JP6628238B1 - Clinical trial qualification system, clinical trial qualification method, clinical trial qualification device and clinical trial qualification program - Google Patents

Abstract

An execution result acquisition unit 21 that instructs a user to execute a predetermined process using medical software, and acquires execution result information indicating a result of the process executed by the user in response to the instruction; and the acquired execution result. Eligibility as a subject to participate in a clinical trial of medical software from at least one viewpoint of the reliability of whether or not the person is an incentive incentive based on the information and the proficiency in operating the information processing device. And a qualification judging unit 23 for judging the gender of the medical software. In conducting a clinical test of the medical software, the medical software is actually used by a user, and is obtained as a result of executing a process for a given instruction. Based on the execution result information, the eligibility as a subject is determined from the viewpoint of reliability and proficiency. User to be able to determine appropriately whether qualify as subjects.

Description

  The present invention relates to a clinical trial qualification system, a clinical trial qualification method, a clinical trial qualification apparatus, and a clinical trial qualification program, and in particular, eligibility as a subject to participate in a clinical trial of medical software. It is suitable for use in a system for determining

  Generally, in the development process of new drugs, medical devices, treatment methods, and the like, clinical tests (clinical trials) are performed on a plurality of subjects in order to confirm their safety, efficacy, and the like. A clinical test is performed using a patient having a specific disease or the like as a subject depending on the purpose. 2. Description of the Related Art Conventionally, systems have been proposed that execute a process of extracting a patient suffering from a disease to be subjected to a clinical test as a subject (for example, see Patent Documents 1 and 2).

  Patent Literature 1 discloses that a patient who is being treated for a disease targeted by a designated investigational drug and whose change number of the administration drug is equal to or more than a threshold value is output as a candidate for a trial target. I have. Patent Document 2 discloses that a patient to which an identifier of a disease related to a clinical trial is associated and whose treatment period exceeds the reference number of days for the disease related to the clinical trial is output as a candidate for a clinical trial. Is disclosed.

  The systems described in Patent Literatures 1 and 2 extract a clinical test subject from a patient who is already under treatment by a doctor. In response to this, the results of interviews, consultations, background surveys, etc. by physicians were collected from test candidates collected through recruitment by drug companies, medical devices, treatment methods, etc., or by recruiting by medical institutions commissioned by the company. In some cases, a subject is extracted from a viewpoint of whether or not a predetermined standard regarding subject compatibility is satisfied through a compatibility test performed based on the subject (for example, see Patent Document 3).

  Patent Literature 3 discloses that a doctor or the like performs an interview, diagnosis, and background investigation on a test candidate before starting a clinical test, and selects an appropriate subject based on the result. Specifically, in the system described in Patent Literature 3, it is determined whether or not the characteristic information at the start of the pre-observation period of the test candidate who has expressed his / her intention to participate in the clinical trial meets the first subject suitability criterion. Along with the determination, it is determined whether or not the characteristic information at the end of the pre-observation period for the test candidate determined to match this matches the second subject suitability criterion, and also matches this. Register the test candidate as a test subject.

  By the way, when medical software was treated as a medical device following the revision of the Medical Products and Medical Devices Act (former Pharmaceutical Affairs Law) in the fall of 2014, a dedicated application for treating disease (hereinafter referred to as a treatment application) ) Is being used to treat diseases. In order to actually use the therapeutic application as a medical device, it is necessary to obtain approval for the Medical Devices and Medical Devices Act. In order to obtain the approval, it is necessary to conduct a clinical trial to verify the effectiveness of the therapeutic effect using the therapeutic application.

  There is a unique problem in clinical trials of therapeutic apps regarding screening to extract appropriate subjects when conducting clinical trials. First, there is a problem regarding the reliability of the subject. In general, participating in clinical trials as a subject often provides some financial incentive as a reward. The same goes for clinical trials of therapeutic apps. However, since the treatment app has a property that it can be used freely at any place (for example, a patient's home or workplace), the use of the treatment app by test candidates is completely restricted by the medical institution. Difficult to be under surveillance. Therefore, if a dishonest person who applied for financial incentives is registered as a subject, he / she will not use the therapeutic app in good faith and will not report information on the results of using the therapeutic app in good faith. May occur.

  Second, there is a problem regarding the suitability of use of the therapeutic application. Patients who are candidates for clinical trials have various attributes, including those who are unfamiliar with the operation of the information processing device. A person with an extremely low level of proficiency in operating the information processing apparatus may be unsuitable for treatment through the use of a treatment application, and cannot be said to be suitable as a subject in a clinical trial. Therefore, if a person who is considered to have a low degree of use of the therapeutic app is registered as a subject, there is a high possibility that the therapeutic app will not be used properly or will be withdrawn during a clinical trial. There is a problem.

  In the future, it is expected that information processing devices using various types of medical software will be used as medical devices, not limited to medical treatment applications installed and used in smartphones. Regarding these information processing apparatuses, it is considered that the above-described problem similarly occurs when a clinical test is performed.

JP 2014-194595 A JP 2014-215935 A JP-A-2004-29894

  The present invention has been made to solve the above-described problems, and has as its object to perform a clinical test of medical software so that it is possible to appropriately determine whether or not the subject is eligible as a subject.

  In order to solve the above-described problem, the clinical test eligibility determination system of the present invention instructs a user of an information processing apparatus in which medical software is installed to execute predetermined processing using medical software. Then, execution result information indicating a result when a predetermined process is executed by the user in response to the instruction is acquired. Then, based on the obtained execution result information, a clinical test of the medical software is performed from at least one viewpoint of the reliability of whether or not the person is an object of acquiring an incentive and the proficiency in operation of the information processing apparatus. To determine the eligibility of the subject to participate.

  According to the present invention configured as described above, when conducting a clinical test of medical software, the test candidate actually uses the medical software, and performs a process for a given instruction. Based on the execution result information obtained as, the eligibility as a subject is determined from the viewpoint of reliability as to whether or not the person is aimed at obtaining an incentive and the viewpoint of proficiency in operation of the information processing device. You. Thus, according to the present invention, it is possible to solve a problem unique to a clinical test of medical software and appropriately determine whether a user of an information processing apparatus is qualified as a subject.

FIG. 1 is a diagram illustrating a network configuration example of a clinical trial system to which a clinical trial eligibility determination system according to a first embodiment is applied. FIG. 3 is a diagram illustrating a hardware configuration example of a user terminal and a clinical trial management server. FIG. 2 is a block diagram illustrating a functional configuration example of a user terminal according to the first embodiment. FIG. 2 is a block diagram illustrating a functional configuration example of a clinical trial management server according to the first embodiment. 5 is a flowchart illustrating an operation example of the user terminal according to the first embodiment. 5 is a flowchart illustrating an operation example of the clinical trial management server according to the first embodiment. It is a figure showing the network configuration example of the clinical trial system to which the clinical trial eligibility judging system by a 2nd embodiment is applied. It is a block diagram showing the example of functional composition of the user terminal by a 2nd embodiment. It is a block diagram showing the example of functional composition of the clinical trial management server by a 2nd embodiment. It is a block diagram showing other examples of functional composition of a user terminal by a 2nd embodiment. It is a block diagram showing other examples of functional composition of a clinical trial management server by a 2nd embodiment.

(1st Embodiment)
Hereinafter, a first embodiment of the present invention will be described with reference to the drawings. FIG. 1 is a diagram illustrating an example of a network configuration of a clinical trial system to which a clinical trial eligibility determination system according to the first embodiment is applied. The clinical trial eligibility determination system of the present embodiment is a system for determining eligibility as a subject to participate in a clinical trial of medical software, and is configured using the configuration of a clinical trial system for conducting clinical trials of medical software. Have been. Note that the clinical test eligibility determination system may be configured separately from the clinical trial system.

  The medical software is, for example, a treatment application installed and used in the information processing device. A specific example of the therapeutic application is an application aimed at treating diseases such as nicotine dependence, sleep disorders, alcoholism, and hypertension through improvement of the patient's lifestyle. Further, the treatment application may be an application for treating a central nervous disease such as depression, Parkinson's disease, and dementia. Hereinafter, the medical software will be described as being the treatment application as described above, but the above is merely an example, and the present invention is not limited to this.

  For example, in a treatment app, the user inputs information on the patient's symptoms and daily behavior in a questionnaire format at any time, or conducts a predetermined behavior test involving the patient's behavior, and executes the input information and behavior test. The information indicating the result is transmitted to the server device. Then, the server device performs a predetermined analysis based on the information, outputs a message regarding predetermined advice to the treatment application, and executes a predetermined process for inviting the patient to take a predetermined action. Or Part of the processing of the predetermined analysis may be performed by the treatment application itself.

