MXPA06001756A - System and method for facilitating centralized candidate selection and monitoring subject participation in clinical trial studies - Google Patents

Abstract

A system and method of facilitating centralized and standardized remote ratings of subjects in clinical trial studies includes providing training to raters located at one or more central rating sites such that the raters are trained to apply substantially similar criteria in determining whether a candidate is a qualified subject for the clinical trial and/or in the actual assessment, or information collection, phase of the clinical trail. By having centralized, consistently trained raters that are independent of clinical trial investigators, inter-rater reliability is enhanced and potential bias is reduced, thus increasing the effectiveness of the clinical trial results by providing more qualified subjects and more accurate results.

Description

SYSTEM AND METHOD TO FACILITATE THE CENTRALIZED SELECTION OF CANDIDATES AND MONITOR THE PARTICIPATION OF SUBJECTS IN CLINICAL ANALYSIS STUDIES Related Request This application claims the priority of the Patent Application of E. U. No. 10 / 640,692, filed on August 14, 2003, which is incorporated herein by reference.

BACKGROUND OF THE INVENTION The present invention relates to medical research business systems and methods; and more particularly, to systems and methods to facilitate centralized and standardized determinations of subjects participating in clinical trials, particularly across large geographies. The trials or clinical studies quickly executed, of high quality, are of great importance for the pharmaceutical industry. Every year, pharmaceutical and biotechnology companies spend billions of dollars on clinical research and development to develop new pharmaceutical compounds. Clinical trials are a vital, expensive and time-consuming part of the research and development process. It has been estimated that, for a given new drug, millions of dollars are lost for each day of delay in bringing the drug to market. These delays also prolong the time before new drugs or treatments are available for patients who need them. Since the term of clinical trials is almost always required before driving a new drug to the market, the delays in the execution and termination of such studies have a dramatic negative effect on the punctual availability of the drugs, as well as on the capacity of earnings. In addition, the delays in the studies lead to significantly higher costs, associated with the study itself. In this way, the pharmaceutical and biotechnology industry has powerful economic incentives to conduct trials as quickly and efficiently as possible. The acceleration of clinical trials often results in the scarce selection of target population, the inclusion of patients who are diagnosed or classified inaccurately, who have had problems with responses or secondary effects of previous treatment, and who are not representatives of the general population of patients with the disorder. Typical multi-run studies for which trials quickly feel precedent for broad-based market penetration are not informative with respect to optimal use because most research sites have relatively small sample sizes of patients. This also increases the likelihood of significant monitoring difficulties, allowing greater variations of income through the cities. In this way, the attempt to increase the power is nullified because the sample sizes can not be enlarged in studies that take place within a short period. (Kane, John MD, "Improving Clinical Trials," Arch Gen Psychiatry, Vol. 59 (Mar. 2002), p 273. Despite advances in many aspects of the design and execution of clinical trial studies, rapidly obtaining participation, enrollment through the completion of sufficient numbers of subjects suitable for studies has remained the most important barrier to the rapid completion of economic, high-quality clinical trials, typically subjects are obtained through advertising campaigns or presentation or assistance to sites actively involved in research recruitment Subjects do not always receive a payment, then candidates are typically selected by observation, interviewed or otherwise evaluated to separate inadequately qualified candidates from the selection and to obtain appropriate subjects for the study.The subjects then typically participate in the study Ediante travel newspaper to clinical research sites for proper consultation, treatment, examination, assessment monitoring, data collection and the like, as required for the particular study. Typically, interested parties, such as pharmaceutical companies, contact organizations, such as contract research organizations, or CROs, in order to coordinate and manage the execution of studies. In controlled clinical trials, the establishment of adequate reliability between different classifiers or "reliability between classifiers" is a major concern. The classifiers may be responsible for the recruitment of qualified subjects, as well as for providing the raw data with which the clinical trial is related. With respect to the recruitment of subjects for a clinical trial, there is considerable difficulty in quickly verifying suitable patients since many, if not most, patients receive routine care at sites (ie, a doctor's office). doctor) not involved in clinical research. Those medical sites involved in such trials are often motivated primarily by the potential benefit and, consequently, are often "stretched" to introduce a sufficient number of patients in order to generate adequate income in order to cover and exceed their fixed costs. . As a result of being paid based on enrolled patient, there is a natural inclination to make mistakes in the sense of choice. In addition, the minimum threshold required by the FDA for a drug to be superior to placebo, a lack of treatment or a specific comparative agent is more easily achieved if a larger sample size is used during the clinical trial, thus promoting number recruitment greater than subjects. Because of this tendency to over-enrollment (ie the inclusion of patients who are not technically eligible if more accurate assessments and classifications were made), it has been observed in some clinical trials, for example, that baseline scores of choice capacity for selected subjects have to be grouped at or slightly above the threshold entry criterion. This grouping can lead to an attenuating effect due to the regression towards the means with respect to enrollment of those patients with borderline scores. However, lack of rigor in baseline assessments may impede the ability to detect the efficacy of an investigational agent (ie, a novel chemical entity). In addition, poor inter-classifier reliability increases measurement error, which in turn increases the chance of Type II error, that is, failure to detect the true differences between an active drug and a placebo when such a difference exists. . For example, the error or variability in the measurement of symptom severity is a major contributor to uninterrupted results in randomized multi-site clinical trials. Additionally, poor reliability decreases the statistical power of the clinical trial, resulting in the need for larger sample sizes to detect significant differences between the active drug and a placebo or between any active treatment or between treatments and control conditions of any kind. For example, a study that has a reliability rating that falls from 1.0 to .80 falls in power from .80 to .71 and requires 25% more subjects to detect a significant difference (Muller &; Szegidi, 2002). Given the time and financial resources involved in clinical trials (eg, drug development), the reduction of this source of error variance is of the greatest importance. Establishing reliability between classifiers in multi-center clinical trials has