Information processing device, information processing method, and program

Abstract

In the past, even for doctors and other experts, it was not easy to find clinical trials in which patients could participate. [Solution] Clinical trials in which a patient can participate can be easily found by an information processing device 1 that includes a trial search unit 131 that determines one or more pieces of clinical trial information from a clinical trial management unit 111, which has genetic identifiers for one or more pieces of abnormal gene information contained in genetic testing data; a subject information acquisition unit 132 that acquires subject information including selection criteria information and exclusion criteria information for each of the one or more pieces of clinical trial information from the clinical trial management unit 111 or an external database 4 in which detailed clinical trial information including the subject information is stored; a judgment unit 133 that acquires participation information regarding whether a patient is eligible to participate in a clinical trial for each of the one or more pieces of clinical trial information using the subject information and one or more patient attribute values; and a judgment result output unit 143 that outputs the participation information.

Description

[Technical Field]

[0001] The present invention relates to an information processing device or the like that uses genetic test data of a patient to output participation information regarding whether or not the patient is eligible to participate in a clinical trial. [Background technology]

[0002] Conventionally, in clinical trials, there has been a remote entry system in which information received from a terminal computer at a medical institution is registered in a server computer at a clinical trial case report support organization (see Patent Document 1). [Prior art documents] [Patent documents]

[0003] [Patent Document 1] Japanese Patent Application Laid-Open No. 2004-5220 Summary of the Invention [Problem to be solved by the invention]

[0004] However, in the past, even for medical professionals and other experts, it was not easy to find clinical trials in which patients could participate. [Means for solving the problem]

[0005] The information processing device of the first invention is an information processing device comprising: a data accepting unit that accepts genetic testing data, which is test data for a patient's genes, information having a gene identifier, and which is test data including one or more abnormal gene information pieces that are information on abnormal genes; a trial search unit that determines one or more clinical trial information pieces having gene identifiers of abnormal genes identified by the one or more abnormal gene information pieces contained in the genetic testing data from a clinical trial management unit that stores one or more clinical trial information pieces that correspond to the trial identifiers and have gene identifiers and target cancer types; an attribute value accepting unit that accepts one or more patient attribute values ​​that are patient attribute values; a subject information acquiring unit that acquires subject information including inclusion criteria information and exclusion criteria information for each of the one or more clinical trial information pieces determined by the trial search unit from the clinical trial management unit or an external database that stores detailed clinical trial information including subject information; a judgment unit that acquires participation information regarding whether a patient is eligible to participate in the clinical trial, for each of the one or more clinical trial information pieces determined by the trial search unit, using the subject information and one or more patient attribute values ​​acquired by the subject information acquiring unit; and a judgment result output unit that outputs the participation information acquired by the judgment unit.

[0006] This makes it easier for patients to find available clinical trials.

[0007] In addition, the information processing device of the second invention, compared to the first invention, further includes a clinical trial output unit that outputs one or more pieces of clinical trial information determined by the trial search unit, and a trial selection receiving unit that receives trial selection information indicating a selection of one or more pieces of clinical trial information from the one or more pieces of clinical trial information output by the clinical trial output unit, wherein the subject information acquisition unit acquires, from an external database, subject information including selection criteria information and exclusion criteria information for each of the one or more pieces of clinical trial information indicated by the trial selection information received by the trial selection receiving unit, and the judgment unit acquires participation information for each of the one or more pieces of clinical trial information indicated by the trial selection information received by the trial selection receiving unit using the subject information acquired by the subject information acquisition unit and one or more patient attribute values.

[0008] This configuration makes it easy to find an appropriate clinical trial from among clinical trials in which patients can participate and which have been selected based on the knowledge of experts such as doctors.

[0009] Furthermore, the information processing device of the third invention is an information processing device in which, compared to the first invention, the genetic testing data includes one or more pieces of abnormal gene information, and further includes an abnormal gene acquisition unit that acquires the one or more pieces of abnormal gene information from the genetic testing data accepted by the data acceptance unit, and the test search unit determines one or more pieces of clinical trial information having gene identifiers of abnormal genes identified by the one or more pieces of abnormal gene information among the one or more pieces of abnormal gene information acquired by the abnormal gene acquisition unit.

[0010] This makes it easier for patients to find available clinical trials.

[0011] Furthermore, the information processing device of the fourth invention is an information processing device that, compared to the third invention, further includes an abnormal gene output unit that outputs one or more pieces of abnormal gene information acquired by the abnormal gene acquisition unit, and a gene selection receiving unit that receives gene selection information indicating the selection of one or more pieces of abnormal gene information from the one or more pieces of abnormal gene information output by the abnormal gene output unit, and the trial search unit is an information processing device that determines, from the clinical trial management unit, one or more pieces of clinical trial information having the gene identifier of the abnormal gene identified by the gene selection information received by the gene selection receiving unit.

[0012] This configuration makes it easier to find clinical trials in which patients can participate and which target abnormal genes selected by experts such as doctors.

[0013] In addition, the information processing device of the fifth invention is an information processing device in which, compared to any one of the first to fourth inventions, the judgment unit provides the generation AI with the target information acquired by the target information acquisition unit, one or more patient attribute values, and a participation decision prompt, which is a command statement that outputs participation information regarding whether the patient is able to participate in a clinical trial, and acquires participation information for each of one or more pieces of clinical trial information from the generation AI.

[0014] This makes it easier for patients to find available clinical trials.

[0015] Furthermore, the information processing device of the sixth invention is an information processing device in which, compared to any one of the first to fifth inventions, the attribute value receiving unit receives medical record information including one or more patient attribute values, and the medical record information has age, gender, disease name, and treatment history.

[0016] This structure makes it easier for patients to find available and appropriate clinical trials.

[0017] In addition, the information processing device of the seventh invention is an information processing device that, compared to any one of the first to sixth inventions, further includes a first trial number acquisition unit that acquires a first trial number, which is the number of clinical trial information for each gene, using a gene identifier contained in each of one or more pieces of clinical trial information determined by the trial search unit, and the clinical trial output unit outputs the one or more pieces of clinical trial information and the first trial number for each gene so that they are displayed together.

[0018] This configuration makes it easier to select clinical trials for which one can decide whether or not one is eligible to participate.

[0019] Furthermore, the information processing device of the eighth invention is an information processing device that, with respect to any one of the first to seventh inventions, further includes a second trial number acquisition unit that acquires a second trial number, which is the number of clinical trial information for each cancer type, using the target cancer type contained in each of the one or more pieces of clinical trial information determined by the trial search unit, and the clinical trial output unit outputs the one or more pieces of clinical trial information and the second trial number for each gene so that they are displayed together.

[0020] This configuration makes it easier to select clinical trials for which one can decide whether or not one is eligible to participate.

[0021] In addition, the information processing device of the ninth invention is an information processing device that, with respect to any one of the first to eighth inventions, further comprises a storage unit that acquires clinical trial information from the clinical trial detailed information for each of one or more clinical trial detailed information items from an external database in which one or more clinical trial detailed information items including target information are stored, and stores the acquired clinical trial information in a clinical trial management unit.

