JP2014194595A - Program, clinical test candidate extraction method and clinical test candidate extraction device - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a program capable of extracting a patient who has a high possibility to be participated in a clinical test as a clinical test candidate.SOLUTION: While referring to a RAM 313 storing information about diseases that patients suffer from and information about medicines administered to the patients, a control section 310 of a medical information server 300 implements the steps of: extracting a patient under medical treatment of a disease subjected to a designated investigational new drug and having the number of times of changing a medicine to be administered equal to or less than a first threshold value; and outputting the patient extracted in the extraction step as a candidate of a clinical test target. Therefore, a patient who has a high possibility to be participated in a clinical test can be extracted as a clinical test candidate.

Description

  The present invention relates to a program, a trial candidate extraction method, and a trial candidate extraction apparatus.

A clinical trial of a new drug (hereinafter referred to as a clinical trial) is conducted by, for example, a pharmaceutical company that has developed a new drug requesting a medical institution and administering the new drug to a subject such as a patient having a disease to which the new drug is applied . The pharmaceutical company confirms the safety, efficacy, dosage and administration of the new drug based on the test data collected from the subjects who received the new drug.
The selection of the subject is performed by a doctor who selects a patient who meets the standard according to the standard set by the pharmaceutical company. The doctor confirms the willingness to participate in the clinical trial for the selected patient, and if consent is obtained, an interview, medical examination, background survey, etc. are performed.

  Patent Document 1 discloses a clinical trial guidance method that enables a clinical trial for a disease that the person is not aware of or a disease that may develop in the future. Patent Document 2 discloses that trial volunteers registered with medical volunteer groups are requested to conduct clinical trials.

JP 2012-248005 A JP 2009-64200 A

  However, patients introduced by doctors about clinical trials may feel anxiety that recovery will be delayed because they will stop taking the drugs they are currently using when they start using the trial drugs. is there. There is also anxiety about taking new drugs for which safety has not been established. For these reasons, patients may have difficulty deciding to participate in a clinical trial, and as a result, clinical trial candidates may be difficult to gather.

  In one aspect, an object of the present invention is to provide a program, a clinical trial candidate extraction method, and a clinical trial candidate extraction apparatus that can support the extraction of clinical trial candidates.

  In one aspect, the program refers to storage means for storing information on a disease affected by a patient and information on a drug administered to the patient in a computer, and a disease targeted by the designated investigational drug. A procedure for extracting one or a plurality of patients whose number of changes in administered drug is not less than a first threshold, and the one or a plurality of patients extracted in the extraction procedure And a procedure for outputting as candidates.

  Also, in one aspect, the trial candidate extraction method refers to a storage means for storing information on a disease affected by a patient and information on a drug administered to the patient. A step of extracting one or a plurality of patients whose number of changes in administration drug is not less than a first threshold, and the one or a plurality of patients extracted in the extracting step. And outputting as a candidate for a clinical trial.

  Further, in one aspect, the trial candidate extracting device is designated with reference to a storage unit that stores information on a disease affected by a patient and information on a drug administered to the patient, and the storage unit. Extracting means for extracting one or a plurality of patients who are treating a disease targeted by the investigational drug and whose number of changes in the administered drug is equal to or more than a first threshold value, and the 1 extracted by the extracting means Or output means for outputting a plurality of patients as candidates for a clinical trial.

  It can assist the extraction of clinical trial candidates.

It is a figure which shows an example of a system configuration. It is a figure which shows an example of the hardware with which a medical information server is provided. It is a figure which shows an example of an administration condition table. It is a figure which shows an example of a clinical trial information table. It is a figure which shows an example of the extraction condition table of 1st Embodiment. It is a figure which shows an example of the functional block with which a medical information server is provided. It is a flowchart which shows the process sequence of the medical information server of 1st Embodiment. It is a figure which shows an example of the clinical trial selection screen displayed on the display apparatus of a medical institution terminal. It is a figure which shows an example of the screen which displays the clinical trial candidate extracted displayed on the display apparatus of a medical institution terminal. It is a flowchart which shows the process sequence of the medical information server of a modification. It is a figure which shows an example of the extraction condition table of 2nd Embodiment. It is a flowchart which shows the process sequence of the medical information server of 2nd Embodiment. It is a figure which shows an example of the administration condition table of 3rd Embodiment. It is a figure which shows an example of the extraction condition table of 4th Embodiment. It is a flowchart which shows the process sequence of the medical information server of 4th Embodiment.

(First embodiment)
FIG. 1 shows an example of the system configuration of this embodiment. The present embodiment includes a system configuration in which a pharmaceutical company terminal 100, a medical institution terminal 200, and a medical information server 300 are connected to a network 400. The network 400 may employ any type of communication network, such as the Internet (Internet), a LAN (Local Area Network), a WAN (Wide Area Network), and a VPN (Virtual Private Network), whether wired or wireless. Although two medical institution terminals 200 are illustrated in FIG. 1, these medical institution terminals 200 may be terminals of the same medical institution or terminals of different medical institutions. Further, the number of medical institution terminals 200 is not limited to two, and may be one or three or more. Similarly, the pharmaceutical company terminal 100 may be a terminal of the same pharmaceutical company or a terminal of a different pharmaceutical company, and the number of terminals is not limited to two. There may be three or more.

  The pharmaceutical company terminal 100 is a computer device installed in a pharmaceutical company that is a client of a clinical trial. A pharmaceutical company that has developed a new drug registers clinical trial information in the medical information server 300 and requests a medical institution to conduct a clinical trial. Details of the clinical trial information will be described later.

