Method, apparatus, and media for producing clinical trial reports on clinical trial data.

Abstract

This invention discloses a method, apparatus, and medium for producing clinical trial reports from clinical trial data. The method includes creating a clinical trial report production project corresponding to the clinical trial data to be processed using a clinical trial report production platform, assigning corresponding roles and responsibilities to relevant processors in the clinical trial report production project, including statistical analysts, reviewers, and annotators; the statistical analyst constructs a report template for review based on the clinical trial design and publishes the report template for review; the reviewer reviews the report template for review online and adds online collaborative comments; the statistical analyst updates the report template for review based on the online collaborative comments and obtains a report template awaiting use; the annotator annotates the report template awaiting use; and the clinical trial report production platform constructs a corresponding SAS program based on the annotations and executes the SAS program to obtain a clinical trial report awaiting use. This method efficiently realizes automated production of clinical trial analysis reports.

Description

Technical Field

[0001] The present invention relates to the technical field of pharmaceutical research and development data analysis, and particularly relates to a method, apparatus, and medium for generating a clinical trial report for clinical trial data.

[0002] <Cross-reference to related applications> The present invention is proposed based on a Chinese patent application with an application number of 202410411133.1, an application date of April 8, 2024, and an invention title of a method, apparatus, and medium for generating a clinical trial report for clinical trial data, and claims the priority of the Chinese patent application. Here, the entire content of the Chinese patent application is incorporated herein by reference.

Background Art

[0003] The field of pharmaceutical research and development data analysis is a complex work field spanning multiple disciplines such as medicine, statistics, and computer science. It has developed in China for more than 20 years, and the industrial scale has been on the rise. There are extremely few majors in domestic universities and schools, and composite talents are needed. Moreover, most of the work heavily depends on manual labor, and there is still a shortage of talents. The analysis of pharmaceutical research and development data has very high requirements for quality and very low requirements for fault tolerance. Also, according to industry practice, usually, all calculation results are required to pass the "independent double programming" quality control, that is, two analysts are required to write program operations independently, and moreover, the results of the two must be 100% identical to pass. Therefore, the dependence on the person in charge is very high, and a large amount of working time is required to write program operations and quality control.

[0004] Regarding the submission of clinical trial data, in response to the advent of the electronic submission era, the EU required pharmaceutical factories to submit data in the eCTD (Electronic Common Technical Document) format in 2014, followed by the US FDA's mandatory requirement in 2016. Nearly 20 years of development and upgrading by CDISC (Clinical Data Interchange Standards Consortium) has resulted in the development of multiple modules to support SEND / SDTM / ADaM / Define.xml, the modules used in clinical data standards. Consequently, clinical trial statistical reports are created based on the SAP (Statistical Analysis Plan) attached to these modules. The number of clinical trial reports varies depending on the complexity of the project, ranging from hundreds to thousands. Therefore, adding clinical trials to these modules has become a primary and critical task for the statistical analysis teams of pharmaceutical factories and CROs in responding to submission requests. Thus, how to efficiently automate the production of clinical trial reports has become an urgent technical issue that needs to be resolved. [Overview of the project] [Problems that the invention aims to solve]

[0005] Embodiments of the present invention provide a method, apparatus, and medium for producing clinical trial reports from clinical trial data, in order to solve the technical problem of efficiently automating the production of clinical trial reports. [Means for solving the problem]

[0006] In the first aspect, embodiments of the present invention provide a method for producing clinical trial reports for clinical trial data, comprising: creating a clinical trial report production project corresponding to the clinical trial data to be processed using a clinical trial report production platform; assigning corresponding roles and responsibilities to relevant processors in the clinical trial report production project, including statistical analysts, reviewers, and annotators; the statistical analyst constructs a review-to-be-reviewed report template based on the clinical trial design and publishes the review-to-be-reviewed report template; the reviewer reviews the review-to-be-reviewed report template online and adds online collaborative comments; the statistical analyst updates the review-to-be-reviewed report template based on the online collaborative comments and obtains a pending report template; the annotator annotates the pending report template; and the clinical trial report production platform constructs a corresponding SAS program based on the annotations and executes the SAS program to obtain a pending clinical trial report.

[0007] In one embodiment of the present invention, constructing a review report template based on a clinical trial design includes determining search keywords based on the clinical trial design, reading a report format knowledge base based on the search keywords, determining whether there is a relevant template whose matching degree is greater than a preset threshold, if it is determined that there is a relevant template whose matching degree is greater than a preset threshold, adjusting the relevant template based on the clinical trial design to obtain a review report template, and if it is determined that there is a relevant template whose matching degree is less than a preset threshold, generating an empty template and constructing a review report template based on the clinical trial design.

[0008] In one embodiment of the present invention, the method further includes marking different field portions in a plurality of similar under review report templates or a plurality of pending report templates; confirming one of the report templates among the plurality of under review report templates or a plurality of pending report templates as an operation pending report template and confirming the other report templates as synchronous report templates; and, if the operation pending report template is corrected, triggering the update assembly of the corresponding synchronous report template and completing the update of the corresponding synchronous report template.

[0009] In one embodiment of the present invention, annotating a pending report template includes identifying parameter report fields awaiting annotation from the pending report template, marking annotations in programmatic expression or natural language for the parameter report fields, triggering a logical verification function to perform logical verification on the marked programmatic expression or natural language annotations to determine whether marking annotations in programmatic expression or natural language conforms to writing standards, and, if it is determined that marking annotations in programmatic expression or natural language conforms to writing standards, completing the annotation of the pending report template.

[0010] In one embodiment of the present invention, the clinical trial report production platform constructs a corresponding SAS program based on annotations, which includes the clinical trial report production platform analyzing the annotations using a cross-platform computer programming language and SAS, converting the annotations into SAS core calculation macro programs and parameters corresponding to macro autofill, and obtaining a corresponding SAS program by combining the SAS core calculation macro programs and parameters corresponding to macro autofill.

[0011] In one embodiment of the present invention, the clinical trial report production platform analyzes annotations using a cross-platform computer programming language and SAS, and the method further includes analyzing the clinical trial data to analyze the clinical trial data as variable units of corresponding fill parameters, and combining the annotations and variable units to obtain an ADaM analysis dataset derived explanatory document.

[0012] In one embodiment of the present invention, after executing a SAS program to obtain a pending clinical trial report, the method further includes storing the pending clinical trial report and the SAS results dataset generated by executing the SAS program.

[0013] In one embodiment of the present invention, the method further includes generating and saving a communication log in real time when a reviewer reviews a review target report template and a pending clinical trial report online and adds online collaboration comments.

[0014] In a second aspect, embodiments of the present invention further provide a clinical trial report production device for clinical trial data, comprising at least one processor and a memory communicated with the at least one processor, the memory storing instructions to be executed by the at least one processor, the instructions being executed by the at least one processor, the at least one processor creating a clinical trial report production project corresponding to the clinical trial data to be processed by the clinical trial report production platform, assigning corresponding roles and responsibilities to relevant processors in the clinical trial report production project, of which the relevant processors include a statistical analyst, a reviewer, and an annotator, the statistical analyst constructing a review report template based on the clinical trial design and publishing the review report template, the reviewer reviewing the review report template online and adding online collaboration comments, the statistical analyst updating the review report template based on the online collaboration comments and obtaining a pending report template, the annotator annotating the pending report template, and the clinical trial report production platform constructing a corresponding SAS program based on the annotations and executing the SAS program to obtain a pending clinical trial report.

[0015] In a third aspect, embodiments of the present invention further provide a non-volatile computer storage medium for clinical trial report production for clinical trial data, wherein the computer executable instructions are stored, and the computer executable instructions are configured such that the clinical trial report production platform creates a clinical trial report production project corresponding to the clinical trial data to be processed, assigns corresponding roles and responsibilities to relevant processors in the clinical trial report production project, among which the relevant processors include statistical analysts, reviewers, and annotators; the statistical analyst constructs a review-target report template based on the clinical trial design and publishes the review-target report template; the reviewer reviews the review-target report template online and adds online collaboration comments; the statistical analyst updates the review-target report template based on the online collaboration comments and obtains a pending report template; the annotator annotates the pending report template; and the clinical trial report production platform constructs a corresponding SAS program based on the annotations and executes the SAS program to obtain a pending clinical trial report. [Effects of the Invention]

[0016] The clinical trial report production method, apparatus, and media provided by the embodiments of the present invention have advanced online collaboration capabilities, significantly reduce communication costs during the review and updating process, provide a clear overview of the project status, eliminate the need for repeated communication confirmations, and retain and derive all communication records. The insights used in the present invention, i.e., the novel methods obtained, can resolve discrepancies in understanding between reviewers and programmers. The final clinical trial report must match the format of the report template seen by the reviewer. After compilation by annotation analysis, the present invention simultaneously produces a SAS program and an ADaM analysis dataset-derived explanatory document, breaking away from the conventional process of first writing the dataset explanatory document, generating the dataset, and then creating the clinical trial program, allowing for a more direct start. It clearly defines what is needed for subsequent analysis, what the ADaM dataset analysis does, and the relationship between the two modules is one-to-one, avoiding redundant variables that cannot be used in many backends. It also eliminates the problem of discovering variables intended for use in the clinical trial report after running the SAS program, even if these variables were not previously created in the dataset. The equipment of this invention automatically generates SAS programs instead of traditional manual methods, resulting in higher efficiency, greater control over details (including formatting and layout), a lower risk of rework or revision, reduced redundant work, and guaranteed consistency and quality. By storing pending clinical trial reports and SAS result datasets generated by running SAS programs, this invention enables comparison between different versions of clinical trial reports, precisely locating where changes occurred, displaying results from previous versions, and resolving the problem of misprints. [Brief explanation of the drawing]

[0017] The drawings described herein are used to provide a further understanding of the invention, which constitutes part of the present invention, and the exemplary embodiments and descriptions thereof are used to interpret the invention and do not constitute an unreasonable limitation to the invention. [Figure 1]This is a flowchart of a method for producing a clinical trial report for clinical trial data provided by an embodiment of the present invention. [Figure 2] This is a schematic diagram of the internal structure of a clinical trial report production device for clinical trial data provided by an embodiment of the present invention. [Modes for carrying out the invention]

[0018] To further clarify the object, technical proposal and advantages of the present invention, the technical proposal of the present invention will be clearly and completely described below in relation to specific embodiments of the present invention and corresponding drawings. Obviously, the embodiments described are only some embodiments of the present invention, not all embodiments. All other embodiments obtained by those skilled in the art without creative work based on the embodiments of the present invention are within the scope of the protection of the present invention.

[0019] In simple terms, the most basic task of statistical analysis of data collected under the clinical research scheme is to use SAS (a professional statistical analysis software recommended in the life sciences field, with all calculation modules certified) to generate datasets (SDTM, ADAM) and hundreds of clinical trial reports compliant with the CDISC standards required by regulatory authorities, for the creation and submission of clinical research reports (CSRs).

[0020] Designing the format of clinical trial reports based on SAP and generating statistical analysis reports before submission is a crucial task for statistical analysts, requiring significant personnel and resources from the statistical analysis teams of pharmaceutical factories and CRO companies.

[0021] The following problem exists.

[0022] 1. Complexity of the report: Clinical trial reports often revise the content and format frequently based on different clinical trials or different stages of the trial, contain a large amount of data and statistical analysis results. During the report creation and review process, it may need to occur and be updated many times based on the actual data, and it may be possible to roll back the revised dataset again because the previous dataset is not ready, which complicates the report manuscript creation process and requires the statistical analysis team to invest a lot of time and energy.

[0023] 2. Data quality issues: Data quality is extremely important for the quality and accuracy of clinical trial reports. However, in actual operation, problems such as data errors, omissions, and inconsistencies may slow down the report creation process and may also affect the final result.

[0024] 3. Communication and coordination: The creation of clinical trial reports is related to multiple departments and teams such as data management, statistical analysis, and medical writing, so communication and coordination become important. If inappropriate, the report design may not match the requirements, resources may be overly consumed, and it may affect the quality of the report.

[0025] 4. Time stress: Since clinical research usually has strict time constraints, the statistical analysis team needs to complete the creation of clinical trial reports in a short time, which may lead to overtime work of team members and increase work stress.

[0026] 5. Compliance and quality management: Clinical trial reports are an important part of clinical research reports and need to meet the requirements of relevant laws, regulations, and norms.

[0027] Therefore, the statistical analysis team needs to pay attention to compliance and quality management during report creation to ensure the accuracy and reliability of the report.

[0028] Embodiments of the present invention provide a method, apparatus, and medium for producing clinical trial reports from clinical trial data, and solve the following technical problem of how to efficiently achieve automated production of clinical trial analysis reports.

[0029] The technical proposals presented by embodiments of the present invention will be described in detail below with reference to the attached drawings.

[0030] Figure 1 is a flowchart of the method for producing a clinical trial report for clinical trial data provided by an embodiment of the present invention. As shown in Figure 1, the method for producing a clinical trial report for clinical trial data provided by an embodiment of the present invention specifically includes the following steps.

[0031] S101, the clinical trial report production platform, creates a clinical trial report production project corresponding to the clinical trial data to be processed, and assigns corresponding roles and permissions to the relevant processing personnel of the clinical trial report production project.

[0032] In one embodiment of the present invention, in order to realize a method for producing clinical trial reports for clinical trial data, the user first needs to create a clinical trial report production project corresponding to the clinical trial data to be processed via the clinical trial report production platform. After the application is approved, the relevant processing personnel for the clinical trial report production project are assigned corresponding roles and permissions. Task permissions differ depending on the role, which helps to prevent accidental manipulation of documents by others.

[0033] The personnel responsible for related processing include statistical analysts, reviewers, and commentators.

[0034] S102, the statistical analyst will construct a review report template based on the clinical trial design and publish the review report template.

[0035] In one embodiment of the present invention, a clinical trial report production project is created, and after assigning corresponding roles and responsibilities to the relevant personnel in the clinical trial report production project, the statistical analyst constructs a review report template based on the clinical trial design.

[0036] Based on the clinical trial design, the search keywords are determined, and based on the search keywords, the report format knowledge base is loaded to determine whether there are relevant templates with a matching degree greater than a predetermined threshold. If it is determined that there are relevant templates with a matching degree greater than the predetermined threshold, the relevant templates are adjusted based on the clinical trial design to obtain the report template for review. If it is determined that there are relevant templates with a matching degree less than the predetermined threshold, an empty template is generated, and the report template for review is constructed based on the clinical trial design.

[0037] According to a novel method readily apparent at a glance, all characters and formatting on this review report template, including titles, footnotes, column titles, display characters for each paragraph, blank lines between paragraphs, and decimal point presentation, are parsed using a cross-platform computer programming language and SAS, and ultimately fully presented in the final clinical trial report. This platform can also derive other clinical trial report formats (Word, PDF, etc.) to meet different needs, such as project group registration.

[0038] Furthermore, the statistical analysts will publish a template for the report to be reviewed.

[0039] S103, the reviewer reviews the report template under review online and adds online collaborative comments, and the statistical analyst updates the report template under review based on the online collaborative comments to obtain the report template awaiting use.

[0040] In one embodiment of the present invention, after a statistical analyst publishes a report template to be reviewed, a reviewer reviews the report template online and adds online collaborative comments.

[0041] Reviewers can review the report template online, add comments or corrections in real time, and the status is updated synchronously in real time, with emails or other notifications sent to relevant personnel in real time. Statistical analysts who receive comments can update or reply based on the online collaborative comments. Online collaboration, which eliminates the need for communication such as back-and-forth emails, significantly reduces communication costs between staff.

[0042] In one embodiment of the present invention, when a reviewer reviews a report template online and adds online collaborative comments, a communication log is generated and saved in real time to prevent unnecessary discussions.

[0043] In one embodiment of the present invention, in order to achieve rapid batch updating of report templates, the present invention can mark different field portions in multiple similar report templates under review or multiple report templates under review when generating pending report templates, confirm one of the multiple report templates under review or multiple report templates under review as a pending report template, confirm the other report templates as synchronized report templates, and when a pending report template is corrected, trigger the update assembly of the corresponding synchronized report template to complete the update of the corresponding synchronized report template.

[0044] S104, the annotator annotates the pending report template, and the clinical trial report production platform builds the corresponding SAS program based on the annotations.

[0045] In one embodiment of the present invention, after obtaining a pending report template, the annotator first annotates the pending report template.

[0046] The process involves identifying parameter report fields awaiting annotation from a pending report template, marking annotations for the parameter report fields using programmatic expressions or natural language, triggering a logical validation function, performing logical validation on the marked programmatic or natural language annotations to determine if marking them conforms to the writing guidelines, and, if it is determined that marking them conforms to the writing guidelines, completing the annotations for the pending report template. Furthermore, the clinical trial report production platform builds corresponding SAS programs based on annotations.

[0047] The clinical trial report generation platform analyzes annotations using a cross-platform computer programming language and SAS, converts the annotations into macro programs for SAS core calculations and parameters corresponding to macro autofill, and then combines the SAS core calculation macro programs and parameters to obtain the corresponding SAS program.

[0048] Furthermore, for specific applications, core statistical analysis calculations can also be performed using the R language, a cross-platform computer programming language, instead of SAS.

[0049] In one embodiment of the present invention, the clinical trial report production platform analyzes annotations using a cross-platform computer programming language and SAS, and the method further includes analyzing the clinical trial data to analyze the clinical trial data as variable units of corresponding fill parameters, and combining the annotations and variable units to obtain an ADaM analysis dataset derived explanatory document.

[0050] Furthermore, when annotated and analyzed, the data is also analyzed variable by variable in the background and summarized along with all annotations within the same project. Finally, these summarized results are automatically generated into an ADaM analysis dataset derivative explanatory document based on CDISC standards, containing all the dataset and variable information necessary to generate a clinical trial report. There is no need to manually create a blank explanatory file or fill in each variable one by one.

[0051] S105, run the SAS program to retrieve the pending clinical trial report.

[0052] In one embodiment of the present invention, after constructing a corresponding SAS program, the SAS program is executed to obtain a pending clinical trial report.

[0053] Furthermore, after executing the SAS program to obtain the pending clinical trial report, the pending clinical trial report and the SAS results dataset generated by executing the SAS program are stored.

[0054] Furthermore, the SAS result dataset of the analysis report and the clinical trial report generated each time the SAS program is run are saved in a specified folder, which is convenient for saving different versions and can also be used for version comparison. Differences (increases, deletions, corrections) are intuitively displayed in the clinical trial report and highlighted in color.

[0055] Correction: Changes in the direct results of different versions are indicated by a red mark, showing the previous result. New: A new result row is added compared to the comparison version, and a green mark is added.

[0056] Delete: Adds a new result row compared to the comparison version, and adds a gray mark at the end.

[0057] The technology used in this feature defines independent key variables for the results of clinical trial reports (each cell in the clinical trial report stores matrix coordinate information, text information, i.e., input dataset, variable name, variable value or label, conditions, etc.) and is used to identify each row, thus avoiding the problem of mis-rows that can make it difficult to identify comparison results during version comparisons.

[0058] The above describes embodiments of the method proposed by the present invention. Based on a similar inventive concept, embodiments of the present invention further provide a clinical trial report production device for clinical trial data having the structure shown in Figure 2.

[0059] Figure 2 is a schematic diagram of the internal structure of a clinical trial report production device for clinical trial data provided by an embodiment of the present invention. As shown in Figure 2, the device is At least one processor 201, It includes at least one processor and a memory 202 connected to it, Memory 202 stores instructions that are executed by at least one processor, and the instructions are executed by at least one processor 201, and at least one processor 201 is The clinical trial report generation platform creates clinical trial report generation projects corresponding to the clinical trial data being processed, assigns corresponding roles and responsibilities to the relevant processing personnel within the clinical trial report generation project, including statistical analysts, reviewers, and annotators. The statistical analyst will create a review report template based on the clinical trial design and publish the review report template. Reviewers review the report templates online, add online collaborative comments, and statistical analysts update the report templates based on the online collaborative comments to obtain the pending report templates. The annotator annotates the pending report template, and the clinical trial report production platform builds the corresponding SAS program based on the annotations. The SAS program is configured to execute and retrieve pending clinical trial reports.

[0060] A non-volatile computer storage medium corresponding to the production of a clinical trial report for clinical trial data shown in Figure 1, provided by some embodiments of the present invention, stores computer executable instructions, and the computer executable instructions are The clinical trial report generation platform creates clinical trial report generation projects corresponding to the clinical trial data being processed, assigns corresponding roles and responsibilities to the relevant processing personnel within the clinical trial report generation project, including statistical analysts, reviewers, and annotators. The statistical analyst will create a review report template based on the clinical trial design and publish the review report template. Reviewers review the report templates online, add online collaborative comments, and statistical analysts update the report templates based on the online collaborative comments to obtain the pending report templates. The annotator annotates the pending report template, and the clinical trial report production platform builds the corresponding SAS program based on the annotations. The SAS program is configured to execute and retrieve pending clinical trial reports.

[0061] Each embodiment of the present invention will be described progressively, with the same similar parts between embodiments referring to one another, and each embodiment will be described in detail in terms of how it differs from the others. In particular, the embodiments of ubiquitous network devices and media are basically similar to the embodiments of methods, so the description will be relatively simple, and relevant points will be referred to in part of the description of the embodiments of methods.

[0062] Since the systems and media provided by the embodiments of the present invention correspond one-to-one with the methods, the systems and media also have the same beneficial technical effects as the corresponding methods. Because the beneficial technical effects of the methods described above have been explained in detail, the beneficial technical effects of the systems and media will not be described here.

[0063] Those skilled in the art will understand that embodiments of the present invention may be provided as methods, systems, or computer program products. Accordingly, the present invention may employ complete hardware embodiments, complete software embodiments, or embodiments combining software and hardware aspects. The present invention may also employ the form of a computer program product implemented on one or more computer-compatible storage media (including, but not limited to, disk memory, CD-ROM, optical memory, etc.) containing computer-compatible program code.

[0064] The present invention will be described with reference to flowcharts and / or block diagrams of methods, apparatus (systems), and computer program products according to embodiments of the present invention. It should be understood that each flow and / or block in a flowchart and / or block diagram, as well as combinations of flows and / or blocks in a flowchart and / or block diagram, are implemented by computer program instructions. These computer program instructions are provided to a processor of a general-purpose computer, a dedicated computer, an embedded processor, or other programmable data processing device, which can generate a machine that generates means for realizing one or more flows in a flowchart and / or one or more blocks in a block diagram by instructions executed by the computer or other programmable data processing device processor.

[0065] These computer program instructions can also be stored in computer-readable memory that can operate a computer or other programmable data processing device in a particular way, and the instructions stored in computer-readable memory generate a product that includes an instruction unit that implements the functions specified in one or more flows of a flowchart and / or one or more blocks of a block diagram.