been difficult for several reasons. For example, most clinical trials of antidepressants use as their basic outcome measure the classification scales of symptoms administered by the physician that have classifications that are based on clinical judgment. However, scales such as the Hamilton Depression Rating Scale (HAMD; Hamilton, 1960; 1996) provide only general guidelines for the administration and qualification of specific topics. No standardized questions or explicit scoring algorithms are provided. As a result, the classifiers vary widely in the way they manage the scale and rating of the issues due to the subjective interpretation of the patient's statements, appearance or behavior. Most of the trials funded by the industry do not adequately establish or assess the reliability between classifiers within and across sites. Normally, a few videotaped interviews are selected at a classificatory board (and often many of the final classifiers on the site are not even presented). No attempt is made to conduct the statistical analysis form of reliability among classifiers on an ongoing basis. Even when a reliability between classifiers is established, there is a shift in such reliability, since there may be a high turn in the classifiers and often the classifiers are poorly supervised. Anything that can be done to reduce the number of different classifiers involved in a clinical trial, improve their supervision, ensure their diligence in accurate assessment of all relevant issues and elimination of any potential incentive to bypass the classifications (for example, in favor of the ability to choose) will improve the quality and validity of clinical trials. It is important to say that, when interested parties have asked researchers to submit audio tapes or videotapes of their ratings for review, despite the fact that they would be submitted "voluntarily", the results have often been disappointing. Researchers often do not train the classifiers to ask all the right questions or clarify the answers in order to conduct an adequate interview and complete the rating scale in a thorough, correct manner. For the most part, the training of the classifier at the start meetings has proven to be insufficient to obtain the appropriate results. For example, in a training effort in reliability between classifiers for a multi-site clinical trial, the difference in scores, maximum and minimum, of total HAMD (full scale range 0-52) (N = 86 classifiers; ), the evaluation of the same subjects in video-recorded presentations varied from a diffusion of 14 points in the best of cases to a diffusion of 21 points in the worst case (Demitrack er al., 1997). The authors of the study concluded that the error in the measurement is large and that "there was no evidence of improved evaluation performance through the 6 hours of reliability training" (p.20). Methods and systems for improving the accuracy of clinical trial studies have been proposed, for example, co-pending US Patent Application No. 1 0 / 076,738, entitled "System and Method for Facilitating Participation of Candidates and Subjects in Clinical Trial Studies ", presented on February 14, 2002, which is expressly incorporated herein by reference. However, none alleviates the fundamental problem of ensuring reliability between classifiers and consistency in clinical trial studies. In this way, the problems described above persist in the existing clinical trial studies.

BRIEF DESCRIPTION OF THE INVENTION A feature and advantage of the present invention is to conduct classifications in clinical trials using a small template of centralized classifiers, well monitored and highly trained. Another feature and advantage of the present invention is to allow the classifiers to obtain the centralized consent of test subjects, thus ensuring that a full and complete consent process is consistently implemented. Another feature and advantage of the present invention is to provide consistency in the training of classifiers, thus allowing a much stronger signal detection in, for example, differences in the performance of a drug against a placebo. Another feature and advantage of the present invention is to provide centralized classifier operations, thus disassociating the classifiers from the researchers and reducing the economic incentives for the classifiers to include subjects with choice ability in the limit in a particular clinical trial, only for meet a certain recruitment objective established by the researchers. Another feature and advantage of the present invention is to conduct classifications in clinical trials in one or more centers using remote communication methods, for example, the Internet, telemedicine and / or videoconference. Another feature and advantage of the present invention is to reduce the downtime of the classifiers and thus the hassle of conducting tests, by eliminating the need for classifiers to be available at local sites to conduct clinical trials. Another feature and advantage of the present invention is to create better opportunities to hide or "mask" evaluations of subjects in clinical trials. Another feature and advantage of the present invention is to improve the quality control of clinical trials by recording (with the appropriate consent) interviews for later review. These and other features and advantages of the present invention are achieved in a method to facilitate centralized and standardized classifications of subjects in clinical trial studies. The method includes training of classifiers in at least one central classifying site in order to employ substantially similar criteria for the recruitment of qualified subjects and / or collection of raw data from the qualified subjects, according to the clinical trial. The at least one central classifier site may be at least one of a physical location or a virtual location. The method also includes the interview of qualified subjects by the classifiers located in the at least one central classifier site. The interview can be carried out to recruit qualified subjects and / or collect raw data from the qualified subjects on an ongoing basis according to the needs of the specific trial. These and other features and advantages of the present invention are also achieved in a system to facilitate centralized and standardized classifications of subjects in clinical trial studies. The system includes at least one central classification site in order to use consistent criteria to recruit qualified subjects and / or collect raw data from the qualified subjects. The at least one central classifier site may be at least one of a physical location or a virtual location. The system also includes at least one satellite site in which the study candidates are available to be interviewed by the centralized classifiers in order to determine if the candidates are qualified subjects and / or to provide raw data to the classifiers. These and other features and advantages of the present invention are also achieved in a medium usable by the computer that stores program codes that, when executed in a computerized device, they cause the computerized device to execute a method to facilitate centralized and standardized classifications of subjects in clinical trial studies. The method includes the training of classifiers in at least one central classifier site to employ substantially similar criteria for the recruitment of qualified subjects and / or collect raw data from the subjects qualified according to the clinical trial. The at least one central classifier site may be at least one of a physical location or virtual locations. The method also includes the interview of the subject qualified by the classifiers located in the at least one central classifying site. The interview can be carried out to recruit qualified subjects and / or collect raw data from the qualified subjects.