[0022] This configuration enables automatic construction of a database for managing clinical trial information. [Effects of the Invention]

[0023] The information processing device according to the present invention allows patients to easily find clinical trials in which they can participate. [Brief explanation of the drawings]

[0024] [Figure 1] Conceptual diagram of information system A in embodiment 1 [Figure 2] Block diagram of Information System A [Figure 3] Block diagram of the information processing device 1 [Figure 4] A flowchart illustrating an example of the operation of the information processing device 1. [Figure 5] A flowchart illustrating an example of the test search process [Figure 6] A flowchart illustrating an example of the participation determination process [Figure 7] A flowchart illustrating an example of the information collection process [Figure 8] A flowchart illustrating an example of the operation of the terminal device 2 [Figure 9] Figure showing an example of clinical trial details from the external database4 [Figure 10] Figure showing an example of clinical trial details from the external database4 [Figure 11] Figure showing an example of the output [Figure 12] Figure showing an example of the output [Figure 13] A diagram showing an example of a participation prompt template [Figure 14] Figure showing an example of the participation decision prompt [Figure 15] Figure showing an example of the output [Figure 16] Block diagram of the computer system DETAILED DESCRIPTION OF THE INVENTION

[0025] Hereinafter, embodiments of an information processing device and the like will be described with reference to the drawings. Note that components with the same reference numerals in the embodiments perform similar operations, and therefore repeated description may be omitted.

[0026] (Embodiment 1) In this embodiment, we will describe an information processing device that accepts genetic testing data, outputs one or more pieces of abnormal gene information contained in the genetic testing data, accepts a selection of one or more pieces of abnormal gene information from the one or more pieces of abnormal gene information, obtains one or more pieces of clinical trial information corresponding to the abnormal genes from a clinical trial database, selects one or more pieces of clinical trial information from the one or more pieces of clinical trial information, and obtains and outputs information regarding whether or not the patient can participate in the clinical trial indicated by each of the one or more pieces of clinical trial information.

[0027] In this specification, information X being associated with information Y means that information Y can be obtained from information X, or information X can be obtained from information Y, and the method of association is not important. Information X and information Y may be linked, may exist in the same buffer, information X may be included in information Y, or information Y may be included in information X, etc.

[0028] Furthermore, in this specification, selecting or determining information Z means obtaining information Z, obtaining a pointer to information Z, obtaining the ID of information Z, setting a flag on information Z, etc., and it is sufficient if information Z can be accessed.

[0029] 1 is a conceptual diagram of an information system A according to this embodiment. The information system A comprises an information processing device 1, one or more terminal devices 2, one or more generation AI devices 3, and an external database 4.

[0030] The information processing device 1 is a device that uses a patient's genetic test data to output information about clinical trials in which the patient can participate. The information processing device 1 is usually a server, but may also be a terminal. When the information processing device 1 is a server, the information processing device 1 is, for example, a cloud server or an ASP server, but the type does not matter. When the information processing device 1 is a terminal, the information processing device 1 is, for example, a so-called personal computer, smartphone, or tablet terminal, but the type does not matter. When the information processing device 1 is a terminal, the terminal device 2 is not required in the information system A.

[0031] The terminal device 2 is a terminal used by a user. The user may be, for example, a doctor, a genetic analysis specialist, or the like. However, the user is not limited to this. The terminal device 2 may be, for example, a personal computer, a smartphone, or a tablet terminal, but the type is not limited thereto.

[0032] The generation AI device 3 is a device that has the function of a generation AI. Here, the generation AI device 3 typically has the function of a text generation AI. The generation AI is, for example, ChatGPT (registered trademark) or Google Gemini (registered trademark), but the type is not important. The generation AI device 3 is, for example, a cloud server or an ASP server, but the type is not important. The generation AI device 3 will be referred to as a generation AI as appropriate. Furthermore, the information processing device 1 may have the function of a generation AI. In such a case, the generation AI device 3 is not necessary.

[0033] The external database 4 stores one or more clinical trial details. The clinical trial details are detailed information about clinical trials that are recruiting participants. The clinical trial details include subject information. The subject information is information used to determine whether a patient can participate in a clinical trial. The subject information includes inclusion criteria information and exclusion criteria information. The inclusion criteria information is information indicating the criteria for clinical trial participants. The inclusion criteria information is information indicating the qualifications for clinical trial participants. The exclusion criteria information is information indicating the conditions for exclusion from clinical trial participants. The external database 4 is, for example, Japan's official clinical trial registration database (Japan Registry of Clinical Trials: jRCT) operated by the Ministry of Health, Labor and Welfare. The external database 4 may be, for example, a server that has the Ministry of Health, Labor and Welfare's clinical trial registration database. The external database 4 is, for example, a web server that stores web pages or a database server. The database may be a so-called relational database, a database with another structure, or simply a collection of data. A simple collection of data may be, for example, one or more web pages, or one or more files.

[0034] The information processing device 1 and one or more terminal devices 2, the information processing device 1 and one or more generation AI devices 3, and the information processing device 1 and external database 4 can communicate with each other via a network such as the Internet.

[0035] 2 is a block diagram of an information system A according to the present embodiment, and FIG.

[0036] The information processing device 1 includes a storage unit 11, a reception unit 12, a processing unit 13, and an output unit 14. The storage unit 11 includes a clinical trial management unit 111 and a prompt management unit 112. The reception unit 12 includes a data reception unit 121, a gene selection reception unit 122, a test selection reception unit 123, and an attribute value reception unit 124. The processing unit 13 includes an abnormal gene acquisition unit 130, a test search unit 131, a subject information acquisition unit 132, a judgment unit 133, a first test number acquisition unit 134, a second test number acquisition unit 135, and an accumulation unit 136. The output unit 14 includes an abnormal gene output unit 141, a clinical trial output unit 142, and a judgment result output unit 143.

[0037] The terminal device 2 includes a terminal storage unit 21, a terminal reception unit 22, a terminal processing unit 23, a terminal transmission unit 24, a terminal reception unit 25, and a terminal output unit 26.

[0038] Various types of information are stored in the storage unit 11 that constitutes the information processing device 1. The various types of information include, for example, clinical trial information and prompts, which will be described later.

[0039] The clinical trial management unit 111 stores one or more pieces of clinical trial information. Clinical trial information is information related to a clinical trial. Clinical trial information is usually information related to a clinical trial that is currently recruiting participants. Clinical trial information is associated with a trial identifier. Clinical trial information includes a genetic identifier and a target cancer type. It is preferable that the clinical trial information includes inclusion criteria information and exclusion criteria information.

[0040] A trial identifier is information that identifies a clinical trial. For example, a trial identifier is the ID or name of a clinical trial. A gene identifier is information that identifies a gene. For example, a gene identifier is the name or ID of a gene. For example, a gene identifier is "BCL6", "CCND1", or "CD19". A target cancer type is information that indicates the type of cancer that a clinical trial targets. A target cancer type is the name of the cancer that a clinical trial targets. For example, a target cancer type is "prostate cancer", "kidney cancer", or "lung cancer".

[0041] The prompt management unit 112 stores one or more participation decision prompts. A prompt is a command statement given to the generation AI to obtain an answer from the generation AI. The one or more prompts in the prompt management unit 112 include a participation decision prompt. A participation decision prompt is a command statement that outputs participation information. Participation information is information regarding whether or not a patient is able to participate in a clinical trial. Participation information includes, for example, participation availability information and reason information. Participation availability information is information indicating whether or not participation is possible. Reason information is information indicating the reason for the participation availability information. An example of a participation decision prompt is, "Please answer whether or not a patient with the following patient attribute values ​​is able to participate in a clinical trial with the following inclusion and exclusion criteria, along with the reason: [Patient attribute value] <Patient attribute value> [Selection criteria] <Selection criteria information> [Exclusion criteria] <Exclusion criteria information>".

