JP6338957B2 - Clinical trial compatible patient selection device, system and method - Google Patents

Description

  The present invention relates to a clinical trial suitable patient selection apparatus capable of providing information on clinical trial compatible patients.

Conventionally, recruitment of clinical trial subjects has been conducted mainly for patients who are hospitalized or visiting a medical institution conducting clinical trials. In other words, the trial coordinator searches for the target patient while confirming the contents of the medical chart.
In addition, public advertisements for clinical trial subjects by pharmaceutical companies have become accepted, and recruiting clinical trial subjects through newspapers, magazines, television, the Internet, etc. is also widely performed. A company with a patient panel (a list of pre-registered patients) may sell to pharmaceutical companies and CROs.

  Furthermore, trials for recruiting / selecting subjects by a trial intermediary server via the Internet from those who wish to participate in trials have been made (Patent Documents 1 and 2 below).

JP 2011-233066 A JP 2008-186039 A

  However, despite the above-mentioned attempts, there is a problem that it is difficult to select a medical institution to conduct a clinical trial and recruit clinical trial subjects according to the patient's schedule. It was also a challenge to obtain information on how many patients could be targeted and to prevent subject dropout after the start of the trial. In addition, recruitment of clinical trial subjects on the premise of protecting patient privacy was also an issue.

  On the other hand, in recent years, recognition of the importance of so-called patient-derived information has increased, and electronic databases including competitive drugs, patient chronic diseases and health checkup data, such as ePRO (Patient Reported Outcome) manufactured by PHT, etc., are also on the market. . Reflecting patient-derived information also in information related to study subjects has been an issue.

  It is an object of the present invention to provide information that promotes recruitment of clinical trial subjects and to ensure the protection of patient privacy, and to prevent the clinical trial subjects from dropping out of clinical trials with accurate medication information based on patient-derived information. And a patient terminal operated by a patient or a patient administrator connected to the apparatus via a network and operated by a pharmacist at a pharmacy An object of the present invention is to provide a clinical trial compatible patient selection system including a pharmacy terminal.

That is, the clinical trial compatible patient selection device according to the present invention is as follows.
[1]
A prescription / dispensing information storage means for storing a prescription / dispensing information database in which prescription / dispensing information, which is information about prescriptions and dispensing prescribed to patients, is stored;
Prescription / dispensing information anonymization means for converting the prescription / dispensing information into anonymized prescription / dispensing information and creating an anonymized prescription / dispensing information database;
Clinical trial information storage means for storing a clinical trial information database that stores clinical trial information indicating predetermined criteria for the clinical trial;
Clinical trial conformity that screens clinical trial relevant patients that satisfy the predetermined criteria by data comparison between the anonymized prescription / dispensing information and the clinical trial information, constructs a clinical trial relevant patient information database, and stores it in the clinical trial relevant patient information storage means Patient information database construction means,
A clinically relevant patient selection device comprising:
[2]
The clinical trial-compatible patient selection device according to [1], wherein the clinical trial-compatible patient information database construction unit further stores patient-derived information in a clinical trial-compatible patient information database.
[3]
The trial-compatible patient selection device according to [2], wherein the patient-derived information is patient consent information for a clinical trial, patient medication information, patient QOL information, and patient body related information.
[4]
A clinical trial compatible patient selection device connected via a network to a patient terminal operated by a patient or a patient administrator and a pharmacy terminal operated by a pharmacist of a pharmacy;
Individual patient information receiving means for receiving individual patient information related to the patient transmitted from the patient terminal to the clinical trial compatible patient selecting device;
Patient identification information transmitting means for transmitting patient identification information for identifying the patient from the clinical trial compatible patient selection device to the patient terminal;
Individual dispensing information receiving means for receiving the individual dispensing information of the patient associated with the patient identification information transmitted from the pharmacy terminal to the clinical trial compatible patient selection device;
Prescription / dispensing information database construction means for constructing the prescription / dispensing information database in which the patient identification information in the prescription / dispensing information database, the individual patient information, and the individual dispensing information are associated with each other;
The trial-compatible patient selection device according to any one of [1] to [3], further comprising:
[5]
[1] to [4], wherein the prescription / dispensing information anonymization means creates anonymized prescription / dispensing information in which data for identifying a patient in the prescription / dispensing information is anonymized. The trial-compatible patient selection device according to any one of the above.
[6]
The clinical trial-compatible patient selection device according to [5], wherein the data specifying the individual patient is a name, an address, and a date of birth.
[7]
The trial-compatible patient selection device according to any one of [1] to [6], wherein the predetermined criteria of the clinical trial are clinical trial patient selection criteria, clinical trial patient exclusion criteria, and a medical institution location. .
[8]
The clinical trial-compatible patient selection device according to [7], wherein the selection criteria for the clinical trial patient are age, sex, prescription drug, and address.
[9]
The trial-compatible patient selection device according to [7], wherein the trial patient exclusion criterion is an exclusion criterion drug.
[10]
The trial-compatible patient selection device according to [9], wherein the exclusion reference drug is developed in a YJ code.
[11]
From [1], the clinical trial compatible patient selection device further includes clinical trial compatible patient number calculation means for calculating the number of clinical trial compatible patients for each medical institution with reference to the clinical trial compliance patient information database. [10] The trial-compatible patient selection device according to any one of [10].
[12]
The clinical trial-compatible patient selection device according to any one of [4] to [11], wherein the patient identification information is one-dimensional barcode information.
[13]
The trial-compatible patient selection device according to any one of [4] to [12], wherein the pharmacy terminal is a receipt computer.
[14]
The clinical trial compatible patient selection device further comprises:
Medication support information transmitting means for transmitting medication support information for encouraging medication based on the individual dispensing information from the clinical trial compatible patient selection device to the patient terminal;
Medication completion information receiving means for receiving medication completion information indicating completion of medication transmitted from the patient terminal to the clinical trial compatible patient selection device;
With
The prescription / dispensing information database constructing unit further constructs a prescription / dispensing information database associated with the medication completion information, according to any one of [4] to [13]. .
[15]
The clinical trial compatible patient selection device further comprises:
[14] The clinical trial conformity according to [14], further comprising: a medication record information transmission unit that refers to the prescription / dispensing information database and creates medication record information cumulatively indicating the medication completion information and transmits the medication record information to the patient terminal. Patient selection device.
[16]
In addition to the patient terminal,
The clinical trial-compatible patient selecting device according to [15], further comprising pharmaceutical information transmitting means for transmitting pharmaceutical information in a pharmaceutical information database.
[17]
[1] to [16] A clinical trial compatible patient selecting device according to any one of [1] to [16], a clinical trial comprising the patient terminal connected to the clinical trial compatible patient selecting device via a network, and the pharmacy terminal Compatible patient selection system.
[18]
A prescription / dispensing information storage step for storing a prescription / dispensing information database in which prescriptions and dispensing information are stored;
A prescription / dispensing information anonymization step for converting the prescription / dispensing information into anonymized prescription / dispensing information to create an anonymized prescription / dispensing information database;
By screening the anonymized prescription / dispensing information and the clinical trial information, the clinical trial patient who satisfies the predetermined criteria is screened, the clinical trial relevant patient information database is constructed, and the clinical trial information indicating the predetermined criteria of the clinical trial is stored. A clinical trial compatible patient information database construction step for storing the clinical trial compatible patient information storage means for storing the clinical trial information database,
A method for selecting clinical trial compatible patients.
[19]
A clinical trial compatible patient selection method executed by a clinical trial patient selection device connected via a network to a patient terminal operated by a patient or a patient administrator and a pharmacy terminal operated by a pharmacist of a pharmacy,
An individual patient information receiving step for receiving individual patient information related to the patient transmitted from the patient terminal to the clinical trial compatible patient selection device;
A patient identification information transmission step for transmitting patient identification information for identifying the patient from the clinical trial compatible patient selection device to the patient terminal;
An individual dispensing information receiving step for receiving the individual dispensing information of the patient associated with the patient identification information transmitted from the pharmacy terminal to the clinical trial compatible patient selecting device;
A prescription / dispensing information database constructing step for constructing the prescription / dispensing information database in which the patient identification information in the prescription / dispensing information database, the individual patient information, and the individual dispensing information are associated with each other;
The method of selecting a clinically relevant patient according to [18], further comprising:

  According to the trial-compatible patient selection system of the present invention, the anonymized prescription / dispensing information converted from the prescription / dispensing information, which is information related to the prescription and dispensing prescribed to the patient, and the clinical trial information indicating the predetermined criteria of the trial Data matching can be used to screen clinically relevant patients that meet this predetermined criteria. Thus, for example, if the prescription / dispensing information includes information identifying the hospital that created the prescription, the trial-compliant patient information indicating which hospitals are likely to be the subject of the trial Can be provided to pharmaceutical companies and medical institutions that intend to conduct clinical trials, and can facilitate search for clinical trial institutions and recruitment of clinical trial subjects. Further, by anonymizing patient information, it is possible to realize a mechanism that does not leak patient privacy information at the same time. Furthermore, it is possible to provide clinical trial compatible patient information based on patient-derived information, and to prevent a subject from dropping out of the clinical trial.

It is a figure which shows the outline | summary of the clinical trial suitable patient selection in the clinical trial relevant patient selection apparatus based on embodiment of this invention. Patient information registration in a clinical trial compatible patient selection device connected via a network to a patient terminal operated by a patient or a patient manager and a pharmacy terminal operated by a pharmacist of the pharmacy according to an embodiment of the present invention It is a figure which shows the outline | summary of construction of a prescription / dispensing information database. Patient medication information in a clinical trial compatible patient selection device connected via a network to a patient terminal operated by a patient or a patient administrator and a pharmacy terminal operated by a pharmacist of the pharmacy according to an embodiment of the present invention It is a figure which shows the outline | summary of memory | storage. It is a figure which shows the function structure of the clinical trial compatible patient selection apparatus which concerns on embodiment of this invention. It is a figure which shows the flow of the clinical trial suitable patient selection method which concerns on embodiment of this invention. It is a figure which shows the flow of the clinical trial suitable patient selection method which concerns on embodiment of this invention. It is a figure which shows the flow of the clinical trial suitable patient selection method which concerns on embodiment of this invention.

  Embodiments of the present invention will be described below in detail with reference to the drawings.

(Clinical trial patient selection in the clinical trial patient selection apparatus according to the embodiment of the present invention)
FIG. 1 is a diagram showing an outline of an outline of clinical trial suitable patient selection in a clinical trial suitable patient selection apparatus according to an embodiment of the present invention.
The trial-compatible patient selection device stores a prescription / dispensing information database (hereinafter also referred to as a prescription / dispensing information DB) in which prescription / dispensing information, which is information related to prescriptions and dispensing prescribed to patients, is stored. Dispensing information storage means;
Prescription / dispensing information anonymization means for converting the prescription / dispensing information into anonymized prescription / dispensing information to create an anonymized prescription / dispensing information database (hereinafter also referred to as anonymized prescription / dispensing information DB);
Clinical trial information storage means for storing a clinical trial information database (hereinafter also referred to as clinical trial information DB) storing clinical trial information indicating predetermined criteria for the clinical trial;
Based on the data comparison between the anonymized prescription / dispensing information and the clinical trial information, clinical trial compatible patients that satisfy the predetermined criteria are screened, and a clinical trial compatible patient information database (hereinafter also referred to as clinical trial compatible patient information DB) is constructed. Clinical trial compatible patient information database construction means for storing the clinical trial compatible patient information storage means,
It is characterized by providing.

  By having the above-mentioned configuration, the clinical trial compatible patient selection device can also provide clinical trial compatible patient information to a pharmaceutical company and a medical institution that intends to conduct a clinical trial. Search for clinical trial-capable medical institutions and recruit clinical trial subjects. Can be promoted. Further, by anonymizing patient information, it is possible to realize a mechanism that does not leak patient privacy information at the same time.

  In the present invention, the “clinical trial” includes not only a “clinical trial” for obtaining an approval application but also a “clinical trial / Clinical studies "are also included.

As shown in FIG. 1, the clinical trial compatible patient selection device includes a prescription / dispensing information database, an anonymized prescription / dispensing information database, a clinical trial information database, and a clinical trial compatible patient information database.
The trial-compatible patient selection device anonymizes prescription / dispensing information in a prescription / dispensing information database in which patient prescriptions and dispensing information are stored, which are constructed by associating received information from a patient terminal and a pharmacy terminal, which will be described later By doing so, anonymized prescription / dispensing information is converted into an anonymized prescription / dispensing information database.
In addition, the clinical trial compatible patient selection device performs data collation between anonymized prescription / dispensing information and clinical trial information indicating a predetermined standard of clinical trial obtained from a pharmaceutical company and stored in a clinical trial information database. Then, a clinical trial compatible patient information database for storing clinical trial compatible patient information in which clinical trial compatible patients satisfying the predetermined criteria are screened is constructed.

The clinical trial suitable patient selection device is preferably a so-called cloud computer. As will be described later, a cloud computer enables a patient or a user such as a patient administrator, a pharmacy, or a pharmacist to use computer processing and data storage via a network.
Examples of the network include various networks as long as they are computer networks that connect the trial-compatible patient selection device and each terminal. The Internet is preferable.

FIG. 4 is a diagram showing a functional configuration of the clinical trial-compatible patient selection device according to the embodiment of the present invention.
As shown in FIG. 4, the clinical trial compatible patient selection device 100 according to the present embodiment is connected to a patient terminal 300 operated by a patient or a patient manager and a pharmacy terminal 400 operated by a pharmacist of the pharmacy via a network. Connected.
The clinical trial suitable patient selection device 100 includes a prescription / dispensing information storage unit 160, a prescription / dispensing information anonymization unit 170, an anonymized prescription / dispensing information storage unit 180, a clinical trial information storage unit 190, a clinical trial compatible patient information storage unit 210, a clinical trial. Conforming patient information database construction means 200 is provided.
The clinical trial suitable patient selection device 100 converts the prescription / dispensing information stored in the prescription / dispensing information database by the prescription / dispensing information storage means 160 into anonymized prescription / dispensing information by the prescription / dispensing information anonymizing means 170. Then, an anonymized prescription / dispensing information database is created and stored in the anonymized prescription / dispensing information storage means 180.
The clinical trial suitable patient selection apparatus 100 includes an anonymized prescription / dispensing information stored in the anonymized prescription / dispensing information database and clinical trial information indicating a predetermined standard of the clinical trial stored in the clinical trial information database. The construction means 200 collates the data, screens the clinical trial compatible patients satisfying the predetermined criteria, and stores the clinical trial compatible patient information in the clinical trial compliance patient information database.

  The anonymized clinical trial compatible patient information obtained by the clinical trial suitable patient selection device 100 can be renamed at the pharmacy that dispensed the patient. The pharmacist at the pharmacy can use the restored patient information to, for example, solicit patients for clinical trials and enlighten the patients. Further, a pharmacist at a pharmacy can acquire patient medication information, patient QOL information, patient body related information, and the like by filling out a survey form by a patient suitable for the survey target and listening to the patient. The patient body related information is information related to the patient's body and can be obtained from a patient diary, medical equipment available at home, and the like. The pharmacist of the pharmacy can provide such patient-derived information to the trial-compatible patient selection device.

  The clinical trial compatible patient information database construction means 200 of the clinical trial compatible patient selection device 100 can further store the patient-derived information, so-called patient outcome information, in the clinical trial compatible patient information database. As described above, the patient-derived information includes patient consent information for clinical trials, patient medication information, patient QOL information, patient body related information, and the like.

  The prescription / dispensing information anonymization means 170 anonymizes the data specifying the individual patient in the prescription / dispensing information, and creates anonymized prescription / dispensing information. Anonymization is performed by a known method used for deleting or anonymizing the data. The data specifying the individual patient may include name, address, and date of birth.

  Study information includes study patient selection criteria, study patient exclusion criteria, and medical institution location. The selection criteria for study patients generally include age, gender, prescription drugs and address. In general, exclusion criteria for study patients include exclusion criteria.