  The medical institution terminal 200 is a terminal installed in a medical institution where a doctor who is conducting a clinical trial is located, and is operated by a doctor or the like. The medical institution terminal 200 connects to the medical information server 300, acquires clinical trial information registered in the medical information server 300, and displays the clinical trial information on a display device (not shown) included in the medical institution terminal 200. The medical institution terminal 200 connects to the medical information server 300 and uploads the patient's electronic medical record created by the doctor to the medical information server 300.

  The medical information server 300 receives the clinical trial information uploaded from the pharmaceutical company terminal 100 and the electronic medical record uploaded from the medical institution terminal 200 and stores them in a storage device (described later) provided in the medical information server 300. In addition, the medical information server 300 extracts a patient that matches the clinical trial condition based on the clinical trial information uploaded from the pharmaceutical company terminal 100 and displays it on the display device of the display device included in the medical institution terminal 200.

Next, an example of hardware included in the medical information server 300 will be described with reference to FIG.
The medical information server 300 includes a control unit 310. The control unit 310 includes a CPU (Central Processing Unit) 311, a ROM (Read Only Memory) 312, and a RAM (Random Access Memory) 313. Each unit of the CPU 311, the ROM 312, and the RAM 313 is connected to the bus 360. The ROM 312 stores a control program used by the CPU 311 for control. The CPU 311 reads out the control program from the ROM 312 or the hard disk device (hereinafter referred to as HDD) 350 and stores it in the RAM 313. Thereafter, the CPU 311 performs processing (calculation) according to the control program stored in the RAM 313. The RAM 313 is used as a work memory for the CPU 311, and the RAM 313 stores data used by the CPU 311 for calculation, data after calculation by the CPU 311, and the like. Functional blocks realized by cooperation of hardware such as the CPU 311 and the RAM 313 and the control program will be described later with reference to FIG.

  The medical information server 300 includes an input device 321 and an input interface (hereinafter, the interface is abbreviated as I / F) 322. The input I / F 322 is connected to the input device 321 and the bus 360. The input device 321 is an input device such as a mouse or a keyboard. When the input device 321 is operated by the user, the input device 321 sends operation information indicating the received operation content to the control unit 310 via the input I / F 322. The input I / F 322 inputs operation information from the input device 321 and sends the input operation information to the control unit 310 via the bus 360.

  The medical information server 300 includes a graphic I / F 332 and a display device 331. The graphic I / F 332 is connected to the bus 360 and the display device 331. The graphic I / F 332 is an interface for causing the display device 331 to display graphic data processed by the control unit 310. The graphic I / F 332 converts the graphic data received from the control unit 310 into a waveform electric signal and sends it to the display device 331. The display device 331 displays, for example, clinical trial information and patient electronic medical record information.

  The medical information server 300 includes a network I / F 340. The network I / F 340 is connected to the bus 360 and the network 400. The network I / F 340 inputs the data sent from the control unit 310 and transmits the input data to the medical institution terminal 200 via the network 400. In addition, the network I / F 340 sends data received from the pharmaceutical company terminal 100 and the medical institution terminal 200 via the network 400 to the control unit 310.

  The medical information server 300 includes an HDD 350. The HDD 350 stores a control program used by the CPU 311 for control, clinical trial information uploaded by the pharmaceutical company terminal 100, electronic medical record information uploaded by the medical institution terminal 200, and the like. In FIG. 2, the HDD 350 is shown as an example of the storage device, but the storage device is not limited to the hard disk device. For example, a portable storage medium such as a computer-readable flexible disk (FD), DVD (Digital Versatile Disc), or DVD-RAM may be used. Further, it may be a portable storage medium such as a CD-ROM (Compact Disc Read Only Memory), a CD-R (Recordable) / RW (ReWritable), a magneto-optical disk, or an IC card.

  Next, details of data stored in the HDD 350 will be described with reference to FIGS. FIG. 3 shows an example of an administration status table generated by the control unit 310 and stored in the HDD 350. The administration status table is generated by the control unit 310 using the electronic medical record information uploaded from the medical institution terminal 200 to the medical information server 300. The information on the electronic medical record includes, for example, patient information such as the patient's name, patient ID (identification) given to the patient, information on the doctor in charge of the patient, and information such as the department and the date the patient was examined. included. In addition, the information of the electronic medical record includes the number of medical examinations, medical history, doctor's examination findings, medical treatment information such as treatment and examination received by the patient, and the like. The control unit 310 obtains patient information for identifying the patient, information on the disease the patient is suffering from, and data indicating the administration status of the drug administered to the patient (hereinafter referred to as administration status data) from the information on the electronic medical record. Then, it is registered in the administration status table shown in FIG. The patient information includes a patient ID and a patient name. The disease information includes a disease ID. The administration status data includes the administration drug name, administration start date, administration completion date, administration period, and status. The patient ID is identification information for identifying a patient. The disease ID is identification information for identifying the disease, and the disease ID of the patient indicated by the patient ID is recorded in the disease ID recording column of the administration status table. The administration drug name indicates the name of the administration drug administered to the patient indicated by the patient ID. The administration start date indicates the date on which administration of the administration drug indicated by the administration drug name is started to the patient indicated by the patient ID. The administration completion date indicates the date when administration of the administration drug indicated by the administration drug name is stopped to the patient indicated by the patient ID. The administration period indicates the number of days from the administration start date to the administration completion date. The status indicates the administration status of the administered drug. The status includes administration, drug change, and treatment complete. If the status is in administration, it indicates that the medication is still being administered to the patient. If the status is drug change, it indicates that the drug to be administered to the patient has been changed to another drug. If the status is treatment complete, it indicates that treatment for the patient has been completed.