[0042] Patient attribute values ​​are attribute values ​​of a patient. Patient attribute values ​​are usually information recorded in a patient's medical record. In other words, patient attribute values ​​are usually information that makes up medical record information. Patient attribute values ​​include, for example, age, sex, disease name, treatment history, medical history, and names of administered medications. Disease name can also be called diagnosis name.

[0043] The reception unit 12 receives various instructions and information. The reception unit 12 usually receives various instructions and information from the terminal device 2. The various instructions and information include, for example, genetic test data (described later), gene selection information (described later), test selection information (described later), and one or more patient attribute values.

[0044] Here, acceptance typically refers to the reception of information transmitted via a wired or wireless communication line, but may also be a concept that includes the reception of information input from an input device such as a keyboard, mouse, or touch panel, or the reception of information read from a recording medium such as an optical disk, magnetic disk, or semiconductor memory.

[0045] The data receiving unit 121 receives genetic test data. The data receiving unit 121 receives, for example, genetic test data associated with a patient identifier.

[0046] Genetic test data is test data on a patient's genes. Genetic testing is testing of genetic information (DNA) extracted from cells that make up a person's body. Genetic test data has one or more gene identifiers. Genetic test data includes information on one or more abnormal genes. Genetic test data includes, for example, information on one or more normal genes. The patient is, for example, a cancer patient. Genetic test data may also include information on testing using drugs that target extragenic regions (e.g., enhancers or splice-related factors). Genetic information testing may include testing such as RNAseq and epigenetics.

[0047] Abnormal gene information is information about a patient's abnormal gene. Abnormal gene information is genetic information about the abnormal gene. Abnormal gene information has a genetic identifier for the abnormal gene. Abnormal gene information has, for example, genetic alteration information, classification, applicable drug, and gene description information. Genetic alteration information is information indicating the type of genetic alteration. Examples of genetic alteration information are "amplification," "deletion," "p.Q56P," "p.R1758Q," and "p.V307L." Classification is information indicating the type of genetic mutation. Examples of classification are "copy number abnormality" and "point / deletion mutation." Applicable drug is information specifying a drug that is applicable to a genetic abnormality. Gene description information is information describing the gene.

[0048] Normal gene information is information about a patient's normal genes, and includes gene identifiers of normal genes.

[0049] The gene selection receiving unit 122 receives gene selection information. The gene selection information is information indicating the selection of one or more pieces of abnormal genetic information from one or more pieces of abnormal genetic information output by the abnormal gene output unit 141, which will be described later. The gene selection information has, for example, a gene identifier for each of the selected one or more pieces of abnormal genetic information. The gene selection information has, for example, an ID indicated by each of the selected one or more pieces of abnormal genetic information, and an ID that identifies the one or more pieces of abnormal genetic information output by the abnormal gene output unit 141. Note that the ID is, for example, the ID of a record in the list of abnormal genetic information output by the abnormal gene output unit 141.

[0050] The trial selection receiving unit 123 receives trial selection information. The trial selection information is information indicating the selection of one or more pieces of clinical trial information from one or more pieces of clinical trial information output by the clinical trial output unit 142, which will be described later. The trial selection information includes, for example, a clinical trial identifier for each of the one or more selected pieces of clinical trial information. The trial selection information includes, for example, an ID indicated by each of the one or more selected pieces of clinical trial information and identifying the one or more pieces of clinical trial information output by the clinical trial output unit 142. The ID is, for example, the ID of a record in the list of clinical trial information output by the clinical trial output unit 142.

[0051] The attribute value receiving unit 124 receives one or more patient attribute values, which are attribute values ​​of a patient. The attribute value receiving unit 124 receives, for example, medical record information. The medical record information is information on a patient's medical record. The medical record information includes one or more patient attribute values.

[0052] The processing unit 13 performs various processes, such as processes performed by the abnormal gene acquisition unit 130, the test search unit 131, the subject information acquisition unit 132, the judgment unit 133, the first test number acquisition unit 134, the second test number acquisition unit 135, or the accumulation unit 136.

[0053] The abnormal gene acquisition unit 130 acquires one or more pieces of abnormal gene information from the genetic testing data accepted by the data acceptance unit 121. The abnormal gene acquisition unit 130 acquires abnormal gene information, which is genetic information containing information indicating an abnormality, from each of two or more pieces of genetic information contained in the genetic testing data accepted by the data acceptance unit 121.

[0054] The trial search unit 131 refers to the clinical trial management unit 111 and determines one or more pieces of clinical trial information having the gene identifier of the abnormal gene indicated in the gene selection information received by the gene selection receiving unit 122. Determining the clinical trial information means, for example, obtaining part or all of the clinical trial information, or obtaining the ID of the clinical trial information.

[0055] The subject information acquisition unit 132 acquires subject information including the selection criteria information and exclusion criteria information for each of one or more pieces of clinical trial information identified by the trial selection information received by the trial selection receiving unit 123 from the clinical trial management unit 111 or the external database 4. The external database 4 stores one or more clinical trial details. The clinical trial details are detailed information related to the clinical trial. The clinical trial details include the selection criteria information and the exclusion criteria information.

[0056] The judgment unit 133 acquires participation information regarding whether or not a patient is eligible to participate in a clinical trial, for each of one or more pieces of clinical trial information identified by the trial selection information accepted by the trial selection acceptance unit 123, using the subject information acquired by the subject information acquisition unit 132 and one or more patient attribute values.

[0057] The determination unit 133 acquires the participation information using, for example, a generation AI. The determination unit 133 acquires the participation information by, for example, natural language processing. The determination unit 133 acquires the participation information by, for example, machine learning. Each of the three cases will be described below. (1) When using generative AI

[0058] The judgment unit 133 acquires one or more pieces of target information and one or more patient attribute values ​​acquired by the target information acquisition unit 132. The judgment unit 133 also acquires a participation determination prompt from the prompt management unit 112. Next, the judgment unit 133 provides the target information, one or more patient attribute values, and the participation determination prompt to the generation AI, and acquires participation information for each of one or more pieces of clinical trial information from the generation AI. (2) By natural language processing

[0059] The judgment unit 133 judges whether one or more patient attribute values ​​for each one or more pieces of subject information acquired by the subject information acquisition unit 132 (for each clinical trial) satisfy the selection criteria information contained in the subject information and do not satisfy the exclusion criteria information, and acquires the judgment result.

[0060] The determination unit 133, for example, performs morphological analysis on the selection criteria information and determines whether or not each of one or more patient attribute values ​​satisfies the selection criteria information. The determination unit 133, for example, performs morphological analysis on the exclusion criteria information and determines whether or not each of one or more patient attribute values ​​satisfies the exclusion criteria information. If the selection criteria information is satisfied but the exclusion criteria information is not satisfied, the determination unit 133 acquires participation information including information indicating that "participation is possible." (3) Machine learning

[0061] The judgment unit 133 constructs a vector using one or more patient attribute values, inclusion criteria information, and exclusion criteria information for each piece of subject information acquired by the subject information acquisition unit 132 (for each clinical trial). This vector is an explanatory variable vector. Next, the judgment unit 133 provides the explanatory variable vector and the learning model to a machine learning prediction module for each piece of subject information acquired by the subject information acquisition unit 132 (for each clinical trial), and acquires a judgment result, which is an objective variable. The judgment result is, for example, whether participation is possible (e.g., "1") or whether participation is not possible (e.g., "0").