The consistency in the training of the classifiers allows a much stronger signal detection in, for example, the differences in the performance of a drug against a placebo. Consistency in training reduces the variability in the valuation strategies employed by the classifiers and allows more consistent and accurate results. In addition, the centralization of operations and dissociation of researchers' classifiers reduces the economic incentives for classifiers to include subjects with the ability to choose within the limits of a particular clinical trial only to meet a certain recruitment objective established by researchers. By centralizing the classifiers and segregating them from the influence of the researchers, much more meaningful and accurate results can be obtained during the clinical trial. In this way, the most important features of the invention have been described in general, rather than broadly, so that the detailed description of the invention can be better understood below and so that the present contribution can be better appreciated. The matter. Of course, there are additional features of the invention that will be described later herein and that will form the subject matter of the appended claims thereto. In this regard, before explaining at least one exemplary embodiment of the invention in detail, it should be understood that the invention is not limited to its application of the details of construction and adaptations of the components set forth in the following description or illustrated in the drawings. . The invention is capable of other modalities and of being practiced and carried out in various ways. Also, it should be understood that the phraseology and terminology used herein are for the purpose of description and should not be considered as limiting. Therefore, those skilled in the art will appreciate that the conception on which this disclosure is based can be readily utilized for the design of other structures, methods and systems to carry out the various purposes of the present invention. Accordingly, it is important that the claims be considered including such equivalent constructions as long as they do not depart from the spirit and scope of the present invention. In addition, the purpose of the above summary is to allow the US Patent and Trademark Office and the general public, and especially scientists, engineers and practitioners in the field, who are not familiar with the patent or legal terms or phraseology , quickly determine, from a routine inspection, the nature and nature of the technical presentation of the application. The abstract is also not intended to define the invention of the application, which is measured by the claims, nor is it intended to be limiting to the scope of the invention in any way. This together with other advantages of the invention, together with the various features of novelty, which characterize the invention, are pointed out with particularity in the appended claims and which form part of this disclosure. For a better understanding of the invention, and the advantages obtained by its uses, reference should be made to the accompanying drawings and the descriptive matter in which exemplary embodiments of the invention are illustrated. Other advantages of the present invention will be apparent to those of ordinary experience, particularly in consideration of the following detailed description of the exemplary embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS The invention is illustrated in the figures of the accompanying drawings, which are understood to be exemplary and not limiting, in which similar references are proposed refer to similar or corresponding parts, and in which: FIGURE 1A is a block diagram of a centralized system, used in conducting a clinical trial study in accordance with one or more embodiments of the present invention; FIGURE 1B is a block diagram of another centralized system, used in conducting a clinical trial study in accordance with one or more embodiments of the present invention; FIGURE 2 is a block diagram of a distributed network computer system, which includes local computers central classifier, local satellite computers, local computers of the interested party, a database of clinical trials and auxiliary databases used in conducting a clinical trial study in accordance with an exemplary embodiment of the invention; FIGURE 3 is a simplified illustration of a A graphical user interface displayed on a local computer monitor, central classifier and an associated graphical user interface, displayed on an associated local satellite computer monitor, in accordance with an exemplary embodiment of the invention; FIGURE 4 is a simplified illustration of one of the graphic user interfaces, illustrated in FIGURE 3 and an associated set of technical equipment, in accordance with an exemplary embodiment of the invention; and FIGURE 5 is a flow chart illustrating a method for facilitating centralized candidate selection and monitoring the subject's participation in a clinical trial study, in accordance with an exemplary embodiment of the invention.

DETAILED DESCRIPTION OF THE PRESENT INVENTION In the following detailed description, numerous specific details are set forth with respect to the system and method of the present invention and to the environment in which the system and method may operate, etc. , in order to provide a thorough understanding of the present invention. However, it will be apparent to one skilled in the art that the present invention can be practiced without such specific details. In other cases, the components, structures and techniques very. known ones have not been shown in detail in order to avoid unnecessary obscuration of the subject matter of the present invention. In addition, various examples are provided to explain the operation of the present invention. It should be understood that these examples are exemplary. It is contemplated that there are other methods and systems that are within the scope of the present invention. In addition, the following detailed description refers to the accompanying drawings that are part of it and in which is shown, by way of illustration, a specific embodiment in which the invention can be practiced. It should be understood that other modalities may be used and structural changes may be made without departing from the scope of the present invention. Generally, the present invention provides systems and methods for facilitating centralized and standardized classifications of subjects in clinical trial studies. Clinical trial patients in medical practices across geographies are evaluated using remote classifiers by using, for example, video conferencing, telemedicine platforms and / or the Internet. The classifiers are highly trained in the use of subjective scales to reduce the variability of classifier to classifier. The use of long distance communication tools, such as video conferencing, allows a high flow of patients and increases the economic justification of centralizing large groups of classifiers. The phrase "interested party", as used herein, means any party or entity, such as, for example, an interested party of the contract research organization, which has an interest in a particular clinical trial study, such as having the responsibility to carry out the clinical trial study or having a need to complete the clinical trial study or the results of the clinical trial study. The phrase "clinical trial study", as used herein, is intended to broadly include many types of clinical or medical studies of subjects, generally in connection with obtaining data with respect to the response of the subject to treatment, such as, for example, taking medication. The term "medical professional", as used herein, generally attempts to include a broad range of individuals employed in fields related to medical or health care, including, for example, doctors and nurses. The term "patient" (of a medical professional), as used herein, is intended to include in general any individual who has received is receiving any treatment or notice related to health care or medical care by, through or in connection with the associated medical professional. The term "pre-existing patient", as used herein, means an individual who has been a patient of a