JP4463300B2 - Subject management method and apparatus - Google Patents

Description

The present invention relates to a subject management method and apparatus capable of reliably collecting periodic progress reports by subjects in clinical trials for foods, pharmaceuticals such as popular drugs, cosmetics, and the like.

  In the case of new foods, especially health foods, new popular pharmaceuticals, and new cosmetics, in order to confirm their effectiveness and safety, appropriate investigators are selected according to the subject and purpose of the trial (clinical trial). It is carried out. The trial is conducted by a trial sponsor such as a developer, seller, etc. of food, pharmaceuticals, cosmetics, etc. directly as the trial investigator, or the trial investigator determined by the trial sponsor is used as a trial investigator. A clinical trial is conducted.

JP2002-41657

  Patent Document 1 discloses that a clinical trial management server, a clinical trial requester terminal, a clinical trial investigator terminal, and a subject terminal are connected via the Internet so that data can be exchanged with each other. It is also shown that the trial client, the trial investigator, and the test subject can browse the data stored in the storage device of the trial management server via the web (paragraph 0145, FIG. 9). Here, it is also shown that the test subject terminal connects to a clinical trial management server to obtain information, and transmits / receives data to / from other trial requesters and test subjects (paragraph 0149).

  In this way, it is known to connect the trial investigator terminal and the subject terminal via the Internet, but this Patent Document 1 only shows that data is transmitted and received, and what kind of data Whether to send or receive is unknown. The method of Patent Document 1 is based on the “principle that the main role of the trial is a patient” (paragraphs 0083 and 0084), and is considered to be intended for relatively severe patients. That is, the community-based medical system of the practitioner in the area of the patient (subject) is used to ensure that the subject goes to the hospital for the management of the subject and the execution of care (paragraphs 0084-0088,0099). , 0150, 0155, etc.).

  For this reason, the sponsor will visit the investigator who is expected to be able to conduct the study and investigate (paragraph 0004). In selecting a subject, consent is obtained after confronting the subject and sufficiently convincing the content of the trial through conversation (paragraphs 0081 and 0083).

  In view of such circumstances, what is described in this Patent Document 1 is mainly sent and received between the subject terminal and the investigator terminal mainly on information such as medication instruction / execution and hospital request / consent. It is thought to become. In this case, however, individual subjects must be individually instructed and requested, and the conventional telephone or postal communication is merely changed to e-mail via the Internet. For this reason, management for each subject was troublesome. Especially in clinical trials involving a large number of subjects, such as health foods, health drinks, nutritional supplements (supplements), cosmetics, etc. Therefore, the emergence of a system that can efficiently manage subjects in such cases is desired.

  This invention is made | formed in view of such a situation, and makes it the 1st objective to provide the test subject management method using the computer which can manage many test subjects efficiently. A second object is to provide an apparatus used for carrying out this method.

According to the present invention, a first object is a subject management method using a computer for managing, via the Internet, subjects who cooperate in a clinical trial conducted based on a request from a clinical trial sponsor, comprising: a. The mediator's computer creates a study plan based on the details of the request from the sponsor, and a diary in which the subject is provided with fields for meal content, test product intake, smoking / drinking, exercise, and health status changes. Create and store formats and schedules, b. The mediator computer sends the trial contents, diary format, schedule, ID, and PW stored in the mediator computer to the subject computer via the Internet, c. The presence or absence of the diary input information from the subject of computer input daily for each entry column of the diary format confirmed intermediary computer every day, shortly fill reminder to the subject of the computer on which the non-input, d. Of intermediary computer, and statistical analysis of the effectiveness of the subject of the test product on the basis of a diary in which a large number of subjects entered completion, and from the mail after dispatch fill reminder to the diary entry completed by the subject of computer time delay of Evaluate low or high reliability of diary entry data based on length , e. The intermediary computer is achieved by a subject management method using a computer characterized by having the above steps a to e for storing and outputting statistical analysis results and data reliability evaluation results.

A second object is a computer of an intermediary used in the implementation of the method of claim 1, and receives a request from a clinical trial client and sends it to the subject's computer based on the content of the clinical trial plan, meal content, and test. Create and store a diary format with entry fields for product intake status, presence / absence of smoking / drinking, exercise amount, change in health status , clinical trial contents, diary format, clinical trial plan, ID, PW The test preparation department that sends the information to the subject's computer; manages the sending and receiving of information between the subject's computer, reads the diary input information entered daily from the subject's computer, creates and stores the diary, and the diary within the deadline send an e-mail of fill reminder to the subject of the computer in case the presence or absence of the entry there is no entry to check daily diary by the subject of computer E-mail transmission and diary management section that memorizes the time delay until admission completion; statistical analysis of the effectiveness of the test article on the subject based on the completed diary entered by a large number of subjects; And a statistical analysis unit that analyzes and records reliability evaluation data for each subject and analyzes and outputs the results together with a clinical trial result report, by a subject management device using a computer, Achieved.