  FIG. 4 shows an example of a clinical trial information table generated by the control unit 310 and stored in the HDD 350. The clinical trial information table is a table in which medical information uploaded by the pharmaceutical company terminal 100 to the medical information server 300 is registered. Information registered in the clinical trial information table includes a clinical trial ID, a clinical trial name, a disease ID, a disease name, and an implementation period. The clinical trial ID is identification information for identifying a clinical trial. The trial name is the name of the trial. The disease ID is identification information for identifying a disease that is the subject of a clinical trial. The disease name is the name of the disease indicated by the disease ID. The implementation period is information indicating a period for conducting the clinical trial.

  FIG. 5 shows an example of an extraction condition table used for extracting trial candidates. The extraction condition table is also a table stored in the HDD 350, for example, information that a pharmaceutical company employee uploads to the medical information server 300 and registers using the pharmaceutical company terminal 100. Information registered in the extraction condition table includes a disease ID, a disease name, and the number of first drug changes. The disease ID is identification information for identifying a disease to be studied, and the disease name is the name of the disease indicated by the disease ID. The first drug change count is a threshold value for identifying a patient whose administration drug change count is large. When the patient suffering from the disease indicated by the disease ID has changed the administered drug more than the first drug change count, the corresponding patient is extracted as a clinical trial candidate. The reason why the number of first drug changes differs depending on the disease is that the number of changes that can be determined to frequently change the drug differs depending on the nature of the disease. For example, in the case of a disease that requires the patient to actually take a medicine and check whether the medicine is effective, the value of the number of medicine changes is set high. Note that the number of first medicine changes corresponds to the first threshold value.

  Next, the functional block 370 included in the medical information server 300 will be described with reference to FIG. The function block 370 is a block in which processes realized by cooperation of hardware such as the CPU 311 and the RAM 313 of the control unit 310 and the control program are grouped for each function realized by a series of processes. The medical information server 300 includes, as a function block 370, an administration status data acquisition unit 371, an input unit 372, an extraction unit 373, and an output unit 374.

  The administration status data acquisition unit 371 acquires patient information, disease information, and administration status data from the electronic medical record information uploaded by the medical institution terminal 200 and stored in the HDD 350, and registers it in the administration status table. The administration status data acquisition unit 371 first reads out the electronic medical record information and the administration status table from the HDD 350 and stores them in the RAM 313. The administration status data acquisition unit 371 reads out information on the disease ID, patient ID, patient name, administration drug name, administration start date, administration completion date, administration period, and status from the electronic medical record information as administration status data. Register in the status table.

  The input unit 372 inputs a trial information acquisition request from the medical institution terminal 200 connected via the network 400. When the input request for the trial information is input, the input unit 372 notifies the extraction unit 373 and the output unit 374 that there is a request for acquiring the trial information. Further, when the selection information for selecting the clinical trial information is input from the medical institution terminal 200 among the plurality of clinical trial information displayed on the display device of the medical institution terminal 200, the input unit 372 extracts the input selection information. Output to.

  Upon receiving notification that the trial information acquisition request has been input from the input unit 372, the extraction unit 373 reads the administration status table, the trial information table, and the extraction condition table from the HDD 350 and stores them in the RAM 313. Further, when the selection information of the clinical trial information is input from the input unit 372, the extraction unit 373 refers to the clinical trial information table and acquires the disease ID of the disease targeted by the selected clinical trial. Next, the extraction unit 373 acquires the administration status data of the patient ID registered with the acquired disease ID with reference to the administration status table. Next, the extraction unit 373 acquires the first medicine change count with reference to the extraction condition table. The extraction unit 373 counts the number of administered drugs whose “medicine change” is registered as the status for each patient ID, and extracts patients who have changed the administered drug more than the acquired first drug change count. The number of patients to be extracted may be one or plural. When there is a patient whose administration drug has been changed more than the number of times of the first drug change, the extraction unit 373 selects the extracted patient as a clinical trial candidate, and selects the patient name and patient ID of the selected clinical trial candidate. The trial candidate information is stored in the RAM 313. Further, the extraction unit 373 issues a transmission instruction to the output unit 374 so as to transmit the extracted clinical trial candidate information to the connected medical institution terminal 200.

  When the output unit 374 receives from the input unit 372 a notification that a request for acquiring clinical trial information has been input, the output unit 374 acquires clinical trial information from the clinical trial information table stored in the RAM 313. The output unit 374 outputs the acquired clinical trial information to the network I / F 340, and instructs the network I / F 340 to transmit the clinical trial information to the medical institution terminal 200 that has output the acquisition request. When the output unit 374 receives a trial candidate information transmission instruction from the extraction unit 373, the output unit 374 acquires trial candidate information stored in the RAM 313. The output unit 374 outputs the acquired clinical trial candidate information to the network I / F 340 and instructs the network I / F 340 to transmit the clinical trial candidate information to the medical institution terminal 200.

Next, the processing procedure of the control unit 310 of the medical information server 300 will be described with reference to the flowchart shown in FIG.
When receiving the connection request from the medical institution terminal 200, the control unit 310 of the medical information server 300 performs authentication processing and connects to the medical institution terminal 200. When receiving the trial information acquisition request from the connected medical institution terminal 200 (step S1 / YES), the control unit 310 transmits the trial information for which the acquisition request has been received to the medical institution terminal 200 (step S2). The control unit 310 outputs the clinical trial information stored in the RAM 313 to the network I / F 340 and instructs the medical institution terminal 200 that has output the acquisition request to send the clinical trial information. The medical institution terminal 200 displays the clinical trial information received from the medical information server 300 on the display device (step S2). FIG. 8 shows an example of a screen displayed on the display device of the medical institution terminal 200. On the display device of the medical institution terminal 200, the name of the trial, the name of the disease targeted for the trial, the duration of the trial, and a selection button for selecting the trial are displayed for each trial.

