WO2021112261A1 - System for proposing treatment options - Google Patents

System for proposing treatment options Download PDF

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Publication number
WO2021112261A1
WO2021112261A1 PCT/JP2020/045545 JP2020045545W WO2021112261A1 WO 2021112261 A1 WO2021112261 A1 WO 2021112261A1 JP 2020045545 W JP2020045545 W JP 2020045545W WO 2021112261 A1 WO2021112261 A1 WO 2021112261A1
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Prior art keywords
information
patient
evidence
unit
evidence information
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PCT/JP2020/045545
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French (fr)
Japanese (ja)
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山田 智之
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Genomedia株式会社
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Priority to JP2021562769A priority Critical patent/JPWO2021112261A1/ja
Publication of WO2021112261A1 publication Critical patent/WO2021112261A1/en

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    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/20ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems

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  • the present invention relates to a system for proposing treatment options using a computer.
  • the above information science platform cannot properly consider treatment options based on genetic abnormalities.
  • the above information science platforms cannot properly evaluate treatment options. Therefore, it is an object of the present invention to provide a system that can appropriately propose treatment options in consideration of genetic abnormalities.
  • This invention basically introduces an index for evaluating treatment options based on information on genetic abnormalities and for ranking (evaluating) the evidence information that is the basis of treatment options. Based on the finding that appropriate treatment options can be proposed.
  • the present invention includes a patient information input unit 3 in which patient information including clinical information of a patient is input, and a patient information input unit 3.
  • Genetic abnormality information input unit 5 for inputting information on the patient's genetic abnormality
  • Evidence information recording unit 7 that records patient information and evidence information related to genetic abnormalities, and Using the patient information of a certain patient input from the patient information input unit and the information on the genetic abnormality of the patient input from the genetic abnormality information input unit, the evidence information recording unit is used to provide evidence information related to the patient.
  • Evidence information extraction unit 9 that extracts the evidence information of Evidence information display unit 11 for displaying the first evidence information on the display unit, and Including the treatment option proposal unit 13 that proposes treatment options based on patient information using the first evidence information. This is a system 1 for proposing treatment options.
  • a preferred embodiment of the present invention is It also has a selection display unit that makes it possible to select the evidence information displayed on the display unit.
  • the treatment option suggestion unit is a system in which the evidence information selected by the selection display unit is used as the first evidence information.
  • a preferred embodiment of the present invention is It also has an evidence information input unit for inputting second evidence information, which is new evidence information.
  • the evidence information display unit displays the second evidence information in addition to the first evidence information.
  • the treatment option proposal unit is a system that proposes treatment options based on patient information using the first evidence information and the second evidence information.
  • a preferred embodiment of the present invention is
  • the patient's clinical information includes information about the type of tumor the patient is suffering from.
  • Evidence information is a system that includes information for each type of tumor.
  • Patient information is a system that includes any one or more of information about a patient's specimen, information about a patient's gender, and information about a patient's medical history.
  • Treatment options are systems, including initiation of anticancer drug treatment.
  • a preferred embodiment of the present invention is Evidence information is divided into two or more categories: (i) guideline publication information, (ii) approved drug information, (iii) clinical trial / clinical trial information, (iv) paper information, and (v) conference presentation information.
  • the treatment option proposal department is a system that proposes treatment options based on patient information using categories.
  • a preferred embodiment of the present invention is a program for operating a computer as any of the above-mentioned systems.
  • This invention considers evidence based on genetic abnormalities and introduces an index for the evidence, so that treatment options can be appropriately proposed.
  • FIG. 1 is a block diagram showing a basic configuration example of the system of the present invention.
  • FIG. 2 is a block diagram showing a basic configuration of a computer.
  • FIG. 3 is a conceptual diagram showing an example of the system of the present invention.
  • FIG. 4 is a flowchart for explaining the process.
  • FIG. 1 is a block diagram showing a basic configuration example of a system for proposing a treatment option of the present invention.
  • the system 1 for proposing a treatment option is a system for proposing a treatment option to a subject such as a doctor or a patient based on a computer.
  • treatment options for example, for tumors, are anti-cancer drug treatment start, anti-cancer drug treatment discontinuation, anti-cancer drug change, clinical trial referral, and clinical trial referral.
  • the system 1 for proposing treatment options includes a patient information input unit 3, a gene abnormality information input unit 5, an evidence information recording unit 7, an evidence information extraction unit 9, and evidence information.
  • the display unit 11 and the treatment option proposal unit 13 are included.
  • the system 1 may further include either or both of the selection display unit 15 and the evidence information input unit 17.
  • this system may further include a display unit 19, an interface unit 21, and a temporary storage unit 23.
  • This system includes a computer, and each element described below is an element implemented by the computer.
  • the computer may be any of various terminals, mobile terminals, notebook personal computers, personal computers and servers.
  • FIG. 2 is a block diagram showing the basic configuration of a computer.
  • the computer has an input unit 31, an output unit 33, a control unit 35, a calculation unit 37, and a storage unit 39, and each element is connected by a bus 41 or the like to exchange information.
  • the control program may be stored in the storage unit, or various types of information may be stored in the storage unit.
  • the control unit reads out the control program stored in the storage unit.
  • the control unit appropriately reads out the information stored in the storage unit and transmits it to the arithmetic unit.
  • the control unit transmits the appropriately input information to the calculation unit.
  • the arithmetic unit performs arithmetic processing using various received information and stores it in the storage unit.
  • the control unit reads the calculation result stored in the storage unit and outputs it from the output unit. In this way, various processes are executed.
  • Each element described below may correspond to any element of the computer.
  • FIG. 3 is a conceptual diagram showing an example of the system of the present invention.
  • the system of the present invention may include a mobile terminal 45 connected to the Internet or an intranet 43 and a server 47 connected to the Internet or an intranet 43.
  • a single computer or mobile terminal may function as the device of the present invention, or a plurality of servers may exist.
  • the system 1 for proposing treatment options may be a server / client system or a stand-alone system.
  • various information may be displayed on the display unit of the computer, or may be displayed on the display unit of a mobile terminal such as a tablet or a smartphone.
  • the patient information input unit 3 is a site (means) for inputting patient information including clinical information of the patient into the system.
  • the input unit of the computer functions as the patient information input unit 3.
  • patient information including clinical information about the patient, include patient name, patient ID (identification information), sample information, information about the sample in which a genetic abnormality was detected, and basic patient information (gender, date of birth, etc.).
  • patient's individual information patient's clinical information (information showing the patient's condition such as cancer type, chief complaint, interview, palpation, various test results such as biochemical test and imaging test) and patient history information (information on the patient's condition)
  • patient history information information on the patient's condition
  • One or more of the patient's various histories such as medical history, hospitalization history, treatment history, and past examination history).
  • a preferred example of a patient's clinical information includes information about the type of tumor the patient is suffering from.
  • the system can then propose treatment options for tumors.
  • Patient information includes any one or more of information about a patient's specimen, information about a patient's gender, and information about a patient's medical history.
  • the genetic abnormality information input unit 5 is a site (means) for inputting information on a patient's genetic abnormality into the system.
  • the input unit of the computer functions as the genetic abnormality information input unit 5.
  • An example of information about a patient's genetic abnormality is that the base located at a specific number in a gene has been replaced by another base.
  • the evidence information recording unit 7 is a site (means) for recording patient information and evidence information related to a genetic abnormality.
  • the storage unit of the computer functions as the evidence information recording unit 7.
  • Evidence information means information that supports the fact that a drug or treatment method is effective or completely ineffective. Examples of evidence information are information on therapeutic agents for specific diseases (for example, tumors and cancers) and information on treatment methods for specific diseases.
  • Evidence information preferably includes information by tumor type, and examples of evidence information include (i) guideline publication information, (ii) approved drug information, (iii) clinical trial / clinical trial information, (iv). It is classified into one or more categories of paper information and (v) conference presentation information.
  • the evidence information extraction unit 9 uses the patient information of a certain patient input from the patient information input unit 3 and the information on the genetic abnormality of the patient input from the gene abnormality information input unit 5 from the evidence information recording unit 7. It is a site (means) for extracting the first evidence information which is the evidence information related to the patient.
  • the control program stored in the calculation unit, the control unit, and the storage unit of the computer functions as the evidence information recording unit 7.
  • the evidence information display unit 11 is a part (means) for displaying the first evidence information on the display unit.
  • the output unit of the computer functions as a display unit
  • the control program stored in the calculation unit, the control unit, and the storage unit of the computer functions as the evidence information display unit 11.
  • the treatment option proposal unit 13 is a site (means) for proposing a treatment option based on patient information using the first evidence information.
  • the control program stored in the calculation unit, the control unit, and the storage unit of the computer functions as the treatment option proposal unit 13.
  • a preferred example of the treatment option suggestion unit 13 proposes treatment options based on patient information using categories.
  • the selection display unit 15 is a part (means) for making the evidence information displayed on the display unit selectable.
  • the control program stored in the calculation unit, the control unit, and the storage unit of the computer functions as the selection display unit 15.
  • the treatment option proposal unit 13 uses the evidence information selected by the selection display unit (selection information is input to the system) as the first evidence information.
  • the evidence information input unit 17 is a part (means) for inputting second evidence information, which is new evidence information (evidence information different from the first evidence information).