  As the exclusion reference drug, an exclusion reference drug developed in the YJ code is generally used. Exclusion criteria drugs are generally expressed by the generic name or group of generic names of pharmaceutical products. Therefore, expand the YJ code with a separate code to each product listed in the uniform name, and select patients eligible for clinical trials. Preferably it is done.

  The clinical trial compatible patient selection device 100 may further include clinical trial compatible patient number calculating means for calculating the number of clinical trial compatible patients for each medical institution with reference to the clinical trial compatible patient information database. Thereby, the number of clinical trial compatible patients for each medical institution can be provided by the clinical trial compatible patient selection device 100.

  As described above, the anonymized clinical trial patient information obtained by the clinical trial patient selection device 100 is utilized by the pharmacist of the pharmacy, and the patient information obtained at the pharmacy is further stored in the clinical trial patient information database. Configure clinical trial patient information provided to pharmaceutical companies and medical institutions.

  As described above, the clinical trial suitable patient selection device according to the present invention can provide information that promotes recruitment of clinical trial subjects and can ensure the protection of patient privacy. It is possible to prevent the subject from dropping out of the clinical trial. In addition, in the normal post-marketing survey, there may be a bias in the patient background. However, according to the clinical trial-compatible patient selection device according to the present invention, the patient is randomly extracted from all applicable patients, or the patient It is possible to improve the accuracy of the survey by extracting the background so that there is no bias.

(Construction of patient information registration and prescription / dispensing information database in the clinical trial compatible patient selection device according to the embodiment of the present invention)
FIG. 2 shows a clinical trial suitable patient selection device connected via a network to a patient terminal operated by a patient or a patient manager and a pharmacy terminal operated by a pharmacist of the pharmacy according to an embodiment of the present invention. It is a figure which shows the outline | summary of the patient information registration and construction of a prescription / dispensing information database.
A clinical trial suitable patient selection device according to an embodiment of the present invention includes a clinical trial patient connected to a patient terminal operated by a patient or a patient manager and a pharmacy terminal operated by a pharmacist of the pharmacy via a network. A selection device,
Individual patient information receiving means for receiving individual patient information related to the patient transmitted from the patient terminal to the clinical trial compatible patient selecting device;
Patient identification information transmitting means for transmitting patient identification information for identifying the patient from the clinical trial compatible patient selection device to the patient terminal;
Individual dispensing information receiving means for receiving the individual dispensing information of the patient associated with the patient identification information transmitted from the pharmacy terminal to the clinical trial compatible patient selection device;
Prescription / dispensing information database construction means for constructing the prescription / dispensing information database in which the patient identification information in the prescription / dispensing information database, the individual patient information, and the individual dispensing information are associated with each other; It is characterized by providing.

  The clinical trial compatible patient selection device according to this embodiment has the above-described configuration, so that clinical trial compatible patient information based on patient-derived information, that is, how many patients may be targeted in which hospital. Patient information can be provided to pharmaceutical companies and medical institutions seeking to conduct clinical trials.

  At the same time, the trial-compatible patient selection device according to the present embodiment is easier to register for patients than conventional systems, can be used by patient managers such as the patient's family, can be easily dispensed at any pharmacy, etc. It also has a function as a medication management system (for example, Pocket Pharmacy (registered trademark: Medical Front Co., Ltd.)) using an electronic health notebook, which has the advantage of being able to improve services.

As shown in FIG. 2, the clinical trial-compatible patient selection device according to the present embodiment further includes a dispensing information database and a prescription / dispensing information database.
When the individual patient information of the patient transmitted from the patient terminal is received and the individual patient information is stored in the prescription / dispensing information database, the clinical trial compatible patient selection device sends the patient identification information to the patient terminal of the patient. Send.
When the patient presents the prescription and patient identification information to the pharmacy, the dispensing information associated with the patient identification information is transmitted from the pharmacy terminal to the dispensing information database of the clinical trial patient selection device, and the information is stored in the clinical trial. Referenced to the prescription / dispensing information database of the compatible patient selection device.
A prescription / dispensing information database in which the patient identification information, the individual patient information, and the individual dispensing information are associated with each other in the prescription / dispensing information database of the clinical trial-compatible patient selection device is constructed.

As described above, the clinical trial-compatible patient selection device according to the present embodiment is preferably a so-called cloud computer. With the cloud computer, a patient or a user such as a patient administrator, a pharmacy, and a pharmacist can use computer processing and data storage via a network.
Examples of the network include various networks as long as they are computer networks that connect the trial-compatible patient selection device according to the present embodiment and each terminal. The Internet is preferable. As the patient identification information, various information can be used as long as it is electronic information for identifying a patient. The patient identification information can be printed on a card that can be carried by the patient and displayed on the screen of the patient terminal, and the pharmacy can realize the simplest and most reliable input method by connecting an inexpensive reading device to the pharmacy terminal. One-dimensional barcode information is preferred. In addition, the pharmacy terminal is preferably a reception computer (also referred to as “recesecon”) for creating a receipt (medical fee description).

As shown in FIG. 4, the clinical trial suitable patient selection device 100 further includes an individual patient information receiving unit 110, a patient identification information transmitting unit 120, an individual dispensing information receiving unit 130, a prescription / dispensing information database construction unit 150, a prescription / dispensing information. Provide a database.
The clinical trial compatible patient selection device 100 receives the individual patient information related to the patient transmitted from the patient terminal 300 to the clinical trial compatibility patient selection device 100 by the individual patient information receiving means 110.
The clinical trial suitable patient selection device 100 transmits patient identification information for identifying a patient from the clinical trial suitability patient selection device 100 to the patient terminal 300 by the patient identification information transmission means 120.
The clinical trial compatible patient selection apparatus 100 receives the individual dispensing information of the patient associated with the patient identification information transmitted from the pharmacy terminal 400 to the clinical trial compatible patient selection apparatus 100 by the individual dispensing information receiving means 130.
The prescription / dispensing information storage means 160 of the clinical trial compatible patient selecting device 100 stores a prescription / dispensing information database in which patient identification information, individual patient information, and individual dispensing information are associated with each other.
The prescription / dispensing information database construction means 150 of the clinical trial suitable patient selecting device 100 constructs a prescription / dispensing information database and stores it in the prescription / dispensing information storage means 160.

The patient terminal 300 is operated by a patient or a patient manager. The patient terminal 300 is generally operated by the patient when the patient can be operated or when the patient can manage medication. However, for example, when the patient is a child or an elderly person and the operation by the patient himself / herself is difficult, or when the patient's own medication management is difficult, the administrator of the patient can perform the operation. In this case, the patient manager is typically one of the patient's family. By the family registration, the patient's family can also operate the patient terminal.
Since the patient terminal 300 in the present embodiment can be operated by a patient manager, when the patient management is difficult, the patient manager can operate the patient terminal 300 to ensure patient medication management. Can improve the medication service to patients. Further, since the terminal information of the child and the distant parent can be seen by the patient manager, the patient and the patient manager can be provided with a sense of security.

  The patient or the patient administrator receives information on the patient transmitted from the clinical trial compatible patient selection device 100 by the patient terminal 300. The patient terminal 300 is not particularly limited as long as it is a computer terminal connected to a network, but is preferably any one selected from the group consisting of a smartphone, a mobile phone, a personal computer, and a tablet. Further, the patient terminal 300 connected from the patient terminal 300 to the clinical trial compatible patient selection apparatus 100 via a network may be a single terminal or a plurality of terminals. For example, it can be accessed from a personal computer installed at home, etc., or from a smartphone carried when traveling. The transmission of the individual patient information to the clinical trial suitable patient selection device can be performed calmly from the home personal computer.

  Individual patient information includes various information related to the patient for identifying the patient. For example, the patient's name, gender, blood type, date of birth, address, telephone number, insurer number, insured number , Medical history, allergies, side effects, vaccination records, disorders, etc.

  The patient or patient administrator who has received the patient identification information for identifying the patient from the clinical trial compatible patient selection device 100 at the patient terminal 300 presents the prescription at the pharmacy and receives the drug, and the patient identification of the patient terminal Present information to the pharmacist. The pharmacist of the pharmacy that has received the patient's prescription and patient identification information from the patient transmits the individual dispensing information of the patient associated with the patient identification information from the pharmacy terminal 400.

  In the clinical trial-compatible patient selection device system including the clinical trial-compatible patient selection device 100, the patient terminal 300, and the pharmacy terminal 400 according to this embodiment, the dispensing information is automatically transmitted in conjunction with the pharmacy terminal 400 by dispensing information automatic transmission. Are taken into the clinical trial compatible patient selection device 100. In addition, it is automatically transmitted to the clinical trial compatible patient selection device 100 in conjunction with the pharmacy terminal 400. Therefore, the patient or the patient manager can immediately check the dispensing information at the patient terminal 300 at hand by simply taking the prescription to the pharmacy connected to the clinical trial compatible patient selection device 100 by the pharmacy terminal 400 via the network. it can.

  In the patient terminal 300, it is possible to search for the relevant pharmacy (hereinafter referred to as “connected pharmacy”) provided with the pharmacy terminal 400 connected to the clinical trial compatible patient selection device 100 via a network. Thus, the patient or the patient manager can know the connected pharmacy. When the pharmacy that prescribes the drug is a pharmacy that is not the pharmacy (hereinafter referred to as “non-connected pharmacy”) provided with the pharmacy terminal 400 that is connected to the clinical trial compatible patient selection device 100 via a network, the patient or patient management A person can also read a medicine prescribed at an unconnected pharmacy by a reader from a QR code (registered trademark) described in a dispensing specification or the like at a connected pharmacy. The read dispensing information is transmitted to the clinical trial compatible patient selection device 100.

  As described above, the patient information registration and the prescription / dispensing information database by the clinical trial compatible patient selection device 100 according to the present embodiment improve various patient services, and at the same time, prescription / Dispensing information can be constructed.

(Outline of patient medication information storage in the clinical trial compatible patient selection device according to the embodiment of the present invention)
FIG. 3 shows a clinical trial suitable patient selection device connected to a patient terminal operated by a patient or a patient manager and a pharmacy terminal operated by a pharmacist of a pharmacy via a network according to an embodiment of the present invention. It is a figure which shows the outline | summary of the patient medication information storage in.
The clinical trial compatible patient selection device according to this embodiment further comprises:
Medication support information transmitting means for transmitting medication support information for encouraging medication based on the individual dispensing information from the clinical trial compatible patient selection device to the patient terminal;
Medication completion information receiving means for receiving medication completion information indicating completion of medication transmitted from the patient terminal to the clinical trial compatible patient selection device;
With
The prescription / dispensing information database construction means further constructs a prescription / dispensing information database associated with the medication completion information.

The clinical trial compatible patient selection device according to this embodiment further comprises:
Reference is made to the prescription / dispensing information database, and medication record information transmitting means for creating medication record information cumulatively indicating the medication completion information and transmitting it to the patient terminal is provided.

As shown in FIG. 3, the clinical trial-compatible patient selection device according to the present embodiment includes a prescription / dispensing information database and a dispensing information database (hereinafter also referred to as a dispensing information DB).
The clinical trial suitable patient selection device further transmits medication support information for encouraging medication based on the individual dispensing information from the clinical trial suitability patient selection device to the patient terminal. The patient takes the medication based on the medication support information, transmits medication completion information indicating that the medication is completed from the patient terminal to the clinical trial-compatible patient selection device, and the medication management device transmits the medication completion information. Receive.
The clinical trial suitable patient selection device further constructs a prescription / dispensing information database in which the medication completion information is associated.
In addition, the trial-compatible patient selection device further refers to the prescription / dispensing information database, creates medication record information cumulatively indicating the medication completion information, and transmits the medication record information to the patient terminal. .

As shown in FIG. 4, the clinical trial-compatible patient selection device 100 further includes a dispensing information database 140, a medication support information transmission unit 220, a medication completion information reception unit 230, and a medication performance information transmission unit 240.
The dispensing information database 140 stores the patient's prescription / dispensing information transmitted from the pharmacy terminal 400. The prescription / dispensing information database constructing unit 150 refers to the dispensing information database 140, constructs a prescription / dispensing information database, and stores it in the prescription / dispensing information storage unit 160.
The clinical trial suitable patient selection device 100 transmits the medication support information to the patient terminal 300 based on the individual dispensing information by the medication support information transmission means 220.
The clinical trial compatible patient selection device 100 receives the medication completion information transmitted from the patient terminal 300 by the medication completion information receiving means 230.
The prescription / dispensing information database construction means 150 of the clinical trial suitable patient selecting device 100 constructs a prescription / dispensing information database associated with the medication completion information.
The medication record information transmission means 240 of the clinical trial suitable patient selection device 100 refers to the prescription / dispensing information database, creates medication record information cumulatively indicating the medication completion information, and transmits the medication record information to the patient terminal 300. To do.

  The clinical trial compatible patient selection device 100 is further characterized in that the patient terminal 300 is provided with a drug information transmitting means 250 for transmitting drug information in the drug information database 280. The patient or the patient administrator can refer to the drug information transmitted from the clinical trial suitable patient selecting device 100 when browsing the medication support information or the medication performance information. In addition, the patient or the patient administrator can search for drug information without having a prescription or a medicine notebook at hand. The drug information includes the generic name, brand name, usage, dose, shape, photo, generic drug of the drug, history, allergies, side effect information, immunization record information, and the like. Examples of the drug information include Mediserve II (registered trademark: Medical Front Co., Ltd.).

  The medication support information is preferably a medication support email that assists the patient in taking medication. In addition, the medication support information includes the type of medication to be taken, the date and time of medication, usage, and dosage. The medication completion information includes the type of medication taken, the date and time of medication, usage, dose, remarks (comment of pharmacist), and the like.

  Self-management in medication can be facilitated by the clinical trial compatible patient selection device according to the present embodiment. In addition, since drug information can be referred to during drug administration, it is possible to refer to drug information such as precautions for taking drugs, photographs of drugs, and drug price differences with generic drugs.

  As described above, patient information registration and prescription / dispensing information database construction by the clinical trial compatible patient selection device 100 according to the present embodiment improve various patient services, and at the same time, medication information based on patient-derived information It is possible to construct a prescription / dispensing information database in which is stored. In particular, since it is possible to provide patient medication information over time from the prescription / dispensing information database, it is possible to prevent the subject from taking the exclusion reference drug in the clinical trial, and to prevent the subject from dropping out of the clinical trial.

(Clinical trial compatible patient selection system according to an embodiment of the present invention)
The clinical trial compatible patient selection system according to the embodiment of the present invention includes a clinical trial compatible patient selection device 100 and a patient terminal connected to the clinical trial compliance patient selection device 100 via a network and operated by a patient or a patient administrator. 300 and a pharmacy terminal 400 operated by a pharmacist at the pharmacy.

  The above-described functional configuration of the present system is merely an example, and one functional block (database and function processing unit) may be divided, or a plurality of functional blocks may be configured as one functional block. Each function processing unit reads a computer program stored in a storage device such as a ROM (Read Only Memory) or a hard disk by a CPU (Central Processing Unit) built in the computer device, and is executed by the CPU. It is realized by. That is, each function processing unit reads / writes necessary data such as a table from a database stored in a storage device or a storage area in a memory, and in some cases, related computer hardware (for example, an input). This is realized by controlling an output device, a display device, and a communication interface device. In addition, the database in the embodiment of the present invention may be a commercial database, but it simply means a collection of tables and files, and the internal structure of the database itself does not matter. The database may be considered as one server (database server).

(Clinical trial compatible patient selection method according to an embodiment of the present invention)
5 to 7 are diagrams showing a flow of the clinical trial suitable patient selection method according to the embodiment of the present invention.
The clinical trial compatible patient selection method according to the present embodiment is a clinical trial compatible patient connected to a patient terminal 300 operated by a patient or a patient manager and a pharmacy terminal 400 operated by a pharmacist of the pharmacy via a network. This is a method executed by the selection device 100.