[0062] Furthermore, the learning model is a model acquired by providing two or more sets of training data, each having an explanatory variable vector and a target variable (judgment result) acquired using one or more patient attribute values, selection criteria information, and exclusion criteria information, to a machine learning learning module and executing the learning module. The learning model is information configured by machine learning learning processing and is information used in machine learning prediction processing. The learning model may also be called a learner, classifier, classification model, etc. Furthermore, any machine learning algorithm may be used, such as deep learning, random forest, decision tree, SVM, etc. Furthermore, various machine learning functions, such as the TensorFlow (registered trademark) library, the random forest module of the R language, fastText, TinySVM, etc., and various existing libraries, may be used for machine learning.

[0063] The first trial number acquisition unit 134 acquires the first trial number, which is the number of clinical trial information for each gene (each gene identifier), using the gene identifier contained in one or more pieces of clinical trial information determined by the trial search unit 131.

[0064] The second trial number acquisition unit 135 acquires the second trial number, which is the number of clinical trial information for each cancer type (each cancer identifier), using the target cancer type contained in one or more pieces of clinical trial information determined by the trial search unit 131.

[0065] The storage unit 136 acquires clinical trial information from the clinical trial detailed information for each of one or more clinical trial detailed information from the external database 4, and stores the clinical trial information in the clinical trial management unit 111. The clinical trial information is usually a part of the information that constitutes the clinical trial detailed information.

[0066] It is preferable that the storage unit 136 periodically acquires clinical trial information from the clinical trial detailed information for each of one or more clinical trial detailed information items from the external database 4 and stores the clinical trial information in the clinical trial management unit 111.

[0067] The output unit 14 outputs various types of information, such as one or more pieces of abnormal gene information, a list of abnormal gene information, one or more pieces of clinical trial information, a list of clinical trial information, and participation information.

[0068] Here, output typically means transmission to terminal device 2, but it may also be a concept that includes display on a display, projection using a projector, printing on a printer, sound output, transmission to a device other than terminal device 2, storage on a recording medium, and handing over processing results to other processing devices or other programs.

[0069] The abnormal gene output unit 141 outputs one or more pieces of abnormal gene information contained in the genetic testing data received by the data receiving unit 121. The abnormal gene output unit 141 outputs, for example, a list of abnormal gene information using the genetic testing data.

[0070] The clinical trial output unit 142 outputs one or more pieces of clinical trial information determined by the trial search unit 131. The clinical trial output unit 142 outputs, for example, a list of clinical trial information.

[0071] It is preferable that the clinical trial output unit 142 outputs one or more pieces of clinical trial information and the number of first trials for each gene so as to be displayed together.

[0072] It is preferable that the clinical trial output unit 142 outputs one or more pieces of clinical trial information and the number of second trials for each gene so as to be displayed together.

[0073] The determination result output unit 143 outputs the participation information acquired by the determination unit 133 .

[0074] Various types of information are stored in the terminal storage unit 21 included in the terminal device 2. The various types of information include, for example, a user identifier and genetic test data.

[0075] The terminal reception unit 22 receives various instructions and information, such as genetic test data, gene selection information, test selection information, and one or more patient attribute values.

[0076] The means for inputting various instructions and information may be any means, such as a touch panel, keyboard, mouse, or menu screen.

[0077] The device processing unit 23 performs various types of processing, such as processing to change instructions, information, etc. received by the device receiving unit 22 into instructions, information, etc. with a structure to be transmitted, and processing to change information received by the device receiving unit 25 into a structure to be output.

[0078] The terminal transmitting unit 24 transmits various instructions and information to the information processing device 1. The various instructions and information are, for example, genetic test data, gene selection information, test selection information, or one or more patient attribute values.

[0079] The terminal receiving unit 25 receives various instructions and information from the information processing device 1. The various instructions and information are, for example, one or more pieces of abnormal gene information, a list of abnormal gene information, one or more pieces of clinical trial information, a list of clinical trial information, or participation information.

[0080] The terminal output unit 26 outputs various types of information, such as one or more pieces of abnormal gene information, a list of abnormal gene information, one or more pieces of clinical trial information, a list of clinical trial information, and participation information.

[0081] The storage unit 11, clinical trial management unit 111, prompt management unit 112, and terminal storage unit 21 are preferably non-volatile recording media, but may also be realized as volatile recording media.

[0082] There is no restriction on the process by which information is stored in the storage unit 11 etc. For example, information may be stored in the storage unit 11 etc. via a recording medium, information transmitted via a communication line etc. may be stored in the storage unit 11 etc., or information input via an input device may be stored in the storage unit 11 etc.

[0083] The reception unit 12, data reception unit 121, gene selection reception unit 122, test selection reception unit 123, and attribute value reception unit 124 are preferably realized by wireless or wired communication means, but may also be realized by a means for receiving broadcasts, a device driver for input means such as a touch panel or keyboard, or control software for a menu screen.

[0084] The processing unit 13, abnormal gene acquisition unit 130, test search unit 131, subject information acquisition unit 132, judgment unit 133, first test number acquisition unit 134, second test number acquisition unit 135, storage unit 136, and terminal processing unit 23 can typically be realized by a processor, memory, etc. The processing procedures of the processing unit 13, etc. are typically realized by software, and the software is recorded on a recording medium such as a ROM. However, they may also be realized by hardware (dedicated circuit). The processor may be a CPU, MPU, GPU, etc., and the type is not important.

[0085] The output unit 14, abnormal gene output unit 141, clinical trial output unit 142, and judgment result output unit 143 are usually realized by wireless or wired communication means, but can also be realized by driver software for an output device such as a display or speaker, or by a combination of driver software for an output device and an output device, etc.

[0086] The terminal reception unit 22 can be realized by a device driver for an input means such as a touch panel or a keyboard, or control software for a menu screen.

[0087] The terminal transmitting unit 24 is usually realized by a wireless or wired communication means, but may also be realized by a broadcasting means.

[0088] The terminal receiving unit 25 is usually realized by a wireless or wired communication means, but may also be realized by a means for receiving broadcasts.

[0089] The terminal output unit 26 may or may not include an output device such as a display, a speaker, etc. The terminal output unit 26 may be realized by driver software for an output device, or by a combination of driver software for an output device and the output device, etc.

[0090] Next, an example of the operation of the information processing device 1 will be described with reference to the flowchart of FIG.

[0091] (Step S401) The data receiving unit 121 determines whether or not genetic testing data has been received. If genetic testing data has been received, the process proceeds to step S402; if not, the process proceeds to step S415. It is preferable that the data receiving unit 121 receive genetic testing data paired with a user identifier.

[0092] (Step S402) The abnormal gene acquisition unit 130 acquires one or more pieces of abnormal gene information from the genetic test data received in step S401.

[0093] (Step S403) The processing unit 13 determines whether or not the gene selection condition is satisfied. If the gene selection condition is satisfied, the process proceeds to step S404, and if not, the process proceeds to step S406.

[0094] The gene selection condition is a condition for a specialist such as a doctor to select genes. For example, the gene selection condition is that the number of acquired abnormal gene information is equal to or greater than a threshold value. For example, the gene selection condition is that a flag indicating that abnormal gene information is to be selected is stored in the storage unit 11. For example, the gene selection condition is that a flag indicating that abnormal gene information is to be selected is stored in the storage unit 11 in association with the user identifier of the user who has transmitted the genetic test data.

[0095] (Step S404) The abnormal gene output unit 141 outputs one or more pieces of abnormal gene information acquired in step S402. The abnormal gene information output here may be a part of the information contained in the abnormal gene information.

[0096] (Step S405) The gene selection receiving unit 122 determines whether or not gene selection information has been received for one or more outputs of abnormal gene information. If gene selection information has been received, the process proceeds to step S406; if not, the process returns to step S405.

[0097] (Step S406) The test search unit 131 acquires gene identifiers of one or more abnormal genes specified by the gene selection information, or gene identifiers included in each of the one or more pieces of abnormal gene information acquired in step S402.

[0098] (Step S407) The trial search unit 131 acquires clinical trial information targeting the abnormal genes identified by the one or more gene identifiers acquired in step S406. An example of such trial search processing will be described using the flowchart in FIG.

[0099] (Step S408) The processing unit 13 determines whether or not the test selection conditions are met. If the test selection conditions are met, the process proceeds to step S409, and if not, the process proceeds to step S412.

[0100] The trial selection conditions are conditions for a specialist such as a doctor to select a clinical trial. For example, the trial selection conditions are that the number of acquired clinical trial information is equal to or greater than a threshold value. For example, the trial selection conditions are that a flag indicating that clinical trial information is to be selected is stored in the storage unit 11. For example, the trial selection conditions are that a flag indicating that clinical trial information is to be selected is stored in the storage unit 11 in association with the user identifier of the user who has transmitted the genetic testing data.

[0101] (Step S409) The clinical trial output unit 142 acquires and outputs one or more pieces of clinical trial information.

[0102] (Step S410) The test selection receiving unit 123 determines whether or not test selection information has been received. If test selection information has been received, the process proceeds to step S411, and if not, the process returns to step S410.

[0103] (Step S411) The subject information acquisition unit 132 acquires clinical trial information, etc. of the selected clinical trial identified by the trial selection information. The clinical trial information, etc., is, for example, one or more pieces of clinical trial information, the number of first trials for each gene, and the number of second trials for each cancer type.

[0104] (Step S412) The attribute value receiving unit 124 determines whether or not the medical record information has been received. If the medical record information has been received, the process proceeds to step S413, and if the medical record information has not been received, the process returns to step S412.

[0105] (Step S413) The determination unit 133 performs participation determination processing. An example of the participation determination processing will be described with reference to the flowchart of FIG.

[0106] (Step S414) The determination result output unit 143 outputs the participation information acquired in step S413. The process returns to step S401.

[0107] (Step S415) The processing unit 13 determines whether or not the clinical trial information collection conditions are met. If the clinical trial information collection conditions are met, the process proceeds to step S416, and if not, the process returns to step S401.

[0108] The clinical trial information collection condition is a condition for collecting clinical trial information, such as a predetermined time (for example, 12:00 every day).

[0109] (Step S416) The accumulation unit 136 performs processing to collect clinical trial information. Return to step S401. An example of such information collection processing will be described with reference to the flowchart in FIG.

[0110] In the flowchart of FIG. 4, the process ends when the power is turned off or an interrupt occurs to end the process.

[0111] Next, an example of the test search process in step S407 will be described with reference to the flowchart in FIG.

[0112] (Step S501) The test search unit 131 assigns 1 to a counter i.

[0113] (Step S502) The test search unit 131 determines whether the gene identifier of the i-th abnormal gene is present among the acquired gene identifiers of the abnormal genes. If the gene identifier of the i-th abnormal gene is present, the process proceeds to step S503; if not, the process proceeds to step S511.

[0114] (Step S503) The test search unit 131 acquires the gene identifier of the i-th abnormal gene.

[0115] (Step S504) The test search unit 131 assigns 1 to the counter j.

[0116] (Step S505) The trial search unit 131 determines whether the j-th clinical trial information exists in the clinical trial management unit 111. If the j-th clinical trial information exists, the process proceeds to step S506; if not, the process proceeds to step S510.

[0117] (Step S506) The trial search unit 131 determines whether the j-th clinical trial information of the clinical trial management unit 111 has the i-th gene identifier acquired in step S503. If it has the gene identifier, the process proceeds to step S507; if it does not have the gene identifier, the process proceeds to step S509.

[0118] (Step S507) The trial search unit 131 determines whether the j-th clinical trial information satisfies other conditions. If it does, the process proceeds to step S508, and if it does not, the process proceeds to step S509.

[0119] The other conditions are, for example, period conditions, which are conditions related to the recruitment period for participants. For example, the period conditions are "today is not past the recruitment period" or "today is more than a threshold before the last day of the recruitment period." Other conditions are not required. Clinical trial information usually includes information specifying the recruitment period for participants.

[0120] (Step S508) The trial search unit 131 acquires the j-th clinical trial information and temporarily stores it in a buffer (not shown).

[0121] (Step S509) The test retrieval unit 131 increments the counter j by 1. The process returns to step S505.

[0122] (Step S510) The test retrieval unit 131 increments the counter i by 1. The process returns to step S502.

[0123] (Step S511) The first trial number acquisition unit 134 acquires the first trial number, which is the number of clinical trial information for each gene (each gene identifier), using the gene identifiers contained in one or more pieces of clinical trial information temporarily stored in a buffer not shown in step S508.

[0124] (Step S512) The second trial number acquisition unit 135 acquires the second trial number, which is the number of clinical trial information for each cancer type (each cancer identifier), using the target cancer type contained in one or more pieces of clinical trial information temporarily stored in a buffer (not shown) in step S508, and returns to the upper-level processing.

[0125] Next, an example of the participation determination process in step S413 will be described with reference to the flowchart of FIG.

[0126] (Step S601) The judgment unit 133 acquires one or more patient attribute values ​​contained in the accepted medical record information. Usually, the patient attribute values ​​to be acquired are predetermined. The acquired patient attribute values ​​include, for example, age, sex, whether or not the patient is pregnant, disease name, and treatment history. The acquired patient attribute values ​​are, for example, part of the medical record information.

[0127] (Step S602) The determination unit 133 acquires a participation determination prompt from the prompt management unit 112.

[0128] (Step S603) The determination unit 133 assigns 1 to the counter i.

[0129] (Step S604) The judgment unit 133 judges whether the i-th clinical trial information exists. If the i-th clinical trial information exists, the process proceeds to step S605, and if not, the process returns to the upper processing.

[0130] (Step S605) The judgment unit 133 acquires a clinical trial identifier that identifies the i-th clinical trial information.

[0131] (Step S606) The judgment unit 133 acquires subject information paired with the clinical trial identifier from the external database 4 or the clinical trial management unit 111. The subject information usually includes inclusion criteria information of the clinical trial information and exclusion criteria information of the clinical trial information.

[0132] (Step S607) The determination unit 133 substitutes one or more patient attribute values ​​and target information into the variables of the participation determination prompt, and configures the participation determination prompt to be given to the generation AI.