  • second evidence information which is new evidence information (evidence information different from the first evidence information).
  • the control program stored in the calculation unit, the control unit, and the storage unit of the computer functions as the evidence information input unit 17.
  • the evidence information display unit 11 displays the second evidence information on the display unit in addition to the first evidence information.
  • the treatment option suggestion unit 13 proposes a treatment option based on the patient information by using the first evidence information and the second evidence information.
  • FIG. 4 is a flowchart for explaining the process.
  • Patient information is input to the system from a computer input unit as the patient information input unit 3 (patient information input step: S101).
  • the entered patient information is appropriately stored in the storage unit.
  • patient information are patient name, patient ID (identification information), and patient clinical information (tumor type: eg, "colorectal cancer").
  • Gene abnormality information input step: S102 Information on the above-mentioned gene abnormality of the patient is input to the system from the input unit of the computer as the gene abnormality information input unit 5 (gene abnormality information input step: S102).
  • the input information is appropriately stored in the storage unit. For example, information is entered into the system (X: TnC) that the base (eg T) located at a particular number n in a patient's gene X has been replaced by another base (eg C).
  • the evidence information recording unit 7 records patient information and evidence information related to genetic abnormalities.
  • the therapeutic agent Z is effective for patients in which the base (eg T) located at a specific number n of the gene X is replaced with another base (eg C).
  • the paper and the guideline for the therapeutic drug Z for colorectal cancer are recorded in the storage unit of the server or computer as the evidence information recording unit.
  • the guidelines for therapeutic drug Z are classified into (i) guideline publication information and (ii) approved drug information.
  • the papers that the therapeutic agent Z was effective are classified in (iv) paper information.
  • the therapeutic agent Y is used for patients in which the base (example: T) located at the specific number n of gene X is replaced with another base (example: C). If there is a paper that is not valid, it is stored in the storage as evidence information of negative evaluation.
  • the evidence information extraction unit 9 uses the patient information of a certain patient input from the patient information input unit 3 and the information on the genetic abnormality of the patient input from the gene abnormality information input unit 5 from the evidence information recording unit 7.
  • the first evidence information which is the evidence information related to the patient, is extracted (first evidence information extraction step: S103).
  • colonrectal cancer which is patient information and "base (example: T) located at a specific number n of gene X is another base” which is information about a patient's genetic abnormality.
  • (X: TnC) information such as being replaced with (Example: C) is input to the system and stored in the storage unit.
  • the control unit receives a command from the control program stored in the storage unit and stores the information.
  • Information on "colorectal cancer” and “X: TnC” is read from the unit, and evidence information on either or both of "colorectal cancer” and “X: TnC” is extracted from the storage unit.
  • the storage unit stores evidence information related to these target diseases and genetic abnormalities, the evidence information related to the target diseases and genetic abnormalities can be easily read out. At this time, a necessary calculation may be performed using the calculation unit. Further, the read evidence information (first evidence information) may be temporarily stored in the storage unit.
  • the calculation unit, control unit, and storage unit of the computer that functions as the evidence information display unit 11 perform image processing so that the first evidence information is displayed on the screen (display unit) of the computer monitor or mobile terminal (evidence).
  • the guideline for the therapeutic agent Z and the paper that the therapeutic agent Z was effective are displayed on the display as evidence information.
  • a paper stating that the therapeutic agent Y is not effective may also be displayed on the display as negative evidence information.
  • the calculation unit, control unit, and storage unit of the computer functioning as the treatment option proposal unit 13 propose the treatment option based on the patient information using the first evidence information (treatment option proposal process: S105).
  • the treatment options may be read from the memory unit and displayed on the display unit.
  • the evidence information related to the treatment option may also be displayed on the display unit.
  • control unit that receives the command of the control program stored in the storage unit causes the arithmetic unit to perform the necessary arithmetic processing, and appropriately stores the information (for example, coefficients and numerical values) necessary for the arithmetic processing. This may be done by reading from the unit.
  • the therapeutic drug Y will be required to be evaluated as ineffective (negative evaluation).
  • the computer functioning as the treatment option proposal unit 13 extracts the start of anticancer drug treatment using the therapeutic agent Z and displays it on the display unit.
  • evidence information the above guidelines and papers may also be displayed so as to be visible.
  • initiation of anticancer drug treatment with therapeutic agent Z was proposed as a treatment option.
  • the evidence information recording section records information on drugs other than the therapeutic drug Z related to "colorectal cancer" and "X: TnC" and the treatment method, those treatment options are also displayed. It may be displayed in the section.
  • this system can propose treatment options based on the genetic abnormality of the patient.
  • the system further includes a selection display unit 15.
  • the control program stored in the calculation unit, the control unit, and the storage unit of the computer functioning as the selection display unit 15 displays the evidence information selected by the selection display unit in a selectable manner.
  • the paper that the therapeutic agent Z was effective (positive evidence information) and the paper that the therapeutic agent Y was not effective (negative evidence information) are displayed on the display and before the information is displayed. A check box is displayed. Then, for example, when a check is entered in the check box of the paper that the therapeutic drug Z was effective (positive evidence information), the paper that the therapeutic drug Z was effective from the evidence information (positive evidence information). Should be erased from the display unit.
  • the guideline for the therapeutic agent Z (positive evidence information) and the paper that the therapeutic agent Y is not effective (negative evidence information) may be used as the first evidence information.
  • the reason for recommending or deprecating the evidence may be displayed together with the display of whether the evidence is recommended or deprecated. If some evidence information is deprecated, the non-recommended evidence information is displayed, but the recommended one is displayed in the selected state, and the non-recommended one is displayed in the unselected state. You may try to do it.
  • the control unit reads out information regarding the deprecation from the storage unit.
  • Guidelines for Therapeutic Agent Z Papers (positive evidence information) that therapeutic agent Z was effective, and are displayed as preselected states (for example, displayed as checked boxes).
  • a paper (negative evidence information) that the therapeutic agent Y is not effective may be displayed as a non-selected state in advance (for example, it may be displayed as a state in which the check box is not checked).
  • This aspect further includes an evidence information input unit 17.
  • the second evidence information which is new evidence information (evidence information different from the first evidence information)
  • the authenticated drug information regarding the therapeutic drug Z is input to the system from the input unit of a certain terminal.
  • the certified drug information (positive evidence information) regarding the therapeutic drug Z is stored in the storage unit as the second evidence information.
  • the evidence information display unit 11 displays the second evidence information on the display unit in addition to the first evidence information.
  • the guideline for therapeutic agent Z positive evidence information
  • Paper that therapeutic drug Z was effective positive evidence information
  • Certified drug information positive evidence information regarding the therapeutic agent Z
  • a paper negative evidence information
  • the treatment option proposal unit 13 uses the information including the first evidence information and the second evidence information (certified drug information regarding the therapeutic drug Z), and the treatment option based on the patient information. The one that proposes is preferable.
  • Another aspect of the present invention relates to a program for making a computer function as any of the above-mentioned systems.
  • the specification also provides a computer-readable information recording medium (floppy disk, CD, DVD, USB memory, or hard disk) that stores such a program.
  • Possible patient-derived information is, for example: ⁇ Specimen information ⁇ Information on genetic abnormalities detected in the sample ⁇ Basic patient information (personal patient information such as gender and date of birth) ⁇ Patient clinical information (information showing the patient's condition such as cancer type, chief complaint, interview, palpation, various test results such as biochemical test and imaging test) ⁇ Patient history information (various history of patients such as medical history, hospitalization history, treatment history, past examination history)
  • Possible treatment options are, for example: ⁇ Start of anti-cancer drug treatment ⁇ Discontinuation of anti-cancer drug treatment ⁇ Change of anti-cancer drug ⁇ Clinical trial, clinical trial introduction
  • the rationale information for associating a possible genetic abnormality with a treatment option based on its interpretation is as follows. ⁇ Guideline publication information ⁇ Approved drug information ⁇ Clinical trials, clinical trial information ⁇ Paper information ⁇ Conference presentation information
  • a kinase is used as the basis information for linking this gene abnormality with the treatment option based on its interpretation.
  • the candidate is "dacomitinib", which is approved by the drug and has the relevant description in the attached document of the drug.
  • tissue sample or cytological sample has an EGFR mutation (Exxon 19 deletion, L858R) (excluding cases where T790M positive is known).
  • the page displaying information on the exon19 deletion of the EGFR gene does not indicate that the same patient also has the T790M mutation.
  • the evidence information is not proposed based on the genetic abnormality or other patient-derived information that is not displayed on the screen. It is also possible to display it as evidence information in the state of being adopted. In addition, by displaying the reason for not adopting it (in this case, it should be excluded because the T790M mutation exists separately), it is easy to confirm the reason for not adopting it as a basis. You can also do it.
  • this invention is a system for providing medical information, it can be used in the information equipment-related industry for medical institutions.

Abstract

[Problem] To provide a system that makes it possible to suitably propose treatment options in which genetic abnormality is taken into account. [Solution] A system 1 for proposing treatment options that includes: a patient information input unit 3 into which patient information including clinical information for a patient is input; a genetic abnormality information input unit 5 into which information regarding genetic abnormality in the patient is input; an evidence information recording unit 7 for recording evidence information relating to patient information and genetic abnormality; an evidence information extraction unit 9 for extracting, from the evidence information recording unit, first evidence information that is evidence information relating to the patient using the patient information for the patient input from the patient information input unit and the information relating to genetic abnormality in the patient input from the genetic abnormality information input unit; an evidence information display unit 11 for displaying the first evidence information on a display unit; and a treatment options proposal unit 13 that proposes treatment options based on the patient information using the first evidence information.