  In the construction of the patient information registration and prescription / dispensing information database, the clinical trial compatible patient selection method executed by the clinical trial compatible patient selection apparatus 100 according to the present embodiment includes an individual patient information receiving step and patient identification information as shown in FIG. A transmitting step, an individual dispensing information receiving step, and a prescription / dispensing information database construction step.

In step S <b> 1, the individual patient information receiving unit 110 receives the individual patient information related to the patient transmitted from the patient terminal 300 to the clinical trial compatible patient selection device 100.
In step S <b> 2, the patient identification information transmission unit 120 transmits patient identification information for identifying a patient from the medication management apparatus 100 to the patient terminal 300.
In step S3, the individual dispensing information receiving means 130 receives the individual dispensing information of the patient associated with the patient identification information transmitted from the pharmacy terminal 400 to the medication management apparatus 100.
In step S5, the prescription / dispensing information database construction unit 150 constructs a prescription / dispensing information database in which patient identification information, individual patient information, and individual dispensing information are associated with each other, and prescription / dispensing information storage unit 160. To remember.

  As shown in FIG. 6, the clinical trial-compatible patient selection method executed by the clinical trial-compatible patient selection device 100 in the clinical trial-compliant patient selection device by the clinical trial-compliant patient selection device according to the embodiment of the present invention includes prescription / dispensing information. An anonymization step and a clinical trial compatible patient information database construction step.

In step S4, the prescription / dispensing information anonymization means 170 converts the prescription / dispensing information into anonymized prescription / dispensing information, and creates an anonymized prescription / dispensing information database.
In step S5, the clinical trial compatible patient information database construction means 200 screens clinical trial compatible patients satisfying the predetermined criteria by collating data with the anonymized prescription / dispensing information and the clinical trial information, and creates a clinical trial compatible patient information database. It is constructed and stored in the clinical trial compatible patient information storage means.

The patient medication information storage method in the clinical trial compatible patient selection device 100 according to the present embodiment includes a medication support information transmission step, a medication completion information reception step, a prescription / dispensing information database construction step, and a medication record as shown in FIG. An information transmission step and a pharmaceutical information transmission step.
In step S <b> 6, the medication support information transmission unit 220 transmits medication support information for encouraging medication from the clinical trial compatible patient selection device 100 to the patient terminal 300 based on the individual dispensing information.
In step S7, the medication completion information receiving means 230 receives from the patient terminal 300 medication completion information indicating that the patient has taken medication based on the medication support information and that the medication has been completed.
In step S4 ′, the prescription / dispensing information database construction means 150 constructs a prescription / dispensing information database associated with the medication completion information.
In step S <b> 8, the medication record information transmission unit 240 refers to the prescription / dispensing information database, creates medication record information cumulatively indicating the medication completion information, and transmits the medication record information to the patient terminal 300.
In step S <b> 9, the drug information transmitting unit 250 transmits the drug information in the drug information database 280 to the patient terminal 300.

  As mentioned above, although this invention was demonstrated using embodiment, it cannot be overemphasized that the technical scope of this invention is not limited to the range as described in the said embodiment. It will be apparent to those skilled in the art that various modifications or improvements can be added to the above-described embodiments. Further, it is apparent from the scope of the claims that the embodiments added with such changes or improvements can be included in the technical scope of the present invention.

DESCRIPTION OF SYMBOLS 100 Clinical trial compatible patient selection apparatus 110 Individual patient information receiving means 120 Patient identification information transmitting means 130 Individual dispensing information receiving means 140 Dispensing information database 150 Prescription / dispensing information database construction means 160 Prescription / dispensing information storage means 170 Prescription / dispensing information anonymization Means 180 Anonymized prescription / dispensing information storage means 190 Clinical trial information storage means 200 Clinical trial compatible patient information database construction means 210 Clinical trial compatible patient information storage means 220 Medication support information transmitting means 230 Medication completion information receiving means 240 Medication completion information transmitting means 250 Pharmaceutical Information transmitting means 280 Drug information database 300 Patient terminal 400 Pharmacy terminal

Claims (19)

A prescription / dispensing information storage means for storing a prescription / dispensing information database in which prescription / dispensing information, which is information about prescriptions and dispensing prescribed to patients, is stored;
Prescription / dispensing information anonymization means for converting the prescription / dispensing information into anonymized prescription / dispensing information and creating an anonymized prescription / dispensing information database;
Clinical trial information storage means for storing a clinical trial information database that stores clinical trial information indicating predetermined criteria for the clinical trial;
Clinical trial conformity that screens clinical trial relevant patients that satisfy the predetermined criteria by data comparison between the anonymized prescription / dispensing information and the clinical trial information, constructs a clinical trial relevant patient information database, and stores it in the clinical trial relevant patient information storage means A patient information database construction means,
The clinical trial compatible patient information database construction means is a clinical trial compatible patient selection device that further stores patient-derived information that is patient outcome information in a clinical trial compatible patient information database,
Here, the clinical trial-compatible patient selection device is a clinical trial-compatible patient selection device connected via a network to a patient terminal operated by a patient or a patient administrator,
Individual patient information receiving means for receiving individual patient information related to the patient transmitted from the patient terminal to the clinical trial compatible patient selecting device;
Patient identification information transmitting means for transmitting patient identification information for identifying the patient from the clinical trial compatible patient selection device to the patient terminal;
The trial-compatible patient selection device further comprising: A clinical trial compatible patient selection device connected via a network to a patient terminal operated by a patient or a patient manager, and further to a pharmacy terminal operated by a pharmacist of a pharmacy,
Furthermore, individual dispensing information receiving means for receiving the individual dispensing information of the patient associated with the patient identification information transmitted from the pharmacy terminal to the clinical trial compatible patient selection device,
Prescription / dispensing information database construction means for constructing the prescription / dispensing information database in which the patient identification information in the prescription / dispensing information database, the individual patient information, and the individual dispensing information are associated with each other;
The trial-compatible patient selection device according to claim 1, comprising:   The clinical trial-compatible patient selection device according to claim 1 or 2, wherein the patient-derived information is patient consent information to a clinical trial, patient medication information, patient QOL information, and patient body related information.   The anonymized prescription / dispensing information in which the data specifying the individual patient in the prescription / dispensing information is anonymized is created by the prescription / dispensing information anonymizing means. The clinical trial compatible patient selection device according to claim 1.   5. The clinical trial-compatible patient selection device according to claim 4, wherein the data for identifying the individual patient is a name, an address, and a date of birth.   The clinical trial suitable patient selection device according to any one of claims 1 to 5, wherein the predetermined criteria of the clinical trial include clinical trial patient selection criteria, clinical trial patient exclusion criteria, and medical institution location.   The clinical trial-compatible patient selection device according to claim 6, wherein the selection criteria for the clinical trial patient are age, sex, prescription drug, and address.   The trial-patient selection apparatus according to claim 6, wherein the trial patient exclusion criteria is an exclusion criteria drug.   The clinical trial-compatible patient selection device according to claim 8, wherein the exclusion reference drug is developed in a YJ code.   The clinical trial compatible patient selection device further comprises clinical trial compatible patient number calculating means for calculating the number of clinical trial compatible patients for each medical institution with reference to the clinical trial compatible patient information database. 10. The clinical trial suitable patient selection device according to any one of 9 above.   The clinical trial compatible patient selection device according to claim 1, wherein the patient identification information is one-dimensional barcode information.   The clinical trial compatible patient selection device according to claim 2, wherein the patient identification information is one-dimensional barcode information.   The trial-compatible patient selection device according to claim 2 or 12, wherein the pharmacy terminal is a receipt computer. The clinical trial compatible patient selection device further comprises:
Medication support information transmitting means for transmitting medication support information for encouraging medication based on the individual dispensing information from the clinical trial compatible patient selection device to the patient terminal;
Medication completion information receiving means for receiving medication completion information indicating completion of medication transmitted from the patient terminal to the clinical trial compatible patient selection device;
With
The clinical trial compatible patient according to any one of claims 1, 2, 11 to 13, wherein the prescription / dispensing information database construction means further constructs a prescription / dispensing information database associated with the medication completion information. Selection device. The clinical trial compatible patient selection device further comprises:
The clinical trial conformity according to claim 14, further comprising: a medication record information transmitting unit that refers to the prescription / dispensing information database and creates medication record information cumulatively indicating the medication completion information and transmits the medication record information to the patient terminal. Patient selection device. In addition to the patient terminal,
The clinical trial compatible patient selecting device according to claim 15, further comprising pharmaceutical information transmitting means for transmitting pharmaceutical information in the pharmaceutical information database. Trial comprising: a trial fit patient selection device according to claim 2, 12 to 16 any one of, are connected via a network to the trial adaptation patient selection device, and the patient terminal, and the pharmacy terminal, the Compatible patient selection system. Prescription / dispensing information storage means for storing a prescription / dispensing information database storing prescription / dispensing information that is information related to prescriptions and dispensing prescribed to a patient, and clinical trial information database storing clinical trial information indicating a predetermined standard of the clinical trial A clinical trial-compatible patient selection method executed by a clinical trial-compatible patient selection device comprising:
A prescription / dispensing information anonymization step for converting the prescription / dispensing information into anonymized prescription / dispensing information to create an anonymized prescription / dispensing information database;
Clinical trial conformity that screens clinical trial compatible patients that satisfy the predetermined criteria by data comparison between the anonymized prescription / dispensing information and the clinical trial information, constructs a clinical trial compatible patient information database, and stores it in the clinical trial compatible patient information storage means A patient information database construction step,
In the trial-compatible patient information database construction step, the patient-derived information that is patient outcome information is further stored in the clinical trial-compatible patient information database.
Here, a clinical trial compatible patient selection method executed by the clinical trial patient selection apparatus connected via a network to a patient terminal operated by a patient or a patient administrator,
An individual patient information receiving step for receiving individual patient information related to the patient transmitted from the patient terminal to the clinical trial compatible patient selection device;
A patient identification information transmission step for transmitting patient identification information for identifying the patient from the clinical trial compatible patient selection device to the patient terminal;
The method for selecting a clinical trial compatible patient, further comprising: A clinical trial patient selection method executed by the clinical trial patient selection device connected via a network to a patient terminal operated by a patient or a patient manager, and further to a pharmacy terminal operated by a pharmacist of a pharmacy via a network There,
Furthermore, the individual dispensing information receiving step for receiving the individual dispensing information of the patient associated with the patient identification information transmitted from the pharmacy terminal to the clinical trial compatible patient selection device;
A prescription / dispensing information database constructing step for constructing the prescription / dispensing information database in which the patient identification information in the prescription / dispensing information database, the individual patient information, and the individual dispensing information are associated with each other;
The method for selecting clinical trial compatible patients according to claim 18, comprising:

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