  As shown in FIG. 1, the clinical trial system according to the first embodiment includes a user terminal 100 that is an information processing device in which a therapeutic application used by a user is installed, a clinical trial management server 200 that manages a clinical trial, A medical institution terminal 300 used by a medical institution is provided. The user terminal 100, the clinical trial management server 200, and the doctor terminal 300 are connected via a communication network 400. The user is a test candidate who uses the therapeutic application (a subject is determined after having been qualified as a subject to participate in a clinical trial).

  The test candidates were collected through recruitment by a development company or a medical institution commissioned by the development company for drugs, medical devices, treatment methods, and the like. All persons who have applied for the recruitment may be set as test candidates, or may be set as test candidates except for those who can be clearly judged to be non-conforming from a doctor's point of view. As described in detail below, the clinical trial eligibility determination system of the present embodiment determines eligibility of each of these test candidates as a subject of the therapeutic application.

  The user terminal 100 is an information processing device on which a treatment application is installed, and is, for example, a smartphone, a tablet terminal, a personal computer, or the like. Any of the user terminals 100 can be applied as long as the application for treatment can be installed and executed. However, when the treatment application is intended for treatment through improvement in the lifestyle of the subject, it is preferable to use a mobile terminal that can be carried around at all times.

  The medical institution terminal 300 is a terminal on which a medical institution treatment application that operates in cooperation with the patient treatment application installed in the user terminal 100 is installed. Any terminal such as a smartphone, a tablet, and a personal computer can be applied as long as the terminal can install and execute this application. In the following description, unless otherwise distinguished, simply “treatment application” means an application for a patient.

  The clinical trial management server 200 is a management device in which a dedicated application that operates in cooperation with each application installed in the user terminal 100 and the medical institution terminal 300 is installed. In particular, in the present embodiment, the clinical trial management server 200 performs processing necessary for determining eligibility as a subject to participate in a clinical trial of the therapeutic application based on information transmitted from the user terminal 100. . The clinical trial management eligibility determination system according to the present embodiment is configured by the clinical trial management server 200 and the user terminal 100.

  FIG. 2 is a diagram illustrating an example of a hardware configuration of the user terminal 100 and the trial management server 200. As shown in FIG. 2A, the user terminal 100 includes a CPU 101, a ROM 102, a RAM 103, an auxiliary storage device 104, an input unit 105, a display unit 106, and a communication unit 107 as its hardware configuration. The auxiliary storage device 104 stores medical software (therapeutic application) and various execution result information obtained when the user executes the therapeutic application.

  The CPU 101 controls the operation of the user terminal 100 according to a program stored in the ROM 102 or the auxiliary storage device 104. The input unit 105 includes a touch panel, a keyboard, and the like, and is used by a user for various types of information input and operations related to various types of processing execution. The display unit 106 is configured by a liquid crystal display, an organic EL display, or the like, and displays various information. The communication unit 107 performs data communication with the clinical trial management server 200 via a communication network 400 such as the Internet or a mobile phone network.

  As shown in FIG. 2B, the clinical trial management server 200 includes a CPU 201, a ROM 202, a RAM 203, an auxiliary storage device 204, and a communication unit 205 as its hardware configuration. The ROM 202 or the auxiliary storage device 204 stores a clinical test eligibility determination program. The auxiliary storage device 204 also stores determination result information indicating a result of determination on eligibility of the user as a subject.

  The CPU 201 qualifies the user (test candidate) using the therapeutic application in the user terminal 100 as a subject who participates in the clinical test according to the clinical test eligibility determination program stored in the ROM 202 or the auxiliary storage device 204. The processing necessary to determine whether or not it has the property is executed. The communication unit 205 performs data communication with the user terminal 100 or the medical institution terminal 300 via the communication network 400. For example, the communication unit 205 receives various information transmitted from the user terminal 100. In addition, the communication unit 205 transmits information indicating a determination result regarding eligibility as a subject to the medical institution terminal 300 in response to a request from the medical institution terminal 300.

  FIG. 3 is a block diagram illustrating a functional configuration example of the user terminal 100 according to the first embodiment. As shown in FIG. 3, the user terminal 100 includes a processing execution instructing unit 11, a processing executing unit 12, an execution result storage unit 13, and an execution result transmitting unit 14 as its functional configuration. These functional blocks 11 to 14 are realized by the operation of the treatment application stored in the auxiliary storage device 104 under the control of the CPU 101 shown in FIG.

  The process execution instructing unit 11 instructs the user of the user terminal 100 to execute a predetermined process using the treatment application. The predetermined process using the treatment application is a process predetermined according to a disease to be treated by the treatment application, and is a process necessary for performing treatment through improvement of lifestyle and the like. The predetermined process is, for example, a process for executing a predetermined behavior test involving a user's behavior using the input unit 105. Further, the predetermined process is a process for executing a predetermined questionnaire involving the user inputting information using the input unit 105.

  For example, in the case of a treatment application for treating sleep disorders, a PVT test for measuring the degree of objective drowsiness of a user, current drowsiness, quality of life (QOL) status, daytime activities A questionnaire asking a question about the user's health condition such as a situation corresponds to the predetermined processing. The PVT test measures a reaction time until the user touches the touch panel of the input unit 105 with respect to a figure or the like which is randomly displayed on the display unit 106, and decreases the arousal level according to the reaction time ( This test measures sleepiness.

  The process execution instructing unit 11 instructs execution of a predetermined process when a predetermined timing set in the treatment application comes. As the predetermined timing, an appropriate time is set according to the content of the predetermined processing. For example, in the case of the above-described PVT test, a predetermined time before the bedtime set by the user operating the input unit 105 is set as a predetermined timing, and when this timing is reached, the execution of the PVT test is instructed. . The instruction is performed by, for example, displaying a message prompting the execution of the process on the display unit 106. At this time, an announcement sound may be output from the speaker of the user terminal 100, or the vibrator may be vibrated.

  The process execution instructing unit 11 instructs the user of the user terminal 100 to execute a predetermined process using the treatment application a plurality of times. The plurality of times may be a plurality of times in a day, or a plurality of times over a plurality of days (for example, a case where an instruction is performed once a day over a plurality of days). For example, the instruction to execute the PVT test may be issued at a predetermined time during the day in addition to the time before the bedtime described above by a predetermined time. In addition, in the case of a therapeutic application that requires a questionnaire regarding the user's health condition to be performed several times a day with different contents of the question, the instruction to execute the questionnaire is issued at a predetermined time during the day. Is performed a plurality of times.

  The process execution unit 12 executes a predetermined process using the treatment application according to a user operation on the input unit 105. The predetermined process is as described above, and is a process such as a behavior test or a questionnaire that is predetermined according to the disease to be treated by the treatment application. When a process execution instruction is given by the process execution instruction unit 11, the user executes a predetermined process according to the instruction. In executing the predetermined process, the user operates the input unit 105 to activate the execution function of the predetermined process, and executes the predetermined process according to the activated execution function.

  The execution result storage unit 13 causes the auxiliary storage device 104 to store execution result information indicating a result when a predetermined process is executed by a user in response to an instruction from the process execution instruction unit 11. The execution result information includes, in addition to the execution result of the behavior test and the contents of the answer to the questionnaire, corresponding time information indicating a corresponding time when the user executes a predetermined process according to the instruction. One example of the response time information is reaction time information indicating a reaction time until the user starts execution of a predetermined process according to an instruction. Another example of the response time information is execution time information indicating an execution time required until the user completes execution of a predetermined process in response to an instruction.

  For example, the processing execution unit 12 measures a time taken from when the execution of the behavior test is instructed by the processing execution instruction unit 11 to when the user activates the execution function of the behavior test, as a reaction time, and calculates the execution time. The storage unit 13 causes the auxiliary storage device 104 to store the information as reaction time information. Further, the processing execution unit 12 determines the time taken from when the execution of the questionnaire is instructed by the process execution instructing unit 11 or when the questionnaire execution function is activated by the user until the answer to the questionnaire is completed. (Response time), and the execution result storage unit 13 stores it in the auxiliary storage device 104 as execution time information (response time information).