Description

治療選択肢を提案するためのシステムA system for proposing treatment options
 この発明は,コンピュータを用いた治療選択肢を提案するためのシステムに関する。 The present invention relates to a system for proposing treatment options using a computer.
 特表2018-533123号公報には,統合された臨床ケアのための情報科学プラットフォームが記載されている。 Special Table 2018-533123 Gazette describes an information science platform for integrated clinical care.
特表2018-533123号公報Special Table 2018-533123 Gazette
 上記の情報科学プラットフォームでは,遺伝子異常に基づく治療選択肢を適正に考慮することができない。また,上記の情報科学プラットフォームでは,治療選択肢を適切に評価できない。このためこの発明は,遺伝子異常を考慮した,治療選択肢を適切に提案できるシステムを提供することを目的とする。 The above information science platform cannot properly consider treatment options based on genetic abnormalities. In addition, the above information science platforms cannot properly evaluate treatment options. Therefore, it is an object of the present invention to provide a system that can appropriately propose treatment options in consideration of genetic abnormalities.
 この発明は,基本的には,遺伝子異常に関する情報を踏まえて,治療選択肢を評価するとともに,治療選択肢の元となるエビデンス情報をランク付け(評価)するための指標を導入したので,遺伝子異常に基づく治療選択肢を適正に提案できるという知見に基づく。 This invention basically introduces an index for evaluating treatment options based on information on genetic abnormalities and for ranking (evaluating) the evidence information that is the basis of treatment options. Based on the finding that appropriate treatment options can be proposed.
 この発明は,患者の臨床情報を含む患者情報が入力される患者情報入力部3と,
 患者の遺伝子異常に関する情報が入力される遺伝子異常情報入力部5と,
 患者情報及び遺伝子異常に関連したエビデンス情報を記録するエビデンス情報記録部7と,
 患者情報入力部から入力されたある患者の患者情報,及び遺伝子異常情報入力部から入力された患者の遺伝子異常に関する情報を用いて,エビデンス情報記録部から,患者に関連したエビデンス情報である第1のエビデンス情報を抽出する,エビデンス情報抽出部9と,
 第1のエビデンス情報を表示部に表示するためのエビデンス情報表示部11と,
 第1のエビデンス情報を用いて,患者情報に基づいた治療選択肢を提案する治療選択肢提案部13とを含む,
 治療選択肢を提案するためのシステム1である。
The present invention includes a patient information input unit 3 in which patient information including clinical information of a patient is input, and a patient information input unit 3.
Genetic abnormality information input unit 5 for inputting information on the patient's genetic abnormality,
Evidence information recording unit 7 that records patient information and evidence information related to genetic abnormalities, and
Using the patient information of a certain patient input from the patient information input unit and the information on the genetic abnormality of the patient input from the genetic abnormality information input unit, the evidence information recording unit is used to provide evidence information related to the patient. Evidence information extraction unit 9 that extracts the evidence information of
Evidence information display unit 11 for displaying the first evidence information on the display unit, and
Including the treatment option proposal unit 13 that proposes treatment options based on patient information using the first evidence information.
This is a system 1 for proposing treatment options.
 この発明の好ましい態様は,
 表示部に表示されたエビデンス情報を選択可能にする選択表示部をさらに有し,
 治療選択肢提案部は,選択表示部により選択されたエビデンス情報を第1のエビデンス情報とする,システムである。
A preferred embodiment of the present invention is
It also has a selection display unit that makes it possible to select the evidence information displayed on the display unit.
The treatment option suggestion unit is a system in which the evidence information selected by the selection display unit is used as the first evidence information.
 この発明の好ましい態様は,
 新たなエビデンス情報である第2のエビデンス情報を入力するエビデンス情報入力部をさらに有し,
 エビデンス情報表示部は,第1のエビデンス情報に加えて第2のエビデンス情報を表示し,
 治療選択肢提案部は,第1のエビデンス情報及び第2のエビデンス情報を用いて,患者情報に基づいた治療選択肢を提案するシステムである。
A preferred embodiment of the present invention is
It also has an evidence information input unit for inputting second evidence information, which is new evidence information.
The evidence information display unit displays the second evidence information in addition to the first evidence information.
The treatment option proposal unit is a system that proposes treatment options based on patient information using the first evidence information and the second evidence information.
 この発明の好ましい態様は,
 患者の臨床情報は,患者が罹患している腫瘍の種類に関する情報を含み,
 エビデンス情報は,腫瘍の種類ごとの情報を含む,システムである。
A preferred embodiment of the present invention is
The patient's clinical information includes information about the type of tumor the patient is suffering from.
Evidence information is a system that includes information for each type of tumor.
 この発明の好ましい態様は,
 患者情報は,患者の検体に関する情報,患者の性別に関する情報,及び患者の病歴に関する情報のいずれか1つ以上を含む,システムである。
A preferred embodiment of the present invention is
Patient information is a system that includes any one or more of information about a patient's specimen, information about a patient's gender, and information about a patient's medical history.
 この発明の好ましい態様は,
 治療選択肢は,抗がん剤治療開始を含む,システムである。
A preferred embodiment of the present invention is
Treatment options are systems, including initiation of anticancer drug treatment.
 この発明の好ましい態様は,
 エビデンス情報は,(i)ガイドライン掲載情報,(ii)承認済み薬剤情報,(iii)臨床試験・治験の情報,(iv)論文情報,(v)学会発表情報のいずれか2つ以上のカテゴリーに分類され,
 治療選択肢提案部は,カテゴリーを用いて,患者情報に基づいた治療選択肢を提案するシステムである。
A preferred embodiment of the present invention is
Evidence information is divided into two or more categories: (i) guideline publication information, (ii) approved drug information, (iii) clinical trial / clinical trial information, (iv) paper information, and (v) conference presentation information. Classified,
The treatment option proposal department is a system that proposes treatment options based on patient information using categories.
 この発明の好ましい態様は,コンピュータを,上記したいずれかのシステムとして機能させるためのプログラムである。 A preferred embodiment of the present invention is a program for operating a computer as any of the above-mentioned systems.
 この発明は,遺伝子異常に基づくエビデンスを考慮し,しかもエビデンスに対し指標を導入したので,治療選択肢を適正に提案できる。 This invention considers evidence based on genetic abnormalities and introduces an index for the evidence, so that treatment options can be appropriately proposed.
図1は,本発明のシステムの基本構成例を示すブロック図である。FIG. 1 is a block diagram showing a basic configuration example of the system of the present invention. 図2は,コンピュータの基本構成を示すブロック図である。FIG. 2 is a block diagram showing a basic configuration of a computer. 図3は,本発明のシステム例を示す概念図である。FIG. 3 is a conceptual diagram showing an example of the system of the present invention. 図4は,処理を説明するためのフローチャートである。FIG. 4 is a flowchart for explaining the process.
 以下,図面を用いて本発明を実施するための形態について説明する。本発明は,以下に説明する形態に限定されるものではなく,以下の形態から当業者が自明な範囲で適宜修正したものも含む。 Hereinafter, a mode for carrying out the present invention will be described with reference to the drawings. The present invention is not limited to the forms described below, and includes those which are appropriately modified by those skilled in the art from the following forms to the extent obvious to those skilled in the art.
 図1は,本発明の治療選択肢を提案するためのシステムの基本構成例を示すブロック図である。治療選択肢を提案するためのシステム1は,コンピュータに基づいて,医者や患者などの対象者に治療選択肢を提案するためのシステムである。
 治療選択肢の例は,例えば腫瘍に対するものである場合,抗がん剤治療開始,抗がん剤治療中止,抗がん剤変更,臨床試験紹介,及び治験紹介である。
FIG. 1 is a block diagram showing a basic configuration example of a system for proposing a treatment option of the present invention. The system 1 for proposing a treatment option is a system for proposing a treatment option to a subject such as a doctor or a patient based on a computer.
Examples of treatment options, for example, for tumors, are anti-cancer drug treatment start, anti-cancer drug treatment discontinuation, anti-cancer drug change, clinical trial referral, and clinical trial referral.
 図1に示されるように,治療選択肢を提案するためのシステム1は,患者情報入力部3と,遺伝子異常情報入力部5と,エビデンス情報記録部7と,エビデンス情報抽出部9と,エビデンス情報表示部11と,治療選択肢提案部13とを含む。また,このシステム1は,選択表示部15と,エビデンス情報入力部17のいずれか又は両方をさらに含んでもよい。また,このシステムは,さらに表示部19,インターフェイス部21,及び一時記憶部23を含んでもよい。このシステムは,コンピュータを含んでおり,以下説明する各要素はコンピュータにより実装される要素である。コンピュータは,各種端末,携帯端末,ノート型パソコン,パーソナルコンピュータ及びサーバのいずれであってもよい。 As shown in FIG. 1, the system 1 for proposing treatment options includes a patient information input unit 3, a gene abnormality information input unit 5, an evidence information recording unit 7, an evidence information extraction unit 9, and evidence information. The display unit 11 and the treatment option proposal unit 13 are included. Further, the system 1 may further include either or both of the selection display unit 15 and the evidence information input unit 17. Further, this system may further include a display unit 19, an interface unit 21, and a temporary storage unit 23. This system includes a computer, and each element described below is an element implemented by the computer. The computer may be any of various terminals, mobile terminals, notebook personal computers, personal computers and servers.