medical professional prior to any recruitment or assistance in recruitment by the individual's medical professional for a particular clinical trial study. . The term "candidates" is intended to generally include individuals who are aware of a clinical trial study so that they may consider participating as a subject, may attempt to participate as a subject or may, in fact, participate as a subject in the study. The phrases "subject recruitment", "recruitment ... as subjects" and the like, as used herein, refer generally to the obtaining of candidates or subjects of study. For example, "subject recruitment" includes making the clinical trial study known to an individual who may be potentially suitable for participation in a clinical trial study, recommending that the individual consider participating or attempting to participate in the study, or recruit the individual as a subject in the study. The term "investigator", as used herein, refers to any individual or group with substantial responsibility in the performance of a clinical trial study, including, for example, the coordination or management of a clinical trial study, or analysis of the data from the clinical trial study, and including, for example, the medical professionals involved with the study. The term "classifier", as used herein, refers to any individual or group with substantial responsibility in the selection of subjects acceptable for a clinical trial, which elaborates the subjective and / or objective assessment of the condition of a subject that is under study by interviewing potential subjects of the clinical trial, classifying potential subjects and / or collecting raw data with respect to the product (s) tested by interviewing acceptable subjects on the course of the trial. A classifier can be a medical professional, for example, doctors, nurses, etc. , non-medical professionals, for example, social workers or non-professionals trained in classification procedures and methodology. The terms "classification" and "classifications", as used herein, refer, but are not limited to, one or more of verification, selection, recruitment, consent, evaluation and monitoring of the subject in clinical trials. FIGURE 1A is a block diagram of a system 1 00 used in conducting a clinical trial study in accordance with an exemplary embodiment of the invention. System 1 00 includes, for example: one or more researchers 102; one or more candidates 104; one or more interested parties 1 08; and at least one central classifier site 106. Stakeholders 108 can instruct researchers 102 to conduct a clinical trial for a new product, for example, a new drug. Alternatively, researchers 1 02 can start a clinical trial on their own. Subjects for the clinical trial are attracted from a candidate pool 104. Although a 1 02 investigator is shown, the researcher 102 may also include one or more primary investigators and one or more respective sub-investigators under the control and direction of the investigator. primary investigator for a particular clinical trial scenario. The individuals in the candidate pool 104 are, for example, patients in the doctor's office and / or clinics. Researchers request expert, independent classifiers on the site of central classifier 106 to select, for example, the appropriate candidates 1 04 based on certain selection criteria and to interview the selection 1 04 candidates in order to obtain the data in gross of the clinical trial. Researchers could also conduct interviews, inform patients about the nature of the investigation, for example, the risks and benefits, and participate in the process of obtaining informed, centralized consent. The implementation of informed, centralized consent of patients ensures that the consenting party, for example, the centralized classifier (s), executes a complete and complete consent process. Frequently, due to lack of time, physicians may not take patients through the full consent process and may skip sections of the consent form. Patients may feel some pressure to consent because their doctor may seem to want them to agree. Withdrawing the consent of the physician, who may be economically motivated to have the patient participate in the trial and placing the consent process in the hands of independent consenters (eg, classifiers) eliminates these problems. Classifiers could also interview and assess family members or other important ones regarding the patient's condition, time course, response to treatment, and level of functioning. Classifiers can also evaluate the care giver, relatives or other important ones about the effects of the patient's condition on their own mental state, subjective discomfort, quality of life or functioning. The classifier can also assess the patient regarding the adverse effects of the treatment received. Classifiers (in your centralized office) may be available to answer questions about the patient's illness, study or other relevant matters to facilitate the patient's ongoing participation in the trial. Candidates 1 04 can be placed in various locations, for example, a doctor's office, a hospital, a clinic, an office, school, work address, factory floor or any place in the community. The classifiers at the site of central classifier 106 can also be directly requested by interested parties 1 08. The site of central classifier 1 06 can be a single physical location. In addition, although a central sorter site 106 is illustrated, several such central sorter sites 106 may be used. Also, the central sorter site 106 may be virtual, such that the central classifiers are not located in any geographical location. specific.

The classifiers in the at least one place of central classifier 1 06 are subject to similar training and preparation, in such a way that the same criteria and standards are used in the selection and subsequent interview of the candidates 104. The classifiers in the ) place (s) of central classifier (s) 106 may be kept alternately blind to such factors as selection criteria, design of clinical trial study, number of visits, etc. , thus improving the sensitivity of the assay. The test sensitivity is the ability of a clinical trial to discern a clear benefit for the product in question, when there is a benefit. In addition, the centralization of classifiers instead of having classifiers associated with a particular researcher removes any incentive for classifiers to inflate baseline scores or recruit unqualified patients or exaggerate change scores, reduce side effect scores or introduce any subjective deviation due to economic incentives offered implicitly or explicitly by the researcher. FIGURE 1A illustrates an example of the centralized system 1 00. In this example, three different clinical trials are conducted: trial A; trial B; and trial C. Individual trials may be initiated by separate interested parties 1 08a, 1 08b and 1 08c. Interested parties 1 08a, 108b, 108c can then indicate a particular investigator 1 02a, 1 02b and 1 02c, respectively, in order to conduct the clinical trial. It is also possible that more than one researcher 1 02 may be contacted by a single interested party 108. Each trial A, B and C may have separate candidate deposits. For example, trial A may focus on candidate pool 1 04a, which is, for example, a target age group. Trial B may focus on candidate pool 104b, which is, for example, a target gender group. Trial C can also focus on the candidate pool 1 04c, which is, for example, an objective ethnic group. Of course, individual patients may fall into more than one deposit of candidates. For trial A, for example, researcher 102a, or alternatively, stakeholder 108a, uses classifiers at the site of central classifier 1 06 to select the deposit of candidates 1 04a in order to determine which individuals in deposit 1 04a are qualified to become subjects of trial A through appropriate selection and discrimination techniques. The classifiers at the central classifier site 106 are trained in such a way that the classifiers apply consistent selection and discrimination procedures for all potential subjects of the clinical trial. After selection of the appropriate subjects from the candidate pool 104a, the classifiers at the site of central classifier 1 06 conduct interviews with subjects through the use of a remote