JPWO2014155714A1 - Program, notification method and notification device - Google Patents

Abstract

When studying a new drug, if an adverse event occurs in a double-blind study in which a control drug is used in combination, multiple study patient groups including multiple study patients to whom either the new drug or the control drug is administered or are administered are stored With reference to the storage unit (S18), among the stored trial patient groups, the trial patient group including the trial patient to which the new drug is administered or has been administered is related to the occurrence of the adverse event in the corresponding notification destination. Notification is made (S22), and for the study patient group that does not include the study patient to whom the new drug is administered or has been administered, notification regarding the occurrence of an adverse event is not made to the corresponding notification destination (S24). Give notices.

Description

  The present invention relates to a program, a notification method, and a notification device.

  Clinical trials of new drugs are conducted by administering a clinical trial drug to a subject patient through a plurality of doctors. Because investigational drugs are not completely safe, adverse events may occur in patients.

  If the adverse event that occurred is a serious adverse event, the law stipulates that all physicians who have requested clinical trials of the investigational drug should be notified at an early stage and the trial stopped. On the other hand, if the adverse event that occurred is not serious, it is common to continue the trial and continue the efficacy and safety studies.

  As a clinical trial method, there is a double blind test. In the double blind test, a new drug (active drug) and a control drug (placebo) were used, and the trial was conducted without notifying both the medical institution (doctor) and the patient, and the drug was compared with the control drug. It is a method to measure the effect of new drugs.

  Conventionally, a technique related to a response system for responding to an inquiry about an investigational drug is known (for example, see Patent Document 1).

JP 2003-323500 A

  As described above, when an adverse event occurs in a clinical trial, it is preferable to notify the risk of the clinical trial drug to the patient and the doctor in charge before administering the clinical trial drug. However, in the past, since there was no notification of an adverse event taking into account the nature of the double blind test, inconvenience may occur due to notification.

  In one aspect, an object of the present invention is to provide a program, a notification method, and a notification device that can perform appropriate notification when an adverse event occurs in a clinical trial.

  In one aspect, the program includes multiple subjects who are or have been administered either a new drug or a control drug when an adverse event occurs in a double-blind study with a control drug during a new drug trial. Referring to a storage unit that stores a plurality of subject groups, out of a plurality of stored subject groups, for subject groups including subjects to whom the new drug is administered or administered, occurrence of the adverse event at the corresponding notification destination This is a program that causes a computer to execute a process for notifying a corresponding notification destination of occurrence of the adverse event for a subject group that does not include subjects to whom the new drug is administered or administered.

  In one aspect, the notification method is for a plurality of subjects who are or have been administered either a new drug or a control drug when an adverse event occurs in a double-blind study with a control drug during a new drug trial. A step of referring to a storage unit that stores a plurality of subject groups including and a step of performing notification based on a reference result in the step of referring to the storage unit, and the step of performing the notification is stored in the step of performing the notification Among subject groups, the subject group including the subjects to whom the new drug is administered or administered is notified to the corresponding notification destination regarding the occurrence of the adverse event, and the new drug is administered or administered For a subject group that does not include subjects, notification regarding the occurrence of the adverse event is not made to the corresponding notification destination.

  In one aspect, the notification device stores a plurality of subject groups including a plurality of subjects to whom a new drug or a control drug is administered or administered in a double blind test in combination with a control drug in a trial of a new drug. And a notification unit that refers to the storage unit and notifies based on the referred result when an adverse event occurs in the double blind test, and the notification unit is stored in the storage unit. Of the plurality of memorized subject groups, for a subject group to which the new drug is administered or includes subjects who have been administered, notification of the occurrence of the adverse event is made to the corresponding notification destination, and the new drug is administered or For a subject group that does not include administered subjects, notification regarding the occurrence of the adverse event is not made to the corresponding notification destination.

  It has the effect that appropriate notification can be made when an adverse event occurs in a clinical trial.