According to the invention of claim 1, the intermediary terminal (computer, server) sends a diary format created based on the clinical trial plan to each subject's terminal (computer). The necessary information such as meal contents, smoking, alcohol consumption, amount of exercise, changes in health status, etc. are entered every day and returned to the mediator terminal. For this reason, the intermediary terminal can immediately grasp the clinical trial progress of the subject from the diary every day . Moreover, since the intermediary terminal can send an instruction change, for example, a change in administration interval, to the subject terminal as necessary, it can be managed efficiently.

If there is no entry in the diary, that is, if there is omission, the mediator terminal confirms this and sends an e-mail prompting entry to the subject terminal, so that a diary with no omission can be created and reliability is improved. Furthermore, the mediator terminal performs statistical processing and analysis on the effectiveness of the test item to the subject based on the input contents of the diary sent from each subject terminal every day , and outputs the result to the trial sponsor. Can report promptly. Furthermore, the reliability of the input data is evaluated based on the delay in filling in the diary entry field. That is, the reliability of data can be evaluated by using the fact that the memory becomes unclear as time passes, and it can be used for evaluation of clinical trial results.

According to the invention of claim 6 , an apparatus used directly for carrying out this method is obtained.

When there is an unfilled part in the diary sent from the subject terminal, the intermediary terminal sends an email prompting entry to the subject terminal, and evaluates the reliability of the diary entry data from the response from the subject terminal at this time (Claims 2 and 9). This evaluation, serial delay time and number of days to complete entry from the point out of the input leakage (omissions days), may be only, combination and frequency of delay time and omissions (dispatch number of reminder e-mail) may be one which (claim 2).

Mail entry prompt, raise a stepwise warning level for continuing diary non-input state desired (claim 3). For example, contact carefully by email first, contact the second with more stringent conditions (for example, with a notice that a penalty will be attached), contact the third by phone, and contact by mobile email the fourth. Can be considered.

If these reliability evaluation results are output together with the statistical analysis results and submitted to the sponsor, the sponsor can refer to this evaluation and use the statistical analysis results, thereby further improving the reliability of the trial results. Can be made. The statistical analysis result is preferably sent from the broker's terminal to the trial client terminal via the Internet (claim 4 ). Alternatively, it may be output once to the mediator terminal and then sent to the trial sponsor.

The intermediary terminal checks whether or not the diary entry data sent from the subject terminal is sent regularly, for example, every day at a certain time, or every half day, and if it is confirmed that it has been entered, it cannot be corrected. (Claim 5 ). In this way, the reliability of the diary data is further improved.

  FIG. 1 is a diagram showing an embodiment of the present invention, FIG. 2 is a diagram showing a flow of signals and data, FIG. 3 is a flowchart of overall operation, and FIG. 4 is a work content of a mediator computer (referred to as a mediator terminal). FIG. 5 is a diagram showing the configuration of the mediator terminal.

  In FIG. 1, reference numeral 10 denotes an intermediary server (intermediary terminal, intermediary computer, also simply referred to as an intermediary), and 12 denotes a terminal (computer) of a clinical trial requester (trial requesting institution), 14 (14A, 14B). ,...) Is the terminal (computer) of the investigator (trial institution), 16 (16A, 16B,...) Is the terminal (computer) of the subject who ingests the test food to be studied and fills in the diary. It is. These are connected to each other via the Internet 18. In the following description, the intermediary terminal 10 is simply the intermediary 10, the trial sponsor terminal 12 is simply the trial sponsor 12, the trial sponsor terminal 14 is simply the trial sponsor 14, and the subject terminal 16 is simply the subject 16. The terminal is also simply called a terminal.

  The investigator's terminal 14 can be omitted when it is not necessary, for example, in a hospital where the medical examination of the subject is actually performed and when the investigator 12 performs it directly. In addition, data transmission / reception between the mediator 10 and the trial client 12, the trial practitioner 14, and the subject 16 is performed by using encryption communication, ID (authentication code), or PW (password), thereby maintaining confidentiality. It is desirable to keep it high.