communication method 1 10a. For example, interviews can be conducted over the phone, can be done through the use of videoconferencing, can be done over the Internet, or any other appropriate means of communication that allows the classifier (s) to interact with the candidates and / or subjects. The raw data collected during the interview process is then passed to the researcher 1 02a (12a), who can then process and analyze the raw data or, in turn, forward the raw data to the interested party 108a for processing and analysis. Alternatively, the raw data can be directly advanced to the interested party 1 08a (1 16a) for processing and analysis. A similar scenario will take place for trial B and trial C. Again, more than one central classifier site 1 06 may be used for any trial, taking into account that there is consistency in the training of classifiers and criteria applied by the classifiers in the section of appropriate subjects from candidate deposits in all central classifier sites. FIGURE 1B illustrates another example of a centralized system for centralizing clinical trials. The centralized system 150 uses a core-and-rung system in which one or more "cores" of researchers 102 interact with one or more "steps" of satellite sites 1 52, respectively. Satellite sites 152 can be a doctor's office, a clinic, a subject's home, an office building, a school, a community center, etc. The coordination, management and administration of satellite locations 152 of the clinical trial study is carried out by researchers 1 02. The classifiers, who are involved in the recruitment, etc. of candidates operate on the site of central classifier 1 06, which acts as a virtual "super-core". Each group of researchers 102 and satellite sites 152 can be involved in the same or different clinical trial activities. However, only the classifiers associated with the central classifier site 1 06 conduct classification activities. Again, the site of central classifier 1 06 can be one or more physical locations or it can be a truly virtual site, in such a way that the classifiers are triggered geographically. However, the classifiers associated with the central classifier site 106 have similar training and experience in valuation and apply similar endpoints, as discussed previously. FIGURE 2 illustrates a block diagram of a distributed network computer system 200 used in conducting a centralized clinical trial, in accordance with an exemplary embodiment of the invention. The computer system 100 includes, for example: one or more local central sorter computers 224 located at the central sorter site 1 06; one or more local satellite computers 204, each set of satellite local computers 204 being located at different satellite sites 152; locating one or more local computers of the interested party 272 on the site of interested party 108; locating one or more local investigator computers 282 on the researcher site 102; a database of the clinical trial 205 and one or more auxiliary databases 206. The network 220, which connects the various computers 204, 224, 272, 282 and the databases 204, 206, is intended to be widely included, but without limited, any of the various types of computer networks or a network installation that may include one or more local area networks, one or more wide area networks, such as the Internet, an intranet, satellite, and media telephone In addition, network 220 can be a wireless network, and communication between computers can be through wireless connections, such as, for example, wireless Internet connections. In addition, the network 220 may include another transmission medium, for example, a T-1 line. Each of the local satellite computers 204, the local central sorter computer 224, the local computer of the interested party 272 and the local investigator computer 282 includes, for example, one or more central processing units (CPUs) 208 , 214, 274, 284 and one or more data storage devices 21 0, 216, 276, 286, comprising one or more examining programs 212, 218, 278, 288, respectively, in order to allow access to and communication through the network 220. For example, in the modalities in which the network 220 is the Internet, the examining programs 212, 218, 278, 288 can be an Internet Explorer from Microsoft or another from the Internet. The data storage devices 21 0, 216, 276, 286 may include various amounts of RAM for storing computer programs and other data. In addition, the local coder of central classifier 224, the local satellite computers 204, the local computer of the interested party 272 and the local computer of the investigator 282 may include other components typically found in the computers, including one or more devices of output, such as monitors, other fixed or removable data storage devices, such as hard disks, floppy disks and CD-ROM drives, and one or more input devices, such as mouse pointing devices, pens, cameras and keyboards. Further. Various other computers and computer-related components can be used, in part, to improve communication between the local 224 central classifier computer and local 204 satellite computers. In general, the local 224 central classifier computer, the local computers by satellite 204 and the local computer of the interested party 272 operate and execute computer programs under the control of an operating system, such as Windows, Macintosh, UNIC, etc. In addition, in general, the computer programs of the present invention are incorporated in a tangible manner in a computer readable medium, for example, one or more data storage devices attached to a computer. Under the control of an operating system, computer programs can be loaded from data storage devices into computer RAM for later execution by the CPU. Computer programs include instructions that, when read and executed by the computer, cause the computer to perform the steps necessary to execute elements of the present invention. Local satellite computers 204 include satellite computer equipment 252, and data storage devices 210 of local satellite computers include a satellite program 250. Satellite local computers 204 are programmed and equipped to allow the professional physician and the participation of subjects from satellite sites 152, and communication of the clinical test data obtained from the subjects to the local central sorter computer 224. An exemplary embodiment of the satellite computer equipment 252 and the satellite program 250 are described in detail with reference to FIGURE 4. The local 224 central classifier computer includes computer. core computer 256 and the data storage device 216 of the central sorter local computer 224 includes a core program 254. The core 256 computer equipment and the 254 core program include all the equipment and programming necessary to support central classifier site functions, including communication and interconnection with local satellite computers 204, as well as study coordination. The data collected from the clinical study is finally sent over the network to the local computer of the interested party 272, where they are analyzed according to the study. For example, in various embodiments of the invention, the data collected from the clinical trial study can be sent from the local satellite computers 204 simultaneously to both the local computer of central classifier 224 and also to the local computer of the interested party 272 , or the clinical trial data may be sent from the local satellite computer 204 to the local central sorter computer 224 and from the local central sorter computer 224 to the local computer of the interested party 272. In addition, in some embodiments of the In addition, data collected from the clinical trial study can be sent from local satellite computers 204 to an intermediate source, and sent from the intermediate source to the local computer of central classifier 224. In some modalities, clinical trial data will be they collect from subjects on satellite sites 152, they they enter into the local satellite computers 204 and communicate over the network 220 to the local central sorter computer 224 by using, for example, video, audio, manual input (i.e., with a keyboard, etc.). The clinical trial data can be stored non-volatile in the data storage devices 216, 210 of the local central sorter computer 224 or the