 図2は,コンピュータの基本構成を示すブロック図である。この図に示されるように,コンピュータは,入力部31,出力部33,制御部35,演算部37及び記憶部39を有しており,各要素は,バス41などによって接続され,情報の授受を行うことができるようにされている。例えば,記憶部には,制御プログラムが記憶されていてもよいし,各種情報が記憶されていてもよい。入力部から所定の情報が入力された場合,制御部は,記憶部に記憶される制御プログラムを読み出す。そして,制御部は,適宜記憶部に記憶された情報を読み出し,演算部へ伝える。また,制御部は,適宜入力された情報を演算部へ伝える。演算部は,受け取った各種情報を用いて演算処理を行い,記憶部に記憶する。制御部は,記憶部に記憶された演算結果を読み出して,出力部から出力する。このようにして,各種処理が実行される。以下説明する各要素は,コンピュータのいずれかの要素に対応していてもよい。 FIG. 2 is a block diagram showing the basic configuration of a computer. As shown in this figure, the computer has an input unit 31, an output unit 33, a control unit 35, a calculation unit 37, and a storage unit 39, and each element is connected by a bus 41 or the like to exchange information. Is made to be able to do. For example, the control program may be stored in the storage unit, or various types of information may be stored in the storage unit. When the specified information is input from the input unit, the control unit reads out the control program stored in the storage unit. Then, the control unit appropriately reads out the information stored in the storage unit and transmits it to the arithmetic unit. In addition, the control unit transmits the appropriately input information to the calculation unit. The arithmetic unit performs arithmetic processing using various received information and stores it in the storage unit. The control unit reads the calculation result stored in the storage unit and outputs it from the output unit. In this way, various processes are executed. Each element described below may correspond to any element of the computer.
 図3は,本発明のシステム例を示す概念図である。図3に示されるように,本発明のシステムは,インターネット又はイントラネット43と接続された携帯端末45と,インターネット又はイントラネット43に接続されたサーバ47とを含むものであってもよい。もちろん,単体のコンピュータや携帯端末が,本発明の装置として機能してもよいし,複数のサーバが存在してもよい。図3に示されるように,治療選択肢を提案するためのシステム1は,サーバ・クライアントシステムであってもよいし,スタンドアロンのシステムであってもよい。また,各種情報は,コンピュータの表示部に表示されてもよいし,タブレットやスマートフォンといった携帯端末の表示部に表示されるようにしてもよい。 FIG. 3 is a conceptual diagram showing an example of the system of the present invention. As shown in FIG. 3, the system of the present invention may include a mobile terminal 45 connected to the Internet or an intranet 43 and a server 47 connected to the Internet or an intranet 43. Of course, a single computer or mobile terminal may function as the device of the present invention, or a plurality of servers may exist. As shown in FIG. 3, the system 1 for proposing treatment options may be a server / client system or a stand-alone system. Further, various information may be displayed on the display unit of the computer, or may be displayed on the display unit of a mobile terminal such as a tablet or a smartphone.
 患者情報入力部3は,患者の臨床情報を含む患者情報をシステムに入力するための部位(手段)である。例えば,コンピュータの入力部が患者情報入力部3として機能する。
 患者の臨床情報を含む患者情報の例は,患者の氏名,患者のID(識別情報),検体の情報,遺伝子異常が検出された検体に関する情報,患者の基本情報(性別,生年月日などの患者がもつ患者個人の情報),患者の臨床情報(がん種,主訴,問診,触診,生化学検査や画像検査などの各種検査結果などの患者の状態を示す情報)及び患者の来歴情報(病歴,入院歴,治療歴,過去の検査履歴などの患者の各種履歴)のうち,1つ以上である。
 患者の臨床情報の好ましい例は,患者が罹患している腫瘍の種類に関する情報を含む。すると,このシステムは,腫瘍に対する治療選択肢を提案できる。
 患者情報は,患者の検体に関する情報,患者の性別に関する情報,及び患者の病歴に関する情報のいずれか1つ以上を含む。
The patient information input unit 3 is a site (means) for inputting patient information including clinical information of the patient into the system. For example, the input unit of the computer functions as the patient information input unit 3.
Examples of patient information, including clinical information about the patient, include patient name, patient ID (identification information), sample information, information about the sample in which a genetic abnormality was detected, and basic patient information (gender, date of birth, etc.). Patient's individual information), patient's clinical information (information showing the patient's condition such as cancer type, chief complaint, interview, palpation, various test results such as biochemical test and imaging test) and patient history information (information on the patient's condition) One or more of the patient's various histories such as medical history, hospitalization history, treatment history, and past examination history).
A preferred example of a patient's clinical information includes information about the type of tumor the patient is suffering from. The system can then propose treatment options for tumors.
Patient information includes any one or more of information about a patient's specimen, information about a patient's gender, and information about a patient's medical history.
 遺伝子異常情報入力部5は,患者の遺伝子異常に関する情報をシステムに入力するための部位(手段)である。例えば,コンピュータの入力部が遺伝子異常情報入力部5として機能する。患者の遺伝子異常に関する情報の例は,ある遺伝子の特定の番号に位置する塩基が他の塩基に置換されているといった情報である。 The genetic abnormality information input unit 5 is a site (means) for inputting information on a patient's genetic abnormality into the system. For example, the input unit of the computer functions as the genetic abnormality information input unit 5. An example of information about a patient's genetic abnormality is that the base located at a specific number in a gene has been replaced by another base.
 エビデンス情報記録部7は,患者情報及び遺伝子異常に関連したエビデンス情報を記録するための部位(手段)である。例えば,コンピュータの記憶部がエビデンス情報記録部7として機能する。エビデンス情報は,ある薬や施術方法が有効であるか,全く効果がなくといったことに関して裏付けとなる情報を意味する。エビデンス情報の例は,特定疾患(例えば腫瘍や癌)に対する治療薬に関する情報,特定疾患に対する施術方法に関する情報である。エビデンス情報は,好ましくは,腫瘍の種類ごとの情報を含む,エビデンス情報の例は,(i)ガイドライン掲載情報,(ii)承認済み薬剤情報,(iii)臨床試験・治験の情報,(iv)論文情報,(v)学会発表情報のいずれか2つ以上のカテゴリーに分類される。 The evidence information recording unit 7 is a site (means) for recording patient information and evidence information related to a genetic abnormality. For example, the storage unit of the computer functions as the evidence information recording unit 7. Evidence information means information that supports the fact that a drug or treatment method is effective or completely ineffective. Examples of evidence information are information on therapeutic agents for specific diseases (for example, tumors and cancers) and information on treatment methods for specific diseases. Evidence information preferably includes information by tumor type, and examples of evidence information include (i) guideline publication information, (ii) approved drug information, (iii) clinical trial / clinical trial information, (iv). It is classified into one or more categories of paper information and (v) conference presentation information.
 エビデンス情報抽出部9は,患者情報入力部3から入力されたある患者の患者情報,及び遺伝子異常情報入力部5から入力された患者の遺伝子異常に関する情報を用いて,エビデンス情報記録部7から,患者に関連したエビデンス情報である第1のエビデンス情報を抽出するための部位(手段)である。例えば,コンピュータの演算部,制御部及び記憶部に記憶された制御プログラムがエビデンス情報記録部7として機能する。 The evidence information extraction unit 9 uses the patient information of a certain patient input from the patient information input unit 3 and the information on the genetic abnormality of the patient input from the gene abnormality information input unit 5 from the evidence information recording unit 7. It is a site (means) for extracting the first evidence information which is the evidence information related to the patient. For example, the control program stored in the calculation unit, the control unit, and the storage unit of the computer functions as the evidence information recording unit 7.
 エビデンス情報表示部11は,第1のエビデンス情報を表示部に表示するための部位(手段)である。例えば,コンピュータの出力部が表示部として機能し,コンピュータの演算部,制御部及び記憶部に記憶された制御プログラムがエビデンス情報表示部11として機能する。 The evidence information display unit 11 is a part (means) for displaying the first evidence information on the display unit. For example, the output unit of the computer functions as a display unit, and the control program stored in the calculation unit, the control unit, and the storage unit of the computer functions as the evidence information display unit 11.
 治療選択肢提案部13は,第1のエビデンス情報を用いて,患者情報に基づいた治療選択肢を提案するための部位(手段)である。例えば,コンピュータの演算部,制御部及び記憶部に記憶された制御プログラムが治療選択肢提案部13として機能する。治療選択肢提案部13の好ましい例は,カテゴリーを用いて,患者情報に基づいた治療選択肢を提案する。 The treatment option proposal unit 13 is a site (means) for proposing a treatment option based on patient information using the first evidence information. For example, the control program stored in the calculation unit, the control unit, and the storage unit of the computer functions as the treatment option proposal unit 13. A preferred example of the treatment option suggestion unit 13 proposes treatment options based on patient information using categories.