  The doctor of the medical institution selects a disease to be studied with reference to the clinical trial information displayed on the display device of the medical institution terminal 200. The medical institution terminal 200 includes input devices such as a mouse and a keyboard, and a doctor operates the input device to select a disease selection button. When the selection button is operated, selection information for selecting a disease corresponding to the button operation is transmitted from the medical institution terminal 200 to the medical information server 300. Specifically, the clinical trial ID is transmitted from the medical institution terminal 200 to the medical information server 300 as selection information.

When the selection information of the clinical trial information is input from the medical institution terminal 200 (step S3 / YES), the control unit 310 refers to the clinical trial information table shown in FIG. 4 and the disease of the disease targeted by the clinical trial corresponding to the selection information. ID is acquired (step S4). Specifically, the control unit 310 acquires a disease ID associated with the clinical trial ID received from the medical institution terminal 200 from the clinical trial information table.
Next, the control unit 310 refers to the administration status table shown in FIG. 3 and determines whether there is a patient registered with the acquired disease ID (step S5). For example, when the disease ID acquired from the clinical trial information table is S01, the control unit 310 determines whether or not there is a patient whose disease ID is registered in S01 in the administration status table shown in FIG. When there is no patient registered with the acquired disease ID in the administration status table (step S5 / NO), the control unit 310 stores information “no trial candidate” in the RAM 313. In addition, the control unit 310 transmits information “no trial candidate” to the connected medical institution terminal 200 via the network I / F 340. Information indicating “no trial candidate” is displayed on the display device of the medical institution terminal 200 (step S10).

  When there is a patient registered with the acquired disease ID in the administration status table (step S5 / YES), the control unit 310 acquires a record registered with the corresponding disease ID in the administration status table (step S5 / YES). S6). Next, the control part 310 acquires the 1st medicine change frequency with reference to the extraction condition table shown in FIG. When the number of first medicine changes is acquired, control unit 310 refers to the record acquired in step S6 and counts the number of records whose status is “drug change” for each patient ID (step S7). When the number of records is counted for each patient ID, control unit 310 determines whether or not there is a patient ID equal to or greater than the “first drug change count” acquired from the extraction condition table (step S8). For example, in the extraction condition table shown in FIG. 5, the number of times of changing the first medicine whose disease ID is S01 is registered as 3 times. Control unit 310 selects a patient whose number of drug changes is three or more from patients who have obtained administration status data. For example, in the example shown in FIG. 3, since “Taro Fujitsu” is a patient who satisfies the condition that the number of drug changes is 3 or more, the control unit 310 extracts “Taro Fujitsu” as a clinical trial candidate. The number of patients to be extracted may be one or a plurality of patients. The control unit 310 stores the extracted patient name of the trial candidate and the patient ID in the RAM 313 as trial candidate information. In addition, the control unit 310 transmits the extracted clinical trial candidate information to the connected medical institution terminal 200 via the network I / F 340. Information on clinical trial candidates is displayed on the display device of the medical institution terminal 200 as shown in FIG. 9 (step S9).

  As described above in detail, in the present embodiment, patients whose number of changes in administered drug is larger than the number of first drug changes, which is a reference value set for each disease, are extracted as trial candidates. Therefore, patients who are highly likely to participate in the clinical trial can be extracted as clinical trial candidates. Moreover, since the trial candidate is a patient whose administration drug is frequently changed, that is, a patient who is difficult to achieve the effect of the conventional drug, when the clinical trial is conducted, the patient can easily verify the superiority to the conventional drug.

<Modification>
In the flowchart shown in FIG. 7, patients whose counted number of records is equal to or greater than the “first drug change count” acquired from the extraction condition table are extracted as clinical trial candidates and displayed on the display device of the medical institution terminal 200. . That is, paying attention to the number of changes of the administered drug registered with the status “medicine change”, patients whose number of changes of the administered drug is equal to or more than the first drug change number have been extracted. However, among the currently administered drugs whose status is registered as “administering” in the administration status table, there are drugs that have just started to be administered to the patient. If it has just begun to be administered to a patient, it may not yet be clear whether it is effective. In addition, there is a case where the administration drug registered with the status “in administration” has not been changed because of the effect of the administration drug. Since such a patient is considered to be unlikely to participate in the clinical trial, the control unit 310 may exclude the patient from the clinical trial candidate.

The processing procedure of this modification will be described with reference to the flowchart shown in FIG. The processing procedure up to step S8 is the same as the processing flow shown in FIG.
The controller 310 determines whether or not there is a patient whose counted number of records is equal to or greater than the “first drug change count” acquired from the extraction condition table (step S8). When there is a patient whose number of records is equal to or greater than the “number of times of first drug change” (step S8 / YES), the control unit 310 has a status of “administering” in the administered drug of the patient with the patient ID extracted in step S8. It is determined whether or not there is. When there is an administered drug whose status is being administered (step S11 / YES), control unit 310 obtains the administration period of the administered drug from the administration status table. And the control part 310 compares the acquired administration period with the preset 1st reference | standard days, and the medicine in administration is whether the number of days after starting administration is below the 1st reference | standard days. Is determined (step S12). In addition, it is good to set the 1st reference | standard days, for example to the average value of the days when the effect was shown in the patient who administered the administration medicine, or the days shorter than this average value. Moreover, you may set the 1st reference | standard days to the number of days considered that the effect of the generally administered medicine appears instead of setting for every medicine to administer. The first reference day corresponds to the fifth threshold value. When the number of days from the start of administration is equal to or less than the first reference number of days (step S12 / YES), control unit 310 excludes the corresponding patient from the trial candidates. When the number of days from the start of administration is greater than the first reference day (step S12 / NO), control unit 310 then compares the number of days from the start of administration with the second reference day (step S13). The second reference number of days is a number of days for determining a case where the patient has not changed the administration drug because he / she feels the effect of the administration drug, and the number of days is set larger than the first reference day. The second reference days correspond to the sixth threshold value. When it is determined that the number of days from the start of administration is equal to or greater than the second reference number of days (step S13 / YES), the control unit 310 excludes the corresponding patient from the trial candidates. Further, when determining that the number of days from the start of administration is less than the second reference number of days (step S13 / NO), the control unit 310 stores the patient ID of the corresponding patient in the RAM 313 as a “trial candidate” (step S14). ).