  A clinical trial sponsor (producer or seller of pharmaceuticals or the like) 12 decides a clinical trial practitioner 14 to develop a new popular drug, a new food, a supplement, or the like. In some cases, the clinical trial requester 12 itself becomes the clinical trial practitioner 14. The clinical trial client 12 presents the clinical trial implementation plan (design document) and the test summary document to the mediator 12 and the clinical practitioner 14 (step S0 in FIG. 3).

  Next, the mediator 10 newly creates test information based on the contents presented by the trial client 10 (step S1 in FIGS. 2 and 3). This study information sets the study name, study period, number of visits, study type, presence / absence of placebo, presence / absence of blinding, presence / absence of post-examination, number of groups, number of subjects, etc. The subject 16 or the like can be searched via the Internet when the subject 16 is selected.

  On the other hand, the mediator 10 sets medical institutions, doctors (examination doctors), and doctors (examination managers in the case of their own) who request management of this test from candidates registered in advance (FIG. 4). Step S2). The mediator 10 also selects a suitable subject 16 from among the test candidates registered in advance (step 3 in FIG. 4). That is, the trial information provided by the mediator 10 is shown to the candidate 16 so that the contents of the clinical trial can be understood, and it is confirmed that the clinical trial is accepted and accepted.

The intermediary 10 creates a diary format (diary format) to be filled in by the subject 16 (step S4 in FIGS. 3 and 4). This diary format is created based on the request of the clinical trial client 12 and the content of the clinical trial. This diary format includes test food intake status, number of meals, dietary content , alcohol, other medicines, other health foods, whether or not other supplements are used, whether or not exercise is performed, physical condition changes, and other noticed physical conditions. The above change, etc. column is provided.

  The intermediary 10 confirms the schedule desired by the subject 16 via the subject 16 and the Internet, and then sets the schedule (steps S5, 6, and 7 in FIGS. 3 and 4). Set up a diary schedule and a visit schedule. Then, a diary in which the date and schedule corresponding to the schedule are entered, that is, a diary for each subject is made displayable, and an address for outputting and displaying the diary on the subject's terminal 16 is sent to the subject 16 (see FIG. 3, 4 steps S8). Also, an ID or PW may be sent together with this.

  The mediator 10 automatically prompts the subject 16 to take the subject of the trial, such as drugs, foods, supplements, etc., according to the start date of the trial, or automatically sends an email prompting entry to the diary according to a preset schedule. Transmit (step S9 in FIGS. 3 and 4). The subject 16 inputs necessary items to the designated diary (in the diary read from the home page of the broker 10) (step S10).

  The intermediary 10 checks whether or not the diary entry by the subject 16 has been entered on the correct date or within the deadline, and performs a confirmation process on the diary for which all items have been completed (step S11). Thereafter, the correction is made impossible (step S11 ′). If there is an unfilled item at this time, the mediator 10 automatically sends a reminder email to the subject 16 (step S12). This reminder mail is set so that it will be automatically sent when the entry deadline has passed and a certain time has passed. If there is still no entry for a certain period of time, a strong message may be sent step by step. Also, from a certain stage, you may contact directly by phone or contact mobile mail.

  Further, the contents of the diary (diary that has been confirmed) for the schedule that has been input and confirmed (S11 ') can be confirmed by the trial requester 12 and the trial practitioner 14. That is, the diary input status can be checked not only by the mediator 10 but also by the clinical trial requester 12 and the clinical practitioner 14 (W check, step S13). For this reason, the physical condition change of the subject 16 can be known on the same day or the next day, and the subject 16 can be quickly protected, which is suitable for improving the reliability.

When the schedule of all schedules is completed and the input of all the diary entry items is completed, the diary is completed (step S14). In this case, the broker 10 can download all the diary data or select necessary items (step S15). The intermediary 10 performs statistical processing on the diary data of a large number of subjects 16, that is, analyzes the effectiveness of the test product on the subjects (step S16). Further, the intermediary 10 can confirm the delay of data for which the diary input by the subject 16 is delayed, and it can be determined that the longer the delay, the more ambiguous the memory of the subject 16 and the lower the reliability. Therefore, after taking measures such as deleting the data with low reliability or excluding the data of the subject 16, a report is submitted (step S17).

  The above operations are sequentially performed as shown in FIG. In FIG. 2, (0) to (17) correspond to steps S0 to S17 in FIGS.