 選択表示部15は,表示部に表示されたエビデンス情報を選択可能にするための部位(手段)である。例えば,コンピュータの演算部,制御部及び記憶部に記憶された制御プログラムが選択表示部15として機能する。選択表示部15をさらに有するシステムにおいて,治療選択肢提案部13は,選択表示部により選択された(選択情報がシステムに入力された)エビデンス情報を第1のエビデンス情報とするものが好ましい。 The selection display unit 15 is a part (means) for making the evidence information displayed on the display unit selectable. For example, the control program stored in the calculation unit, the control unit, and the storage unit of the computer functions as the selection display unit 15. In a system further including a selection display unit 15, it is preferable that the treatment option proposal unit 13 uses the evidence information selected by the selection display unit (selection information is input to the system) as the first evidence information.
 エビデンス情報入力部17は,新たなエビデンス情報(第1のエビデンス情報とは異なるエビデンス情報)である第2のエビデンス情報を入力するための部位(手段)である。例えば,コンピュータの演算部,制御部及び記憶部に記憶された制御プログラムがエビデンス情報入力部17として機能する。 The evidence information input unit 17 is a part (means) for inputting second evidence information, which is new evidence information (evidence information different from the first evidence information). For example, the control program stored in the calculation unit, the control unit, and the storage unit of the computer functions as the evidence information input unit 17.
 このシステム態様のシステムにおいて,エビデンス情報表示部11は,第1のエビデンス情報に加えて第2のエビデンス情報を表示部に表示するものが好ましい。そして,治療選択肢提案部13は,第1のエビデンス情報及び第2のエビデンス情報を用いて,患者情報に基づいた治療選択肢を提案するものが好ましい。 In the system of this system aspect, it is preferable that the evidence information display unit 11 displays the second evidence information on the display unit in addition to the first evidence information. Then, it is preferable that the treatment option suggestion unit 13 proposes a treatment option based on the patient information by using the first evidence information and the second evidence information.
 次に,このシステムの動作例を説明する。
 図4は,処理を説明するためのフローチャートである。
 患者情報入力部3としてのコンピュータの入力部から,患者情報がシステムに入力される(患者情報入力工程:S101)。入力された患者情報は,記憶部に適宜記憶される。患者情報の例は,患者の氏名,患者のID(識別情報),及び患者の臨床情報(腫瘍の種類:例えば「大腸がん」)である。
Next, an operation example of this system will be described.
FIG. 4 is a flowchart for explaining the process.
Patient information is input to the system from a computer input unit as the patient information input unit 3 (patient information input step: S101). The entered patient information is appropriately stored in the storage unit. Examples of patient information are patient name, patient ID (identification information), and patient clinical information (tumor type: eg, "colorectal cancer").
 遺伝子異常情報入力部5としてのコンピュータの入力部から,上記の患者の遺伝子異常に関する情報がシステムに入力される(遺伝子異常情報入力工程:S102)。入力された情報は,記憶部に適宜記憶される。
 例えば,患者のある遺伝子Xの特定の番号nに位置する塩基(例:T)が他の塩基(例:C)に置換されているといった情報が,システムに入力される(X:TnC)。
Information on the above-mentioned gene abnormality of the patient is input to the system from the input unit of the computer as the gene abnormality information input unit 5 (gene abnormality information input step: S102). The input information is appropriately stored in the storage unit.
For example, information is entered into the system (X: TnC) that the base (eg T) located at a particular number n in a patient's gene X has been replaced by another base (eg C).
 エビデンス情報記録部7は,患者情報及び遺伝子異常に関連したエビデンス情報を記録している。例えば,大腸がんの患者において,遺伝子Xの特定の番号nに位置する塩基(例:T)が他の塩基(例:C)に置換されている患者については,治療薬Zが有効であったという論文や,大腸がんに対する治療薬Zのガイドラインが,エビデンス情報記録部としてのサーバやコンピュータの記憶部に記録されている。治療薬Zのガイドラインは,(i)ガイドライン掲載情報,(ii)承認済み薬剤情報に分類されている。治療薬Zが有効であったという論文は,(iv)論文情報に分類されている。なお,この際に,大腸がんの患者において,遺伝子Xの特定の番号nに位置する塩基(例:T)が他の塩基(例:C)に置換されている患者については,治療薬Yが有効ではないという論文があれば,負の評価のエビデンス情報として,記憶部に記憶する。 The evidence information recording unit 7 records patient information and evidence information related to genetic abnormalities. For example, in patients with colorectal cancer, the therapeutic agent Z is effective for patients in which the base (eg T) located at a specific number n of the gene X is replaced with another base (eg C). The paper and the guideline for the therapeutic drug Z for colorectal cancer are recorded in the storage unit of the server or computer as the evidence information recording unit. The guidelines for therapeutic drug Z are classified into (i) guideline publication information and (ii) approved drug information. The papers that the therapeutic agent Z was effective are classified in (iv) paper information. At this time, in patients with colorectal cancer, the therapeutic agent Y is used for patients in which the base (example: T) located at the specific number n of gene X is replaced with another base (example: C). If there is a paper that is not valid, it is stored in the storage as evidence information of negative evaluation.
 エビデンス情報抽出部9が,患者情報入力部3から入力されたある患者の患者情報,及び遺伝子異常情報入力部5から入力された患者の遺伝子異常に関する情報を用いて,エビデンス情報記録部7から,患者に関連したエビデンス情報である第1のエビデンス情報を抽出する(第1のエビデンス情報抽出工程:S103)。 The evidence information extraction unit 9 uses the patient information of a certain patient input from the patient information input unit 3 and the information on the genetic abnormality of the patient input from the gene abnormality information input unit 5 from the evidence information recording unit 7. The first evidence information, which is the evidence information related to the patient, is extracted (first evidence information extraction step: S103).
 先に説明した通り,例えば,システムに,患者情報である「大腸がん」,患者の遺伝子異常に関する情報である「遺伝子Xの特定の番号nに位置する塩基(例:T)が他の塩基(例:C)に置換されているといった(X:TnC)情報が,システムに入力され,記憶部に記憶されている。制御部は,記憶部に記憶した制御プログラムの指令を受けて,記憶部から,「大腸がん」及び「X:TnC」に関する情報を読み出し,記憶部から,「大腸がん」及び「X:TnC」のいずれか又は両方に関するエビデンス情報を抽出する。 As explained earlier, for example, in the system, "colorectal cancer" which is patient information and "base (example: T) located at a specific number n of gene X is another base" which is information about a patient's genetic abnormality. (X: TnC) information such as being replaced with (Example: C) is input to the system and stored in the storage unit. The control unit receives a command from the control program stored in the storage unit and stores the information. Information on "colorectal cancer" and "X: TnC" is read from the unit, and evidence information on either or both of "colorectal cancer" and "X: TnC" is extracted from the storage unit.
  この例では,
(i)ガイドライン掲載情報,(ii)承認済み薬剤情報に分類される治療薬Zのガイドライン(正のエビデンス情報),
 (iv)論文情報に分類される治療薬Zが有効であったという論文(正のエビデンス情報),
 (iv)論文情報に分類される治療薬Yが有効ではないという論文(負のエビデンス情報)が エビデンス情報として抽出される。
In this example
(I) Guideline publication information, (ii) Guidelines for therapeutic drug Z classified as approved drug information (positive evidence information),
(Iv) A paper (positive evidence information) that the therapeutic drug Z classified in the paper information was effective,
(Iv) A paper (negative evidence information) that the therapeutic agent Y classified in the paper information is not effective is extracted as evidence information.
 記憶部は,これらの対象疾患や,遺伝子異常と関連してエビデンス情報を記憶しているので,対象疾患や,遺伝子異常と関連したエビデンス情報を容易に読み出すことができる。この際,演算部を用いて,必要な演算を行わせてもよい。また,読み出したエビデンス情報(第1のエビデンス情報)を,記憶部に一時的に記憶してもよい。 Since the storage unit stores evidence information related to these target diseases and genetic abnormalities, the evidence information related to the target diseases and genetic abnormalities can be easily read out. At this time, a necessary calculation may be performed using the calculation unit. Further, the read evidence information (first evidence information) may be temporarily stored in the storage unit.
 エビデンス情報表示部11として機能するコンピュータの演算部,制御部及び記憶部は,第1のエビデンス情報をコンピュータのモニタや携帯端末の画面(表示部)に表示するように,画像処理を行う(エビデンス情報表示処理工程:S104)。この画像処理は,記憶部に記憶された制御プログラムの指令を受けた制御部が,必要な演算処理を演算部に行わせ,また画面表示に必要な情報を適宜記憶部から読み出すことにより行えばよい。 The calculation unit, control unit, and storage unit of the computer that functions as the evidence information display unit 11 perform image processing so that the first evidence information is displayed on the screen (display unit) of the computer monitor or mobile terminal (evidence). Information display processing step: S104). This image processing can be performed by the control unit receiving the command of the control program stored in the storage unit, causing the calculation unit to perform the necessary arithmetic processing, and reading the information necessary for screen display from the storage unit as appropriate. Good.
 上記の例では,治療薬Zのガイドライン,及び治療薬Zが有効であったという論文が,エビデンス情報として,表示部に表示される。なお,治療薬Yが有効ではないという論文も負のエビデンス情報として表示部に表示されてもよい。 In the above example, the guideline for the therapeutic agent Z and the paper that the therapeutic agent Z was effective are displayed on the display as evidence information. A paper stating that the therapeutic agent Y is not effective may also be displayed on the display as negative evidence information.
 治療選択肢提案部13として機能するコンピュータの演算部,制御部及び記憶部は,第1のエビデンス情報を用いて,患者情報に基づいた治療選択肢を提案する(治療選択肢提案工程:S105)。具遺体的には,記憶部から,治療選択肢を読み出して,表示部に表示すればよい。この際に,治療選択肢に関連してたエビデンス情報を併せて表示部に表示するようにしてもよい。 The calculation unit, control unit, and storage unit of the computer functioning as the treatment option proposal unit 13 propose the treatment option based on the patient information using the first evidence information (treatment option proposal process: S105). As for the corpse, the treatment options may be read from the memory unit and displayed on the display unit. At this time, the evidence information related to the treatment option may also be displayed on the display unit.
 上記の例では,例えば,エビデンス情報が正か負かにより指標(評価点)に,+及び-が付されており,(i)ガイドライン掲載情報,(ii)承認済み薬剤情報,(iii)臨床試験・治験の情報,(iv)論文情報,(v)学会発表情報のいずれかといった情報により,評価点が付されている。
 すると,上記の患者の例では,「大腸がん」及び「X:TnC」という情報がシステムに入力されており,治療薬Zについては,(i)ガイドライン掲載情報,(ii)承認済み薬剤情報,及び,(iv)論文情報があるので,これらに割り当てられた評価点が加算される。また,エビデンス情報の数による加算を行ってもよい。このような処理は,記憶部に記憶された制御プログラムの指令を受けた制御部が,必要な演算処理を演算部に行わせ,また演算処理に必要な情報(例えば係数や数値)を適宜記憶部から読み出すことにより行えばよい。
In the above example, for example, + and-are added to the indicators (evaluation points) depending on whether the evidence information is positive or negative, (i) guideline publication information, (ii) approved drug information, (iii) clinical trial. Evaluation points are given based on information such as trial / clinical trial information, (iv) paper information, or (v) conference presentation information.
Then, in the above patient example, the information "colorectal cancer" and "X: TnC" are input to the system, and for the therapeutic drug Z, (i) guideline publication information and (ii) approved drug information. , And (iv) Since there is paper information, the evaluation points assigned to these are added. In addition, addition may be performed according to the number of evidence information. In such processing, the control unit that receives the command of the control program stored in the storage unit causes the arithmetic unit to perform the necessary arithmetic processing, and appropriately stores the information (for example, coefficients and numerical values) necessary for the arithmetic processing. This may be done by reading from the unit.
 また,治療薬Yについては,有効ではないという評価(マイナス評価)が求められることとなる。 In addition, the therapeutic drug Y will be required to be evaluated as ineffective (negative evaluation).
 すると,この例では,治療選択肢提案部13として機能するコンピュータは,治療薬Zを用いた抗がん剤治療開始を抽出し,表示部に表示する。この際,エビデンス情報として,上記のガイドライン及び論文も視認可能なように表示してもよい。
 この例では,治療薬Zを用いた抗がん剤治療開始が,治療選択肢として提案された。
 一方,エビデンス情報記録部に,「大腸がん」及び「X:TnC」に関連する治療薬Z以外の薬剤の情報や,施術方法が記録されている場合は,それらの治療選択肢も併せて表示部に表示されてもよい。
 また,例えば,患者情報として,現在治療薬Yによる投薬治療が行われていることに関する情報がシステムに入力された場合,「抗がん剤変更」が,治療選択肢として提案されるようにしてもよい。この場合,治療薬Z及び治療薬Yに関するエビデンス情報及び上記の評価値のいずれか又は両方が表示部に表示されるようにしてもよい。
Then, in this example, the computer functioning as the treatment option proposal unit 13 extracts the start of anticancer drug treatment using the therapeutic agent Z and displays it on the display unit. At this time, as evidence information, the above guidelines and papers may also be displayed so as to be visible.
In this example, initiation of anticancer drug treatment with therapeutic agent Z was proposed as a treatment option.
On the other hand, if the evidence information recording section records information on drugs other than the therapeutic drug Z related to "colorectal cancer" and "X: TnC" and the treatment method, those treatment options are also displayed. It may be displayed in the section.
Further, for example, when information on the fact that medication treatment with the therapeutic drug Y is currently being performed is input to the system as patient information, "change of anticancer drug" may be proposed as a treatment option. Good. In this case, the evidence information regarding the therapeutic agent Z and the therapeutic agent Y and / or both of the above evaluation values may be displayed on the display unit.
 このようにすることで,このシステムは,患者の遺伝子異常を踏まえた治療選択肢を提案できることとなる。 By doing so, this system can propose treatment options based on the genetic abnormality of the patient.
 次に,このシステムの別の態様について説明する。
 この例は,システムが選択表示部15をさらに有するものである。選択表示部15として機能するコンピュータの演算部,制御部及び記憶部に記憶された制御プログラムが,選択表示部により選択されたエビデンス情報を選択可能に表示する。
Next, another aspect of this system will be described.
In this example, the system further includes a selection display unit 15. The control program stored in the calculation unit, the control unit, and the storage unit of the computer functioning as the selection display unit 15 displays the evidence information selected by the selection display unit in a selectable manner.
例えば,
治療薬Zのガイドライン(正のエビデンス情報),
治療薬Zが有効であったという論文(正のエビデンス情報),及び
治療薬Yが有効ではないという論文(負のエビデンス情報)が,表示部に表示されるとともに,それらの情報表示の前にチェックボックスが表示される。
そして,例えば,治療薬Zが有効であったという論文(正のエビデンス情報)のチェックボックスにチェックが入力されると,エビデンス情報から治療薬Zが有効であったという論文(正のエビデンス情報)が表示部から消去されるようにすればよい。
この場合,治療薬Zのガイドライン(正のエビデンス情報),及び
治療薬Yが有効ではないという論文(負のエビデンス情報)が
第1のエビデンス情報とされてもよい。
For example
Guidelines for Therapeutic Agent Z (Positive Evidence Information),
The paper that the therapeutic agent Z was effective (positive evidence information) and the paper that the therapeutic agent Y was not effective (negative evidence information) are displayed on the display and before the information is displayed. A check box is displayed.
Then, for example, when a check is entered in the check box of the paper that the therapeutic drug Z was effective (positive evidence information), the paper that the therapeutic drug Z was effective from the evidence information (positive evidence information). Should be erased from the display unit.
In this case, the guideline for the therapeutic agent Z (positive evidence information) and the paper that the therapeutic agent Y is not effective (negative evidence information) may be used as the first evidence information.
また,この態様では,エビデンス情報を表示部に表示する際に,それぞれのエビデンスが推奨又は非推奨かの表示と合わせて,推奨又は非推奨とする理由も併せて表示するようにしてもよい。また,あるエビデンス情報が,非推奨の場合には、エビデンス情報としては,非推奨のものも表示するものの,推奨のものは選択した状態で表示し、非推奨のものは未選択の状態で表示するようにしてもよい。 Further, in this aspect, when displaying the evidence information on the display unit, the reason for recommending or deprecating the evidence may be displayed together with the display of whether the evidence is recommended or deprecated. If some evidence information is deprecated, the non-recommended evidence information is displayed, but the recommended one is displayed in the selected state, and the non-recommended one is displayed in the unselected state. You may try to do it.
例えば,治療薬Yが有効ではないという論文が,非推奨である旨が記憶部に記憶されている場合,制御部は,非推奨である旨に関する情報を記憶部から読み出し,
治療薬Zのガイドライン(正のエビデンス情報),
治療薬Zが有効であったという論文(正のエビデンス情報),及びについては,あらかじめ選択された状態として表示し(例えば,チェックボックスにチェックが入った状態として表示し),
治療薬Yが有効ではないという論文(負のエビデンス情報)については,あらかじめ非選択とされた状態として表示する(例えば,チェックボックスにチェックが入っていない状態として表示する)ようにしてもよい。
For example, if a paper stating that the therapeutic agent Y is not effective is stored in the storage unit to the effect that it is deprecated, the control unit reads out information regarding the deprecation from the storage unit.
Guidelines for Therapeutic Agent Z (Positive Evidence Information),
Papers (positive evidence information) that therapeutic agent Z was effective, and are displayed as preselected states (for example, displayed as checked boxes).
A paper (negative evidence information) that the therapeutic agent Y is not effective may be displayed as a non-selected state in advance (for example, it may be displayed as a state in which the check box is not checked).
 次に,このシステムの別の態様について説明する。
 この態様は,エビデンス情報入力部17をさらに有するものである。
 この場合,ある端末の入力部から,システムに,新たなエビデンス情報(第1のエビデンス情報とは異なるエビデンス情報)である第2のエビデンス情報が入力される。
 例えば,治療薬Zに関する認証済み薬剤情報が,ある端末の入力部から,システムに入力される。すると,治療薬Zに関する認証済み薬剤情報(正のエビデンス情報)は,第2のエビデンス情報として,記憶部に記憶される。
Next, another aspect of this system will be described.
This aspect further includes an evidence information input unit 17.
In this case, the second evidence information, which is new evidence information (evidence information different from the first evidence information), is input to the system from the input unit of a certain terminal.
For example, the authenticated drug information regarding the therapeutic drug Z is input to the system from the input unit of a certain terminal. Then, the certified drug information (positive evidence information) regarding the therapeutic drug Z is stored in the storage unit as the second evidence information.
 このシステム態様のシステムにおいて,エビデンス情報表示部11は,第1のエビデンス情報に加えて第2のエビデンス情報を表示部に表示する。
 この場合,例えば,治療薬Zのガイドライン(正のエビデンス情報),
治療薬Zが有効であったという論文(正のエビデンス情報),
治療薬Zに関する認証済み薬剤情報(正のエビデンス情報)及び
治療薬Yが有効ではないという論文(負のエビデンス情報)が表示部に表示されてもよい。
そして,この態様のシステムにおける,治療選択肢提案部13は,第1のエビデンス情報及び第2のエビデンス情報(治療薬Zに関する認証済み薬剤情報)を含む情報を用いて,患者情報に基づいた治療選択肢を提案するものが好ましい。
In the system of this system aspect, the evidence information display unit 11 displays the second evidence information on the display unit in addition to the first evidence information.
In this case, for example, the guideline for therapeutic agent Z (positive evidence information),
Paper that therapeutic drug Z was effective (positive evidence information),
Certified drug information (positive evidence information) regarding the therapeutic agent Z and a paper (negative evidence information) that the therapeutic agent Y is not effective may be displayed on the display unit.
Then, in the system of this aspect, the treatment option proposal unit 13 uses the information including the first evidence information and the second evidence information (certified drug information regarding the therapeutic drug Z), and the treatment option based on the patient information. The one that proposes is preferable.
 本発明の上記とは別の側面は,コンピュータを,上記したいずれかのシステムとして機能させるためのプログラムに関する。この明細書は,そのようなプログラムを記憶したコンピュータが読み取り可能な情報記録媒体(フロッピーディスク,CD,DVD,USBメモリ,又はハードディスク)をも提供する。 Another aspect of the present invention relates to a program for making a computer function as any of the above-mentioned systems. The specification also provides a computer-readable information recording medium (floppy disk, CD, DVD, USB memory, or hard disk) that stores such a program.
 摘出された腫瘍や血液,体液などの検体を対象に,遺伝子パネル検査,エクソーム解析,全ゲノム解析などを行って検出された遺伝子異常の解釈に基づいて,適切な治療を実施するためには,遺伝子異常とその解釈に基づいた治療選択肢とを紐づける根拠情報による臨床的意義付けのプロセスが必要である。また個々の患者にあわせた適切な臨床的意義付けのため,追加の患者由来情報も必要に応じて用いる。 In order to carry out appropriate treatment based on the interpretation of genetic abnormalities detected by performing gene panel tests, exome analysis, whole genome analysis, etc. on excised tumors, blood, body fluids, and other specimens. There is a need for a process of clinical significance based on evidence that links genetic abnormalities with treatment options based on their interpretation. Additional patient-derived information will also be used as needed for appropriate clinical significance for individual patients.
 現在,このような臨床的意義付けは,専門家や専門家を構成員とするエキスパートパネルで実施されているが,その過程において根拠情報となる情報の収集と整理が必要であり,煩雑な作業となっている。
今回提案する方式は,これらの遺伝子異常の解釈に基づいた適切な治療選択を効率的に実施できるように提案するためのものである。
Currently, such clinical significance is carried out by experts and expert panels consisting of experts, but in the process it is necessary to collect and organize information that will be the basis information, which is a complicated task. It has become.
The method proposed this time is for proposing that appropriate treatment selection based on the interpretation of these genetic abnormalities can be efficiently carried out.
 想定される患者由来情報は,例えば以下である。
・検体の情報
・検体から検出された遺伝子異常の情報
・患者の基本情報(性別,生年月日などの患者がもつ患者個人の情報)
・患者の臨床情報(がん種,主訴,問診,触診,生化学検査や画像検査などの各種検査結果などの患者の状態を示す情報)
・患者の来歴情報(病歴,入院歴,治療歴,過去の検査履歴などの患者の各種履歴)
Possible patient-derived information is, for example:
・ Specimen information ・ Information on genetic abnormalities detected in the sample ・ Basic patient information (personal patient information such as gender and date of birth)
・ Patient clinical information (information showing the patient's condition such as cancer type, chief complaint, interview, palpation, various test results such as biochemical test and imaging test)
・ Patient history information (various history of patients such as medical history, hospitalization history, treatment history, past examination history)
 想定される治療選択肢は,例えば以下である。
・抗がん剤治療開始
・抗がん剤治療中止
・抗がん剤変更
・臨床試験,治験紹介
Possible treatment options are, for example:
・ Start of anti-cancer drug treatment ・ Discontinuation of anti-cancer drug treatment ・ Change of anti-cancer drug ・ Clinical trial, clinical trial introduction
 想定される遺伝子異常とその解釈に基づいた治療選択肢とを紐づける根拠情報は,例えば以下である。
・ガイドライン掲載情報
・承認済み薬剤情報
・臨床試験,治験の情報
・論文情報
・学会発表情報
For example, the rationale information for associating a possible genetic abnormality with a treatment option based on its interpretation is as follows.
・ Guideline publication information ・ Approved drug information ・ Clinical trials, clinical trial information ・ Paper information ・ Conference presentation information
 例えば,EGFR遺伝子のexon19欠失が検出された非小細胞肺癌患者に対する治療選択肢の候補を提案する場合,この遺伝子異常とその解釈に基づいた治療選択肢とを紐づける根拠情報として,例えば「a kinase inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test.」とFDAに承認され,薬剤の添付文書に当該記載がある「dacomitinib」が候補となる。
また,EGFR遺伝子のexon19欠失は,EGFR遺伝子変異陽性変異として知られていることから,例えば「EGFR遺伝子変異陽性の手術不能又は再発非小細胞肺癌」に対する効能・効果をPMDAに承認され,薬剤の添付文書に当該記載がある「ダコミチニブ水和物錠」についても候補となる。
For example, when proposing a candidate treatment option for a patient with non-small cell lung cancer in which an exon19 deletion of the EGFR gene is detected, for example, "a kinase" is used as the basis information for linking this gene abnormality with the treatment option based on its interpretation. inhibitor indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test. " The candidate is "dacomitinib", which is approved by the drug and has the relevant description in the attached document of the drug.
In addition, since the exon19 deletion of the EGFR gene is known as an EGFR gene mutation-positive mutation, for example, the indication for "EGFR gene mutation-positive inoperable or recurrent non-small cell lung cancer" was approved by PMDA, and the drug was approved. "Dacomitinib hydrate tablets", which is mentioned in the package insert of, is also a candidate.
 また別の例としては,EGFR遺伝子のexon19欠失とT790M変異が検出された非小細胞肺癌患者に対する治療選択肢の候補を提案する場合,例えば「組織学的又は細胞学的に非扁平上皮非小細胞肺癌と診断されている。」ことと,「組織検体又は細胞診検体でEGFR変異(エクソン19欠失,L858R)を有することが確認されている(ただしT790M陽性が判明している場合は除外とする)。」とを選択基準に含む「EGFR遺伝子変異陽性非扁平上皮非小細胞肺癌に対する,初回化学療法としてのオシメルチニブ+ラムシルマブとオシメルチニブのランダム化第II相試験」について,遺伝子異常とその解釈に基づいた治療選択肢とを紐づける根拠情報の候補となる。ここで,仮にT790M変異が検出されていなかった場合を想定すると,当該臨床試験の選択基準に合致しないことから,遺伝子異常とその解釈に基づいた治療選択肢とを紐づける根拠情報の候補としては提案されないことが望ましい。 As another example, when proposing treatment options for patients with non-small cell lung cancer in which the exon19 deletion of the EGFR gene and the T790M mutation have been detected, for example, "histologically or cytologically non-squamous epidermal non-small cell lung cancer" "It has been diagnosed as cell lung cancer." And "It has been confirmed that the tissue sample or cytological sample has an EGFR mutation (Exxon 19 deletion, L858R) (excluding cases where T790M positive is known). ”” Is included in the selection criteria for “Random phase II study of osimertinib + lambylumab and osimertinib as initial chemotherapy for EGFR gene mutation-positive non-squamous non-small cell lung cancer”, and its interpretation It is a candidate for evidence information that links treatment options based on. Here, assuming that the T790M mutation is not detected, it does not meet the selection criteria of the clinical trial, so it is proposed as a candidate for evidence information that links the genetic abnormality with the treatment option based on its interpretation. It is desirable not to be done.
 このように,患者が持つ一つないし複数の遺伝子異常とその解釈に基づいた治療選択肢とを紐づける根拠情報を,必要に応じて患者由来情報とともに総合的評価することによって提案される。 In this way, it is proposed by comprehensively evaluating the evidence information that links one or more genetic abnormalities possessed by the patient with the treatment options based on the interpretation, together with the patient-derived information as necessary.
 しかし,これらの情報を収集してもなお,最新の根拠情報が提案されていない場合等も想定されることから,今回提案する方式においては,臨床的意義付けを行うエキスパートパネル参加者ないし担当医師は,画面上に表示されるこれら提案された根拠情報を一つ一つ確認のうえ,最終的な判断に使用するか否かを変更することが可能となっている。 However, even if this information is collected, it is possible that the latest evidence information has not been proposed. Therefore, in the method proposed this time, expert panel participants or doctors in charge who give clinical significance. Is able to change whether or not to use these proposed rationale information displayed on the screen for the final decision after checking each one.