  Next, the controller 310 determines whether there is another patient ID extracted in step S8 (step S15). If there is another patient ID (step S15 / YES), control unit 310 repeats the processing from step S11. When determining that there is no other patient ID (step S15 / NO), the control unit 310 generates information to be displayed on the display device of the medical institution terminal 200. The control unit 310 first determines whether or not there is a patient ID stored as “trial candidate” in the RAM 313 (step S16). When it is determined that there is a patient ID stored as a “clinical trial candidate” (step 16 / YES), the control unit 310 refers to the administration status table and the patient name of the patient with the corresponding patient ID and information on the administered drug. To get. The control unit 310 displays information such as the acquired patient ID and patient name on the display device of the medical institution terminal 200 (step S17). In addition, when it is determined that there is no patient ID stored as “trial candidate” (step S16 / NO), the control unit 310 displays “no trial candidate” on the display device of the medical institution terminal (step S16). S18).

  In this modification, the accuracy of extracting patients who are likely to participate in the trial by excluding patients who have just been administered a new drug or patients who are effective for the drug being administered from the trial candidates is further improved. be able to.

(Second Embodiment)
A second embodiment will be described. The system configuration of the second embodiment is the same as that of the first embodiment shown in FIG. 1, and the hardware configuration of the medical information server 300 is also the same as that of the first embodiment shown in FIG. To do.

  FIG. 11 shows an example of the configuration of the extraction condition table of the second embodiment. In the extraction condition table of the second embodiment, in addition to the number of drug changes, a reference number of days is registered for each disease ID. The extraction unit 373 of the second embodiment has a drug change count equal to or greater than the “first drug change count”, and the average value of the administration period of each administered drug acquired from the extraction condition table “third criterion” Patients who are less than “days” are selected as trial candidates. Patients whose average drug administration period is less than or equal to a predetermined number of days change the drug frequently, so there is a high possibility that the effect of the administered drug is not so much. For this reason, by adding the condition that “the average value of the administration period of the administered drug is equal to or less than the third reference number of days” to the condition for extracting trial candidates, the accuracy of extracting patients who are difficult to achieve with conventional drugs is improved. Can be made. Note that the third reference number of days corresponds to the second threshold value.

The processing procedure of this embodiment will be described with reference to the flowchart shown in FIG. Note that the procedure up to step S8 in the flowchart shown in FIG. 7 is the same as that in the first embodiment, and a description thereof will be omitted.
The control unit 310 counts the number of records whose status is “drug change”, and determines whether or not there is a patient ID equal to or greater than the “first drug change count” acquired from the extraction condition table. (Step S8). When there is a patient ID with the number of records equal to or greater than the “number of times of first drug change”, the control unit 310 calculates an average value of the administration periods of each administered drug administered to the patient with the corresponding patient ID (step S21). . When the average value of the administration period is calculated, the control unit 310 compares the calculated average value with the “third reference number of days” registered in the extraction condition table (step S22). When it is determined that the calculated average value is equal to or less than the “third reference day” registered in the extraction condition table (step S22 / YES), the control unit 310 extracts the patient name and patient ID of the extracted clinical trial candidate. Are stored in the RAM 313 as trial candidate information. In addition, the control unit 310 transmits the extracted clinical trial candidate information to the connected medical institution terminal 200 via the network I / F 340. Information on clinical trial candidates is displayed on the display device of the medical institution terminal 200 as shown in FIG. 9 (step S23). If it is determined that the calculated average value is larger than the “third reference number of days” registered in the extraction condition table (step S22 / NO), the control unit 310 stores information “no trial candidate” in the RAM 313. Remember me. In addition, the control unit 310 transmits information “no trial candidate” to the connected medical institution terminal 200 via the network I / F 340. Information indicating “no trial candidate” is displayed on the display device of the medical institution terminal 200 (step S24).

As described above, in the present embodiment, the trial candidates are extracted in consideration of the average number of days of administration of each administered drug as well as the number of changes in the administered drug. Accuracy can be improved.
In the second embodiment, as in the modification of the first embodiment shown in FIG. 10, the administration days of the administration drug whose status is “in administration” are compared with the first reference days and the second reference days. Also good. By excluding patients who have just been administered a new drug or patients who are effective for the drug being administered from the trial candidates, the accuracy of extracting patients who are likely to participate in the trial can be further increased.

(Third embodiment)
A third embodiment will be described with reference to the accompanying drawings. The system configuration of the third embodiment is the same as that of the first embodiment shown in FIG. 1, and the hardware configuration of the medical information server 300 is also the same as that of the first embodiment shown in FIG. To do.

  In the first and second embodiments described above, it is determined whether or not the patient frequently changes the administration drug using information on the electronic medical record generated by one medical institution. However, patients may change medical institutions and visit other medical institutions if they are unable to feel the effects of prescribed medications. For this reason, the medical information server 300 according to the third embodiment outputs a patient whose total number of changes of the administered drug administered at a plurality of hospitals is equal to or more than the first drug change number as a candidate for the investigational drug.

