1 to 4, wherein the telecommunications company system further includes a process of invalidating the SIM. An information acquisition method in a clinical trial using the electronic patient report outcome / patient diary acquisition method according to any one of claims 1 to 5.
A process in which the medical institution server communicates the case data of the subject to the EDC system.
An information acquisition method in a clinical trial, further comprising a process in which the EDC system receives the case data from the medical institution server and stores the case data in association with the subject information. An EDC system that receives and stores subject information about the subject and at least one of the patient report outcomes and medication records.
Equipped with a SIM that can switch between disabled and enabled states, the subject can input at least one of the patient-reported outcome and the medication record, or obtain at least one of the patient-reported outcome and the medication record from the subject. A communication device that communicates at least one of the patient report outcome and the medication record to the EDC system after the SIM is activated.
With the telecommunications company system that receives the communication regarding the SIM activation application and activates the SIM.
A management server that receives information related to usage start registration and communicates with the telecommunications company system regarding the activation application.
A medical institution server that communicates subject information about the subject using the communication device to the EDC system, and
The applicant server that communicates the information related to the usage start registration of the SIM to the management server, and
Electronic patient reporting outcomes and patient diary acquisition system with. The electronic patient report outcome / patient diary acquisition system according to claim 7, wherein the EDC system also serves as the management server. The electronic patient report outcome / patient diary acquisition system according to claim 7 or 8, wherein the medical institution server also serves as the applicant server.

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