  The execution result transmitting unit 14 transmits the execution result information (reaction time information of the behavior test and response time information of the questionnaire) stored in the auxiliary storage device 104 to the communication unit clinical trial management server 200. The execution result transmitting unit 14 may transmit the stored execution result information every time the execution result information is stored in the auxiliary storage device 104, or may transmit the execution result information in a batch at a predetermined timing. It may be. For example, the execution result information may be transmitted at a predetermined time every day or every several days, or may be transmitted when a predetermined number of execution result information is stored in the auxiliary storage device 104. Is also good. Alternatively, a certain period (for example, one week after the treatment application is installed on the user terminal 100) for determining the eligibility of each user as a subject of a clinical trial is determined, and at the time when the certain period has elapsed. The execution result information may be transmitted.

  The execution result information transmitted by the execution result transmitting unit 14 may be all of the execution result of the behavior test, the contents of the answer to the questionnaire, and the corresponding time information, or may be only the corresponding time information. For example, either the pre-use mode or the main use mode can be set in the treatment application. Then, at the initial stage when the therapeutic application is installed in the user terminal 100, the pre-use mode is set to the initial setting state, and when the pre-use mode is set, the execution result transmitting unit 14 manages only the corresponding time information for the trial management. To the server 200. After that, the mode setting of the therapeutic application is performed by transmitting a mode switching signal from the clinical trial management server 200 to the user terminal 100 of the user determined to have eligibility as a subject by analyzing the response time information. Switch from the pre-use mode to the main use mode. After setting the use mode, the execution result transmitting unit 14 transmits the execution result of the behavior test and the contents of the questionnaire to the clinical trial management server 200.

  Next, the functional configuration of the clinical trial management server 200 will be described. FIG. 4 is a block diagram illustrating a functional configuration example of the clinical trial management server 200 according to the first embodiment. As shown in FIG. 4, the clinical trial management server 200 includes an execution result acquisition unit 21, an execution result storage unit 22, an eligibility determination unit 23, a determination result storage unit 24, and a determination result transmission unit 25 as its functional configuration. ing. Each of these functional blocks 21 to 25 is realized by the operation of the clinical test eligibility determination program stored in the ROM 202 or the auxiliary storage device 204 under the control of the CPU 201 shown in FIG. .

  The execution result acquisition unit 21 acquires execution result information transmitted from the plurality of user terminals 100 by the execution result transmission unit 14, respectively. For example, when the treatment application of the user terminal 100 is set to the pre-use mode, the execution result acquisition unit 21 acquires the corresponding time information transmitted by the execution result transmission unit 14 of the user terminal 100. When the treatment application of the user terminal 100 is set to the main use mode, the execution result acquisition unit 21 executes the behavior test execution result and the questionnaire response content transmitted by the execution result transmission unit 14 of the user terminal 100. To get.

  The execution result storage unit 22 causes the auxiliary storage device 204 to store the execution result information acquired by the execution result acquisition unit 21. For example, when the treatment application of the user terminal 100 is set to the pre-use mode, the execution result storage unit 22 causes the auxiliary storage device 204 to store the corresponding time information acquired by the execution result acquisition unit 21. When the treatment application of the user terminal 100 is set to the main use mode, the execution result storage unit 22 stores the execution result of the behavior test acquired by the execution result acquisition unit 21 and the answer content of the questionnaire in the auxiliary storage device. 204.

  The execution result information transmitted from the plurality of user terminals 100 is stored in the auxiliary storage device 204. The execution result storage unit 22 stores a plurality of pieces of execution result information in a form that can identify which execution result information is transmitted from which user terminal 100 (or which user corresponds). The data is stored in the auxiliary storage device 204.

  It should be noted that the clinical test eligibility determination system according to the present embodiment focuses on determining whether a user has eligibility as a subject when conducting a clinical test of a therapeutic application. The functional configuration illustrated in FIG. 4 relates to a process of determining the eligibility of a user as a subject based on the corresponding time information acquired by the execution result acquiring unit 21 when the therapeutic application is set to the pre-use mode. It is shown. When the treatment application is set to the use mode, a functional configuration for executing a process related to treatment of a disease based on the execution result of the behavior test acquired by the execution result acquisition unit 21 and the contents of the questionnaire answer is as follows. The illustration is omitted, and the description thereof is omitted.

  Based on the execution result information (corresponding time information) acquired by the execution result acquisition unit 21 and stored in the auxiliary storage device 204 by the execution result storage unit 22, the eligibility determination unit 23 obtains an incentive. The eligibility of the user as a test subject is determined from at least one viewpoint of the reliability of whether or not the user is the user and the proficiency of the operation of the information processing apparatus. Determining eligibility may mean determining whether a user is eligible as a subject, but in the present embodiment, how likely it is that a user is eligible (or not) as a subject It is assumed that

  The credibility of a person for the purpose of obtaining incentives is the degree of likelihood that a person has applied for the purpose of obtaining economic incentives that are rewarded for participating in clinical trials as subjects. It is shown that the reliability is lower and the eligibility of the user as a subject is lower as it is estimated that there is a high possibility that the applicant has applied for the purpose of obtaining economic incentive.

  In addition, the proficiency level regarding the operation of the information processing device indicates the degree of possibility that the user is unfamiliar with the operation of the information processing device because of low IT literacy, and is a person unfamiliar with the operation of the information processing device. The more likely it is to be, the lower the proficiency and the lower the eligibility of the user as a subject.

  The eligibility determination unit 23 calculates at least one of the reliability evaluation value and the proficiency evaluation value for the user by performing predetermined statistical processing based on the corresponding time information stored in the auxiliary storage device 204. The eligibility of the user as a subject is determined based on the calculated evaluation value.

  For example, the eligibility determination unit 23 calculates the relative evaluation value of the response time of one user with respect to the response time of another user based on the response time information acquired for a plurality of users, Is calculated as the evaluation value. Here, the response time for one user is, for example, a statistical value (for example, a median value, an average value, a maximum value, a minimum value, a mode value, etc.) of a plurality of response times obtained for execution of a plurality of processes. Is used.

  More specifically, based on the response time of the questionnaire, the eligibility determination unit 23 calculates the relative evaluation value of the response time of one user with respect to the response time of another user, and evaluates the reliability of the one user. Calculate as a value. This means that users who have a certain difference in response time compared to the response time that would normally be taken by a reliable user to answer the questionnaire may not have answered the questionnaire seriously. It is estimated that the reliability is low in that respect.

  The relative evaluation value in this case can be calculated as follows, for example. That is, a plurality of users use the treatment application under the supervision of a doctor or the like, and answer a questionnaire. In this case, the user is preferably a patient known to be suffering from a disease to be treated by the treatment application, for example, a patient selected by a doctor. Such a patient is not a person who uses the therapeutic application for the purpose of economic incentive obtained when participating as a subject in a clinical trial, and thus can be said to be a reliable user.

  The eligibility judging unit 23 calculates a statistical value (median value, average value, maximum value, A minimum evaluation value, a mode value, and the like) and a response evaluation time corresponding to one user whose eligibility is to be determined are calculated. The relative evaluation value according to the magnitude of the difference can be calculated as, for example, a Euclidean distance. The greater the Euclidean distance, the lower the reliability of the user as a subject, and the smaller the Euclidean distance, the higher the reliability of the user as a subject.

  For example, the eligibility determination unit 23 determines that a user whose Euclidean distance calculated as described above is larger than a predetermined value has low eligibility as a subject. Alternatively, a predetermined number of users counted from the smallest Euclidean distance calculated as described above, or a predetermined percentage of the total number of users counted from the smallest Euclidean distance are qualified as subjects. You may make it determine that it is low. Note that the Euclidean distance is merely an example, and is not limited to this.

  The eligibility determination unit 23 may calculate the relative evaluation value as follows. That is, the eligibility determination unit 23 performs machine learning using the response time of the user who responded to the questionnaire (equivalent to “other user” in the claims) under the monitoring of a doctor or the like as the correct answer data, and A prediction model in which a relative evaluation value is output when an answer time is input is generated in advance. This prediction model outputs, for example, any numerical value from a value “0” indicating the lowest reliability to a value “1” indicating the highest reliability. Then, the eligibility determination unit 23 calculates a relative evaluation value for one user by inputting a response time of a questionnaire regarding one user whose eligibility is to be determined to the prediction model.

  In this case, the eligibility determination unit 23 determines that a user whose value output from the prediction model is smaller than a predetermined value has low eligibility as a subject. It should be noted that the prediction model is generated as an output of a value representing one of the classifications when the degree of reliability is expressed in a plurality of stages (two or three or more stages), and the degree of reliability is the lowest. A user whose classification value is output from the prediction model may be determined to be low in eligibility as a subject.