1 is a diagram schematically illustrating a configuration of an electronic medical record / clinical trial information management system according to an embodiment. FIG. FIG. 2A is a diagram illustrating a hardware configuration of a server, and FIG. 2B is a diagram illustrating a hardware configuration of a medical institution terminal and a pharmaceutical company terminal. It is a functional block diagram of a server, a medical institution terminal, and a pharmaceutical company terminal. It is a figure which shows an example of clinical trial patient DB. It is a figure which shows an example of allocation DB. It is a figure which shows an example of an adverse event DB. It is a flowchart which shows the process of a clinical trial information management part. FIG. 8A is a diagram illustrating an example of an order screen, and FIG. 8B is a diagram illustrating an example of an administration message that notifies an adverse event. It is a figure which shows an example of the administration message which notifies that there is no adverse event. FIG. 10A to FIG. 10D are diagrams schematically showing a processing result when the processing of FIG. 7 is performed. It is a figure for demonstrating a modification.

  Hereinafter, an embodiment of an electronic medical record / clinical trial information management system will be described in detail with reference to FIGS. The electronic medical record / clinical trial information management system 100 according to the present embodiment is a system for accumulating and managing information (data) related to an electronic medical record and information (data) related to a clinical trial for effective use. The clinical trial in this embodiment is a so-called double blind test. In the double blind test, a new drug (active drug) and a control drug (placebo) were used, and the trial was conducted without notifying both the medical institution (doctor) and the patient, and the drug was compared with the control drug. It is a method to measure the effect of new drugs.

  FIG. 1 schematically shows the configuration of an electronic medical record clinical trial information management system 100 according to an embodiment. As shown in FIG. 1, the electronic medical record clinical trial information management system 100 includes a server 10 as a notification device, a medical institution terminal 20, and a pharmaceutical company terminal 30. The server 10, the medical institution terminal 20, and the pharmaceutical company terminal 30 are connected to a network 80 such as the Internet or a LAN (Local Area Network). In the present embodiment, it is assumed that there are a plurality of medical institution terminals 20 and pharmaceutical company terminals 30.

  The server 10 accumulates and manages data related to electronic medical records and data related to clinical trials, and provides various information and notifications to the medical institution terminal 20 and the pharmaceutical company terminal 30. FIG. 2A shows the hardware configuration of the server 10. As shown in FIG. 2A, the server 10 includes a CPU (Central Processing Unit) 90, a ROM (Read Only Memory) 92, a RAM (Random Access Memory) 94, and a storage unit (here, an HDD (Hard Disk Drive)). 96, a network interface 97, a portable storage medium drive 99, and the like. Each component of the server 10 is connected to a bus 98. In the server 10, the CPU 90 executes a program stored in the ROM 92 or the HDD 96 or a program read from the portable storage medium 91 by the portable storage medium drive 99, whereby the medical information management unit 11 shown in FIG. And the function of the clinical trial information management part 12 as a notification part is implement | achieved. The medical information management unit 11 stores (accumulates) electronic medical record data input from the medical institution terminal 20 in an electronic medical record DB (database) 16 and manages it. The clinical trial information management unit 12 stores (accumulates) data related to clinical trials input from the pharmaceutical company terminal 30 in the clinical trial patient DB 17 and the allocation DB 18 and manages them. In addition, the clinical trial information management unit 12 stores (accumulates) in the adverse event DB 19 when data indicating that an adverse event has occurred in the clinical trial is input from the medical institution terminal 20, and for each medical institution terminal 20, Notify about adverse events.

  Here, various DBs included in the server 10 will be described. Various DBs are stored in the HDD 96 of the server 10 or the like.

  The clinical trial patient DB 17 is a database that stores data of a patient (subject) who has undergone a clinical trial and a patient (subject) who has consented to take the clinical trial (subject to receive a clinical trial) (hereinafter also referred to as “trial patient”). . As shown in FIG. 4, the clinical trial patient DB 17 includes “trial clinical institution”, “patient ID by medical institution”, “clinical department”, “patient name”, “trial drug”, “investigator”, “situation”, It has fields of “administration date”, “content”, “main disease name”, “age”, “gender”, and “acceptance date”.