  The intermediary terminal 10 has the functions shown in FIG. 5 in order to perform the various processes described above. That is, the test preparation unit 10A prepares for transmission / reception of data, diary format, ID, PW, etc. (S8), creates test information (step S1), and creates a diary format (S2, 4). In the subject registration unit 10B, subjects suitable for the clinical trial selected from candidates stored in advance are registered (step S3).

  The mail transmission / diary management unit 10C checks the schedule (S5, 6, 7), checks the input status (S11, 11 '), prompts the unfilled person (S12), and inputs the selected subject 16 Status check (S13) and diary completion confirmation (S14-15), the number of times of mail transmission / reception, diary input time management, etc. are performed. The statistical analysis (reliability evaluation) unit 10D statistically processes and analyzes the diary input data, and performs reliability evaluation based on the number of times of mail transmission and time management. Data for reliability evaluation is created from the number of times the reminder mail is sent, the diary entry time, the diary entry delay, and the like. This reliability evaluation data is sent to the clinical trial sponsor 12 together with the statistical analysis result, and is used for evaluation of the clinical trial result. The control unit 10E controls the entire units 10A to 10D of the mediator terminal 10. The memory unit 10F stores data of the units 10A to 10E.

The figure which shows the structure of one Example of this invention Diagram showing signal / data flow Flow chart of overall operation List of work contents of the broker terminal Configuration block diagram showing functions of intermediary terminal

Explanation of symbols

10 Broker terminal (computer)
10A Test preparation unit 10B Subject registration unit 10C Mail transmission / diary management unit 10D Statistical analysis (reliability evaluation) unit 10E Control unit 10F Memory unit 12 Clinical trial client terminal (computer)
14 Clinical trial operator terminal (computer)
16 Subject terminal (computer)

Claims (6)

A test subject management method using a computer for managing a subject who cooperates in a trial based on a request of a trial sponsor via the Internet,
a. The mediator's computer creates a study plan based on the details of the request from the sponsor, and a diary in which the subject is provided with fields for meal content, test product intake, smoking / drinking, exercise, and health status changes. Create and store formats and schedules,
b. The mediator computer sends the trial contents, diary format, schedule, ID, and PW stored in the mediator computer to the subject computer via the Internet.
c. The presence or absence of the diary input information from the subject of computer input daily for each entry column of the diary format confirmed intermediary computer every day, shortly fill reminder to the subject of the computer on which the non-input,
d. Of intermediary computer, and statistical analysis of the effectiveness of the subject of the test product on the basis of a diary in which a large number of subjects entered completion, and from the mail after dispatch fill reminder to the diary entry completed by the subject of computer time delay of Evaluate low or high reliability of diary entry data based on length
e. The intermediary computer stores and outputs statistical analysis results and data reliability evaluation results.
A subject management method using a computer, characterized by having the above steps a to e.   2. The subject management method according to claim 1, wherein, in the step d of claim 1, the mediator computer evaluates the reliability based on the time delay until completion of diary entry and the number of times the reminder mail is sent out.   2. The subject management method according to claim 1, wherein in the step d of claim 1, the mail for prompting the entry sent by the mediator computer to the subject computer raises the warning level step by step with respect to the continuation of the diary non-input state.   2. The subject management method according to claim 1, wherein the computer of the mediator sends the statistical analysis result to the trial sponsor via the Internet.   In step c of claim 1, the mediator's computer periodically checks the subject's diary input, and if the entry is confirmed, the subject's computer cannot correct or correct the diary. Management method. An intermediary computer used to implement the method of claim 1, comprising:
A diary with columns for the study plan and meal contents to be sent to the subject's computer based on the contents of the request, the intake status of the test product, the presence or absence of smoking / drinking, the amount of exercise, and the change in health status A study preparation section that creates and stores the format and sends the study content, diary format, study plan, ID, and PW stored on the mediator computer to the subject computer;
Controls the sending and receiving of information to and from the subject's computer, reads the diary input information entered daily from the subject's computer, creates and stores the diary, and checks the diary entry within the deadline every day to check whether or not there is no entry An email sending / diary management unit that sends a reminder email to the subject's computer and stores the time delay until completion of diary entry by the subject's computer;
Statistical analysis of the effectiveness of test products on test subjects based on completed diaries entered by a large number of subjects, and preparation of clinical trial results reports A statistical analysis unit that creates, stores and outputs the results together with the clinical trial report,
A test subject management apparatus using a computer comprising: