An automated evaluation system for the quality assessment of SUSAR reports in drug clinical trials

Abstract

The present invention relates to the technical field of data analysis, and in particular to an automated evaluation system for evaluating the quality of a drug clinical trial SUSAR report, comprising: a control terminal, which is a main control terminal of the system and is used to issue an execution command; an upload module, which is used to upload the drug clinical trial SUSAR report of a drug trial target in real time; and an analysis module, which is used to traverse the drug clinical trial SUSAR report of the drug trial target uploaded in the upload module and analyze the degree of influence of the drug on the physical state of the drug trial target. The present invention can bring data management effects to the drug clinical trial SUSAR report by identifying the source of data, so that data can be stably stored, which is more convenient in the later call stage of the drug clinical trial SUSAR report, and at the same time further sets the analysis logic to analyze the degree of influence of the drug on the physical state of the drug trial target, and further combines the information in the drug clinical trial SUSAR report to evaluate the effectiveness and safety of the drug respectively.

Description

Technical Field

[0001] The present invention relates to the technical field of data analysis, and in particular to an automated evaluation system for evaluating the quality of SUSAR reports of drug clinical trials. Background Art

[0002] The safety of a trial drug in a clinical trial is one of the key factors that determine whether it can be marketed, and suspected and unexpected serious adverse reactions are the most noteworthy safety data for trial drugs. High-quality SUSAR reports can help all parties further understand and evaluate the safety of trial drugs.

[0003] However, there are currently problems with SUSAR reports, such as excessive numbers of SUSAR reports and poor report quality, which need to be addressed, directly affecting the safety assessment and supervision of experimental drugs.

[0004] To this end, we proposed an automated evaluation system for the quality assessment of SUSAR reports of drug clinical trials. Summary of the invention

[0005] In view of the above shortcomings of the prior art, the present invention provides an automated evaluation system for the quality evaluation of SUSAR reports of drug clinical trials, which solves the technical problems raised in the above background technology.

[0006] To achieve the above objectives, the present invention is implemented through the following technical solutions:

[0007] An automated evaluation system for the quality evaluation of SUSAR reports of drug clinical trials, including:

[0008] The control terminal is the main control end of the system and is used to issue execution commands; the upload module is used to upload the SUSAR report of the drug clinical trial of the drug test target in real time; the analysis module is used to traverse the SUSAR report of the drug clinical trial of the drug test target uploaded in the upload module, and analyze the degree of influence of the drug on the physical state of the drug test target; the evaluation module is used to receive the analysis results of the degree of influence of the drug on the physical state of the drug test target in the analysis module, and evaluate the effectiveness and safety of the drug used by the drug test target based on the analysis results and the SUSAR report of the drug clinical trial of the drug test target; the recording module is used to record the effectiveness and safety evaluation results of the drug used by the drug test target in the evaluation module; the feedback module is used to obtain the effectiveness and safety evaluation results of the drug used by the drug test target recorded in the recording module, and feedback to the system end user.

[0009] Furthermore, the upload module is provided with submodules at the lower level, including:

[0010] A marking unit, used to mark the drug clinical trial SUSAR report of the drug trial target uploaded in real time in the upload module, so as to distinguish different drug trial targets from which the drug clinical trial SUSAR report comes;

[0011] A storage unit, used for receiving a drug clinical trial SUSAR report of a drug test target uploaded in an upload module with a distinguishing mark, and distinguishing and storing the drug clinical trial SUSAR report based on the distinguishing mark of the drug clinical trial SUSAR report;

[0012] Among them, the distinguishing mark for the SUSAR report of the drug clinical trial in the marking unit can be any one of a digital serial number, a drug target name, a code, or a drug target observation area.

[0013] Furthermore, the data types in the drug clinical trial SUSAR report of the drug trial target include: drug usage time, dosage, usage method, and physical state parameters. The storage unit distinguishes and stores the drug clinical trial SUSAR report based on the distinguishing marks of the drug clinical trial SUSAR report, and further distinguishes and stores the distinguished drug clinical trial SUSAR report based on the data types in the drug clinical trial SUSAR report.

[0014] Furthermore, in the initial operation phase of the analysis module, the initial physical state parameters of the drug test target and the target physical state parameters of the drug test target are synchronously uploaded. When the analysis module analyzes the degree of influence of the drug on the physical state of the drug test target, the analysis is performed based on the physical state parameters of the drug test target recorded in the SUSAR report of the drug clinical trial of the drug test target. The source of the analysis parameters is the SUSAR report of the drug clinical trial stored in the storage unit. The analysis logic of the degree of influence of the drug on the physical state of the drug test target in the analysis module is expressed as follows:

[0015]

[0016] Where: k is the value of the degree of influence of the drug on the physical state of the drug test target; n is the set of physical state parameters of the drug test target; i init is the initial value of the target body state parameter of the i-th group of drug testing; i new is the latest physical status parameter of the target drug in group i recorded in the SUSAR report of the clinical trial of the target drug; ω i is the weight of the target physical state parameter of the i-th group of experiments;

[0017] Among them, the larger the expression value k of the degree of influence of the drug on the physical state of the drug trial target, the greater the degree of influence of the drug on the physical state of the drug trial target, and vice versa, the smaller the degree of influence of the drug on the physical state of the drug trial target. The set n of physical state parameters of the drug trial target includes: weight, body temperature, heart rate, blood pressure, blood routine, liver function indicators, blood lipids and blood sugar, immunoglobulins, thyroid function indicators, fat-to-muscle ratio, and cardiopulmonary function indicators.

[0018] Furthermore, the weights of the test target's physical state parameters are manually set by the system end user, the weights of the test target's physical state parameters are not equal and are greater than zero, and The value of the weight of the test target body state parameter follows the following rules: the higher the correlation between the test target body state parameter and the test target body and organs, the greater the weight of the test target body state parameter; conversely, the smaller the weight of the test target body state parameter.

[0019] Furthermore, the analysis module is internally provided with submodules, including:

[0020] A visualization unit is used to construct a numerical axis for representing the physical state parameters of the drug trial target, and to represent the initial physical state parameters of the drug trial target, the target physical state parameters of the drug trial target, and the physical state parameters in the SUSAR report of the drug clinical trial uploaded by the upload module on the constructed numerical axis;

[0021] Among them, the visualization unit is constructed with number axes equal to the number of drug target physical state parameters in the drug target physical state parameter set n, each group of number axes corresponds to a group of drug target physical state parameters, and the unit length of each group of number axes is set using the corresponding weight of the drug target physical state parameter.

[0022] Furthermore, when evaluating the effectiveness and safety of the drug used by the drug trial target in the evaluation module, the content of the drug clinical trial SUSAR report of the drug trial target used is the drug use time, dosage, and method of use in the drug clinical trial SUSAR report of the drug trial target. The effectiveness evaluation logic of the drug used by the drug trial target is expressed as:

[0023]

[0024] Where: f is the effectiveness performance value of the drug used by the drug trial target; m is the total amount of the drug trial target physical status parameters updated in the SUSAR report of the drug clinical trial; s j The overall graphic size of the target physical state parameter side of the drug target on the number axis corresponding to the target physical state parameter of the drug target when the drug target physical state parameter is updated for the jth time in the SUSAR report of the drug clinical trial; s j+1When the drug clinical trial target physical state parameter is updated for the j+1th time in the SUSAR report, the overall graphic size of the target physical state parameter side of the drug target on the number axis corresponding to the drug target physical state parameter; t j The SUSAR report of the drug clinical trial is the time when the drug target last took the drug during the jth update of the physical status parameters of the drug target; t j+1 The SUSAR report of the drug clinical trial is the last medication time of the drug target at the j+1th update of the drug target's physical status parameters; g j The SUSAR report of the drug clinical trial is the last dosage of the drug target at the jth update of the drug target's physical condition parameters; g j+1 The last dosage of the drug target during the j+1th update of the drug target's physical status parameters in the SUSAR report of the drug clinical trial;

[0025] Among them, g j Always greater than g j+1 The larger the effectiveness performance value f of the drug used by the drug trial target is, the better the effectiveness of the drug used by the drug trial target is. Conversely, the smaller the effectiveness of the drug used by the drug trial target is, the worse the effectiveness of the drug used by the drug trial target is.

[0026] Furthermore, the number axes representing the physical state parameters of the drug test target are arranged vertically in a grid shape, and the spacing between each group of adjacent number axes is equal. The endpoints of the upper and lower groups of number axes in the number axes arranged vertically in a grid shape are adjacent to each other and connected to form a closed figure. The points on each number axis representing the physical state parameters of the drug test target are adjacent to each other and connected to form a group of line segments composed of several groups of line segments connected to each other. The closed figure is segmented based on the composed line segments, and two groups of figures are obtained, which are recorded as: the overall figure on the target physical state parameter side of the drug test target and the overall figure on the initial physical state parameter side of the drug test target.

[0027] Furthermore, the safety of the drug use by the drug trial target in the evaluation module is determined based on the overall graph on the target body state parameter side of the drug trial target obtained by dividing the line segments on the number axis representing the body state parameters of the drug trial target arranged vertically in a grid shape. The size of the overall graph on the target body state parameter side of the drug trial target gradually decreases, indicating that the safety of the drug use by the drug trial target is higher, and vice versa, indicating that the safety of the drug use by the drug trial target is lower.

[0028] Furthermore, the control terminal is interactively connected to an upload module via a local area network, the upload module is interactively connected to a marking unit and a storage unit via a local area network, the upload module is interactively connected to an analysis module via a local area network, the analysis module is interactively connected to the storage unit via a local area network, the analysis module is electrically connected to a visualization unit via a medium, the analysis module is interactively connected to an evaluation module, a recording module and a feedback module via a local area network, and the evaluation module is interactively connected to the visualization unit via a local area network.

[0029] Compared with the known public technology, the technical solution provided by the present invention has the following beneficial effects:

[0030] The present invention provides an automated evaluation system for the quality evaluation of a drug clinical trial SUSAR report. During operation, the system can bring data management effects to the drug clinical trial SUSAR report by identifying data sources, so that data can be stably stored, which is more convenient in the later call stage of the drug clinical trial SUSAR report. At the same time, the analysis logic is further set to analyze the degree of influence of the drug on the physical state of the drug trial target, and further combine the information in the drug clinical trial SUSAR report to evaluate the effectiveness and safety of the drug separately, thereby realizing automated evaluation of drugs based on the drug clinical trial SUSAR report and improving the efficiency of the drug research and development process. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the prior art descriptions are briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention, and for ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work.

[0032] Figure 1 A schematic diagram of the structure of an automated evaluation system for the quality evaluation of SUSAR reports of drug clinical trials;

[0033] Figure 2 It is a structural schematic diagram of the system derivative system in the present invention;

[0034] Figure 3 For the present invention Figure 3 Mind map of each functional module of the system;

[0035] Figure 4 is an example diagram of a number axis representing a parameter of a drug test target's physical state in the present invention;

[0036] The numbers in the figure represent: 1. control terminal; 2. upload module; 21. marking unit; 22. storage unit; 3. analysis module; 31. visualization unit; 4. evaluation module; 5. recording module; 6. feedback module. DETAILED DESCRIPTION

[0037] In order to make the purpose, technical solution and advantages of the embodiments of the present invention clearer, the technical solution in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0038] The present invention will be further described below in conjunction with the embodiments.

[0039] Embodiment 1:

[0040] This embodiment provides an automated evaluation system for evaluating the quality of SUSAR reports of drug clinical trials, such as Figure 1 As shown, including:

[0041] Control terminal 1 is the main control terminal of the system and is used to issue execution commands;

[0042] Upload module 2, used to upload the drug clinical trial SUSAR report of the drug trial target in real time;

[0043] The upload module 2 is provided with submodules at the lower level, including:

[0044] The marking unit 21 is used to mark the drug clinical trial SUSAR report of the drug trial target uploaded in real time by the uploading module 2, so as to distinguish different drug trial targets from which the drug clinical trial SUSAR report is sourced;

[0045] The storage unit 22 is used to receive the drug clinical trial SUSAR report of the drug test target uploaded by the uploading module 2 with a distinguishing mark, and distinguish and store the drug clinical trial SUSAR report based on the distinguishing mark of the drug clinical trial SUSAR report;

[0046] The distinguishing mark of the drug clinical trial SUSAR report in the marking unit 21 may be any one of a digital serial number, a drug target name, a code, or a drug target observation area;

[0047] Analysis module 3, used to traverse the SUSAR report of the clinical trial of the test target drug uploaded in upload module 2, and analyze the degree of influence of the drug on the physical condition of the test target;

[0048] The analysis module 3 is internally provided with submodules, including:

[0049] The visualization unit 31 is used to construct a numerical axis representing the physical state parameters of the drug test target, and represent the initial physical state parameters of the drug test target, the target physical state parameters of the drug test target, and the physical state parameters in the drug clinical trial SUSAR report uploaded by the uploading module 2 on the constructed numerical axis;

[0050] The visualization unit 31 is constructed with number axes equal to the number of the drug test target physical state parameters in the drug test target physical state parameter set n, each set of number axes corresponds to a set of drug test target physical state parameters, and the unit length of each set of number axes is set by the weight corresponding to the drug test target physical state parameter;

[0051] Evaluation module 4 is used to receive the analysis result of the degree of influence of the drug on the physical condition of the drug test target in the analysis module 3, and evaluate the effectiveness and safety of the drug used by the drug test target based on the analysis result and the drug clinical trial SUSAR report of the drug test target;

[0052] Recording module 5, used to record the effectiveness and safety evaluation results of the drug used by the drug trial target in evaluation module 4;

[0053] Feedback module 6, used to obtain the effectiveness and safety evaluation results of the drug used by the drug trial target recorded in the recording module 5, and provide feedback to the system end user;

[0054] The control terminal 1 is interactively connected to the upload module 2 through the local area network, the upload module 2 is interactively connected to the marking unit 21 and the storage unit 22 through the local area network, the upload module 2 is interactively connected to the analysis module 3 through the local area network, the analysis module 3 is interactively connected to the storage unit 22 through the local area network, the analysis module 3 is electrically connected to the visualization unit 31 through a medium, the analysis module 3 is interactively connected to the evaluation module 4, the recording module 5 and the feedback module 6 through the local area network, and the evaluation module 4 is interactively connected to the visualization unit 31 through the local area network.

[0055] In this embodiment, the control terminal 1 controls the upload module 2 to run the uploaded drug clinical trial SUSAR report of the drug test target, the marking unit 21 marks the drug clinical trial SUSAR report of the drug test target uploaded in real time in the upload module 2 to distinguish different drug test targets from which the drug clinical trial SUSAR report comes, the storage unit 22 synchronously receives the drug clinical trial SUSAR report of the drug test target uploaded in the upload module 2 with the distinguishing mark, and distinguishes and stores the drug clinical trial SUSAR report based on the distinguishing mark of the drug clinical trial SUSAR report, the analysis module 3 further traverses the drug clinical trial SUSAR report of the drug test target uploaded in the upload module 2, analyzes the degree of influence of the drug on the physical state of the drug test target, and visualizes the single Element 31 synchronously constructs a numerical axis representing the physical state parameters of the drug test target, and represents the initial physical state parameters of the drug test target, the target physical state parameters of the drug test target, and the physical state parameters in the drug clinical trial SUSAR report uploaded by the upload module 2 on the constructed numerical axis, and then the evaluation module 4 receives the analysis result of the degree of influence of the drug on the physical state of the drug test target in the analysis module 3, and evaluates the effectiveness and safety of the drug used by the drug test target based on the analysis result and the drug clinical trial SUSAR report of the drug test target. The recording module 5 post-records the effectiveness and safety evaluation results of the drug used by the drug test target in the evaluation module 4, and finally obtains the effectiveness and safety evaluation results of the drug used by the drug test target recorded in the recording module 5 through the feedback module 6, and feeds back to the system end user;

[0056] Based on the operation of the system in the above embodiment, an automated evaluation effect is brought to the SUSAR report of drug clinical trials, thereby improving the efficiency of the drug research and development process;

[0057] It should be noted that the effectiveness and safety evaluation results of the drugs used by the drug trial targets fed back by the feedback module 6 to the system-side users are transmitted to the control terminal 1 and placed therein. The system-side users access the system through the local area network and read the effectiveness and safety evaluation results of the drugs used by the drug trial targets in the control terminal 1.

[0058] Further based on Figure 4 As shown, the formation logic of the target body state parameter side overall graph b of the drug trial target and the initial body state parameter side overall graph a of the drug trial target is further shown.

[0059] Based on the system in the above embodiment, a derivative system based on the operation of the system is further provided, such as Figure 2 , Figure 3 As shown:

[0060] The DocRating system is composed of Spring Model View Controller (Spring MVC) + Java Persistence API (JPA) + Thymeleaf + My Structured Query Language (MySQL) + aliyun linux. The system architecture can be divided into the front-end user interface (UI) layer, business logic layer, data layer and operating environment.

[0061] Front-end UI layer: The front-end UI layer is responsible for creating the user interaction interface (WEB UI), which is mainly composed of HyperText Markup Language (HTML), JavaScript and Bootstrap Cascading Style Sheets (Bootstrap CSS).

[0062] (2) Business logic layer: The business logic layer is mainly composed of several modules, including file upload module, data parsing module, classifier management module and scoring module. The implementation of the business logic layer is based on Spring MVC and JPA technology.

[0063] (3) Data layer: The data layer is composed of the MySQL database system. MySQL has high availability and high performance and is suitable for storing and managing large amounts of data.

[0064] (4) Operating environment: The operating environment of the system mainly includes two types: Alibaba Cloud Server and private independent server. Alibaba Cloud Server provides a stable and reliable cloud computing environment that can meet the operation and expansion requirements of the system. Private independent server provides higher autonomy and customization, which is suitable for deployment and management in specific scenarios;

[0065] System architecture design: DocRating system is composed of Spring Model-View-Controller (Spring ModelView Controller, Spring MVC) + Java Persistence API (Java PersistenceAPI, JPA) + Thymeleaf + My Structured Query Language (My Structured Query Language, MySQL) + aliyunlinux. Figure 2As shown, it can be divided into several layers: front-end user interface (UI) layer, business logic layer, data layer and operating environment layer.

[0066] ① Front-end UI layer: The front-end UI layer is responsible for creating the user interaction interface (WEB UI), which is mainly composed of HyperText Markup Language (HTML), JavaScript and Bootstrap Cascading Style Sheets (Bootstrap CSS). HTML is responsible for defining the page structure, JavaScript is responsible for implementing the page interaction logic, and Bootstrap CSS is responsible for the page style and layout. The front-end UI layer interacts with the business logic layer to present system functions and operation interfaces to users, thereby realizing interaction between users and the system.

[0067] ②Business logic layer: The business logic layer is mainly composed of several modules, including file upload module, data analysis module, classifier management module and scoring module, etc. For details, see Figure 2 The business logic layer is implemented based on Spring MVC and JPA technologies. The Spring MVC framework provides a flexible framework structure and good scalability for processing user requests and scheduling business logic. JPA technology is a Java Object-Relational Mapping (Java ORM) technology that simplifies data persistence operations. By combining with the MySQL database system, data persistence and management are achieved.

[0068] ③Data layer: The data layer is composed of the MySQL database system. MySQL has high availability and high performance, and is suitable for storing and managing large amounts of data. JPA technology is combined with the MySQL database system to provide data persistence technology. Through JPA, Java objects can be easily mapped to database tables and operations such as addition, deletion, modification, and query can be performed.

[0069] ④Operation environment: The system's operation environment mainly includes two types: Alibaba Cloud Server and private independent server. Alibaba Cloud Server provides a stable and reliable cloud computing environment that can meet the system's operation and expansion requirements. Private independent servers provide higher autonomy and customization, and are suitable for deployment and management in specific scenarios.

[0070] Functional module design: The DocRating system consists of Web UI, MySQL database, document management module, document identification module, and report rating module;

[0071] ① Web UI: Web UI provides an interface for users to interact with the system. Users can upload files, submit scoring tasks, query and edit data through the browser web page. The design of Web UI makes user operation simple and intuitive, improving the system's ease of use and user experience.

[0072] ②MySQL database: MySQL is a high-performance, open-source relational database. The DocRating system chooses MySQL as a data persistence storage solution. Through the MySQL database, the system can efficiently perform SQL queries, retrieve and manage data, and meet the system's needs for data storage and query.

[0073] ③ File management module: The file management module is responsible for the effective management of files uploaded by users, mainly including two functions: file upload and file retrieval. The file upload function uses Hypertext Transfer Protocol (HTTP) to request to send the files uploaded by users to the Web server in binary format, and supports the parallel upload of multiple files, which improves the system's processing efficiency and user experience.

[0074] ④ Document recognition module: The document recognition module is the core function of the system. Its main task is to extract text from PDF reports and integrate them into custom structured data and store them in the database. The project uses Alibaba Cloud's intelligent document recognition function and the powerful document recognition interface provided by Alibaba Cloud's Optical Character Recognition (OCR) technology to quickly and accurately recognize and process reports, reducing system development time and improving system availability.

[0075] ⑤ Report scoring module: The report scoring module is another core function of the project. Its function is to score the content of the report according to the user-defined scoring criteria. Through the scoring module, users can make quantitative evaluations of the report content and provide reference for subsequent decision-making.

[0076] Data storage method: The system uses relational database as the storage method. The main data tables are source_file, extract_job, extract_result_file, score, etc. Most data tables use file_id as the unique id of the data table. Source_file is used to store the information of the report file, extract_job stores the data extraction tasks submitted by the system, extract_result_file stores the information of the extracted file, and score stores the scores of all reports.

[0077] Data flow path: The data in the system business layer can be divided into three types: file (Byte) data, JavaScript Object Notation (JSON) data, and Java entity. The flow of the three types of data in the system business layer can be summarized as the following processes:

[0078] ① File upload process: Users upload files through the system interface, and the file upload module receives and processes the upload request. After receiving the file, the file upload module stores the file name, file format, file address and other information in the database. After the storage is completed, the file upload module returns a successful upload message to the user.

[0079] ②Data parsing process: The classifier management module is used by users to create report parsing tasks and obtain file data from the database. After obtaining the file data, the classifier management module parses the file through the Alibaba Cloud interface and converts it into JSON data. After the parsing is completed, the classifier management module transmits the JSON data back to the system and hands it over to the classifier for further processing.

[0080] ③ Classifier processing flow: After receiving the JSON data, the classifier classifies and processes the data according to the pre-defined classification rules. After the processing is completed, the classifier converts the results into Java entity data and stores it in the database.

[0081] ④ Scoring process: The scoring module regularly obtains processed Java entity data from the database. After obtaining the data, the scoring module scores the data according to the set scoring rules. After the scoring is completed, the scoring module stores the scoring results in the database and may return them to the user or other modules. Through the above process, the system realizes functions such as batch uploading of files, file search, scoring, and viewing score details. These functions together constitute the core process in the system business layer, ensuring the integrity and accuracy of the data flow and processing process. At the same time, the process also reflects the collaboration and dependency between the various modules in the system, providing a reliable foundation for the operation of the system.

[0082] Embodiment 2:

[0083] In terms of specific implementation, based on Example 1, this example refers to Figure 1 The automated evaluation system for evaluating the quality of SUSAR reports of a drug clinical trial in Example 1 is further described in detail:

[0084] The data types in the SUSAR report of the drug clinical trial of the drug trial target include: drug use time, dosage, method of use, and physical state parameters. The storage unit 22 distinguishes and stores the drug clinical trial SUSAR report based on the distinguishing marks of the drug clinical trial SUSAR report, and further distinguishes and stores the distinguished and stored drug clinical trial SUSAR report based on the data types in the SUSAR report.

[0085] Through the above configuration, the storage management logic of the storage unit 22 for the data in the SUSAR report of the drug clinical trial is further defined.

[0086] like Figure 1 As shown, in the initial operation phase of the analysis module 3, the initial physical state parameters of the drug test target and the target physical state parameters of the drug test target are uploaded synchronously. When the analysis module 3 analyzes the influence of the drug on the physical state of the drug test target, the analysis is based on the physical state parameters of the drug test target recorded in the SUSAR report of the drug clinical trial of the drug test target. The source of the analysis parameters is the SUSAR report of the drug clinical trial stored in the storage unit 22. The analysis logic of the influence of the drug on the physical state of the drug test target in the analysis module 3 is expressed as follows:

[0087]

[0088] Where: k is the value of the degree of influence of the drug on the physical state of the drug test target; n is the set of physical state parameters of the drug test target; i init is the initial value of the target body state parameter of the i-th group of drug testing; i new is the latest physical status parameter of the target drug in group i recorded in the SUSAR report of the clinical trial of the target drug; ω i is the weight of the target physical state parameter of the i-th group of experiments;

[0089] The larger the expression value k of the degree of influence of the drug on the physical state of the drug test target is, the greater the degree of influence of the drug on the physical state of the drug test target is, and vice versa, the smaller the degree of influence of the drug on the physical state of the drug test target is. The physical state parameters of the drug test target in the set n of the physical state parameters of the drug test target include: weight, body temperature, heart rate, blood pressure, blood routine, liver function index, blood lipid and blood sugar, immunoglobulin, thyroid function index, fat-muscle ratio, and cardiopulmonary function index;

[0090] The weights of the test target's physical state parameters are manually set by the system end user. The weights of the test target's physical state parameters are not equal and are greater than zero, and The value of the weight of the test target body state parameter follows the following rules: the higher the correlation between the test target body state parameter and the test target body and organs, the greater the weight of the test target body state parameter; conversely, the smaller the weight of the test target body state parameter.

[0091] By setting the above-mentioned analysis logic of the degree of influence of the drug on the physical state of the drug trial target, the degree of influence of the drug on the physical state of the drug trial target is analyzed and represented in a digital form, providing necessary operation data support for the operation of subsequent modules in the system.

[0092] Embodiment 3:

[0093] In terms of specific implementation, based on Example 1, this example refers to Figure 1 The automated evaluation system for evaluating the quality of SUSAR reports of a drug clinical trial in Example 1 is further described in detail:

[0094] When evaluating the effectiveness and safety of the drug used by the drug trial target in evaluation module 4, the content of the SUSAR report of the drug clinical trial target applied is the drug use time, dosage, and method of use in the SUSAR report of the drug clinical trial target. The effectiveness evaluation logic of the drug used by the drug trial target is expressed as:

[0095]

[0096] Where: f is the effectiveness performance value of the drug used by the drug trial target; m is the total amount of the drug trial target physical status parameters updated in the SUSAR report of the drug clinical trial; s j The overall graphic size of the target physical state parameter side of the drug target on the number axis corresponding to the target physical state parameter of the drug target when the drug target physical state parameter is updated for the jth time in the SUSAR report of the drug clinical trial; s j+1 When the drug clinical trial target physical state parameter is updated for the j+1th time in the SUSAR report, the overall graphic size of the target physical state parameter side of the drug target on the number axis corresponding to the drug target physical state parameter; t j The SUSAR report of the drug clinical trial is the time when the drug target last took the drug during the jth update of the physical status parameters of the drug target; t j+1 The SUSAR report of the drug clinical trial is the last medication time of the drug target at the j+1th update of the drug target's physical status parameters; g j The SUSAR report of the drug clinical trial is the last dosage of the drug target at the jth update of the drug target's physical condition parameters; g j+1 The last dosage of the drug target during the j+1th update of the drug target's physical status parameters in the SUSAR report of the drug clinical trial;

[0097] Among them, g j Always greater than g j+1 , the larger the effectiveness performance value f of the drug used by the drug trial target is, the better the effectiveness of the drug used by the drug trial target is, and vice versa, the worse the effectiveness of the drug used by the drug trial target is;

[0098] The number axes representing the physical state parameters of the drug test target are arranged vertically in a grid shape, and the spacing between each group of adjacent number axes is equal. The endpoints of the upper and lower groups of number axes in the number axes arranged vertically in a grid shape are adjacent to each other and connected to form a closed figure. The points on each number axis representing the physical state parameters of the drug test target are adjacent to each other and connected to form a group of line segments composed of a plurality of groups of line segments connected to each other. The closed figure is segmented based on the formed line segments, and two groups of figures are obtained, which are recorded as: the overall figure on the target physical state parameter side of the drug test target and the overall figure on the initial physical state parameter side of the drug test target.

[0099] The safety of the drug used by the drug trial target in the evaluation module 4 is determined based on the overall graph on the target body state parameter side of the drug trial target obtained by dividing the line segments on the number axis representing the body state parameters of the drug trial target arranged vertically in a grid shape. The size of the overall graph on the target body state parameter side of the drug trial target gradually decreases, indicating that the drug is safer when the drug is used by the drug trial target, and vice versa.

[0100] In this embodiment, by setting the drug effectiveness evaluation logic used by the drug trial target and further setting the operation logic of each module in the system, the system operation is made more stable, ensuring the stable output of the system's drug effectiveness evaluation results.

[0101] In summary, during operation, the system in the above embodiment can bring data management effects to the drug clinical trial SUSAR report by identifying the source of data, so that the data can be stored stably, which is more convenient in the later calling stage of the drug clinical trial SUSAR report. At the same time, the analysis logic is further set to analyze the degree of influence of the drug on the physical condition of the drug trial target, and further combine the information in the drug clinical trial SUSAR report to evaluate the effectiveness and safety of the drug separately, thereby realizing the automated evaluation of drugs based on the drug clinical trial SUSAR report and improving the efficiency of the drug research and development process.

[0102] The above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit the same. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that the technical solutions described in the aforementioned embodiments may still be modified, or some of the technical features may be replaced by equivalents. Such modifications or replacements will not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. An automated evaluation system for the quality evaluation of SUSAR reports of drug clinical trials, characterized in that: include: The control terminal (1) is the main control terminal of the system and is used to issue execution commands; An upload module (2) for uploading the SUSAR report of the drug clinical trial of the drug trial target in real time; The analysis module (3) is used to traverse the SUSAR report of the clinical trial of the test target drug uploaded in the upload module (2) and analyze the degree of influence of the drug on the physical condition of the test target; An evaluation module (4) is used to receive the analysis result of the degree of influence of the drug on the physical condition of the drug test target in the analysis module (3), and evaluate the effectiveness and safety of the drug used by the drug test target based on the analysis result and the SUSAR report of the drug clinical trial of the drug test target; A recording module (5) is used to record the effectiveness and safety evaluation results of the drug used by the test drug target in the evaluation module (4); A feedback module (6) is used to obtain the effectiveness and safety evaluation results of the drug used by the drug trial target recorded in the recording module (5) and provide feedback to the system end user; In the initial operation phase of the analysis module (3), the initial physical state parameters of the drug test target and the target physical state parameters of the drug test target are synchronously uploaded. When the analysis module (3) analyzes the degree of influence of the drug on the physical state of the drug test target, the analysis is performed based on the physical state parameters of the drug test target recorded in the SUSAR report of the drug clinical trial of the drug test target. The source of the analysis parameters is the SUSAR report of the drug clinical trial stored in the storage unit (22). The analysis logic of the degree of influence of the drug on the physical state of the drug test target in the analysis module (3) is expressed as follows: Where: k is the expression value of the degree of influence of the drug on the physical state of the drug test target; n is the set of physical state parameters of the drug test target; iinit is the initial value of the physical state parameters of the i-th group of drug test targets; inew is the latest physical state parameters of the i-th group of drug test targets recorded in the SUSAR report of the clinical trial of the drug test target drug; ωi is the weight of the physical state parameters of the i-th group of drug test targets; The larger the expression value k of the degree of influence of the drug on the physical state of the drug test target is, the greater the degree of influence of the drug on the physical state of the drug test target is, and vice versa, the smaller the degree of influence of the drug on the physical state of the drug test target is. The physical state parameters of the drug test target in the set n of the physical state parameters of the drug test target include: weight, body temperature, heart rate, blood pressure, blood routine, liver function index, blood lipid and blood sugar, immunoglobulin, thyroid function index, fat-muscle ratio, and cardiopulmonary function index; The weights of the test target's physical state parameters are manually set by the system end user. The weights of the test target's physical state parameters are not equal and are greater than zero, and The value of the weight of the test target body state parameter follows the following rules: the higher the correlation between the test target body state parameter and the test target body and organs, the greater the weight of the test target body state parameter; conversely, the smaller the weight of the test target body state parameter.

2. The automated evaluation system for the quality evaluation of SUSAR reports of drug clinical trials according to claim 1, characterized in that: The upload module (2) is provided with submodules at the lower level, including: A marking unit (21) is used to mark the drug clinical trial SUSAR report of the drug trial target uploaded in real time by the uploading module (2) to distinguish different drug trial targets from which the drug clinical trial SUSAR report is sourced; A storage unit (22) is used to receive a drug clinical trial SUSAR report of a drug test target uploaded by the upload module (2) with a distinguishing mark, and to distinguish and store the drug clinical trial SUSAR report based on the distinguishing mark of the drug clinical trial SUSAR report; The distinguishing mark for the SUSAR report of the drug clinical trial in the marking unit (21) may be any one of a digital serial number, a drug target name, a code, or a drug target observation area.

3. The automated evaluation system for the quality evaluation of SUSAR reports of drug clinical trials according to claim 2, characterized in that: The data types in the drug clinical trial SUSAR report of the drug trial target include: drug use time, dosage, method of use, and physical state parameters. The storage unit (22) distinguishes and stores the drug clinical trial SUSAR report based on the distinguishing mark of the drug clinical trial SUSAR report, and further distinguishes and stores the distinguished and stored drug clinical trial SUSAR report based on the data types in the drug clinical trial SUSAR report.

4. The automated evaluation system for the quality evaluation of SUSAR reports of drug clinical trials according to claim 1, characterized in that: The analysis module (3) is internally provided with submodules, including: A visualization unit (31) is used to construct a numerical axis representing the physical state parameters of the drug trial target, and to represent the initial physical state parameters of the drug trial target, the target physical state parameters of the drug trial target, and the physical state parameters in the drug clinical trial SUSAR report uploaded by the upload module (2) on the constructed numerical axis; The visualization unit (31) is constructed with number axes equal to the number of the drug test target physical state parameters in the drug test target physical state parameter set n, each group of number axes corresponds to a group of drug test target physical state parameters, and the unit length of each group of number axes is set using the corresponding weight of the drug test target physical state parameter.

5. The automated evaluation system for the quality evaluation of SUSAR reports of drug clinical trials according to claim 1, characterized in that: When evaluating the effectiveness and safety of the drug used by the drug trial target in the evaluation module (4), the content of the drug trial target's drug clinical trial SUSAR report is the drug trial target's drug clinical trial SUSAR report: drug use time, dosage, and method of use. The effectiveness evaluation logic of the drug used by the drug trial target is expressed as: Where: f is the effectiveness performance value of the drug used by the drug target; m is the total amount of the drug target physical state parameters updated in the drug clinical trial SUSAR report; sj is the overall graphic size on the target physical state parameter side of the drug target on the number axis corresponding to the drug target physical state parameters when the drug clinical trial SUSAR report updates the drug target physical state parameters for the jth time; sj+1 is the overall graphic size on the target physical state parameter side of the drug target on the number axis corresponding to the drug target physical state parameters when the drug clinical trial SUSAR report updates the drug target physical state parameters for the j+1th time; t j is the time when the drug target last took the drug during the jth update of the drug target physical state parameter phase in the SUSAR report of the drug clinical trial; tj+1 is the time when the drug target last took the drug during the j+1th update of the drug target physical state parameter phase in the SUSAR report of the drug clinical trial; g j The SUSAR report of the drug clinical trial is the last dosage of the drug target at the jth update of the drug target's physical condition parameters; g j+1 The last dosage of the drug target during the j+1th update of the drug target's physical status parameters in the SUSAR report of the drug clinical trial; Among them, g j Always greater than g j+1 The larger the effectiveness performance value f of the drug used by the drug trial target is, the better the effectiveness of the drug used by the drug trial target is. Conversely, the smaller the effectiveness of the drug used by the drug trial target is, the worse the effectiveness of the drug used by the drug trial target is.

6. The automated evaluation system for the quality evaluation of SUSAR reports of drug clinical trials according to claim 5, characterized in that: The number axes representing the physical state parameters of the drug test target are arranged vertically in a grid shape, and the spacing between adjacent number axes in each group is equal. The endpoints of the upper and lower groups of number axes in the grid-like vertical arrangement are adjacent to each other and connected to form a closed figure. The points on each number axis representing the physical state parameters of the drug test target are adjacent to each other and connected to form a group of line segments composed of several groups of line segments connected to each other. The closed figure is segmented based on the composed line segments, and two groups of figures are obtained, which are recorded as: the overall figure on the target physical state parameter side of the drug test target and the overall figure on the initial physical state parameter side of the drug test target.

7. The automated evaluation system for the quality evaluation of SUSAR reports of drug clinical trials according to claim 6, characterized in that: The safety of the drug used by the drug trial target in the evaluation module (4) is determined based on the overall graph of the target physical state parameters of the drug trial target obtained by segmenting the line segments on the number axis representing the physical state parameters of the drug trial target arranged vertically in a grid shape. The size of the overall graph of the target physical state parameters of the drug trial target gradually decreases, indicating that the safety of the drug used by the drug trial target is higher, and vice versa, indicating that the safety of the drug used by the drug trial target is lower.

8. The automated evaluation system for the quality evaluation of SUSAR reports of drug clinical trials according to claim 1, characterized in that: The control terminal (1) is interactively connected to an upload module (2) via a local area network; the upload module (2) is interactively connected to a marking unit (21) and a storage unit (22) via a local area network; the upload module (2) is interactively connected to an analysis module (3) via a local area network; the analysis module (3) is interactively connected to the storage unit (22) via a local area network; the analysis module (3) is electrically connected to a visualization unit (31) via a medium; the analysis module (3) is interactively connected to an evaluation module (4), a recording module (5) and a feedback module (6) via a local area network; the evaluation module (4) is interactively connected to the visualization unit (31) via a local area network.

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