  Specifically, the medical information server 300 receives electronic medical chart information from a plurality of medical institutions in order to cope with a case where a patient is visiting a plurality of medical institutions. When acquiring administration status data from the electronic medical record, the administration status data acquiring unit 371 shown in FIG. 6 refers to the patient name, the current address of the patient, information on the health insurance insured card, etc. recorded in the electronic medical record. The administration status data acquisition unit 371 determines whether or not the patient is a patient who has already registered the administration status data in the administration status table. When the administration status data of the patient is already registered in the administration status table, the administration status data acquisition unit 371 registers the administration status data in association with the patient ID registered in the administration status table. FIG. 13 shows an example of the administration status table of this embodiment. The administration status table of this embodiment is provided with a medical institution ID record field for identifying a medical institution. That is, in the administration status table of this embodiment, the medical institution ID of the medical institution received by the patient is recorded together with the patient information, disease information, and administration status data. When acquiring administration status data from the electronic medical record, the administration status data acquisition unit 371 also acquires information on the medical institution and determines the medical institution from the acquired information on the medical institution. The administration status data acquisition unit 371 records the determined medical institution ID of the medical institution in the administration status table.

Moreover, when the extraction part 373 shown in FIG. 6 extracts each patient's record from an administration condition table, the record to which the same patient ID was attached | subjected belongs to the same patient even if medical institution ID differs. Judge that there is. That is, the extraction unit 373 counts the number of records whose status is “drug change” for each patient ID. For this reason, in this embodiment, a patient whose total number of changes of administered drugs administered at a plurality of hospitals is equal to or greater than the number of first drug changes can be output as a candidate for an investigational drug.
Also in the present embodiment, as in the second embodiment, the extraction unit 373 extracts the average value of the administration period of each administered drug with the drug change count equal to or greater than the “first drug change count”. You may extract the patient below "the 3rd standard days" acquired from the condition table.
Also in the second embodiment, as in the modification of the first embodiment shown in FIG. 10, the administration days of the administration drug whose status is “in administration” are compared with the first reference days and the second reference days. Also good. By excluding patients who have just been administered a new drug or patients who are effective for the drug being administered from the trial candidates, the accuracy of extracting patients who are likely to participate in the trial can be further increased.

  As described above, in the present embodiment, even when the patient is visiting a plurality of medical institutions, the administration status data is registered in association with the same patient ID, so that the administration drug to which the patient is administered is changed. It can be determined whether or not the patient has a high frequency. For this reason, it is possible to improve the accuracy of extracting patients who are difficult to achieve with conventional drugs.

(Fourth embodiment)
A fourth embodiment will be described. The system configuration of the fourth embodiment is the same as that of the first embodiment shown in FIG. 1, and the hardware configuration of the medical information server 300 is also the same as that of the first embodiment shown in FIG. To do.

  In the present embodiment, when the number of clinical trial candidates extracted using the first drug change count and the third reference day number is less than a predetermined number, at least one condition of the drug change count and the reference day number is changed. Then, trial candidates are extracted again.

FIG. 14 shows an example of the extraction condition table of this embodiment. In the extraction condition table of the present embodiment, two change counts, the first drug change count and the second drug change count, are registered as the drug change count. Similarly, two reference days, a third reference day and a fourth reference day, are registered as the reference days.
When the number of trial candidates was extracted using the number of first medicine changes and the number of third standard days, the number of trial candidates changed and the fourth standard days were below a predetermined number. This is a parameter used in the case. The conditions for the number of times of the second drug change are relaxed than those for the number of times of the first drug change, and the conditions for the fourth standard days are also relaxed than for the third standard days. That is, the number of times of changing the second medicine is set to be smaller than the number of times of changing the first medicine. In addition, the fourth reference day is set to have a larger number of days than the third reference day. The number of times of changing the second medicine corresponds to the third threshold value, and the fourth reference day corresponds to the fourth threshold value.

The processing procedure of this embodiment will be described with reference to the flowchart shown in FIG. Note that the procedure up to step S22 in the flowchart shown in FIG. 12 is the same as that in the second embodiment, and a description thereof will be omitted.
When the trial candidate is extracted in the determination process of step S22, the control unit 310 determines whether or not the extracted number of clinical trial candidates is a predetermined number or more (step S31). When the extracted number of clinical trial candidates is equal to or greater than the predetermined number (step S31 / YES), the control unit 310 displays the patient ID and patient name of the extracted patient on the display device of the medical institution terminal 200 as clinical trial candidates. (Step S32). If the extracted number of trial candidates is less than the predetermined number (step S31 / NO), the control unit 310 changes the number of drug changes and the reference days to other values, Repeat the extraction. Control unit 310 changes the first medicine change count to the second medicine change count, and changes the third reference days to the fourth reference days (step S33).

  Next, the control unit 310 determines whether or not there is a patient ID whose drug change count is equal to or greater than the second drug change count in the number of records counted for each patient ID in step S7 shown in FIG. S34). When it is determined that there is no patient ID whose number of medicine changes is equal to or greater than the number of times of changing the second medicine (step S34 / NO), the controller 310 proceeds to the process of step S39. When it is determined that there is a patient ID whose number of drug changes is equal to or greater than the number of times of changing the second drug (step S34 / YES), the control unit 310 administers each administration drug administered to the patient with the corresponding patient ID. Is calculated (step S35). When the average value of the administration period is calculated, the control unit 310 compares the calculated average value with the fourth reference day (step S36). When it is determined that the calculated average value of the administration period is equal to or less than the fourth reference number of days (step S36 / YES), the control unit 310 displays the extracted trial candidate patient name and patient ID as trial candidate information. Is stored in the RAM 313 (step S37). Further, when the calculated average value of the administration period is larger than the fourth reference number of days (step S36 / NO), the control unit 310 proceeds to the process of step S38.

  In step S38, control unit 310 determines whether there is another patient ID extracted in step S34. If there is another patient ID (step S38 / YES), control unit 310 repeats the processing from step S35. When determining that there is no other patient ID (step S38 / NO), the control unit 310 generates information to be displayed on the display device of the medical institution terminal 200. The controller 310 determines whether or not there is a patient ID stored as “trial candidate” in the RAM 313 (step S39). When it is determined that there is a patient ID stored as a “trial candidate” (step 39 / YES), the control unit 310 refers to the administration status table and information on the patient name and the administered drug of the patient with the corresponding patient ID. To get. The control unit 310 displays information such as the acquired patient ID and patient name on the display device of the medical institution terminal 200 (step S32). Further, when it is determined that there is no patient ID stored as “trial candidate” (step S39 / NO), the control unit 310 displays “no trial candidate” on the display device of the medical institution terminal (step S39). S40).

  In the flowchart shown in FIG. 15, the example in which the trial candidate is extracted again by changing the conditions of both the drug change count and the reference number of days has been described. However, it is not always necessary to change both conditions to extract trial candidates, and it is preferable to re-extract trial candidates while relaxing at least one of the conditions for the number of drug changes and the reference days.

  As described above, in the present embodiment, when the number of clinical trial candidates extracted is less than the predetermined number, the clinical trial candidates are extracted again by relaxing the extraction conditions. For this reason, possibility that the number of patients extracted as a clinical trial candidate will become more than predetermined number can be raised.

  The above-described embodiment is 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. For example, in the above-described embodiment, the case where the program is stored in the ROM 312 or the HDD 350 has been described as an example. However, the program is not necessarily stored in the ROM 312 or the HDD 350. For example, a portable storage medium such as a computer-readable flexible disk (FD), DVD, or DVD-RAM may be used. Moreover, portable storage media, such as CD-ROM, CD-R / RW, a magneto-optical disc, and an IC card, may be sufficient. Alternatively, the program may be stored in another computer (for example, a server) connected to the computer via a public line, the Internet, a LAN, a WAN, or the like, and the computer may read and execute the program. Alternatively, the program may be stored in a portable storage medium or storage medium from another computer (or server) via a public line, the Internet, a LAN, a WAN, or the like, and the computer may read the program from there and execute it.

In addition, the following additional notes are disclosed regarding the above description.
(Supplementary note 1)
A patient who is treating a disease targeted by a designated investigational drug with reference to a storage means for storing information on the disease affected by the patient and information on a drug administered to the patient, A procedure for extracting one or more patients whose number of changes is equal to or greater than a first threshold;
Outputting the one or more patients extracted in the extracting procedure as a candidate for a clinical trial;
A program characterized by having executed.
(Additional remark 2) The said extraction procedure is the number of days from the start date of administration to the date of ending administration for each administered drug administered to the patient, wherein the number of changes of the administered drug is not less than the first threshold value. The program according to appendix 1, wherein patients whose average value is equal to or less than a second threshold value are extracted as candidates for the trial subject.
(Additional remark 3) The said extraction procedure is the 3rd threshold value whose value is smaller than the said 1st threshold value when the number of patients extracted as said candidate for clinical trial is below a predetermined number. The corresponding patient is extracted by changing the value, and the average value of the number of days from the start date of administration to the end date of administration for each administered drug administered to the patient is extracted from the extracted patients. 3. The program according to appendix 2, wherein a patient having a value greater than a threshold value and not more than a fourth threshold value is further extracted as a candidate for the trial.
(Supplementary Note 4) When the patient is undergoing a medical examination at a plurality of hospitals, the procedure for extracting the patients whose total number of changes in administered drugs administered at a plurality of hospitals is greater than or equal to the first threshold value The program according to appendix 1, wherein the program is output as a candidate for an investigational drug.
(Additional remark 5) The said extraction procedure is for the patient who is the subject of the clinical trial, the patients whose elapsed days from the administration start date of the administration drug being administered are less than or equal to the fifth threshold, and the administration drug being administered From the supplementary note 1, characterized in that at least one of the patients whose elapsed days from the administration start date is not less than the sixth threshold value, which is larger than the fifth threshold value, is excluded from the candidates for the trial. 5. The program according to any one of 4.
(Appendix 6) A patient who is treating a disease targeted by a specified investigational drug with reference to storage means for storing information on the disease affected by the patient and information on a drug administered to the patient. Extracting one or a plurality of patients whose administration drug change count is equal to or greater than a first threshold;
Outputting the one or more patients extracted in the extracting step as trial candidates;
A clinical trial candidate extraction method characterized by comprising:
(Additional remark 7) The said extraction step is the number of days from the start date of administration to the date of ending administration for each administered drug administered to the patient, wherein the number of changes of the administered drug is not less than the first threshold value. 7. The trial candidate extraction method according to appendix 6, wherein a patient whose average value is equal to or smaller than a second threshold is extracted as a candidate for the trial.
(Supplementary Note 8) In the extracting step, when the number of patients extracted as candidates for the clinical trial is equal to or smaller than a predetermined number, the number of changes of the administration drug is set to a third threshold value smaller than the first threshold value. The corresponding patient is extracted by changing the value, and the average value of the number of days from the start date of administration to the end date of administration for each administered drug administered to the patient is extracted from the extracted patients. 8. The trial candidate extraction method according to appendix 7, wherein a patient who is not more than a fourth threshold value that is larger than a threshold value is further extracted as a candidate for the trial target.
(Supplementary Note 9) In the step of extracting, when a patient is undergoing a medical examination at a plurality of hospitals, a patient whose total number of changes in administered drugs administered at a plurality of hospitals is equal to or more than the first threshold value is selected. The clinical trial candidate extraction method according to appendix 6, wherein the clinical trial candidate is output as a trial drug candidate.
(Supplementary Note 10) In the extraction step, among the candidate patients for the trial, patients whose elapsed days from the administration start date of the administration drug being administered are not more than a fifth threshold value, and the administration drug being administered From the supplementary note 6, characterized in that at least one of the patients whose elapsed days from the administration start date are not less than the sixth threshold value, which is larger than the fifth threshold value, is excluded from the candidates for the trial. The trial candidate extraction method according to any one of claims 9 to 9.
(Additional remark 11) The memory | storage means to memorize | store the information of the disease which a patient suffers, and the information of the administration medicine administered to the said patient,
Extracting means for extracting one or a plurality of patients who are treating a disease targeted by the designated investigational drug with reference to the storage means and whose number of changes in the administered drug is equal to or more than a first threshold value When,
Output means for outputting the one or more patients extracted by the extraction means as candidates for clinical trials;
A clinical trial candidate extraction apparatus comprising:
(Additional remark 12) The said extraction means is the average of the number of days from the day of administration start to the day when administration was completed for each of the drugs administered to the patient whose number of changes of the administration drug is not less than the first threshold value. The trial candidate extracting device according to supplementary note 11, wherein a patient whose value is equal to or less than a second threshold is extracted as a candidate for the trial.
(Supplementary note 13) When the number of patients extracted as candidates for the clinical trial is less than or equal to a predetermined number, the extraction means sets the number of changes of the administered drug to a third threshold value that is smaller than the first threshold value. The corresponding patient is extracted and the average value of the number of days from the start date of administration to the end date of administration for each administered drug administered to the patient is extracted from the extracted patients. 13. The trial candidate extracting device according to appendix 12, wherein a patient having a value larger than a value and not more than a fourth threshold value is further extracted as a candidate for the trial target.
(Additional remark 14) The said extraction means, when the patient is consulting in several hospitals, the said trial is a patient whose sum total of the frequency | count of change of the administration medicine administered in several hospitals is more than the said 1st threshold value. The trial candidate extracting device according to appendix 11, wherein the candidate for clinical trial is output as a drug candidate.
(Supplementary Note 15) The extraction means includes a patient whose number of days elapsed from the administration start date of the administration drug being administered is less than or equal to a fifth threshold among the candidate patients to be studied, and administration of the administration drug being administered Appendices 11 to 14, wherein at least one of the patients whose elapsed days from the start date are not less than a sixth threshold value that is larger than the fifth threshold value is excluded from the candidates for the trial. The trial candidate extraction device according to any one of the above.

