JP2014219945A - Clinical trial information output device, clinical trial information output method, and clinical trial information output program - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide proper medical treatment to a patient.SOLUTION: A clinical trial information output device 100 according to an embodiment comprises a first output unit 152 and a second output unit 153. The first output unit 152 receives patient information from a terminal device installed in a medical institution where the patient is to be transported. The first output unit 152 notifies information on adverse reaction of an investigational new drug to the terminal device on the basis of the patient information, if the patient is taking part in a clinical trial. The second output unit 153 notifies information on treatment of the adverse reaction to the terminal device, if symptoms of the patient correspond with symptoms of the adverse reaction.

Description

  The present invention relates to a clinical trial information output device and the like.

  In clinical trials, new drugs developed by pharmaceutical companies are generally used by doctors at multiple medical institutions, with the consent of patients at the medical institutions, and then taken by patients who are considered preferable for the trial. Is.

  For example, the trial is promoted by a team of investigators and investigators, but if an adverse event occurs in a subject, it is assumed that it will be transported first aid. At this time, the possibility that the subject is transported to the medical institution conducting the clinical trial is low, and the subject may be transported to other than the medical institution conducting the clinical trial.

JP 2006-158490 A JP 2006-107321 A

  However, the above-described conventional technology has a problem in that an appropriate medical practice cannot be applied to a patient.

  For example, when a patient is transported to a medical institution other than the one that conducts the clinical trial, the doctor on duty at the transported medical institution may conduct medical practice without knowing the fact that the patient is conducting the clinical trial. It is hard to say that it can be treated.

  In one aspect, an object is to provide a clinical trial information output apparatus, a clinical trial information output method, and a clinical trial information output program capable of performing appropriate medical practice on a patient.

  The first proposal includes a storage unit and a control unit. The storage unit stores a patient, a symptom of a side effect of an investigational drug for a trial performed by the patient, and a method for dealing with the side effect in association with each other. When the control unit receives a symptom of a certain patient and matches the symptom of the side effect of the investigational drug associated with the certain patient stored in the storage unit, a method for dealing with the side effect associated with the certain patient Is read from the storage unit and output.

  According to one embodiment of the present invention, it is possible to perform an appropriate medical practice on a patient.

FIG. 1 is a diagram illustrating a configuration of a system according to the present embodiment. FIG. 2 is a functional block diagram illustrating the configuration of the clinical trial information output apparatus according to the present embodiment. FIG. 3 is a diagram illustrating an example of a data structure of the electronic medical record information table. FIG. 4 is a diagram showing an example of the data structure of the trial patient table. FIG. 5 is a diagram illustrating an example of the data structure of the side effect table. FIG. 6 is a diagram illustrating an example of patient symptom information. FIG. 7 is a flowchart illustrating the processing procedure of the clinical trial information output apparatus according to the present embodiment. FIG. 8 is a diagram illustrating an example of a computer that executes a clinical trial information output program.

  Embodiments of a clinical trial information output device, a clinical trial information output method, and a clinical trial information output program disclosed in the present application will be described below in detail with reference to the drawings. Note that the present invention is not limited to the embodiments.

  The configuration of the system according to the present embodiment will be described. FIG. 1 is a diagram illustrating a configuration of a system according to the present embodiment. As shown in FIG. 1, this system includes a clinical trial information output device 100 and terminal devices 10a, 10b, and 10c. The clinical trial information output device 100 and the terminal devices 10a, 10b, and 10c are connected to each other via the network 50. Although not described here, this system may include other terminal devices.

  The clinical trial information output device 100 is a device that stores information related to a patient under study and outputs information on symptoms of a side effect of the study drug administered to the patient under study and information on how to deal with the side effect of the study drug.

  The terminal devices 10a, 10b, and 10c are terminal devices used by various users. For example, the terminal device 10a is a terminal device installed in a medical institution that conducts a clinical trial. For example, the investigator and the investigator use the terminal device 10a.

  For example, the terminal device 10b is a terminal device installed in a normal medical institution. For example, a doctor who performs a medical action other than the clinical trial uses the terminal device 10b.

  For example, the terminal device 10c is a terminal device installed in a medical institution that accepts emergency transport. For example, a doctor performing emergency medical care uses the terminal device 10c. For example, when accepting a patient, the terminal device 10 c transmits patient information including a patient ID that uniquely identifies the patient to the clinical trial information output device 100.

  If the patient is in a clinical trial, the terminal device 10c receives information on the side effect symptom from the trial from the clinical trial information output device 100, and displays the side effect symptom information on the display device. The doctor in charge compares the symptom of the side effect with the symptom of the patient to determine whether the symptom of the side effect matches the symptom of the patient. The doctor in charge inputs response information indicating whether or not the side effect symptom matches the patient's symptom to the terminal device 10c, and the terminal device 10c transmits the response information to the clinical trial information output device 100. The response information includes the patient ID. If the side effect symptom does not match the patient's symptom, the attending physician includes information on the patient's symptom in the response information.

  When the symptom of the side effect matches the symptom of the patient, the terminal device 10c receives information on the coping method corresponding to the symptom of the side effect from the clinical trial information output device 100, and displays the information on the coping method. Display on the device. The doctor in charge treats the patient with reference to the information on such a countermeasure.

  Next, the configuration of the clinical trial information output apparatus 100 shown in FIG. 1 will be described. FIG. 2 is a functional block diagram illustrating the configuration of the clinical trial information output apparatus according to the present embodiment. As shown in FIG. 2, the clinical trial information output apparatus 100 includes a communication unit 110, an input unit 120, a display unit 130, a storage unit 140, and a control unit 150.

  The communication unit 110 is a processing unit that performs data communication with the terminal devices 10 a, 10 b, 10 c and other external devices via the network 50. The control unit 150 described later exchanges data with the terminal devices 10a, 10b, and 10c, other external devices, and the like via the communication unit 110. The communication unit 110 corresponds to a communication device.

  The input unit 120 is an input device for a user of the clinical trial information output device 100 to input various types of information to the clinical trial information output device 100. For example, the input device corresponds to a keyboard, a mouse, a touch panel, and the like.

  The display unit 130 is a display device that displays information output from the control unit 150. For example, the display device corresponds to a liquid crystal monitor, a touch panel, or the like.

  The storage unit 140 includes an electronic medical record information table 141, a clinical trial patient table 142, and a side effect table 143. The storage unit 140 corresponds to a semiconductor memory element such as a random access memory (RAM), a read only memory (ROM), and a flash memory. The storage unit 140 corresponds to a storage device such as a hard disk or an optical disk.

  The electronic medical record information table 141 is a table that holds medical chart information for each patient. FIG. 3 is a diagram illustrating an example of a data structure of the electronic medical record information table. As shown in FIG. 3, this electronic medical record information table 141 includes a medical care institution, patient ID (identification), patient name, age, sex, disease name, medication name, clinical trial state, clinical trial institution, investigator, Associate emergency contact, investigational drug name, and renewal date.

  In FIG. 3, the medical care institution is information that uniquely identifies the medical care institution. The patient ID is information that uniquely identifies a patient. The patient name, age, and sex are the patient name, patient age, and patient sex, respectively. The disease name is the name of the disease the patient is suffering from. The medication name is information that uniquely identifies the medication that the patient is taking. This medication name does not correspond to the study drug.

  In FIG. 3, the state of the trial is information indicating whether or not the patient is in the trial. If the clinical trial status is “Yes”, the patient is in the clinical trial. In the present embodiment, as an example, the clinical trial has been conducted in the past, and the clinical trial status is “Yes” even when the clinical trial is not currently in progress.

  In FIG. 3, when the state of the clinical trial is “none”, it is assumed that the patient is not in the clinical trial and the patient has not undergone the clinical trial in the past. The clinical trial medical institution is information that uniquely identifies the clinical trial medical institution. The investigator is information that uniquely identifies the doctor responsible for the trial. The emergency contact information is, for example, information indicating the contact information of the investigator. The emergency contact may be an email address. The investigational drug name is information for uniquely identifying the investigational drug. The update date is information indicating the date when the corresponding record is updated.

  For example, in the electronic medical record information table 141 shown in FIG. 3, information related to a disease name, a medication name, and the like is registered by a normal doctor who operates the terminal device 10b. In the electronic medical record information table 141, information on the clinical trial status, the clinical trial medical institution, the investigator, the emergency contact information, the name of the investigational drug, etc. is registered by the investigator or clinical investigator who operates the terminal device 10b. The

  The trial patient table 142 is a table that holds information on patients who undergo clinical trials. FIG. 4 is a diagram showing an example of the data structure of the trial patient table. As shown in FIG. 4, this trial patient table 142 associates a patient ID, a trial medical institution, a medication start date, a medication completion date, a state, and a period. The explanation about the patient ID and the clinical trial medical institution is the same as the explanation about the patient ID and the clinical trial medical institution in the electronic medical record information table 141 of FIG.

  In FIG. 4, the administration start date indicates the date on which the administration of the study drug was started. The completion date of administration indicates the date on which the administration of the investigational drug is completed. The status is information indicating whether the trial is in progress or the trial has been completed. For example, if the trial is in progress, the status is “in trial”. If the clinical trial is complete, the status is “Clinical Trial Completed”. The period is information indicating a period during which a symptom of a side effect may occur after the completion of the clinical trial. For example, when the period is “5 months after completion of the trial”, the period during which the symptoms of side effects may occur after the completion of the trial is 5 months after the completion of the trial. For example, the information in the trial patient table 142 shown in FIG. 4 is registered by the investigator or investigator who operates the terminal device 10b.

  The side effect table 143 is a table that holds information on side effects that may occur due to the investigational drug. FIG. 5 is a diagram illustrating an example of the data structure of the side effect table. As shown in FIG. 5, this side effect table 143 associates the name of the investigational drug, the name of the pharmaceutical company, the emergency contact information, the symptom of the side effect, the countermeasure, and the report date. The investigational drug name is information for uniquely identifying the investigational drug. The name of the pharmaceutical company is the name of the pharmaceutical company. The emergency contact information is, for example, a contact information of a pharmaceutical company. The side effect symptom is information indicating the side effect symptom of the investigational drug. The coping method is information indicating a coping method for a side effect. The reporting date indicates the date on which the symptoms of adverse reactions and the countermeasures were reported. The information in the side effect table 143 shown in FIG. 5 is registered by the investigator or the investigator who operates the terminal device 10b.

  The control unit 150 includes a data management unit 151, a first output unit 152, and a second output unit 153. For example, the control unit 150 corresponds to an integrated device such as an application specific integrated circuit (ASIC) or a field programmable gate array (FPGA). Moreover, the control part 150 respond | corresponds to electronic circuits, such as CPU and MPU (Micro Processing Unit), for example.

  The data management unit 151 is a processing unit that acquires information on the electronic medical record information table 141, the trial patient table 142, and the side effect table 143 from the terminal devices 10a and 10b, and updates the information in the tables 141, 142, and 143. The data management unit 151 updates the information in the tables 141, 142, and 143 after authenticating the terminal devices 10a and 10b using a known technique.

  The first output unit 152 is a processing unit that outputs information on side effects of clinical trials to the terminal device 10c. Hereinafter, the processing of the first output unit 152 will be specifically described.

  The first output unit 152 receives patient information from the terminal device 10c. This patient information is information including the patient ID of the patient information urgently transported to a certain medical institution, for example. The first output unit 152 compares the patient information with the electronic medical record information table 141 and determines whether or not the clinical trial state corresponding to the patient ID of the patient information is “Yes”.

  When the clinical trial state is “present”, the first output unit 152 specifies the name of the clinical trial drug from the electronic medical record information table 141 using the patient ID of the patient information as a key. The first output unit 152 detects information on the symptom of the side effect of the study drug from the side effect table 143 using the specified study drug name as a key. The first output unit 152 transmits information on the detected symptom of the side effect to the terminal device 10c. Note that the first output unit 152 does not perform the process of transmitting the information on the side effects of the trial when the state of the trial is “none”.

  By the way, when the clinical trial state is “Yes”, the first output unit 152 further uses the clinical trial patient table 142 to determine whether or not to transmit clinical trial side effect information to the terminal device 10c. Also good. Based on the patient ID of the patient information and the trial patient table 142, the first output unit 152 displays the side effect symptom information on the terminal device 10c when the state of the trial patient table 142 is “in trial”. Send to.

  On the other hand, based on the patient ID of the patient information and the trial patient table 142, the first output unit 152 determines that the “period of trial” indicates that the trial patient table 142 is in the “period of trial”. Is satisfied. This will be described with reference to FIG. As an example, the patient ID is “1001”. For example, for the patient ID “1001”, if the current date is within “6 months” from the “drug completion date”, the first output unit 152 determines that the “period” in the clinical trial patient table 142 is satisfied. On the other hand, if the current date is not within “6 months” from the “drug completion date”, the first output unit 152 determines that the “period” of the trial patient table 142 is not satisfied.

  If the first output unit 152 determines that the “period” in the trial patient table 142 is satisfied, the first output unit 152 transmits information on side effects of the trial to the terminal device 10c. On the other hand, if the first output unit 152 determines that the “period” of the clinical trial patient table 142 is not satisfied, the first output unit 152 does not transmit the side effect information of the clinical trial to the terminal device 10c.

  The second output unit 153 is a processing unit that outputs information on how to deal with side effects to the terminal device 10c. Hereinafter, the processing of the second output unit 153 will be specifically described.

  The second output unit 153 receives response information including information on whether or not the side effect symptom output from the first output unit 152 matches the patient's symptom from the terminal device 10c. In the following, a process in a case where information indicating that a symptom of a side effect matches a patient's symptom is received and a process in a case where information indicating that the symptom does not match will be described. Note that the response information includes a patient ID.

  A process in the case where the second output unit 153 receives information indicating that the symptom of the side effect matches the symptom of the patient will be described. The second output unit 153 specifies the name of the investigational drug administered to the patient based on the patient ID of the response information and the electronic medical record information table 141. The second output unit 153 detects information on how to deal with side effects caused by the investigational drug using the specified investigational drug name as a key. The second output unit 153 transmits information on how to deal with the detected side effect to the terminal device 10c.

  A process when the second output unit 153 receives information indicating that the symptom of the side effect does not match the symptom of the patient will be described. The second output unit 153 transmits information regarding the patient's symptoms included in the response information to the terminal device 10a used by the investigator. For example, the second output unit 153 compares the patient ID of the response information with the electronic medical record information table 141, determines the investigator, and notifies the investigator of the patient's symptom information. FIG. 6 is a diagram illustrating an example of patient symptom information.

  Next, a processing procedure of the clinical trial information output apparatus 100 according to the present embodiment will be described. FIG. 7 is a flowchart illustrating the processing procedure of the clinical trial information output apparatus according to the present embodiment. For example, the process illustrated in FIG. 7 is executed when patient information is received from the terminal device 10c.

  As shown in FIG. 7, the clinical trial information output device 100 receives patient information from the terminal device 10c (step S101), and based on the electronic medical record information table 141 and patient information, the clinical trial status of the patient is “Yes”. Is determined (step S102). The clinical trial information output device 100 ends the process when the clinical trial state of the patient is “none” (No in step S103).

  On the other hand, when the clinical trial state of the patient is “Yes” (step S103, Yes), the clinical trial information output device 100 transmits information on the side effect symptom corresponding to the patient information from the side effect table 143 to the terminal device 10c. (Step S104).

  The clinical trial information output apparatus 100 determines whether or not information indicating that the side effect symptoms match is acquired (step S105). When receiving information indicating that the symptoms of side effects do not match (No in step S105), the clinical trial information output device 100 notifies the terminal device 10a of the patient's symptoms (step S107).

  On the other hand, when the clinical trial information output apparatus 100 acquires information indicating that the symptoms of the side effects coincide (Yes in step S105), the clinical trial information output device 100 reads the side effects from the side effect table 143 for the countermeasures corresponding to the symptoms of the side effects corresponding to the patient information. Information is transmitted to the terminal device 10c (step S106).

  Whether or not the clinical trial information output device 100 further uses the clinical trial patient table 142 to transmit side effect information of the clinical trial to the terminal device 10c when the clinical trial status is “Yes” in step S103. May be determined.

  Next, effects of the clinical trial information output apparatus 100 according to the present embodiment will be described. The clinical trial information output apparatus 100 according to the present embodiment provides information on how to deal with a side effect associated with a clinical trial drug when the side effect symptom of the clinical trial drug administered to the patient under clinical trial matches the patient's symptom. Is output to the terminal device 10c. For this reason, according to the clinical trial information output device 100, it becomes possible for the doctor in charge to perform an appropriate treatment on the patient.

  In addition, when the patient is in a clinical trial, the clinical trial information output apparatus 100 transmits side effect information to the terminal device 10c in consideration of the time limit for the side effect of the trial drug to appear in the patient. For this reason, it is possible to prevent the side effect information from being communicated to the doctor in charge during the period when the side effect information from the investigational drug does not appear.

  In addition, the clinical trial information output apparatus 100 transmits the patient's symptom to the terminal device 10a when receiving information indicating that the side effect symptom of the clinical trial drug does not match the patient's symptom. For this reason, the investigator can be notified of information on symptoms that may have undiscovered side effects related to the investigational drug.

  Next, an example of a computer that executes a clinical trial information output program that realizes the same function as the clinical trial information output apparatus shown in the above embodiment will be described. FIG. 8 is a diagram illustrating an example of a computer that executes a clinical trial information output program.

  As shown in FIG. 8, the computer 200 includes a CPU 201 that executes various arithmetic processes, an input device 202 that receives input of data from a user, and a display 203. The computer 200 includes a reading device 204 that reads a program and the like from a storage medium, and an interface device 205 that exchanges data with other computers via a network. The computer 200 also includes a RAM 206 that temporarily stores various information and a hard disk device 207. The devices 201 to 207 are connected to the bus 208.

  The hard disk device 207 has a first output program 207a and a second output program 207b. The CPU 201 reads out each program 207a, 207b and develops it in the RAM 206.

  The first output program 207a functions as the first output process 206a. The second output program 207b functions as the second output process 206b.

  For example, the first output process 206 a corresponds to the first output unit 152. The second output process 206 b corresponds to the second output unit 153.

  Note that the programs 207a and 207b are not necessarily stored in the hard disk device 207 from the beginning. For example, each program is stored in a “portable physical medium” such as a flexible disk (FD), a CD-ROM, a DVD disk, a magneto-optical disk, and an IC card inserted into the computer 200. Then, the computer 200 may read and execute the programs 207a and 207b from these.

  The following supplementary notes are further disclosed with respect to the embodiments including the above examples.

(Additional remark 1) The memory | storage part which associates and memorize | stores the patient, the symptom of the side effect of the investigational drug about the clinical trial which this patient performs, and the coping method to this side effect,
If a symptom of a side effect associated with a certain patient is matched with a symptom of a side effect of an investigational drug associated with the certain patient when the symptom of a certain patient is received, A clinical trial information output device comprising: a control unit that reads out and outputs from the unit.

(Additional remark 2) The said memory | storage part further associates and memorize | stores the period when the symptom of the said side effect appears in a patient,
The control unit matches the symptom of a side effect of an investigational drug associated with the patient stored in the storage unit, and the time limit for the side effect symptom to appear in the patient has not passed. The clinical trial information output device according to appendix 1, wherein a coping method for a side effect associated with a patient is read from the storage unit and output.

(Additional remark 3) When the said control part does not correspond to the symptom of the side effect of the investigational drug linked | related with the said certain patient memorize | stored in the said memory | storage part, the said symptom of the said certain patient is received, and the symptom of the said certain patient is received. 3. The clinical trial information output device according to appendix 1 or 2, wherein the clinical trial information output device outputs the data to a designated external device.

(Appendix 4) A clinical trial information output method executed by a computer,
Refers to a storage device that stores a patient, a symptom of a side effect of an investigational drug for a trial performed by the patient, and a method for dealing with the side effect,
When a symptom of a certain patient is received and the symptom of the side effect of the investigational drug associated with the certain patient stored in the storage device is matched, the method for coping with the side effect associated with the certain patient is stored in the memory. A clinical trial information output method characterized by executing each processing to be read from the apparatus and output.

(Additional remark 5) The said memory | storage device memorize | stores the period when the symptom of the said side effect appears in a patient further in relation, The said process to output is the side effect of the investigational drug linked | related with the said certain patient memorize | stored in the said memory | storage device When the time limit for appearance of the side effect has not yet elapsed in the patient, the method for dealing with the side effect associated with the patient is read out from the storage device and output. The clinical trial information output method according to appendix 4.

(Additional remark 6) The said process to output receives the said symptom of the said certain patient, when it does not correspond to the symptom of the side effect of the investigational medicine linked | related with the said certain patient memorize | stored in the said memory | storage device, The symptom of the said certain patient Is output to a designated external device. 6. The clinical trial information output method according to appendix 4 or 5, wherein:

(Appendix 7)
Refers to a storage device that stores a patient, a symptom of a side effect of an investigational drug for a trial performed by the patient, and a method for dealing with the side effect,
When a symptom of a certain patient is received and the symptom of the side effect of the investigational drug associated with the certain patient stored in the storage device is matched, the method for coping with the side effect associated with the certain patient is stored in the memory. A clinical trial information output program that executes each process that is read from the apparatus and output.

(Additional remark 8) The said memory | storage device memorize | stores the period when the symptom of the said side effect appears in a patient further linked | related, and the said process to output is the side effect of the investigational drug linked | related with the said certain patient memorize | stored in the said memory | storage device When the time limit for appearance of the side effect has not yet elapsed in the patient, the method for dealing with the side effect associated with the patient is read out from the storage device and output. The clinical trial information output program according to appendix 7.

(Additional remark 9) The said process to output receives the said symptom of the said certain patient, when it does not correspond to the symptom of the side effect of the investigational medicine linked | related with the said certain patient memorize | stored in the said memory | storage device, The said symptom of the said certain patient Is output to a designated external device. 9. The clinical trial information output program according to appendix 7 or 8, wherein

100 Clinical Trial Information Output Device 152 First Output Unit 153 Second Output Unit

Claims (5)

A storage unit that stores a patient, a symptom of a side effect of an investigational drug for a clinical trial conducted by the patient, and a method for coping with the side effect;
If a symptom of a side effect associated with a certain patient is matched with a symptom of a side effect of an investigational drug associated with the certain patient when the symptom of a certain patient is received, A clinical trial information output device comprising: a control unit that reads out and outputs from the unit. The storage unit further stores a period in which the symptoms of the side effect appear in a patient,
The control unit matches the symptom of a side effect of an investigational drug associated with the patient stored in the storage unit, and the time limit for the side effect symptom to appear in the patient has not passed. The clinical trial information output apparatus according to claim 1, wherein a coping method for a side effect associated with a patient is read from the storage unit and output.   The control unit receives an symptom of the certain patient when the symptom of the side effect of the investigational drug associated with the certain patient stored in the storage unit is not matched, and designates the symptom of the certain patient as an external device The clinical trial information output device according to claim 1 or 2, wherein A clinical trial information output method executed by a computer,
Refers to a storage device that stores a patient, a symptom of a side effect of an investigational drug for a trial performed by the patient, and a method for dealing with the side effect,
When a symptom of a certain patient is received and the symptom of the side effect of the investigational drug associated with the certain patient stored in the storage device is matched, the method for coping with the side effect associated with the certain patient is stored in the memory. A clinical trial information output method characterized by executing each processing to be read from the apparatus and output. On the computer,
Refers to a storage device that stores a patient, a symptom of a side effect of an investigational drug for a trial performed by the patient, and a method for dealing with the side effect,
When a symptom of a certain patient is received and the symptom of the side effect of the investigational drug associated with the certain patient stored in the storage device is matched, the method for coping with the side effect associated with the certain patient is stored in the memory. A clinical trial information output program that executes each process that is read from the apparatus and output.

Images