[0133] (Step S608) The judgment unit 133 provides the participation determination prompt constructed in step S607 to the generation AI. Note that here, the judgment unit 133 executes, for example, an API that uses the participation determination prompt as an argument. Note that this API is an API that provides a prompt to the generation AI and obtains an answer.

[0134] (Step S609) The determination unit 133 determines whether or not an answer has been acquired from the generation AI. If an answer has been acquired, the process proceeds to step S610, and if not, the process returns to step S609.

[0135] (Step S610) The determination unit 133 acquires the i-th participation information from the response acquired in step S609, and temporarily stores it in a buffer (not shown).

[0136] (Step S611) The determination unit 133 increments the counter i by 1. The process returns to step S604.

[0137] Next, an example of the information collection process in step S416 will be described with reference to the flowchart in FIG.

[0138] (Step S701) The storage unit 136 accesses the external database 4 (starts communication).

[0139] (Step S702) The accumulation unit 136 assigns 1 to the counter i.

[0140] (Step S703) The accumulation unit 136 determines whether the i-th clinical trial detailed information exists in the external database 4. If the i-th clinical trial detailed information exists, the process proceeds to step S704, and if not, the process returns to the upper processing.

[0141] (Step S704) The accumulation unit 136 acquires the i-th clinical trial detailed information from the external database 4.

[0142] (Step S705) The accumulation unit 136 acquires the clinical trial information from the i-th clinical trial detailed information. Note that the clinical trial information is part of the clinical trial detailed information.

[0143] (Step S706) The accumulation unit 136 determines whether or not the clinical trial information acquired in step S705 exists in the clinical trial management unit 111. If it exists in the clinical trial management unit 111, the process proceeds to step S707, and if it does not exist, the process proceeds to step S708.

[0144] (Step S707) The storage unit 136 determines whether the update date of the i-th clinical trial detailed information is newer than when the clinical trial information existing in the clinical trial management unit 111 was stored. If it is newer, the process proceeds to step S708, and if it is not newer, the process proceeds to step S709.

[0145] (Step S708) The accumulation unit 136 accumulates the clinical trial information acquired in step S705 in the clinical trial management unit 111.

[0146] (Step S709) The accumulation unit 136 increments the counter i by 1. The process returns to step S703.

[0147] Next, an example of the operation of the terminal device 2 will be described with reference to the flowchart of FIG.

[0148] (Step S801) The terminal reception unit 22 determines whether or not genetic test data has been received. If genetic test data has been received, the process proceeds to step S802, and if not, the process proceeds to step S805.

[0149] (Step S802) The device processing unit 23 acquires the user identifier from the device storage unit 21. The terminal transmitting unit 24 transmits the genetic test data to the information processing device 1 in combination with the user identifier.

[0150] (Step S803) In response to the transmission of the genetic test data, the terminal receiving unit 25 determines whether or not one or more pieces of abnormal genetic information have been received from the information processing device 1. If abnormal genetic information has been received, the process proceeds to step S804; if not, the process returns to step S803.

[0151] (Step S804) The terminal processing unit 23 composes a list of abnormal gene information to be output. The terminal output unit 26 outputs the list of abnormal gene information. Return to step S801.

[0152] (Step S805) The terminal reception unit 22 determines whether or not gene selection information has been received. If gene selection information has been received, the process proceeds to step S806, and if not, the process proceeds to step S809.

[0153] (Step S806) The device processing unit 23 acquires the user identifier from the device storage unit 21. The terminal transmitting unit 24 transmits the gene selection information to the information processing device 1 in combination with the user identifier.

[0154] (Step S807) In response to the transmission of the gene selection information, the terminal receiving unit 25 determines whether or not one or more pieces of clinical trial information have been received from the information processing device 1. If clinical trial information has been received, the process proceeds to step S808; if not, the process returns to step S807.

[0155] (Step S808) The terminal processing unit 23 composes a list of clinical trial information to be output. The terminal output unit 26 outputs the list of clinical trial information. Return to step S801.

[0156] (Step S809) The terminal reception unit 22 determines whether or not test selection information has been received. If test selection information has been received, the process proceeds to step S810, and if not, the process proceeds to step S815.

[0157] (Step S810) The device processing unit 23 acquires the user identifier from the device storage unit 21. The terminal transmitting unit 24 transmits the test selection information to the information processing device 1 in combination with the user identifier.

[0158] (Step S811) The terminal processing unit 23 determines whether or not medical chart information exists in a buffer (not shown). If medical chart information exists, the process proceeds to step S812, and if not, the process proceeds to step S815.

[0159] (Step S812) The device processing unit 23 acquires the user identifier from the device storage unit 21. The terminal transmitting unit 24 transmits the medical record information to the information processing device 1 in combination with the user identifier.

[0160] (Step S813) In response to the transmission of the trial selection information, etc., the terminal receiving unit 25 determines whether or not participation information for one or more clinical trials has been received from the information processing device 1. If participation information has been received, proceed to step S814; if not, return to step S813.

[0161] (Step S814) The terminal processing unit 23 composes the participation information to be output for each clinical trial. The terminal output unit 26 outputs the participation information. Return to step S801.

[0162] (Step S815) The terminal reception unit 22 determines whether or not the medical record information has been received. If the medical record information has been received, the process proceeds to step S816, and if not, the process returns to step S801.

[0163] (Step S816) The terminal processing unit 23 temporarily stores the medical record information in a buffer (not shown).

[0164] (Step S817) The terminal processing unit 23 determines whether or not the test selection information has been transmitted to the information processing device 1. If it has been transmitted, the process proceeds to step S812, and if it has not been transmitted, the process returns to step S801.

[0165] In the flowchart of FIG. 8, the process ends when the power is turned off or an interrupt occurs to end the process.

[0166] A specific example of the operation of information system A in this embodiment will be described below. The external database 4 is the official Japanese clinical trial registration database (Japan Registry of Clinical Trials: jRCT) operated by the Ministry of Health, Labor and Welfare. Detailed clinical trial information in the external database 4 is, for example, the information shown in FIGS. 9 and 10.

[0167] The storage unit 136 of the information processing device 1 acquires clinical trial information from the detailed clinical trial information of each of the many clinical trial information stored in the external database 4, and stores the many pieces of clinical trial information in the clinical trial management unit 111. The clinical trial management unit 111 is, for example, a relational database. The clinical trial information stored in the clinical trial management unit 111 is records in the relational database. Each record includes a gene identifier (here, a gene name), one or more target cancer types, inclusion criteria information, and exclusion criteria information.

[0168] In this situation, it is assumed that doctor D inputs genetic test data of one patient P into terminal device 2. Next, terminal device 2 accepts the genetic test data and transmits it to information processing device 1.

[0169] The data receiving unit 121 of the information processing device 1 receives genetic testing data. The genetic testing data contains, for example, a large number of pieces of genetic information. Each piece of genetic information is the test result for one gene. Next, the abnormal gene acquisition unit 130 acquires 15 pieces of abnormal genetic information from the received genetic testing data. The abnormal genetic information is, for example, information associated with information indicating "abnormality" among the genetic information that is the test result for the gene contained in the genetic testing data. Next, the abnormal gene output unit 141 transmits a list including the 15 pieces of abnormal genetic information to Doctor D's terminal device 2.