  When the relative evaluation value is calculated by machine learning in this manner, the contents of the questionnaire may be used in addition to the questionnaire response time. For example, a plurality of questions that should have a correlation in the response result are prepared as checkpoints, and among users who have used the therapeutic app under monitoring, there is no correlation in the content of the checkpoint response (or the correlation value is less than or equal to a predetermined value). As an example, it is conceivable to perform a process of removing the answer time relating to the user from the correct answer data.

  In addition, the eligibility determination unit 23 calculates the relative evaluation value of the response time of one user with respect to the response time of another user based on the response time information acquired for a plurality of users, and the proficiency level of the user. Is calculated as the evaluation value. For example, based on the reaction time from when the instruction is given to when the execution of the behavior test is started, the eligibility determination unit 23 determines the relative evaluation value of the reaction time for one user with respect to the reaction time for another user. Is calculated as an evaluation value of the proficiency level of one user.

  This is because the reaction time, which is assumed to normally take until a user having a level of proficiency with respect to the use of the information processing device or more to activate the execution function of the behavior test in response to the instruction, is longer than a certain time. It is estimated that the user who has the difference between the two may have trouble in performing the operation until the function for executing the behavior test is started, and at that point, the proficiency of the information processing apparatus is low.

  The relative evaluation value in this case can be calculated as follows, for example. That is, the eligibility determination unit 23 determines the position of the reaction time for one user in the distribution of the reaction times for a plurality of users (for example, the position of one user counted from the slowest reaction time among all the users). The value indicating the lower percentage of the reaction time) is calculated as a relative evaluation value for one user whose eligibility is to be determined. In this case, the eligibility determination unit 23 determines that the number of users counted from the lowest or the number of users who are within a predetermined ratio is low as the eligibility for the subject, with the reaction time being the fastest.

<Modification>
In the above embodiment, the evaluation calculated as the Euclidean distance as a relative evaluation value of the response time of one user with respect to the response time of another user based on the response time of the questionnaire obtained for a plurality of users. Although the example of calculating the value or the evaluation value output from the machine-learned prediction model has been described, the position of the answer time for one user in the distribution of the answer time for a plurality of users is calculated. Is also good. For example, of all the users, a predetermined number of users or users located within a predetermined ratio counted from the one with the fastest response time are considered to have answered the question without seriously considering the answer. Can be determined to be low.

  Further, in the above embodiment, based on the reaction times up to the execution of the behavior test acquired for a plurality of users, a relative evaluation value of the reaction time for one user with respect to the reaction time for another user is used as a relative evaluation value. Although the example of calculating the position of the reaction time for one user in the distribution of the reaction time has been described, an evaluation value calculated as a Euclidean distance or an evaluation value output from a machine-learned prediction model is calculated. You may do so.

  Further, based on the response time of the questionnaire obtained for a plurality of users, a relative evaluation value of the response time of one user with respect to the response time of another user (an evaluation value calculated as a Euclidean distance, The evaluation value output from the prediction model or the evaluation value calculated as the position of the response time for one user in the distribution of the response time for a plurality of users) is calculated as the evaluation value of the proficiency level for one user. You may make it.

  In addition, based on the reaction times until the start of the questionnaire acquired for a plurality of users, a relative evaluation value of the reaction time for one user with respect to the reaction time for another user (evaluation value calculated as a Euclidean distance, The evaluation value output from the machine-learned prediction model or the evaluation value calculated as the position of the response time for one user in the distribution of the response time for a plurality of users) It may be calculated as an evaluation value or a proficiency evaluation value.

  Further, based on the reaction times up to the execution of the behavior test acquired for a plurality of users, a relative evaluation value of the reaction time for one user with respect to the reaction time for another user (evaluation value calculated as a Euclidean distance, machine The evaluation value output from the learned prediction model or the evaluation value calculated as the position of the response time for one user in the distribution of the response time for a plurality of users) is used to evaluate the reliability of one user. It may be calculated as a value.

  Furthermore, based on the execution time of the behavior test acquired for a plurality of users, a relative evaluation value of the execution time of one user with respect to the execution time of another user (evaluation value calculated as a Euclidean distance, machine learning, The evaluation value output from the predicted model, or the evaluation value calculated as the position of the response time for one user in the distribution of the response times for a plurality of users) as the reliability evaluation value for one user or It may be calculated as an evaluation value of the proficiency level.

<Specific Example 1 of Modification>
For example, instead of calculating the evaluation value of the proficiency level based on the reaction time until the activation of the behavior test execution function, the eligibility determination unit 23 starts execution of the answer to the questionnaire after the instruction is given. The relative evaluation value of the reaction time of one user with respect to the reaction time of another user may be calculated as the evaluation value of the proficiency level of one user, based on the reaction time until the reaction time.

  It is assumed that, similarly to the reaction time until the behavior test is performed, it usually takes a time for a user having a proficiency of a normal level or more in using the information processing device to activate the questionnaire execution function in accordance with the instruction. For users whose reaction time differs by more than a certain value compared to the reaction time, it may be difficult to perform the operation until the questionnaire execution function is started. It can be estimated.

  In this way, the evaluation value of the reliability of one user is calculated based on the response time of the questionnaire, and the evaluation value of the proficiency level of one user is calculated based on the reaction time until the execution function of the questionnaire is activated. By calculating, there is an advantage that the eligibility of the user as a subject can be determined from the two viewpoints of reliability and proficiency by conducting a questionnaire.

<Specific Example 2 of Modification>
The eligibility determination unit 23 calculates the evaluation value of the proficiency based on the reaction time until the activation of the behavior test execution function. Instead, the eligibility determination unit 23 calculates the response time of one user based on the response time of the questionnaire. Relative evaluation value with respect to response time for other users (evaluation value calculated as Euclidean distance, evaluation value output from machine-learned prediction model, or one user in distribution of response time for multiple users) The evaluation value calculated as the position of the answer time for the user) may be calculated as the evaluation value of the proficiency level for one user.

  This is because the user who has a proficiency of a normal level or more regarding the use of the information processing apparatus has a fixed answer time compared to the answer time normally required to answer all of a series of questionnaires including a plurality of questions. The user having the above difference may be troublesome in the information input operation or the like for answering the questionnaire, and it is estimated that the proficiency of the information processing apparatus is low at that point.

  In this case, both the evaluation value of the reliability and the evaluation value of the proficiency level of one user can be calculated based on the response time of the questionnaire. This has the advantage that the eligibility of the user as a subject can be determined from.

<Specific Example 3 of Modification>
Instead of calculating the reliability evaluation value for one user based on the response time of the questionnaire, the eligibility determination unit 23 executes the behavior test execution time (the time required for the user to start and finish the behavior test). ), The relative evaluation value of the execution time for one user with respect to the execution time for another user (evaluation value calculated as a Euclidean distance, evaluation value output from a machine-learned prediction model, or Alternatively, the evaluation value calculated as the position of the response time for one user in the distribution of the response time for a plurality of users may be calculated as the reliability evaluation value for one user.

  The PVT test is a test for measuring a user's reaction time from when a graphic is presented at each timing determined by the treatment application, and therefore, the execution time does not change depending on the user. However, the execution time may vary depending on the user depending on the content of the behavior test. In the case of a behavior test having such a property, a relative evaluation value relating to the execution time of the behavior test can be used as a reliability evaluation value for one user. This is because a user aiming at obtaining an economic incentive does not seriously conduct a behavior test, and can estimate that the user may finish in a shorter or longer time than usual.

  In this case, the evaluation value of the reliability of one user is calculated based on the execution time of the behavior test, and the evaluation value of the proficiency level of the one user is calculated based on the reaction time until the execution function of the behavior test is activated. Has the advantage of being able to determine the eligibility of a user as a subject from two perspectives, reliability and proficiency, by performing an action test.

<Specific Example 4 of Modification>
Instead of calculating the evaluation value of the proficiency based on the reaction time until the activation of the action test execution function, the eligibility determination unit 23 calculates the execution time of one user based on the action test execution time. Alternatively, a relative evaluation value with respect to the execution time of another user may be calculated as an evaluation value of the proficiency level of one user. In the case of the PVT test, the execution time hardly changes regardless of the user's proficiency, but the execution time may change depending on the user's proficiency depending on the content of the behavior test. Therefore, in the case of a behavior test having such a property, it is possible to use a relative evaluation value regarding the execution time of the behavior test as an evaluation value of the proficiency level regarding one user.