DESCRIPTION OF SYMBOLS 100 Pharmaceutical company terminal 200 Medical institution terminal 300 Medical information server 310 Control part 371 Administration condition data acquisition part 372 Input part 373 Extraction part 374 Output part

Claims (7)

On the computer,
A patient who is treating a disease targeted by a designated investigational drug with reference to a storage means for storing information on the disease affected by the patient and information on a drug administered to the patient, A procedure for extracting one or more patients whose number of changes is equal to or greater than a first threshold;
A procedure for outputting the extracted one or more patients as candidates for a clinical trial;
A program characterized by having executed.   In the extraction procedure, the average number of days from the start date of administration to the end date of administration for each of the administered medications administered to the patient is equal to or greater than the first threshold value. The program according to claim 1, wherein patients having two threshold values or less are extracted as candidates for the clinical trial.   In the extracting procedure, when the number of patients extracted as candidates for the clinical trial is equal to or less than a predetermined number, the number of changes of the administration drug is changed to a third threshold value that is smaller than the first threshold value. And the average value of the number of days from the start date of administration to the end date of administration is greater than the second threshold value for each administered drug administered to the patient. 3. The program according to claim 2, wherein a patient having a large value that is not more than a fourth threshold value is further extracted as a candidate for the trial.   In the extraction procedure, when a patient is being examined at a plurality of hospitals, a patient whose total number of changes in administration drugs administered at a plurality of hospitals is not less than the first threshold is selected as a candidate for the investigational drug. The program according to claim 1, wherein the program is output as:   The extraction procedure includes, among the candidate patients to be studied, patients whose elapsed days from the administration start date of the administration drug being administered are not more than a fifth threshold, and from the administration start date of the administration agent being administered. 5. The method according to claim 1, wherein at least one of a patient whose elapsed days are not less than a sixth threshold value greater than the fifth threshold value is excluded from the candidates for the trial. A program according to any one of the above. A patient who is treating a disease targeted by a designated investigational drug with reference to a storage means for storing information on the disease affected by the patient and information on a drug administered to the patient, Extracting one or more patients whose number of changes is greater than or equal to a first threshold;
Outputting the one or more patients extracted in the extracting step as trial candidates;
A clinical trial candidate extraction method characterized by comprising: Storage means for storing information on a disease affected by a patient and information on a drug administered to the patient;
Extracting means for extracting one or a plurality of patients who are treating a disease targeted by the designated investigational drug with reference to the storage means and whose number of changes in the administered drug is equal to or more than a first threshold value When,
Output means for outputting the one or more patients extracted by the extraction means as candidates for clinical trials;
A clinical trial candidate extraction apparatus comprising:

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