[0170] Next, the terminal device 2 receives and outputs the list including the 15 pieces of abnormal gene information. An example of such a list is shown in Figure 11. In Figure 11, 1101 is information on the 14 abnormal genes of patient P.

[0171] Next, it is assumed that doctor D selects four genes from the 14 abnormal genes that should be included in a clinical trial from an expert's perspective, taking into consideration the condition of patient P. Here, the abnormal gene information of the selected four genes is 1102 in FIG. 11. Next, terminal device 2 receives gene selection information including gene identifiers of the four genes and transmits the gene selection information to information processing device 1.

[0172] Next, the gene selection receiving unit 122 of the information processing device 1 receives the gene selection information. Next, the trial search unit 131 performs the trial search process described using the flowchart of FIG. 5 using the gene identifiers of each of the four abnormal genes identified by the gene selection information. The trial search unit 131 then acquires clinical trial information having any of the four gene identifiers from the clinical trial management unit 111. The first trial number acquisition unit 134 calculates the first trial number, which is the number of clinical trial information for each gene, using the gene identifiers included in each of the one or more pieces of clinical trial information determined by the trial search unit 131. The first trial number acquisition unit 134 creates a graph showing the first trial number for each abnormal gene. The second trial number acquisition unit 135 calculates the second trial number, which is the number of clinical trial information for each cancer type, using the target cancer type included in each of the one or more pieces of clinical trial information determined by the trial search unit 131. The second trial number acquisition unit 135 creates a graph showing the second trial number for each cancer type.

[0173] Next, the clinical trial output unit 142 acquires the acquired clinical trial information, etc., and transmits it to the terminal device 2. The clinical trial information, etc., includes the clinical trial information, the number of first trials for each gene, and the number of second trials for each cancer type.

[0174] Next, Doctor D's terminal device 2 receives and outputs the clinical trial information, the number of first trials for each gene, and the number of second trials for each cancer type. An example of such output is shown in FIG. 12. In FIG. 12, a large amount of clinical trial information is shown as 1201. An image of a graph showing the number of first trials for each gene is shown as 1202. An image of a graph showing the number of second trials for each cancer type is shown as 1203.

[0175] Next, suppose that Doctor D looks at the output example in FIG. 12 and selects three pieces of clinical trial information that he or she believes are effective for Patient P (see 1204 in FIG. 12). Then, the terminal device 2 receives the trial selection information having the three clinical trial identifiers. Next, the terminal device 2 transmits the trial selection information to the information processing device 1.

[0176] Also, assume that doctor D inputs the medical record information “Age: 45 years old, Gender: Female, Diagnosis: DLBCL, PS: 0, Treatment history: R-CHOP therapy” into the terminal device 2 (see 1205 in FIG. 12). Next, the terminal device 2 accepts the medical record information and transmits it to the information processing device 1.

[0177] Next, the attribute value receiving unit 124 of the information processing device 1 receives the medical record information. Next, the determination unit 133 performs the participation determination process described using the flowchart in Fig. 6. Note that the participation determination process is performed for the three clinical trials selected in Fig. 12.

[0178] That is, the determination unit 133 acquires one or more patient attribute values ​​"age: 45 years old, sex: female, diagnosis: DLBCL, PS: 0, treatment history: R-CHOP therapy" contained in the accepted medical record information. The determination unit 133 also acquires a participation determination prompt from the prompt management unit 112. The participation determination prompt of the prompt management unit 112 is, for example, as shown in FIG. 13.

[0179] Next, the judgment unit 133 performs the following process for each of the three clinical trials. The judgment unit 133 acquires a clinical trial identifier that identifies the clinical trial information. Next, the judgment unit 133 acquires the inclusion criteria information and exclusion criteria information that are paired with the clinical trial identifier from the external database 4 or the clinical trial management unit 111. Next, the judgment unit 133 assigns the patient attribute values, the inclusion criteria information, and the exclusion criteria information to the variables of the participation decision prompt, and constructs a participation decision prompt to be given to the generation AI. An example of such a participation decision prompt is shown in Figure 14.

[0180] Next, the judgment unit 133 provides a participation decision prompt to the generation AI for each of the three clinical trials. Then, the judgment unit 133 obtains a response from the generation AI. Next, the judgment unit 133 obtains participation information from the obtained response and temporarily stores it in a buffer (not shown). Then, the judgment unit 133 obtains participation information for each of the three clinical trials and temporarily stores it in a buffer (not shown).

[0181] Next, the determination result output unit 143 acquires the three pieces of participation information from a buffer (not shown) and transmits them to the terminal device 2.

[0182] Doctor D's terminal device 2 receives and outputs the three pieces of participation information. An example of such output is shown in Figure 15. 1501 in Figure 15 shows the three pieces of participation information. In 1501 in Figure 15, the participation information includes a clinical trial identifier, participation availability information, and reason information.

[0183] As described above, according to this embodiment, patients can easily find clinical trials in which they can participate. This makes it easier for cancer patients, for example, to participate in clinical trials. In particular, participation in clinical trials by cancer patients for whom standard treatments have not been effective can help save their lives.

[0184] Furthermore, according to this embodiment, it is possible to easily find an appropriate clinical trial from among clinical trials in which patients can participate and which have been selected based on the knowledge of experts such as doctors.

[0185] Furthermore, according to this embodiment, it is possible to more easily find clinical trials in which patients can participate and which target abnormal genes selected by experts such as doctors.

[0186] Furthermore, according to this embodiment, it becomes easier to select a clinical trial for which it is determined whether or not one can participate.

[0187] Furthermore, according to this embodiment, a database for managing clinical trial information can be automatically constructed.

[0188] The processing in this embodiment may be realized by software. This software may be distributed by software download or the like. This software may also be recorded on a recording medium such as a CD-ROM and distributed. This also applies to the other embodiments in this specification. The software that realizes the information processing device 1 in this embodiment is the following program. In other words, this program causes a computer to function as: a data accepting unit that accepts genetic testing data, which is test data for a patient's genes, information having a genetic identifier, and test data including one or more abnormal gene information pieces that are information on abnormal genes; a trial search unit that determines one or more clinical trial information pieces having genetic identifiers of abnormal genes identified by the one or more abnormal gene information pieces contained in the genetic testing data from a clinical trial management unit that stores one or more clinical trial information pieces that correspond to the trial identifiers and have genetic identifiers and target cancer types; an attribute value accepting unit that accepts one or more patient attribute values ​​that are attribute values ​​of the patient; a subject information acquiring unit that acquires subject information including inclusion criteria information and exclusion criteria information for each of the one or more clinical trial information pieces determined by the trial search unit from the clinical trial management unit or an external database that stores detailed clinical trial information including subject information; a judgment unit that acquires participation information regarding whether the patient is eligible to participate in the clinical trial, for each of the one or more clinical trial information pieces determined by the trial search unit, using the subject information and the one or more patient attribute values ​​acquired by the subject information acquiring unit; and a judgment result output unit that outputs the participation information acquired by the judgment unit.

[0189] FIG. 16 is a block diagram of a computer system 300 that executes the programs described in this specification to realize the information processing device 1 and the like according to the various embodiments described above.

[0190] In FIG. 16, a computer system 300 includes a computer 301 including a CD-ROM drive, a keyboard 302, a mouse 303, and a monitor 304.