  The determination result storage unit 24 stores the result determined by the eligibility determination unit 23 in the auxiliary storage device 204. The result determined by the eligibility determination unit 23 includes information indicating a user who is determined to be unlikely to be eligible as a subject of a clinical trial of a therapeutic application, and may have eligibility. It is at least one of the information indicating the user determined to be. The evaluation value calculated by the eligibility determination unit 23 may be stored together with the information indicating the user.

  The determination result transmitting unit 25 transmits the determination result information stored in the auxiliary storage device 204 by the determination result storage unit 24 to the medical institution terminal 300 in response to a request from the medical institution terminal 300. For example, the determination result transmitting unit 25 transmits HTML data including the determination result information to the medical institution terminal 300 in response to a request from a web browser provided in the medical institution terminal 300, and makes a determination on the web browser of the medical institution terminal 300. Display the result information.

  Here, the configuration is such that the eligibility of the user as a subject is determined from both the viewpoint of reliability of whether or not the person is aimed at acquiring an incentive and the viewpoint of proficiency in operation of the information processing apparatus. In this case, the determination result transmitting unit 25 transmits information to the medical institution terminal 300 so that each determination result can be understood from both viewpoints. The medical institution determines which user is excluded from the subject by referring to the determination result information.

  FIG. 5 is a flowchart illustrating an operation example of the user terminal 100 according to the first embodiment configured as described above. The flowchart shown in FIG. 5 shows an operation example related to the embodiment described before the modified example, not the various modified examples described above. The operation of the flowchart shown in FIG. 5 is executed in each of the plurality of user terminals 100.

  The treatment application installed in the user terminal 100 has some functions operating in the background even when it is not activated by clicking an activation icon or the like, and is set in advance as a timing for instructing execution of a predetermined process. It is monitored whether or not a predetermined timing has come (step S1).

  When the predetermined timing has come, the process execution instructing unit 11 instructs the execution of the predetermined process by displaying a message on the display unit 106 (step S2). Next, the process execution unit 12 determines whether the process instructed by the process execution instructing unit 11 is related to a behavior test (Step S3). If what is instructed by the process execution instructing unit 11 is the execution of the behavior test, the process executing unit 12 starts counting the elapsed time after the instruction (step S4).

  Thereafter, the process execution unit 12 monitors whether or not the user has activated the designated action test execution function (step S5). When activated, the process execution unit 12 notifies the execution result storage unit 22 of the count value. In response to this, the execution result storage unit 22 stores the reaction time (count value of the elapsed time) from when the execution of the behavior test is instructed by the process execution instruction unit 11 to when the user activates the execution function of the behavior test. ) Is stored in the auxiliary storage device 104 (step S6).

  In step S3, when it is determined that the process instructed by the process execution instructing unit 11 is not related to the behavior test (that is, related to the questionnaire), the process executing unit 12 executes the designated function of executing the questionnaire. It is monitored whether or not has been activated by the user (step S7). If activated, the process execution unit 12 starts counting the time elapsed since the activation of the questionnaire execution function (step S8).

  Thereafter, the process execution unit 12 monitors whether the answer to the questionnaire has been completed (step S9). When the answer is over, the processing execution unit 12 notifies the execution result storage unit 22 of the count value. In response to this, the execution result storage unit 22 stores the response time (count value of the elapsed time) taken from the time the questionnaire execution function is activated and the user's response is started to the time the response is completed, to the auxiliary storage device 104. (Step S10).

  After step S6 or S10, the execution result transmitting unit 14 sets a certain period of time (for example, one week after the therapeutic application is installed on the user terminal 100) set to determine eligibility as a subject of the clinical trial. Is determined (step S11). If the certain period has not elapsed, the process returns to step S1. On the other hand, when a certain period has elapsed, the execution result transmitting unit 14 transmits the execution result information stored in the auxiliary storage device 104 to the communication unit trial management server 200 (step S12). Thus, the processing of the flowchart illustrated in FIG. 5 ends.

  FIG. 6 is a flowchart illustrating an operation example of the clinical trial management server 200 according to the first embodiment configured as described above. The execution result acquisition unit 21 acquires the execution result information transmitted from the user terminal 100 by the execution result transmission unit 14 (Step S21). The execution result storage unit 22 stores the execution result information acquired by the execution result acquisition unit 21 in the auxiliary storage device 204 (Step S22).

  The eligibility determination unit 23 determines whether a sufficient number of pieces of execution result information have been stored in the auxiliary storage device 204 (step S23). For example, the trial management server 200 grasps the number of therapeutic applications downloaded from a certain download site, and determines whether or not the same number of execution result information is stored in the auxiliary storage device 204 as the number of downloads. You may do so. Alternatively, it may be determined whether or not the execution result information of a predetermined ratio or more with respect to the number of downloads is stored in the auxiliary storage device 204, or the execution result information of the predetermined number or more as the absolute number may be determined. May be determined.

  Here, if it is determined that a sufficient number of pieces of execution result information have not been stored in the auxiliary storage device 204, the process returns to step S21. On the other hand, when it is determined that a sufficient number of pieces of execution result information are stored, the eligibility determination unit 23 is a person who aims to obtain an incentive based on the execution result information stored in the auxiliary storage device 204. The eligibility of the user as a subject is determined from at least one viewpoint of the reliability of whether or not the information processing device is proficient in operation of the information processing device (step S24), and the determination result is stored in the auxiliary storage device 204 (step S24). S25). Thus, the processing of the flowchart illustrated in FIG. 6 ends. After that, when there is a request to obtain the determination result from the medical institution terminal 300 at an arbitrary timing, the determination result transmitting unit 25 transmits the determination result information stored in the auxiliary storage device 204 to the medical institution terminal 300. .

  As described above in detail, in the first embodiment, the user of the user terminal 100 on which the medical software (therapeutic application) is installed is instructed to execute a predetermined process using the therapeutic application, The clinical trial management server 200 acquires execution result information (corresponding time information) representing a result when a predetermined process is executed by the user in response to the instruction. Then, based on the obtained execution result information, a clinical test of the medical software is performed from at least one viewpoint of the reliability of whether or not the person is an object of acquiring an incentive and the proficiency in operation of the information processing apparatus. To determine the eligibility of the subject to participate.

  According to the first embodiment configured as described above, in performing a clinical test of a therapeutic app, when the user actually uses the therapeutic app and executes processing in response to a given instruction, the result is as follows. Based on the execution result information obtained as, the eligibility as a subject is determined from the viewpoint of reliability as to whether or not the person is aimed at obtaining an incentive and the viewpoint of proficiency in operation of the information processing device. You. Thus, according to the first embodiment, it is possible to solve a problem specific to a clinical test of medical software and appropriately determine whether a user of the information processing apparatus is qualified as a subject.

  In the above embodiment, as execution result information indicating a result when a predetermined process is executed by a user in response to an instruction, corresponding time information (a reaction time until the execution function of the indicated process is activated, Although the example in which the execution time required for executing the instructed process is used has been described, the instruction compliance status information may be used instead or in addition. The instruction compliance status information is information indicating an instruction compliance rate, which is a ratio of the number of times the user has actually executed the predetermined process in response to the instructions a plurality of times.

  In this case, the eligibility determination unit 23 calculates at least one of the reliability evaluation value and the proficiency evaluation value for the user by performing predetermined statistical processing based on the instruction compliance status information, and calculates the calculated evaluation value. The eligibility of the user as a subject is determined based on the value.

  Specifically, based on the instruction compliance status information acquired by the execution result acquisition unit 21 for a plurality of users, the eligibility determination unit 23 determines whether the instruction compliance rate for one user is higher than the instruction compliance rate for another user. The relative evaluation value is calculated as at least one of the reliability evaluation value and the proficiency evaluation value for one user.

  The relative evaluation value in this case is an evaluation value calculated as a Euclidean distance, an evaluation value output from a machine-learned prediction model, or an instruction regarding a plurality of users, as calculated based on the corresponding time information. It can be calculated as an evaluation value calculated as the position of the instruction compliance rate for one user in the distribution of the compliance rate. With respect to the position of the instruction compliance rate for one user, the eligibility determination unit 23 sets the one with the higher instruction compliance rate as the higher rank, and counts a predetermined number of users or users who are located within the predetermined ratio from the lowest position as subjects. Is determined to be low.

(Second embodiment)
Next, a second embodiment of the present invention will be described with reference to the drawings. In the second embodiment, in addition to determining eligibility as a subject from the viewpoint of reliability of whether or not a person is aimed at acquiring an incentive and the viewpoint of proficiency in operation of an information processing device, The eligibility of a user as a subject is determined from the viewpoint of the presence or absence of a disease to be treated through the use of medical software.