[0066] These computer program instructions can also be loaded onto a computer or other programmable data processing device to perform a series of operational steps on the computer or other programmable device to generate computer implementation processing, and so the instructions executed on the computer or other programmable device provide steps for implementing a function specified in one or more flows of a flowchart and / or one or more blocks of a block diagram.

[0067] In a typical configuration, a computing device includes one or more processors (CPUs), input / output interfaces, network interfaces, and memory.

[0068] Memory can take various forms, including non-persistent memory in computer-readable media such as read-only memory (ROM) or flash memory (flash RAM), random-access memory (RAM), and / or non-volatile memory. Memory is an example of computer-readable media.

[0069] Computer-readable media include persistent, non-persistent, removable, and non-removable media and can be implemented by any method or technique for implementing information storage. Information may be computer-readable instructions, data structures, program modules, or other data. Examples of computer storage media include, but are not limited to, phase-change memory (PRAM), static random-access memory (SRAM), dynamic random-access memory (DRAM), other types of random-access memory (RAM), read-only memory (ROM), electrically erasable programmable read-only memory (EEPROM), flash memory or other memory technologies, read-only optical disc memory (CD-ROM), digital multifunction optical disc (DVD) or other optical storage, magnetic cassette tapes, magnetic tape / disk storage devices or other magnetic storage devices or other non-transmission media that can be used to store information accessible by a computer. According to the definition herein, computer-readable media does not include temporary storage computer-readable media such as modulated data signals or carrier waves.

[0070] Furthermore, the terms “includes,” “equipped with,” or any other variation thereof are intended to include non-exclusive inclusion, and therefore a process, method, product, or apparatus that includes a set of elements must include not only those elements but also other elements not explicitly listed, or elements specific to such a process, method, product, or apparatus. Unless otherwise specified, an element limited by “includes one” does not preclude other identical elements from being present in the process, method, product, or device that includes that element.

[0071] The above describes only embodiments of the present invention and is not intended to limit it. The present invention is open to various modifications and changes for those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of the claims.

Claims

1. A method for producing clinical trial reports for clinical trial data, The clinical trial report generation platform creates a clinical trial report generation project corresponding to the clinical trial data being processed, assigns corresponding roles and responsibilities to the relevant processing personnel within the said clinical trial report generation project, including statistical analysts, reviewers, and annotators. The aforementioned statistical analyst will construct a review report template based on the clinical trial design and publish the said review report template. The reviewer reviews the report template under review online and adds online collaborative comments, and the statistical analyst updates the report template under review based on the online collaborative comments to obtain a report template awaiting use. The aforementioned annotator annotates the pending report template, and the clinical trial report production platform constructs the corresponding SAS program based on the annotations. This includes executing the aforementioned SAS program to obtain a pending clinical trial report, A method for producing clinical trial reports for clinical trial data, characterized by the features described above.

2. Based on the aforementioned clinical trial design, constructing a review report template is possible. Based on the aforementioned clinical trial design, the search keywords are determined, and based on the search keywords, the report format knowledge base is read to determine whether the relevant template has a matching degree greater than a predetermined threshold. If it is determined that there is a related template with a matching degree greater than a predetermined threshold, the related template is adjusted based on the clinical trial design to obtain the review report template. If it is determined that there is a related template whose matching degree is less than a predetermined threshold, the process includes generating an empty template and constructing a review report template based on the clinical trial design. A method for producing a clinical trial report for clinical trial data according to the feature described in 1.

3. Marking different field sections in multiple similar review report templates or multiple pending report templates, The process involves confirming one of the above multiple report templates subject to review or the above multiple report templates awaiting use as a pending report template, and confirming the other report templates as synchronized report templates. If a pending report template is corrected, this further includes triggering the corresponding synchronous report template update assembly and completing the update of the corresponding synchronous report template. A method for producing a clinical trial report for clinical trial data according to the feature described in 1.