[0191] 16, computer 301 includes, in addition to CD-ROM drive 3012, MPU 3013, bus 3014 connected to CD-ROM drive 3012 etc., ROM 3015 for storing programs such as a boot-up program, RAM 3016 connected to MPU 3013 for temporarily storing instructions of application programs and providing temporary storage space, and hard disk 3017 for storing application programs, system programs, and data. Although not shown here, computer 301 may further include a network card for providing connection to a LAN.

[0192] A program that causes computer system 300 to execute the functions of information processing device 1 and the like of the above-described embodiment may be stored on CD-ROM 3101, inserted into CD-ROM drive 3012, and then transferred to hard disk 3017. Alternatively, the program may be transmitted to computer 301 via a network (not shown) and stored on hard disk 3017. The program is loaded into RAM 3016 when executed. The program may also be loaded directly from CD-ROM 3101 or the network.

[0193] The program does not necessarily include an operating system (OS) or a third-party program that causes the computer 301 to execute the functions of the information processing device 1 of the above-described embodiment. The program only needs to include instructions that call appropriate functions (modules) in a controlled manner and achieve desired results. How the computer system 300 operates is well known, and a detailed description thereof will be omitted.

[0194] In addition, in the above program, the steps of transmitting information and receiving information do not include processing performed by hardware, such as processing performed by a modem or interface card in the transmission step (processing that can only be performed by hardware).

[0195] The computer that executes the program may be a single computer or a plurality of computers, that is, it may perform centralized processing or distributed processing.

[0196] Furthermore, in each of the above embodiments, it goes without saying that two or more communication means present in one device may be physically realized by one medium.

[0197] Furthermore, in each of the above embodiments, each process may be realized by centralized processing in a single device, or may be realized by distributed processing in a plurality of devices.

[0198] The present invention is not limited to the above-described embodiment, and various modifications are possible, and it goes without saying that these modifications are also included within the scope of the present invention. [Industrial Applicability]

[0199] As described above, the information processing device 1 according to the present invention has the effect of enabling patients to easily find clinical trials in which they can participate, and is useful as a server or the like that supports the work of specialists such as doctors.

Claims

1. a data receiving unit that receives genetic test data, which is test data for a patient's genes, information having a gene identifier, and test data including one or more pieces of abnormal gene information, which is information about abnormal genes; a trial search unit that determines one or more pieces of clinical trial information having gene identifiers of abnormal genes identified by one or more pieces of abnormal gene information contained in the genetic testing data from a clinical trial management unit that stores one or more pieces of clinical trial information that correspond to the trial identifiers and have gene identifiers and target cancer types; an attribute value receiving unit that receives one or more patient attribute values ​​that are attribute values ​​of the patient; a subject information acquisition unit that acquires subject information including inclusion criteria information and exclusion criteria information for each of the one or more clinical trial information items determined by the trial search unit from the clinical trial management unit or an external database that stores detailed clinical trial information including subject information; a determination unit that acquires participation information regarding whether the patient is eligible to participate in a clinical trial, for each of the one or more pieces of clinical trial information determined by the trial search unit, using the subject information acquired by the subject information acquisition unit and the one or more patient attribute values; a determination result output unit that outputs the participation information acquired by the determination unit; a first trial number acquisition unit that acquires a first trial number, which is the number of clinical trial information for each gene, using the gene identifiers included in the one or more pieces of clinical trial information determined by the trial search unit; an information processing device comprising: a clinical trial output unit that outputs the one or more pieces of clinical trial information and the number of first tests for each gene so that they are displayed together.

2. A data receiving unit that receives genetic test data, which is test data for a patient's genes, information having a gene identifier, and test data including one or more pieces of abnormal gene information, which is information about abnormal genes; a trial search unit that determines one or more pieces of clinical trial information having gene identifiers of abnormal genes identified by one or more pieces of abnormal gene information contained in the genetic testing data from a clinical trial management unit that stores one or more pieces of clinical trial information that correspond to the trial identifiers and have gene identifiers and target cancer types; an attribute value receiving unit that receives one or more patient attribute values ​​that are attribute values ​​of the patient; a subject information acquisition unit that acquires subject information including inclusion criteria information and exclusion criteria information for each of the one or more clinical trial information items determined by the trial search unit from the clinical trial management unit or an external database that stores detailed clinical trial information including subject information; a determination unit that acquires participation information regarding whether the patient is eligible to participate in a clinical trial, for each of the one or more pieces of clinical trial information determined by the trial search unit, using the subject information acquired by the subject information acquisition unit and the one or more patient attribute values; a determination result output unit that outputs the participation information acquired by the determination unit; a second trial number acquisition unit that acquires a second trial number, which is the number of clinical trial information for each cancer type, using the target cancer types contained in the one or more pieces of clinical trial information determined by the trial search unit; and a clinical trial output unit that outputs the one or more pieces of clinical trial information and the number of second tests for each gene so that they are displayed together.

3. and a trial selection receiving unit that receives trial selection information indicating a selection of one or more pieces of clinical trial information from the one or more pieces of clinical trial information output by the clinical trial output unit, The target information acquisition unit Acquire, from the external database, subject information including inclusion criterion information and exclusion criterion information for each of the one or more pieces of clinical trial information indicated by the study selection information accepted by the study selection accepting unit; The determination unit An information processing device as described in claim 1 or claim 2, wherein for each of the one or more pieces of clinical trial information indicated by the trial selection information accepted by the trial selection accepting unit, the participation information is acquired using the subject information and the one or more patient attribute values ​​acquired by the subject information acquiring unit.

4. The genetic testing data includes information on one or more abnormal genes, an abnormal gene acquisition unit that acquires one or more pieces of abnormal gene information from the genetic testing data accepted by the data acceptance unit; The test search unit 3. The information processing device according to claim 1, wherein one or more pieces of clinical trial information having gene identifiers of abnormal genes identified by one or more pieces of abnormal gene information among the one or more pieces of abnormal gene information acquired by the abnormal gene acquisition unit are determined.

5. an abnormal gene output unit that outputs the one or more pieces of abnormal gene information acquired by the abnormal gene acquisition unit; a gene selection receiving unit that receives gene selection information indicating selection of one or more pieces of abnormal gene information from the one or more pieces of abnormal gene information output by the abnormal gene output unit, The test search unit 5. The information processing device according to claim 4, wherein one or more pieces of clinical trial information having a gene identifier of the abnormal gene specified by the gene selection information received by the gene selection receiving unit are determined from the clinical trial management unit.

6. The determination unit An information processing device as described in claim 1 or claim 2, which provides the target information acquired by the target information acquisition unit, the one or more patient attribute values, and a participation decision prompt which is a command statement that outputs participation information regarding whether the patient is able to participate in a clinical trial to a generation AI, and acquires the participation information for each of the one or more clinical trial information from the generation AI.

7. The attribute value receiving unit accepting medical record information including the one or more patient attribute values; 3. The information processing device according to claim 1, wherein the medical record information includes age, sex, disease name, and medical history.

8. 3. The information processing device according to claim 1, further comprising a storage unit that acquires clinical trial information from the clinical trial detailed information for each of one or more clinical trial detailed information from an external database in which one or more clinical trial detailed information including subject information is stored, and stores the acquired clinical trial information in the clinical trial management unit.

9. 3. An information processing method for causing a computer to execute all of the processes executed by the information processing device according to claim 1.

10. Computer, A program for causing the information processing device according to any one of claims 1 to 2 to function.

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