  In the field of “Clinical trial medical institution”, the name of the medical institution (hospital, clinic, etc.) in which the trial patient receives (receives) the clinical trial is stored. In the “patient ID by medical institution” field, identification information of the clinical patient in the medical institution is stored. The name of the clinical department in which the clinical trial patient is receiving treatment is stored in the “clinical department” field. The name of the trial patient is stored in the “patient name” field. The name of the investigational drug to be administered in the clinical trial is stored in the “investigation drug” field. In this embodiment, since a double blind test is performed in the clinical trial, the investigational drug is either a new drug (active drug) or a control drug (placebo) (depending on the clinical trial patient). However, information on whether the investigational drug is a new drug (active drug) or a control drug (placebo) is not stored in the field of “trial drug”.

  The name of the doctor who is in charge of the clinical trial of the trial patient (in the case of FIG. 4 only) is stored in the “in-charge doctor” field. The “status” field stores information on whether an investigational drug was administered to the study patient, whether the study drug was administered, or whether an adverse event occurred after administration. Adverse events include not only serious adverse events but also non-serious adverse events (such as vomiting, diarrhea, and fever).

  In the “administration date” field, the date on which the study drug was administered to the study patient is stored. Note that “−” is stored in the case before the study drug is administered to the study patient. The “content” field stores information on the content of an adverse event (such as vomiting, diarrhea, and fever) when an adverse event occurs in the study patient. Note that “−” is stored in the case before the investigational drug is administered to the investigational patient or in the case where the investigational drug has been administered but no adverse event has occurred. In the “main disease name” field, information on the main disease name of the clinical trial patient is stored. In the “age” and “sex” fields, information on the age and sex of the trial patient is stored. In the “acceptance date” field, the date when the trial patient consents to participate in the trial is stored.

  The allocation DB 18 is a database that stores information (input from the pharmaceutical company terminal 30) on which clinical trial patients were administered (scheduled to administer) which new drug or control drug. In this embodiment, since a double blind test is performed in the clinical trial, the contents of the allocation DB 18 cannot be viewed by a medical institution (doctor) or a patient.

  As shown in FIG. 5, the allocation DB 18 has fields of “patient name”, “trial medical institution”, and “drug type”. The name of the trial patient is stored in the “patient name” field. In the field of “Clinical trial medical institution”, the name of the medical institution conducting the clinical trial for the trial patient is stored. In the “drug type” field, information on whether (or whether to administer) a new drug or a control drug is stored for the trial patient.

  The adverse event DB 19 is a database that stores information on which investigational drug (new drug) and what adverse event occurred with what probability. As shown in FIG. 6, the adverse event DB 19 has fields of “study drug name”, “adverse event”, and “possibility”. The name of the investigational drug (new drug) in which the adverse event has occurred is stored in the “investigation drug name” field. The contents of adverse events (vomiting, diarrhea, fever, etc.) are stored in the “adverse event” field. In the “possibility” field, the number (percentage) of clinical trial patients in which an adverse event has occurred is stored with respect to the number of clinical trial patients who received the clinical trial drug (new drug).

  The data structure of the electronic medical record DB 16 is not shown, but the electronic medical record DB 16 stores patient information, illness information, doctor information, and the like.

  Returning to FIG. 1, the medical institution terminal 20 is a terminal at which a doctor browses and inputs electronic medical record data, orders medicines, and browses and inputs data related to clinical trials. As shown in FIG. 2B, the medical institution terminal 20 includes a CPU 190, a ROM 192, a RAM 194, a storage unit (HDD) 196, a display unit 193, an input unit 195, a network interface 197, a portable storage medium drive 199, and the like. The components of the medical institution terminal 20 are connected to the bus 198. The display unit 193 includes a liquid crystal display and the like, and the input unit 195 includes a keyboard, a mouse, a touch panel, and the like. In the medical institution terminal 20, the CPU 190 executes a program stored in the ROM 192 or the HDD 196 or a program read by the portable storage medium drive 199 from the portable storage medium 191, whereby the display processing unit shown in FIG. 21 and the function as the input processing unit 22 are realized. In response to an instruction from the medical information management unit 11 or the clinical trial information management unit 12 of the server 10, the display processing unit 21 displays a screen related to an electronic medical record, a screen related to a clinical trial, an adverse event, or the like on the display unit 193 of the medical institution terminal 20. indicate. The input processing unit 22 receives electronic medical records, clinical trials, information on adverse events, information on orders, etc. input by a user (doctor or the like) of the medical institution terminal 20 via the input unit 195, and manages the information as medical information management It transmits to the part 11 and clinical trial information management part 12.

  The pharmaceutical company terminal 30 is a terminal for a person in charge to view and input data related to a clinical trial in a pharmaceutical company. As shown in FIG. 2B, the pharmaceutical company terminal 30 is similar to the medical institution terminal 20, and includes a CPU 190, a ROM 192, a RAM 194, a storage unit (HDD) 196, a display unit 193, an input unit 195, a network interface 197, and an acceptable device. A portable storage medium drive 199 and the like are provided. In the pharmaceutical company terminal 30, the functions as the display processing unit 31 and the input processing unit 32 illustrated in FIG. 3 are realized by the CPU 190 executing the program. The display processing unit 31 displays a screen related to the clinical trial on the display unit 193 of the pharmaceutical company terminal 30 in response to an instruction from the medical information management unit 11 or the clinical trial information management unit 12 of the server 10. The input processing unit 32 transmits information related to the clinical trial and the like input by the user (person in charge) of the pharmaceutical company terminal 30 via the input unit 195 to the medical information management unit 11 and the clinical trial information management unit 12.

  Next, the process of the clinical trial information management unit 12 in this embodiment will be described in detail along the flowchart of FIG. In this processing, in response to a request from the medical institution terminal 20, the medical information management unit 11 transmits the medicine order screen data to the display processing unit 21, and the display processing unit 21 displays the data on the display unit 193 in FIG. ) Is started from the state where the order screen shown in FIG. The order screen in FIG. 8A is a screen used when a doctor orders medicines (including investigational drugs) prescribed for a patient to a pharmacy.

  In the process of FIG. 7, first, in step S10, the clinical trial information management unit 12 stands by until receiving an order for a clinical trial drug from a doctor (until selected on the order screen). In this case, it is assumed that the trial drug (gastritis drug A) is ordered for the trial patient “Naoko Sato” before the trial drug is administered in the trial patient DB 17 of FIG.

  Next, in step S12, the clinical trial information management unit 12 determines whether there is an adverse event in the ordered investigational drug using the adverse event DB 19 in FIG. Here, since the order of the gastritis drug A is made, it is determined from FIG. 6 that there is an adverse event (vomiting).

  Next, in step S14, the clinical trial information management unit 12 determines whether an adverse event has occurred. If the determination is negative, the process proceeds to step S24. If the determination is positive, the process proceeds to step S16.

  In step S16, the clinical trial information management unit 12 determines whether or not a new drug is to be administered. In this case, the clinical trial information management unit 12 refers to the allocation DB 18 in FIG. 5 to determine whether the clinical trial drug assigned to the clinical trial patient “Naoko Sato” is a new drug or a control drug. In this case, since “new drug” is assigned to the clinical trial patient “Naoko Sato”, the determination in step S16 is affirmed, and the process proceeds to step S20.

  In step S20, the clinical trial information management unit 12 acquires an adverse event corresponding to the investigational drug from the adverse event DB 19 (FIG. 6). In step S <b> 22, the clinical trial information management unit 12 transmits the image data of the administration message including the content related to the acquired adverse event to the display processing unit 21 of the medical institution terminal 20. Specifically, the clinical trial information management unit 12 displays image data of an administration message (message notifying that vomiting, which is an adverse event, occurred in the past) as shown in FIG. To send. Thereby, on the display unit 193 of the medical institution terminal 20, an administration message for notifying an adverse event as shown in FIG. 8B is displayed. The administration message is provided with buttons for selecting “administer” or “do not administer”. In this way, the doctor informs the study patient (the patient to whom the new drug is assigned) of the adverse event, consults with the study patient, and decides whether or not to administer (order or not) Can do.

  On the other hand, when the order of the investigational drug is for the investigational patient “Ichiro Tanaka” in FIG. 4, the “control drug” is assigned to “Ichiro Tanaka” from the assignment DB 18 in FIG. 5. The determination in step S16 is negative. Then, the clinical trial information management unit 12 proceeds to step S18.

  In step S18, the clinical trial information management unit 12 determines whether or not there is a patient to whom a new drug is administered (or is administered) in the medical institution. That is, the clinical trial information management unit 12 determines whether or not there is a clinical trial patient to whom “new drug” of the clinical trial drug “gastritis A” is assigned in the same medical institution as the clinical trial patient “Ichiro Tanaka”. In this case, the clinical trial patient “Ichiro Tanaka” has undergone a clinical trial at Hospital B from the clinical trial patient DB 17 in FIG. 4, and a new drug has already been assigned to the clinical trial patient “Hanako Takeda” in Hospital B from the assignment DB 18 in FIG. The judgment here is affirmed.

  If the determination in step S18 is affirmed, the clinical trial information management unit 12 executes the processes in steps S20 and S22 in the same manner as described above. Thereby, the administration message in FIG. 8B is displayed on the display unit 193 of the medical institution terminal 20. As described above, in this embodiment, different administration messages are not notified to the study patient to which the new drug is administered (or administered) and the study patient to which the control drug is administered in the same medical institution. Therefore, from the notification, doctors and patients cannot determine who is assigned the new drug and who is assigned the target drug in the double blind test.

  On the other hand, when the order of the investigational drug is for the trial patient “Saburo Yamada” in FIG. 4, the “control drug” is assigned to “Saburo Yamada” from the assignment DB 18 in FIG. 5. Therefore, the determination at step S16 is negative. Then, the clinical trial information management unit 12 proceeds to step S18 and determines whether or not there is a patient to whom a new drug is administered (or is administered) in the same medical institution as the clinical trial patient “Saburo Yamada”. In this case, the clinical trial patient “Saburo Yamada” has undergone clinical trials at Hospital D from the clinical trial patient DB 17 in FIG. 4, and no new drug has yet been assigned within Hospital D from the assignment DB 18 in FIG. 5. The judgment here is denied. In this case, the clinical trial information management unit 12 proceeds to step S24.

  In step S24, the clinical trial information management unit 12 transmits the screen data of the administration message including the message indicating that there is no adverse event to the display processing unit 21 of the medical institution terminal 20. Specifically, the clinical trial information management unit 12 transmits image data of an administration message (message notifying that no adverse event has occurred) as shown in FIG. 9 to the display processing unit 21. As a result, the administration message as shown in FIG. 9 is displayed on the display unit 193 of the medical institution terminal 20. The administration message is provided with buttons for selecting “administer” or “do not administer”. Thus, the doctor can inform the trial patient (the patient to whom the control drug is assigned) that there is no adverse event, and after consulting with the trial patient, can determine whether or not to administer.

  Even if the determination in step S14 is negative (when there is no adverse event), the process proceeds to step S24, and thus a screen similar to FIG. 9 is displayed on the display unit 193 of the medical institution terminal 20. Will be displayed.

  Here, the processing results when the processing of FIG. 7 is performed will be further described with reference to FIGS.

  In this embodiment, as shown in FIG. 10 (a), when an adverse event exists, the trial patient who is about to administer a new drug is assigned to the new drug and the control drug for the trial patient within the same medical institution. Regardless, the existence of an adverse event is always notified (see FIG. 8B). Thereby, the trial patient can determine whether or not to receive a new drug in consideration of an adverse event.

  On the other hand, in the case where an adverse event exists and the control drug is assigned to all the clinical trial patients in the same medical institution as shown in FIG. 10 (b), the clinical trial in which the target drug is to be administered. The patient is not notified of adverse events (see FIG. 9). As a result, the control drug can be administered without causing anxiety to the clinical trial patient to whom the target drug is assigned (without letting the user become irritated), and thus it is possible to collect a large amount of clinical trial data of the target drug.