4. Annotating the aforementioned pending report template is: The parameter report fields awaiting annotation are identified from the aforementioned pending report template, and annotations are marked on the parameter report fields using programmatic expressions or natural language. The logic verification function is triggered, and the program expression or natural language is marked with annotations to perform logic verification, thereby determining whether the marking of annotations on the program expression or natural language conforms to the writing standards. If it is determined that marking annotations on the aforementioned program formula or the aforementioned natural language conforms to the writing standards, this includes completing the annotations on the pending report template, A method for producing a clinical trial report for clinical trial data according to the feature described in 1.

5. Based on the above annotation, the aforementioned clinical trial report production platform will construct the corresponding SAS program. The clinical trial report production platform analyzes the annotations using a cross-platform computer programming language and SAS, and converts the annotations into macro programs for SAS core calculations and parameters corresponding to macro autofilling. This includes obtaining a corresponding SAS program by combining the macro program for SAS core calculation and the parameters corresponding to the automatic macro filling. A method for producing a clinical trial report for clinical trial data according to the feature described in 1.

6. The clinical trial report production platform analyzes the annotations using a cross-platform computer programming language and SAS, and then the method The aforementioned clinical trial data is analyzed, and the aforementioned clinical trial data is analyzed as a variable unit of the corresponding filling parameter, This further includes obtaining an ADaM analysis dataset derivative descriptive document by combining the aforementioned annotations and the aforementioned variable units, A method for producing a clinical trial report for clinical trial data according to the feature described in 1.

7. After executing the SAS program and obtaining the pending clinical trial report, the method is as follows: The further includes storing the pending clinical trial report and the SAS results dataset generated by running the SAS program, A method for producing a clinical trial report for clinical trial data according to the feature described in 1.

8. The following further includes generating and saving a real-time communication log when the reviewer reviews the review target report template and the pending clinical trial report online and adds online collaborative comments: A method for producing a clinical trial report for clinical trial data according to the feature described in 1.

9. A device for producing clinical trial reports for clinical trial data, At least one processor, The memory includes at least one processor and is connected to it in communication, The memory stores instructions to be executed by the at least one processor, and the instructions are executed by the at least one processor, The clinical trial report generation platform creates a clinical trial report generation project corresponding to the clinical trial data being processed, assigns corresponding roles and responsibilities to the relevant processing personnel within the said clinical trial report generation project, including statistical analysts, reviewers, and annotators. The aforementioned statistical analyst will construct a review report template based on the clinical trial design and publish the said review report template. The reviewer reviews the report template under review online and adds online collaborative comments, and the statistical analyst updates the report template under review based on the online collaborative comments to obtain a report template awaiting use. The aforementioned annotator annotates the pending report template, and the clinical trial report production platform constructs the corresponding SAS program based on the annotations. The SAS program is configured to execute and obtain pending clinical trial reports. A clinical trial report production device for clinical trial data, characterized by the following features.

10. A non-volatile computer storage medium for producing clinical trial reports for clinical trial data, which stores computer executable instructions, The aforementioned computer executable instructions are: The clinical trial report generation platform creates a clinical trial report generation project corresponding to the clinical trial data being processed, assigns corresponding roles and responsibilities to the relevant processing personnel within the said clinical trial report generation project, including statistical analysts, reviewers, and annotators. The aforementioned statistical analyst will construct a review report template based on the clinical trial design and publish the said review report template. The reviewer reviews the report template under review online and adds online collaborative comments, and the statistical analyst updates the report template under review based on the online collaborative comments to obtain a report template awaiting use. The aforementioned annotator annotates the pending report template, and the clinical trial report production platform constructs the corresponding SAS program based on the annotations. The SAS program is configured to execute and obtain pending clinical trial reports. A non-volatile computer storage medium for generating clinical trial reports on clinical trial data, characterized by the following features.

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