  Regarding screening for extracting appropriate subjects when conducting clinical trials, clinical trials of therapeutic apps also have the following unique problems. That is, in the case of a treatment application, a subject is often extracted from unspecified candidates who want to use the treatment application, and it is known that a doctor is already undergoing treatment and suffers from the disease as in Patent Documents 1 and 2. The subjects are not necessarily extracted from the patients. Therefore, there is a problem that it is difficult to objectively determine whether or not the subject is suffering from the disease. The second embodiment aims at solving such a problem at the same time.

  FIG. 7 is a diagram illustrating an example of a network configuration of a clinical trial system to which the clinical trial eligibility determination system according to the second embodiment is applied. As shown in FIG. 7, the clinical trial system according to the second embodiment manages a user terminal 100 ′ and a wearable terminal 110 (corresponding to a second information processing device in the claims) used by a user, and manages a clinical trial. A clinical trial management server 200 'to be performed and a medical institution terminal 300 used by a medical institution are provided. The user terminal 100', the clinical trial management server 200 ', and the doctor's terminal 300 are connected via a communication network 400. .

  The user terminal 100 ′ and the wearable terminal 110 are wirelessly connected by using a wireless communication technology such as Bluetooth (registered trademark). As a result, state information (to be described in detail later) representing the physical state of the user detected by the wearable terminal 110 is wirelessly transmitted to the user terminal 100 ′, and this state information is transmitted from the user terminal 100 ′ to the clinical trial management server 200. 'To be sent to.

  FIG. 8 is a block diagram illustrating a functional configuration example of a user terminal 100 'according to the second embodiment. FIG. 9 is a block diagram illustrating a functional configuration example of a clinical trial management server 200 'according to the second embodiment. In FIGS. 8 and 9, those given the same reference numerals as those shown in FIGS. 3 and 4, respectively, have the same functions, and thus duplicate description will be omitted here.

  As shown in FIG. 8, the user terminal 100 ′ according to the second embodiment further includes a state information detection unit 15, a state information storage unit 16, and a state information transmission unit 17 as its functional configuration. Further, the clinical trial management server 200 ′ according to the second embodiment further includes, as its functional configuration, a state information acquisition unit 26 and a state information storage unit 27, and qualification determination unit 23 instead of qualification determination unit 23. 'Have.

  The wearable terminal 110 illustrated in FIG. 7 is a wearable information processing device including a sensor that detects a physical state of a user. The sensor is, for example, an acceleration sensor, an angular velocity sensor, an activity sensor, or the like. When the user is wearing and using the wearable terminal 110 (while the power is on), these sensors can be used to determine the user's physical state such as acceleration, angular velocity, and activity associated with the user's physical activity. The status information to be represented is continuously detected. The state information detected by each sensor is transmitted to the user terminal 100 'by wireless communication.

  Note that it is sufficient that the configuration is such that the state information of the user is detected, and it is not always necessary to use the wearable terminal 110. For example, if the portable user terminal 100 'includes the above-described sensor, the wearable terminal 110 can be omitted.

  The state information detection unit 15 of the user terminal 100 'detects state information transmitted from the wearable terminal 110. When the user terminal 100 'includes the above-described sensor, the state information detection unit 15 detects state information output from the sensor. The state information storage unit 16 causes the auxiliary storage device 104 to store the state information detected by the state information detection unit 15.

  The status information transmitting unit 17 transmits the status information stored in the auxiliary storage device 104 to the clinical trial management server 200 '. The timing at which the status information transmitting unit 17 transmits the status information to the clinical trial management server 200 'may be the same as the timing at which the execution result transmitting unit 14 transmits the execution result information to the clinical trial management server 200'. That is, for example, the status information may be transmitted at a predetermined time every day or every several days, or the status information may be transmitted when a predetermined period of time has elapsed.

  The state information acquisition unit 26 of the clinical trial management server 200 'acquires the state information transmitted from the plurality of user terminals 100' by the state information transmission unit 17, respectively. That is, the state information acquisition unit 26 acquires, from the user terminal 100 ', state information indicating the physical state of the user during use of the wearable terminal 110. The status information storage unit 27 causes the auxiliary storage device 204 to store the status information acquired by the status information acquisition unit 26.

  The eligibility determination unit 23 'performs the determination processing described in the first embodiment. In addition, the eligibility determination unit 23 'is performed through the use of medical software based on the status information acquired by the status information acquisition unit 26 and stored in the auxiliary storage device 204 by the status information storage unit 27. The eligibility of the user as a subject is determined from the viewpoint of the presence or absence of the disease to be treated.

  For example, the eligibility determination unit 23 ′ uses the state information of a user known to be suffering from a specific disease among the state information stored in the auxiliary storage device 204 as the correct answer data, and calculates a feature amount from the correct answer data. And perform machine learning to build a prediction model. This prediction model is a model in which an evaluation value relating to the presence or absence of a disease is output when state information of a user is input.

  The feature amount is appropriately set according to the type of the target disease. For example, when the target disease is Parkinson's disease, a feature quantity representing tremor (tremor of a hand) is generated based on acceleration or angular velocity. Further, when the target disease is a sleep disorder, depression, dementia, or the like, a feature amount such that the daytime activity amount is reduced is generated based on the activity amount.

  The eligibility determination unit 23 ′ calculates an evaluation value for one user by inputting state information about one user whose eligibility is to be determined to the prediction model, and based on the calculated evaluation value, The eligibility of the user as a subject is determined from the viewpoint of presence or absence.

  In addition, by performing predetermined statistical processing based on the length of time during which the state information is acquired, at least one of the evaluation value of the reliability and the evaluation value of the proficiency level of the user is calculated, and the calculated evaluation value is calculated. In consideration of the above, the eligibility of the user as a subject may be determined from at least one viewpoint of reliability and proficiency.

  The length of time during which the state information is acquired can be said to be the length of time during which the user is wearing the wearable terminal 110. That is, this is for estimating whether or not the user is seriously wearing the wearable terminal 110, and can be considered in the same manner as the above-described instruction compliance rate. For example, the eligibility determination unit 23 ′ calculates the length of time during which the state information is acquired as the wearing time of the wearable terminal 110 based on the state information acquired for a plurality of users, and calculates the calculated wearing time information. , A relative evaluation value of the wearing time of one user with respect to the wearing time of another user is calculated as at least one of an evaluation value of reliability and an evaluation value of proficiency of one user.

  In this case, the relative evaluation value is an evaluation value calculated as a Euclidean distance, an evaluation value output from a machine-learned prediction model, or a wearing time for one user in a distribution of wearing times for a plurality of users. It can be calculated as an evaluation value calculated as the position of. With respect to the mounting position for one user, the eligibility determination unit 23 'regards the user having the longer mounting time as the higher rank, and counts the predetermined number of users or the users located within the predetermined ratio from the lowest position as subjects. Judge as low eligibility.

  According to the second embodiment described above, based on the execution result information obtained through the use of the treatment application installed on the user terminal 100 ′, it is determined whether or not the person is a person who aims to obtain an incentive. In addition to determining eligibility as a subject in terms of reliability and proficiency in operation of the information processing device, the physical state of the user detected by a sensor included in the wearable terminal 110 or the user terminal 100 ′ Based on the displayed state information, the eligibility of the user as a subject can be determined from the viewpoint of the presence or absence of a disease.

  Further, based on the length of time during which the state information is acquired, an evaluation value of the reliability and an evaluation value of the proficiency level of the user are calculated, and the eligibility of the user as a subject is evaluated in consideration of the calculated evaluation value. When configured to determine, based on state information representing the physical state of the user detected by a sensor provided in the wearable terminal 110 or the user terminal 100 ', the viewpoint of reliability, the viewpoint of proficiency, and the morbidity of the disease The eligibility of the user as a subject can be determined from the viewpoint of the presence or absence of the user.

  In the second embodiment, based on state information continuously acquired while the user is using the wearable terminal 110 or the user terminal 100 ′, the user is qualified as a subject from the viewpoint of whether or not the user is ill. Although the example of determining the sex has been described, the present invention is not limited to this. For example, in a configuration in which the user terminal 100 ′ includes an acceleration sensor or an angular velocity sensor, the wearable terminal 110 is omitted, and when a predetermined process is executed by the user in accordance with an instruction from the process execution instruction unit 11 of the user terminal 100 ′. State information indicating the physical state of the user may be obtained.

  Also in this case, the eligibility determination unit 23 ′ is a person who aims to obtain an incentive based on the execution result information acquired by the execution result acquisition unit 21 and the state information acquired by the state information acquisition unit 26. Eligibility of the user as a subject in terms of at least one of the reliability of whether or not the user is proficient in the operation of the information processing device and the presence or absence of a disease to be treated through the use of medical software. Is determined.

  In the second embodiment, the wearable terminal 110 or the portable user terminal 100 ′ includes an acceleration sensor, an angular velocity sensor, and an activity amount sensor, and the acceleration, angular velocity, and activity amount of the user detected by these sensors. Although an example has been described in which the eligibility of a user as a subject is determined from the viewpoint of the presence or absence of a disease based on state information indicating a physical state, the present invention is not limited to this. For example, as shown in FIGS. 10 and 11, the wearable terminal 110 or the portable user terminal 100 ″ further includes a position detection sensor such as a GPS, and position information indicating a user's position detected by the position detection sensor. Is transmitted from the user terminal 100 ″ to the clinical trial management server 200 ″ so that the eligibility of the user as a subject is determined from the viewpoint of the presence / absence of the disease based on the position information in addition to the state information of the user. Is also good.

  FIGS. 10 and 11 are block diagrams showing an example of a functional configuration of the user terminal 100 "and the trial management server 200" in this case. In FIGS. 10 and 11, those denoted by the same reference numerals as those shown in FIGS. 8 and 9 have the same functions, and thus redundant description is omitted here.

  The user terminal 100 "shown in FIG. 10 further includes a position information detection unit 15A, a position information storage unit 16A, and a position information transmission unit 17A as its functional configuration. Further, the clinical trial management server 200" shown in FIG. Has a position information acquisition unit 26A and a position information storage unit 27A as its functional configuration, and also has a qualification determination unit 23 ″ instead of the qualification determination unit 23 ′.

  The position information detection unit 15A of the user terminal 100 "detects the user position information transmitted from the wearable terminal 110. When the user terminal 100" includes a position detection sensor, the state information detection unit 15A The position information of the user output from the position detection sensor of the terminal 100 "is detected. The position information storage unit 16A stores the position information of the user detected by the position information detection unit 15A in the auxiliary storage device 104.

  The position information transmitting unit 17A transmits the position information stored in the auxiliary storage device 104 to the clinical trial management server 200 ″. The timing at which the positional information transmitting unit 17A transmits the positional information to the clinical trial management server 200 ″ is The timing at which the result transmitting unit 14 and the state information transmitting unit 17 transmit the execution result information and the state information to the clinical trial management server 200 "may be the same.

  The position information acquisition unit 26A of the clinical trial management server 200 ″ acquires the user position information transmitted from the plurality of user terminals 100 ″ by the position information transmission unit 17A. That is, the position information obtaining unit 26A obtains, from the user terminal 100 ″, position information indicating the user's existing position while using the wearable terminal 110. The position information storage unit 27A stores the user information obtained by the position information obtaining unit 26A. Is stored in the auxiliary storage device 204.

  The eligibility determination unit 23 ″ performs the determination process described in the first embodiment. In addition, the eligibility determination unit 23 ″ is acquired by the state information acquisition unit 26 and assisted by the state information storage unit 27. Treatment performed through the use of medical software based on the state information stored in the storage device 204 and the position information acquired by the position information acquisition unit 26A and stored in the auxiliary storage device 204 by the position information storage unit 27A. The eligibility of the user as a subject is determined from the viewpoint of the presence / absence of the target disease.

  For example, the eligibility determination unit 23 ″ uses the state information and the position information of the user known to be suffering from the specific disease among the state information and the position information stored in the auxiliary storage device 204 as the correct answer data, A prediction model is constructed by generating a feature amount from the correct answer data and performing machine learning, which outputs an evaluation value regarding the presence or absence of a disease when the user's state information and position information are input. Such a model.

  The feature amount is appropriately set according to the type of the target disease. As described above, when the target disease is Parkinson's disease, a feature amount representing a tremor (hand tremor) is generated based on the acceleration or the angular velocity. Further, when the target disease is a sleep disorder, depression, dementia, or the like, a feature amount such that the daytime activity amount is reduced is generated based on the activity amount.

  In addition, when the target disease is a partial mental illness such as bipolar disorder, based on the user's position information, it represents a specific geographical moving distance or movement pattern when the patient has bipolar disorder. Such a feature amount is generated. Specifically, when the depression symptoms become severe in bipolar disorder, the moving distance becomes shorter and the moving pattern becomes monotonous. Therefore, a feature quantity representing such a moving distance or a moving pattern is generated. For the movement pattern, for example, the number of visited places and the number of visits are detected based on the position information, and the entropy of a small value calculated from these detected values is determined as the movement pattern when the person suffers from bipolar disorder. Can be generated as a feature quantity indicating that is monotonous. In addition, since the amount of activity decreases when depression symptoms become severe in bipolar disorder, it is also possible to use a feature amount related to the amount of activity as a feature amount in the case of bipolar disorder.

  The eligibility determination unit 23 ″ calculates an evaluation value for one user by inputting state information and position information regarding one user whose eligibility is to be determined to the prediction model, and calculates a disease based on the calculated evaluation value. The eligibility of the user as a subject is determined from the viewpoint of the presence or absence of illness.

  In addition, by performing predetermined statistical processing based on the length of time during which the state information and the position information are acquired (the length of time the user wears the wearable terminal 110), the reliability of the user is evaluated. At least one of the value and the proficiency evaluation value may be calculated, and the user's eligibility as a subject may be determined from at least one viewpoint of reliability and proficiency in consideration of the calculated evaluation value. .

  In the first and second embodiments, a relative evaluation value is calculated for each of the reliability evaluation value and the proficiency evaluation value in comparison with other users, and the user is evaluated based on the relative evaluation value. Although the example of determining eligibility as a subject has been described, the eligibility of a user as a subject may be determined based on an absolute evaluation value that is not a comparison with another user.

  For example, whether the reaction time from when the instruction is given to when the execution function of the predetermined process is activated is longer (or shorter) than a predetermined value, and whether the execution time of the predetermined process is longer than the predetermined value The reliability or proficiency may be evaluated based on whether the wearable terminal 110 is worn longer than a predetermined value (or shorter) or not (or shorter). .

  When the eligibility of the user as a subject is determined based on the absolute evaluation value in this manner, the execution result acquisition unit 21, the eligibility determination units 23, 23 ′, 23 ″, the state information acquisition unit 26, and the position information acquisition unit 26A may be provided in the user terminals 100, 100 ', 100 ", and the eligibility determination process may be performed in the user terminals 100, 100', 100". Server 200, 200 ′, 200 ″, and stores the determination result information in the auxiliary storage device 204.

  Further, in the first and second embodiments, the medical treatment software is described as an example of the medical software for the purpose of treating the patient through the improvement of the lifestyle of the patient. It is not limited to those aimed at treating through habit improvement. In addition, the medical software is not an application for treating a disease by itself, but may be an information providing type application in which patient's biological information, behavior information, questionnaire response information, etc. are collected and transmitted to a server device. Good.

  In addition, each of the first and second embodiments is merely an example of the embodiment of the present invention, and the technical scope of the present invention should not be interpreted in a limited manner. It must not be. That is, the present invention can be implemented in various forms without departing from the gist or the main features thereof.

REFERENCE SIGNS LIST 11 process execution instruction unit 12 process execution unit 13 execution result storage unit 14 execution result transmission unit 15 state information detection unit 15A position information detection unit 16 state information storage unit 16A position information storage unit 17 state information transmission unit 17A position information transmission unit 21 Execution result acquisition unit 22 Execution result storage unit 23, 23 ′, 23 ″ Eligibility determination unit 24 Determination result storage unit 25 Determination result transmission unit 26 State information acquisition unit 26A Position information acquisition unit 27 State information storage unit 27A Position information storage unit 100, 100 ', 100 "user terminal (information processing device)
110 wearable terminal (second information processing device)
200, 200 ', 200 "Clinical Trial Management Server 300 Medical Institution Terminal

Claims (16)

A system for determining eligibility of a medical software as a subject to participate in a clinical trial,
A process execution instructing unit that instructs a user of the information processing apparatus in which the medical software is installed, to instruct execution of a predetermined process using the medical software,
An execution result acquisition unit that acquires execution result information indicating a result when the predetermined process is executed by the user in accordance with an instruction from the process execution instruction unit;
Based on the execution result acquisition unit said execution result information obtained by, whether or not the reliability evaluation value is a person for the purpose of acquisition of incentive and the evaluation value of proficiency on the operation of the information processing apparatus At least one of them is calculated, and it is determined whether the user has eligibility as a subject by determining whether at least one of the reliability evaluation value and the proficiency evaluation value satisfies a predetermined condition. And a qualification unit for performing a clinical trial qualification. The execution result information includes corresponding time information indicating a corresponding time when the user executes the predetermined process in response to the instruction,
The eligibility determination unit, by performing a predetermined statistical process based on the correspondence time information to calculate at least one of the evaluation values of the reliability of the evaluation value and the proficiency relating to the user, the reliability depending on whether at least one of whether a predetermined condition is satisfied among the evaluation values and the learning level of evaluation values, to claim 1 where said user and judging whether or not having qualify as subjects A clinical trial eligibility determination system as described.   The eligibility determination unit is configured to calculate a relative evaluation value of the response time for one user with respect to the response time for another user based on the response time information acquired by the execution result acquisition unit for a plurality of users. 3. The clinical test eligibility determination system according to claim 2, wherein the evaluation value is calculated as at least one of the reliability evaluation value and the proficiency evaluation value of the one user.   The eligibility determination unit is configured to determine a statistic value of the distribution of the response time for the other user who has performed the predetermined process under monitoring and a magnitude of a difference between the value of the response time for the one user. The clinical test eligibility determination system according to claim 3, wherein the calculated relative evaluation value is calculated. The eligibility determination unit, the corresponding time for the other user who performed the predetermined processing as the correct data under surveillance, so that the corresponding time information the relative evaluation value is output when input 4. The relative evaluation value for the one user is calculated by inputting the corresponding time information about the one user to the prediction model using a prediction model that has been machine-learned. 4. The clinical trial eligibility determination system according to 1.   The eligibility determination unit calculates a value indicating the position of the corresponding time for the one user in the distribution of the corresponding times for the plurality of users as a relative evaluation value for the one user. The clinical test eligibility determination system according to claim 3.   The clinical test eligibility determination according to claim 2, wherein the response time information includes reaction time information indicating a reaction time until the user starts execution of the predetermined process in response to the instruction. system.   3. The eligibility for a clinical trial according to claim 2, wherein the response time information includes execution time information indicating an execution time required until the user completes the execution of the predetermined process in response to the instruction. Judgment system. The process execution instructing unit instructs a user of the information processing apparatus to execute a predetermined process using the medical software a plurality of times,
The execution result information includes instruction compliance status information indicating an instruction compliance rate that is a ratio of the number of times the user has actually performed the predetermined process in response to the instruction a plurality of times,
The eligibility determination unit, by performing a predetermined statistical process based on the instruction compliance information, then calculate at least one of the evaluation values of the reliability of the evaluation value and the proficiency relating to the user, the trust 2. A method according to claim 1, wherein whether the user has eligibility as a subject is determined based on whether at least one of a sex evaluation value and the proficiency evaluation value satisfies a predetermined condition. Or the clinical test qualification system according to 2.   The eligibility determination unit is configured to determine, based on the instruction compliance status information acquired by the execution result acquisition unit for a plurality of users, a relative ratio of the instruction compliance ratio for one user to the instruction compliance ratio for another user. The clinical test eligibility determination system according to claim 9, wherein the evaluation value is calculated as at least one of the reliability evaluation value and the proficiency evaluation value of the one user. A state information acquisition unit that acquires state information representing a physical state of the user when the predetermined processing is executed by the user in accordance with an instruction from the processing execution instruction unit;
The eligibility determination unit, based on the execution result information acquired by the execution result acquisition unit, whether or not the reliability evaluation value is a person for the purpose of acquisition of incentives and of the information processing apparatus At least one of the evaluation values of the proficiency level regarding the operation is calculated, and based on the state information acquired by the state information acquiring unit , the morbidity of the disease to be treated through the use of the medical software is determined. The evaluation value of presence / absence is calculated, and the user as a subject is determined based on whether at least one of the evaluation value of the reliability, the evaluation value of the proficiency level, and the evaluation value of the presence / absence of the disease satisfies a predetermined condition. The clinical test eligibility determination system according to claim 1, wherein it is determined whether or not the eligibility is high. The information processing device or further includes a state information acquisition unit that acquires state information indicating a physical state of the user during use of the portable or wearable second information processing device,
The eligibility determination unit,
Based on the state information acquired by the state information acquisition unit, the evaluation value of the presence or absence of the disease for the disease to be treated through the use of the medical software is calculated, the evaluation value of the presence or absence of the disease is depending on whether a predetermined condition is satisfied, with the user to determine whether it has the eligibility of a subject,
By performing a predetermined statistical process based on the length of time that the state information has been acquired, and calculates at least one of the evaluation values of the reliability of the evaluation value and the proficiency relating to the user, the execution At least one of the reliability evaluation value and the proficiency evaluation value calculated based on the result information, and the reliability evaluation value calculated based on the length of time during which the state information is obtained and Determining whether the user has eligibility as a subject by determining whether at least one of the evaluation values of the proficiency level satisfies a predetermined condition. Item 10. The clinical test eligibility determination system according to item 2 or 9. The information processing apparatus or the second information processing apparatus further includes a position information obtaining unit that obtains position information indicating a position of the user while using the information processing apparatus,
The eligibility determination unit,
Based on the state information obtained by the state information obtaining unit and the position information obtained by the position information obtaining unit, an evaluation value of the presence or absence of the disease is calculated, and the evaluation value of the presence or absence of the disease is calculated. depending on whether a predetermined condition is satisfied, with the user to determine whether it has the eligibility of a subject,
Calculating at least one of the reliability evaluation value and the proficiency evaluation value for the user by performing predetermined statistical processing based on the length of time during which the state information and the position information are acquired And calculating based on at least one of the reliability evaluation value and the proficiency evaluation value calculated based on the execution result information, and a length of time during which the state information and the position information are obtained. by the or at least one whether a predetermined condition is satisfied in at least one of the evaluation values of the evaluation value and the proficiency of the reliability, the user whether having qualify as subjects The clinical test eligibility determination system according to claim 12, wherein the determination is performed. A computer-based method of determining eligibility of a medical software as a subject to participate in a clinical trial,
A process execution instructing unit of the information processing apparatus in which the medical software is installed, instructing a user of the information processing apparatus to execute a predetermined process using the medical software;
The execution result acquisition unit of the information processing device or a server device connected thereto via a communication network represents a result when the predetermined process is executed by the user according to an instruction from the process execution instruction unit. Obtaining execution result information;
Based on the execution result information acquired by the execution result acquisition unit, the eligibility determination unit of the information processing device or the server device evaluates reliability of whether or not the person is a person who aims to obtain an incentive. calculating at least one of the evaluation values of the proficiency on working with the values and the information processing apparatus, by at least one of whether or not a predetermined condition is satisfied among the evaluation values of the evaluation value and the proficiency of the reliability, Determining whether or not the user has eligibility as a subject. An apparatus for determining eligibility as a subject to participate in a clinical trial of medical software,
An execution result representing a result when the predetermined process is executed by a user of the information processing apparatus in which the medical software is installed, in response to an instruction to execute the predetermined process using the medical software. An execution result acquisition unit for acquiring information;
Based on the execution result acquisition unit said execution result information obtained by, whether or not the reliability evaluation value is a person for the purpose of acquisition of incentive and the evaluation value of proficiency on the operation of the information processing apparatus At least one of them is calculated, and it is determined whether the user has eligibility as a subject by determining whether at least one of the reliability evaluation value and the proficiency evaluation value satisfies a predetermined condition. And a qualification unit for performing a clinical trial. A program for determining the eligibility of a medical software as a subject to participate in a clinical trial,
An execution result representing a result when the predetermined process is executed by a user of the information processing apparatus in which the medical software is installed, in response to an instruction to execute the predetermined process using the medical software. An execution result information acquiring unit for acquiring information; and an evaluation value of reliability of whether or not the person is a person aiming to obtain an incentive based on the execution result information acquired by the execution result information acquiring unit. calculating at least one of the evaluation values of the proficiency on the operation of the information processing apparatus, depending on whether at least one of whether a predetermined condition is satisfied among the evaluation values of the evaluation value and the proficiency of the reliability, the user For qualifying clinical trials to make a computer function as a qualification judging unit for judging whether or not a subject is eligible program.