  In addition, in the case where an adverse event exists, as shown in FIG. 10 (c), when a new drug is assigned to at least one clinical trial patient at the same medical institution, the clinical trial patient who is about to administer the target drug Is notified of the presence of an adverse event (see FIG. 8B). Here, for example, if a different message is notified to a patient who is administered the same study drug in the same medical institution, a new drug is assigned to which study patient, and a control drug is assigned to which study patient. There is a case where a doctor or the like knows. However, if notification as shown in FIG. 10 (c) is performed as in the present embodiment, an adverse event (risk) is notified to the clinical trial patient, and the clinical trial patient within the same medical institution is identical. This notification makes it possible to maintain the reliability of the double blind test.

  In addition, when there is no adverse event, as shown in FIG. 10 (d), since the adverse event is not notified (notified that there is no adverse event), the trial patient participates in the trial with peace of mind. be able to.

  In the present embodiment, a clinical trial patient group is formed in units of medical institutions, and among clinical trial patient groups, a clinical trial patient group including a clinical trial patient to which a new drug is administered or has been administered has an adverse event in the corresponding notification destination. It can be said that the existence of In addition, it can be said that for the study patient group that does not include the study patient to which the new drug is administered or is administered, the presence of an adverse event is not notified to the corresponding notification destination. In the present embodiment, the trial patient DB 17 and the assignment DB 18 realize a function as a storage unit that stores a plurality of treatment patient groups.

  As described above in detail, according to this embodiment, when an adverse event occurs in a double-blind test in which a control drug is used in the trial of a new drug, the clinical trial information management unit 12 performs the trial patient DB 17 and the allocation DB 18. If the study patient of the same medical institution includes a study patient to whom a new drug is administered or has been administered (study patient to which a new drug has been assigned), When notifying the existence of an adverse event (Fig. 8 (b)) and not including a study patient to whom a new drug is administered or administered (study patient to which a new drug is assigned) among trial patients at the same medical institution Is not notified of the presence of an adverse event to the trial patient to be notified (FIG. 9). As a result, if there are clinical trial patients who are assigned new drugs among clinical trial patients at the same medical institution, the same notification (adverse event notification) is sent to the trial clinical trial subject to be notified. Decrease in the reliability of the double blind test can be suppressed while making the clinical patient aware of the existence. In addition, if there are no trial patients assigned to the new drug among trial patients in the same medical institution, adverse events are not notified and the trial patient is not worried. It is possible to collect a large number of clinical trial results of highly control drugs. As described above, according to the present embodiment, when an adverse event occurs in the double blind test, it is possible to appropriately notify the trial patient.

  In this embodiment, in step S18, it is determined whether or not there is a clinical trial patient to whom a new drug is administered or administered in units of medical institutions. This is particularly effective in maintaining the reliability of the clinical trial when a doctor involved in the clinical trial is determined for each medical institution and a double blind test is performed by the medical doctor.

  In the above-described embodiment, the case has been described in which it is determined in step S18 whether or not there is a clinical trial patient to whom a new drug is administered or administered, but the present invention is not limited to this. For example, it may be determined in units of medical departments or may be determined in units of doctors in charge. In the case of the clinical department unit, the number of clinical trial patients to be referred to can be reduced rather than the medical institution unit. In addition, when the unit is a doctor unit in charge, it is particularly effective when a doctor has a plurality of medical institutions.

  In the above-described embodiment, the case where the clinical trial information management unit 12 notifies the presence / absence of an adverse event when an investigational drug is ordered on the order screen has been described. However, the present invention is not limited to this. For example, the clinical trial information management unit 12 may notify the clinical trial patient to whom the clinical trial drug has already been administered and the doctor in charge of the presence or absence of an adverse event. In this case, the notification to the clinical trial patient may be made to a terminal (such as a portable terminal) used by the clinical trial patient.

  In the above embodiment, since the adverse event DB 19 in FIG. 6 has a “possibility” field, the clinical trial information management unit 12 reflects the “possibility” when notifying the adverse event. Notification may be performed. For example, “possibility” that an adverse event occurs in the notified message may be displayed, or the importance (high, medium, low, etc.) of the message is set according to the “probability” and notified. It is good to do.