local satellite computers 204, respectively, in the clinical trial database 205 or any combination of them. For example, the clinical trial data can be entered into the local satellite computer 204 and immediately communicate over the network 220 to the local central sorter computer 224 for non-volatile storage therein, or it can be communicated to the test database clinician 205 and access or manipulate remotely from the local computer of central classifier 224. Although only the clinical trial database 205 is illustrated, in other embodiments, the clinical trial databases are illustrated in one or more locations . The information from the clinical trial database 205 can be used and analyzed in various ways to complete the objectives of the study and, in some embodiments, for other purposes as well, as explained further below. The databases 204, 206, 258 may include, for example, any of the numerous types of databases, including, for example, an Oracle® relational database system, commercially available from Oracle® Corporation, a database of commercially available DB2 data, a Lotus® Domino ™ server computer database, a Sybase® database, available from Sybase® Corporation, Microsoft® Structured Query Language (SQL) servers and various Open DataBase databases Compliant (ODBC). Figure 3 is a simplified illustration of a graphical user interface 334 displayed on a local computer monitor of central classifier 308 at a central sorter site 1 06 and an associated graphical user interface 332 displayed on a local satellite computer monitor associated 306 on a satellite site 1 52, according to an exemplary embodiment of the invention. In some embodiments of the invention, real-time or near real-time video and / or audio, online chat or other communications technologies, such as videoconferencing, are used to improve communications between the central classifier sites 106 and satellite sites 152. In addition, in some embodiments of the invention, software as well as hardware or other equipment is used in the proportion of improved communications in relation to the clinical trial study between local computers of central classifier 224 and local computers Satellite 204. FIGURE 3 is intended to help illustrate a modality in which real-time or near real-time video is used in communications between the local central sorter computer 224 at a central sorter site 1 06 and a computer local satellite 204 in a satellite site 152, and in which software is used to further improve or simplify the user experience. FIGURE 3 includes a simplified click trigger 302 of the local satellite computer area and a simplified click trigger 304 of the local central classifier computer area. The double-ended arrow 326 is intended to indicate that the local central classifier computer 224 as well as the local satellite computer 204 connect both to the network 220, for example, the Internet, and communicate with each other using, for example , high-speed Internet access connections, such as cable or DSL connection modems. As illustrated in FIGURE 3, the graphical user interfaces 332, 334 are provided in a customary manner using software that can be programmed by a person skilled in the art based on the description provided herein, to suit the anticipated needs of a participant subject by use of the local satellite computer 204 at a satellite site 1 52 that communicates with, for example, a medical professional or a researcher by using the local computer of central classifier 224 at a central classifier site 1 06. Specifically, FIGURE 3 illustrates an example of a video or audio conference in real time or almost in real time between a subject using a local satellite computer 204 located at a satellite site 1 52 and a classifier using a local central sorter computer 224 located at a central sorter site 106. On the local computer monitor by satellite 306, a window 31 0 shows an image of the classifier engaged in the conference. The small window 314 shows an image of the subject sitting in front of the monitor 306. Similarly, in the local computer monitor of central classifier 308, a window 312 shows an image of the subject engaged in the conference. The small window 316 shows an image of the classifier sitting in front of the monitor 308. The speaker sets 322, 324 in each of the computers 204, 224 are used in the proportion of audio conferencing capacity in real time or almost in real time. Each of the graphic user interfaces 332, 334 may also include text areas 31 8, 320 with lines of text, which are shown in simplified form as straight lines. The text areas 318, 320, as illustrated, are used for online conversation between the subject and the classified, but may be used for other purposes in various modalities, such as displaying medical or health care information, or a passage of an online article or to mention questions or topics included in the assessment process. Graphical user interfaces 332, 334 also include multi-button toolbars 328, 330. Special software programs can be executed to facilitate the use of buttons in toolbars 328, 330 in order to assist in the conference, which may be a "domestic virtual call" in which the subject communicates from the satellite site computer 204 clinical trial data or other medical data to the classifier in the local classifier computer central 224, and the classifier interacts with the subject to ask questions regarding the suitability of the subject for the clinical trial and / or the substantive questions related to the clinical trial, itself. For example, the buttons can each be used to represent a particular medical monitoring instrument and pressing the button can cause a new window to open that displays detailed information about current or past readings of the instrument, or the new window can show the instrument itself showing the readings. In some embodiments, the screens of the monitors 306, 308 are touch sensitive, and a device similar to a pen, or pen, can be used to select buttons or interact in other ways with the graphic user interfaces 332, 334. In other modalities, a pointing device such as a "mouse" can be used, or simply a keyboard. In some modalities, users participate in virtual virtual calls even when they have a minimum of computer proficiency. Although one or more embodiments of the present invention may use computer videoconferencing, as described above, other methods of communication between the subject (s) and the classifier (s) are contemplated. For example, communication can be done through the use of conventional videoconferencing methods without the use of a computer or using conventional telephone means. In addition, the fact of conducting a conference through the use of a computer can be carried out without the use of a visual component and / or an audio component and can be text-only, for example, a live online conversation. Other methods of computer communication other than real-time communication, such as email, may also be used. FIGURE 4 is a simplified illustration of one of the computer monitor 308 illustrated in FIGURE 3 and an associated set 412 of technical equipment that can be used in or as part of some modalities of the local satellite computer 204 and in the implementation of the domestic virtual call as discussed in relation to FIGURE 3 above. The equipment and programming described in relation to FIGURE 4 represent an exemplary embodiment of the local satellite computer 204, including the local satellite computer equipment 252 and the local satellite computer program 250. As shown, the set 412 includes , for example: a local control computer 402; a 403 camera for use with a computer or "Network Camera"; a cable communication modem 404 or a router, or another such device that allows the local satellite computer 204 to connect to the network 220; and one or more electronic medical monitoring devices 406. The 403 camera is used in the proportion of videoconferencing functionality. The cable modem or router 404 provides high-speed Internet access, such as, for example, Internet access at a download speed of 1,00,000 bits per second or greater. The one or more electronic medical monitoring devices 406 may include, for example, a stethoscope, an impulse oximetry monitor, a thermometer, a weight scale, a blood pressure monitor, and other devices to provide clinical trial data and other medical or health care information of subjects or other participants. In the illustrated embodiment, the electronic medical monitoring devices are connected to the control station computer 402 and the information from it may be displayed or interacted with the use of graphic user interfaces 332, 334 (as shown in FIGURE 3). ). In some modalities, the set 412 of equipment is used in the acquisition of clinical trial data from subjects in satellite sites 152, in some cases, with the help of medical professionals and in the communication of data to (a) central classifier site (s) 106. The set of equipment may also include other electronic devices, such as personal digital assistants (PDAs) that can be connected to and operate in cooperation with a computer and which can assist a medical professional participating in a study or a subject in activities to carry out the connection with the study. The control station computer 402 includes, for example, a CPU 414 and a data storage device 416. The control station computer 402 is used in some embodiments of the invention in which the local central sorter computer 224 or the satellite local computer 204, together with other diverse equipment to be used with the computers, are specially provided for the clinical trial study. In some embodiments, the control station computer 402 and the associated peripheral equipment may be one of the local central sorter computers 224 or one of the local satellite site computers 204 or, in other embodiments, may be part of the same. . In one or more embodiments of the present invention, the data storage device 416 includes, for example, a virtual home call program 417. The virtual home call program 417 is intended to broadly represent all the programming necessary to carry out adequate computer functions when carrying out activities related to clinical trial studies, such as, in some modalities, virtual domestic calls, as described above in relation to FIGURE 3. The exact configuration of local satellite computers 204 and, if used, the control station computer 402, will vary depending on the exact requirements of the particular clinical trial study for which they are used. Similarly, the virtual home calling program 417 or other software used to provide uses related to the clinical trial study will also vary. In some embodiments, the electronic virtual call program 41 7 assists users to participate in such conferences with a minimum of computer proficiency or experience with the use of the virtual home calling program 417. Although FIGURE 4 describes local computer equipment By satellite and programming, it should be understood that the local central sorter computer 224 may also include, among other things, all the hardware and programming necessary to support the interface with the local post-satellite computers 204. It should be understood that, in different embodiments of the invention, the local central classifier computer 224 and local satellite computers 204 may be computers that are already presented before any clinical trial study and may have been used for general office purposes, provided with additional software , or provided with Internet access or faster Internet access, in order to allow them to be used in a particular clinical trial study, in accordance with the invention. In other modalities, computers 204, 224, software, equipment and Internet access may be designed or provided especially or exclusively for use in the clinical trial study. FIGURE 5 is a flow diagram illustrating a method 500 for facilitating centralized and standardized classifications of subjects in a clinical trial study in accordance with one or more embodiments of the present invention. The method 500 can be used, for example, in conjunction with the system model of FIGURE 1 A. An interested party 108 initiates the process by commissioning the performance of a clinical trial (step 502). Interested party 1 08 can commission one or more researchers 1 02 directly to conduct the clinical trial. However, it should be noted that in some modalities, the clinical trial can be carried out without the use of separate investigators. In such cases, the classifiers, in themselves, can carry out any function typically associated with researchers. The interested party can be, for example, a pharmaceutical company, a biotechnology company, etc. The classifiers at the site of central classifier 1 06 are then trained, for example, by the investigator (s) 1 02, or some other entity, in order to identify qualified subjects from the deposit (s). ) of candidate (s) 1 04 (stage 504). As previously discussed, the classifiers at the central classifier site 106 receive consistent training and employ consistent selection criteria, in such a way as to increase the reliability between classifiers. The classifiers in the central classifier site 106 identify qualified subjects for the clinical trial (stage 506) through interviews with candidates. These interviews can be carried out by using the means described with respect to FIGURES 3 and 4, with the candidates communicating with the classifiers from, for example, the satellite local computer (s) 204 The classifiers, in turn, can communicate with the candidates using local computer (s) of central classifier 224. In stage 507, the recruitment of candidates is carried out by classifiers in the site (s). ) of central classifier 1 06. Stage 507 can include any necessary selection of candidates by the classifiers to ensure that they are sufficiently qualified to participate in the study, such as being of the appropriate age, having the appropriate medical condition, etc. . In some embodiments, stage 507 includes obtaining data from candidates, such as candidates indicating that they may wish to participate in future studies and storing the data in an auxiliary database to be used in planning and recruitment activities for future studies. Also, step 507 may include using information of this type from previous studies in order to identify, direct or approach potential candidates for the study. Stage 507 also includes the invitation of qualified candidates to participate as subjects, and the obtaining of any necessary agreement or consent, including agreements or written consent, from candidates who agree to participate as subjects. Stage 507 also attempts to include any recruitment, may need to be carried out at a later time to replace any subject who unexpectedly decides not to participate or who desists but can be replaced. Thus, stage 507 can be revisited at different stages in method 600. Subsequent to the identification of qualified subjects, the classifier (s) can then conduct assessment interviews with the qualified subjects and collect the desired raw data for the clinical trial (stage 508). Again, the assessment interviews can also be carried out by using the means described with respect to FIGURES 3 and 4. In step 509, the qualified subjects participate in the study and the data is obtained and communicated in accordance with the invention. Step 509 includes the communication of clinical trial data from satellite sites to the central classifier site (s), according to the study. Step 509 also includes, in some embodiments of the invention, monitoring by the organization of integration of the conduction and execution of the study. After the assessment interviews are concluded, the classifiers in the central classifier site (s) 106 forward the raw data to the researcher (s) 102 for analysis (step 510). The investigator (s) 1 02 can then, in turn, forward the analysis and / or the raw data, itself, to the interested party 108 for further analysis in conjunction with the clinical trial (step 512). Alternatively, the classifiers can forward the raw data directly to the interested party 108 for analysis. Although the invention has been described and illustrated in connection with exemplary embodiments, many variations and modifications may be made as will be apparent to those skilled in the art without departing from the spirit and scope of the invention, and the invention is thus not limited to the precise details of methodology or construction set forth above since such variations and modification are proposed to be included within the scope of the invention.

Claims (32)

1. CLAIMS 1. A method to facilitate centralized and standardized classifications of subjects in clinical trial studies, characterized the method because it comprises: training the classifiers located in at least one central classifier site to employ substantially similar criteria for at least one of recruiting qualified subjects and collection of information from qualified subjects; and interview the qualified subjects by the classifiers located in the at least one central classifier site, where the interview is to carry out at least one of recruiting qualified subjects and collecting information from the qualified subjects. The method according to claim 1, characterized in that the classifiers obtain informed, centralized consent from the qualified subjects. The method according to claim 1, characterized in that the at least one central classifier site is at least one of remote and centralized of the subjects. The method according to claim 1, characterized in that the at least one central classifier site is at least one of a similar physical location or a virtual location. 5. The method according to claim 1, characterized in that the qualified subjects are located in at least one place by satellite. The method according to claim 5, characterized in that the at least one place per satellite comprises at least one of a medical office, a clinic, a home of qualified subject, a hospital, a school, an office building, a shopping center , a work address, and a factory. The method according to claim 1, characterized in that the interview is carried out using virtual communications over a network. The method according to claim 7, characterized in that the network comprises the Internet. The method according to claim 7, characterized in that the virtual communications comprise at least one of a video and an audio conference, a live online chat and email. The method according to claim 1, characterized in that the interview stage is carried out using videoconferencing. eleven . The method according to claim 1, characterized in that the interview stage is carried out using at least one of audio and video telephone means. The method according to claim 1, characterized in that it also comprises the step of advancing the collected information to at least one researcher for analysis. The method according to claim 12, characterized in that the step of advancing comprises the step of advancing at least one of the information collected and an analysis of the information collected towards at least one interested party. The method according to claim 1, characterized in that it also comprises the step of advancing the collected information to at least one interested party for analysis. 1 5. A system for facilitating centralized and standardized classifications of subjects in clinical trial studies, characterized in that the system comprises: at least one central classifier site comprising classifiers that are trained to employ consistent criteria for at least one recruitment of qualified subjects and collection of information from the qualified subjects; and at least one satellite site, coupled to at least one central classifier site, in whose study the candidates are interviewed by the classifiers in order to determine at least whether the candidates are qualified subjects and to provide information to the classifiers. The system according to claim 1 5, characterized in that the at least one central classifier site comprises at least one local central classifier computer. The system according to claim 15, characterized in that each of the at least one satellite site comprises at least one local satellite computer. The system according to claim 15, characterized in that the at least one central classifier site is at least one of remote and centralized of the subjects. 19. The system according to claim 1 5, characterized in that the at least one central classifier site is at least one of a similar physical location and a virtual location. The system according to claim 1, characterized in that the classifiers use the at least one local central classifier computer to interview the candidates in the at least one satellite site over a network, where the network is coupled to the minus one satellite site for the at least one central classifier site. twenty-one . The system according to claim 20, characterized in that the candidates receive interview questions and answer interview questions by using the at least one local satellite computer. The system according to claim 20, characterized in that the network comprises at least one of the Internet, an intranet, satellite and telephone communication means. 23. The system according to claim 21, characterized in that the candidates receive interview questions and answer interview questions using video telephone media, audio telephone media, videoconference, online conversation and e-mail. The system according to claim 22, characterized in that it further comprises means for connecting the at least one central classifier site and the at least one local satellite computer to the Internet by high speed connections. 25. The system according to claim 22, characterized in that it further comprises means for allowing candidates in the at least one satellite site to communicate with classifiers in the at least one central classifier site by communication between the at least one local computer by satellite and the at least one local central classifier computer on the network in at least one real time and almost real time. 26. The system according to claim 24, characterized in that it further comprises means for facilitating at least one of the interactive video interactive and audio media presentations in progress, presented through peripheral equipment of the at least one local satellite computer and the at least one local central classifier computer. The system according to claim 15, characterized in that the at least one satellite site comprises at least one of a medical office, a clinic, a home of the qualified subject, a hospital, a school, a factory floor, a building of offices, a shopping center, and a work address. 28. The system according to claim 15, characterized in that it also comprises a videoconferencing system to allow the classifiers to interview candidates. 29. A computer-readable medium that stores program codes that, when executed on a computerized device, cause the computerized device to execute a method for centralized and standardized classifications of subjects in clinical trial studies, characterized by the method because it comprises: training to classifiers located in at least one central classifier site to employ substantially similar criteria for at least one of the recruitment of qualified subjects and the collection of information from the qualified subjects, wherein the at least one central classifier site is at least one of a similar physical location or virtual location; and interviewing the qualified subject by the classifiers located in the at least one central classifier site, where the interview is to carry out the at least one of qualified subjects' recruitment and collection of information from the qualified subjects. 30. The computer readable medium according to claim 28, characterized in that the computer-readable medium also allows the interview to be carried out using communications over a network. 31 The method according to claim 29, characterized in that the network comprises the Internet, an intranet, satellite and telephone communication means. 32. The method according to claim 29, characterized in that the interviews are carried out by using at least one videoconference, audio conference, a live online conversation, and electronic mail.