 臨床的意義付けを行うエキスパートパネル参加者ないし担当医師が,この確認を行う際には,一人の患者が持つ一つないし複数の遺伝子異常に関する情報と,がん種,性別,年齢その他患者由来情報の多くの情報を用いて根拠情報の確認ができることが望ましいが,これらの情報を全て一つの画面上に表示することは画面の煩雑さを招き確認作業が困難になると考えられる。 When an expert panel participant or doctor in charge of clinical significance makes this confirmation, information on one or more genetic abnormalities possessed by one patient, and cancer type, gender, age, and other patient-derived information It is desirable to be able to confirm the basis information using a lot of information in the above, but displaying all of this information on one screen will cause the screen to become complicated and the confirmation work will be difficult.
 そのため,今回提案する方式においては,一つの画面において,一人の患者がもつ個々の遺伝子異常に関する情報と,患者由来情報を表示する。このような表示とすることによって,遺伝子変異ごとに治療選択肢と根拠情報の確認を実施しやすくなっている。 Therefore, in the method proposed this time, information on individual genetic abnormalities possessed by one patient and patient-derived information are displayed on one screen. This display makes it easier to confirm treatment options and evidence information for each gene mutation.
 一方で,このような一つの画面において,一人の患者がもつ個々の遺伝子異常に関する情報と,患者由来情報を表示する方式においては,根拠情報が画面に表示されていない理由により抑止されてしまう状況が起きてしまう。 On the other hand, in such a method of displaying information on individual genetic abnormalities possessed by a patient and patient-derived information on one screen, the situation is suppressed due to the reason that the evidence information is not displayed on the screen. Will happen.
 例えば上記例の,EGFR遺伝子のexon19欠失とT790M変異を有する患者の場合,EGFR遺伝子のexon19欠失に関する情報を表示するページにおいては,同一患者がT790M変異も併せ持っていることが表示されていないにも関わらず,「ただしT790M陽性が判明している場合は除外とする」という条件によって,表示されているexon19欠失という変異だけからすると,一見対象となるべき臨床試験が候補として提案されないという状況が起きてしまう。 For example, in the case of the patient with the exon19 deletion of the EGFR gene and the T790M mutation in the above example, the page displaying information on the exon19 deletion of the EGFR gene does not indicate that the same patient also has the T790M mutation. Despite this, the condition "However, if T790M positive is known, it is excluded", it is said that the clinical trial that should be the target at first glance is not proposed as a candidate only from the mutation of exon19 deletion displayed. The situation will happen.
 そのため,今回提案する方式においては,このような画面上に表示されていない遺伝子異常やその他患者由来情報に基づいて,根拠情報が提案されないという状況が起きる場合には,その根拠情報を根拠として不採用とした状態で根拠情報として表示することも可能である。また,不採用とした状態で表示する理由(この場合はT790M変異が別途存在しているため,除外されるべき)も合わせて表示することで,根拠として不採用とする理由を容易に確認することもできる。 Therefore, in the method proposed this time, if the evidence information is not proposed based on the genetic abnormality or other patient-derived information that is not displayed on the screen, the evidence information is not used as the basis. It is also possible to display it as evidence information in the state of being adopted. In addition, by displaying the reason for not adopting it (in this case, it should be excluded because the T790M mutation exists separately), it is easy to confirm the reason for not adopting it as a basis. You can also do it.
 この発明は,医療情報を提供するシステムであるから,医療機関用の情報機器関連産業において利用され得る。  Since this invention is a system for providing medical information, it can be used in the information equipment-related industry for medical institutions.
1 治療選択肢を提案するためのシステム
3 患者情報入力部
5 遺伝子異常情報入力部
7 エビデンス情報記録部
9 エビデンス情報抽出部
11 エビデンス情報表示部
13 治療選択肢提案部
15 選択表示部
17 エビデンス情報入力部
1 System for proposing treatment options 3 Patient information input unit 5 Genetic abnormality information input unit 7 Evidence information recording unit 9 Evidence information extraction unit 11 Evidence information display unit 13 Treatment option proposal unit 15 Selection display unit 17 Evidence information input unit

Claims (8)

  1.  患者の臨床情報を含む患者情報が入力される患者情報入力部と,
     患者の遺伝子異常に関する情報が入力される遺伝子異常情報入力部と,
     患者情報及び遺伝子異常に関連したエビデンス情報を記録するエビデンス情報記録部と,
     前記患者情報入力部から入力されたある患者の患者情報,及び前記遺伝子異常情報入力部から入力された前記患者の遺伝子異常に関する情報を用いて,前記エビデンス情報記録部から,前記患者に関連したエビデンス情報である第1のエビデンス情報を抽出する,エビデンス情報抽出部と,
     第1のエビデンス情報を表示部に表示するためのエビデンス情報表示部と,
     第1のエビデンス情報を用いて,前記患者情報に基づいた治療選択肢を提案する治療選択肢提案部とを含む,
     治療選択肢を提案するためのシステム。
    Patient information input section where patient information including clinical information of patients is input, and
    A genetic abnormality information input unit that inputs information about a patient's genetic abnormality,
    Evidence information recording unit that records patient information and evidence information related to genetic abnormalities,
    Evidence related to the patient from the evidence information recording unit using the patient information of a certain patient input from the patient information input unit and the information regarding the genetic abnormality of the patient input from the genetic abnormality information input unit. The evidence information extraction unit that extracts the first evidence information, which is information, and
    The evidence information display unit for displaying the first evidence information on the display unit,
    It includes a treatment option suggestion unit that proposes treatment options based on the patient information using the first evidence information.
    A system for proposing treatment options.
  2.  請求項1に記載のシステムであって,
     前記表示部に表示されたエビデンス情報を選択可能にする選択表示部をさらに有し,
     前記治療選択肢提案部は,前記選択表示部により選択されたエビデンス情報を第1のエビデンス情報とする,
     システム。
    The system according to claim 1.
    It also has a selection display unit that makes it possible to select the evidence information displayed on the display unit.
    The treatment option suggestion unit uses the evidence information selected by the selection display unit as the first evidence information.
    system.
  3.  請求項1又は2に記載のシステムであって,
     新たなエビデンス情報である第2のエビデンス情報を入力するエビデンス情報入力部をさらに有し,
     前記エビデンス情報表示部は,第1のエビデンス情報に加えて第2のエビデンス情報を表示し,
     前記治療選択肢提案部は,第1のエビデンス情報及び第2のエビデンス情報を用いて,前記患者情報に基づいた治療選択肢を提案する,
     システム。
    The system according to claim 1 or 2.
    It also has an evidence information input unit for inputting second evidence information, which is new evidence information.
    The evidence information display unit displays the second evidence information in addition to the first evidence information.
    The treatment option suggestion unit proposes a treatment option based on the patient information by using the first evidence information and the second evidence information.
    system.
  4.  請求項1~3のいずれかに記載のシステムであって,
     前記患者の臨床情報は,患者が罹患している腫瘍の種類に関する情報を含み,
     前記エビデンス情報は,腫瘍の種類ごとの情報を含む,
     システム。
    The system according to any one of claims 1 to 3.
    The patient's clinical information includes information about the type of tumor the patient is suffering from.
    The evidence information includes information for each type of tumor.
    system.
  5.  請求項1~4のいずれかに記載のシステムであって,
     前記患者情報は,患者の検体に関する情報,患者の性別に関する情報,及び患者の病歴に関する情報のいずれか1つ以上を含む,システム。 
    The system according to any one of claims 1 to 4.
    A system in which the patient information includes any one or more of information about a patient's specimen, information about a patient's gender, and information about a patient's medical history.
  6.  請求項1~5のいずれかに記載のシステムであって,
     前記治療選択肢は,抗がん剤治療開始を含む,システム。
    The system according to any one of claims 1 to 5.
    The treatment options include a system that includes initiation of anti-cancer drug treatment.
  7.  請求項1に記載のシステムであって,
     前記エビデンス情報は,(i)ガイドライン掲載情報,(ii)承認済み薬剤情報,(iii)臨床試験・治験の情報,(iv)論文情報,(v)学会発表情報のいずれか2つ以上のカテゴリーに分類され,
     前記治療選択肢提案部は,前記カテゴリーを用いて,前記患者情報に基づいた治療選択肢を提案する,
     システム。
    The system according to claim 1.
    The evidence information includes two or more categories: (i) guideline publication information, (ii) approved drug information, (iii) clinical trial / clinical trial information, (iv) paper information, and (v) conference presentation information. Classified as
    The treatment option suggestion unit proposes a treatment option based on the patient information using the category.
    system.
  8.  コンピュータを,請求項1に記載のシステムとして機能させるためのプログラム。 A program for making a computer function as the system according to claim 1.
PCT/JP2020/045545 2019-12-05 2020-12-07 System for proposing treatment options WO2021112261A1 (en)

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Citations (2)

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JP2018533123A (en) * 2015-09-10 2018-11-08 エフ.ホフマン−ラ ロシュ アーゲーF. Hoffmann−La Roche Aktiengesellschaft An information science platform for integrated clinical care
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