  In the above embodiment, the case where the server 10 has the function as the clinical trial information management unit 12 and holds the clinical trial patient DB 17, the allocation DB 18, and the adverse event DB 19 has been described. However, the present invention is not limited to this. For example, as shown in FIG. 11, the pharmaceutical company terminal 30 ′ may have a function as the clinical trial information management unit 112, and may hold a clinical trial patient DB 17, an assignment DB 18, and an adverse event DB 19. Even if it does in this way, the effect similar to the said embodiment can be acquired.

  The above processing functions can be realized by a computer. In that case, a program describing the processing contents of the functions that the processing apparatus should have is provided. By executing the program on a computer, the above processing functions are realized on the computer. The program describing the processing contents can be recorded on a computer-readable recording medium (except for a carrier wave).

  When the program is distributed, for example, it is sold in the form of a portable recording medium such as a DVD (Digital Versatile Disc) or a CD-ROM (Compact Disc Read Only Memory) on which the program is recorded. It is also possible to store the program in a storage device of a server computer and transfer the program from the server computer to another computer via a network.

  The computer that executes the program stores, for example, the program recorded on the portable recording medium or the program transferred from the server computer in its own storage device. Then, the computer reads the program from its own storage device and executes processing according to the program. The computer can also read the program directly from the portable recording medium and execute processing according to the program. Further, each time the program is transferred from the server computer, the computer can sequentially execute processing according to the received program.

  The above-described embodiment is an example of a preferred embodiment of the present invention. However, the present invention is not limited to this, and various modifications can be made without departing from the scope of the present invention.

10 Server (Notification device)
12 Clinical Trial Information Management Department (Notification Department)
17 Clinical trial patient DB (part of memory)
18 Allocation DB (part of storage)

Claims (6)

Memory unit that stores multiple subject groups including multiple subjects who are administered or administered either a new drug or a control drug when an adverse event occurs in a double-blind study with a control drug in a clinical trial of a new drug Refer to
Of the plurality of memorized subject groups, for a subject group to which the new drug is administered or includes subjects who have been administered, notification of the occurrence of the adverse event is made to the corresponding notification destination, and the new drug is administered or For subject groups that do not include administered subjects, do not notify the corresponding notification destination regarding the occurrence of the adverse event,
A program that causes a computer to execute processing.   The program according to claim 1, wherein the subject group is formed in a medical institution unit, a medical department unit, or a doctor in charge. Memory unit that stores multiple subject groups including multiple subjects who are administered or administered either a new drug or a control drug when an adverse event occurs in a double-blind study with a control drug in a clinical trial of a new drug A step of referring to
The computer executes the step of performing notification based on the reference result in the step of referring to the storage unit,
In the step of performing the notification, among the plurality of stored subject groups, the subject group including the subjects to whom the new drug is administered or administered, a notification about the occurrence of the adverse event is made to the corresponding notification destination, A notification method characterized in that, for a subject group to which the new drug is administered or does not include subjects who have been administered, notification regarding the occurrence of the adverse event is not made to the corresponding notification destination.   The notification method according to claim 3, wherein the subject group is formed in a medical institution unit, a medical department unit, or a doctor in charge. In a trial of a new drug, a storage unit for storing a plurality of test subject groups including a plurality of subjects to which a new drug or a control drug is administered or administered in a double blind test in combination with a control drug,
When an adverse event occurs in the double blind test, the storage unit is referred to, and a notification unit that performs notification based on the referred result is provided,
The notification unit is configured to notify a corresponding notification destination of the occurrence of the adverse event for a subject group including the subjects to whom the new drug is administered or administered among the plurality of subject groups stored in the storage unit. A notification device characterized in that a notification regarding the occurrence of the adverse event is not sent to a corresponding notification destination for a group of subjects who do and do not include subjects to whom the new drug is administered or are administered.   The notification apparatus according to claim 5, wherein the subject group is formed in a medical institution unit, a medical department unit, or a doctor in charge.

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