Clinical trial report generation method and device for clinical trial data, and medium

Abstract

Disclosed in the present application are a clinical trial report generation method and device for clinical trial data, and a medium. The method comprises: by means of a clinical trial report generation platform, creating a clinical trial report generation project corresponding to clinical trial data to be processed, and allocating corresponding roles and permissions to related processors involved in the clinical trial report generation project; a statistical analyst constructing, on the basis of a clinical trial design, a report template to be reviewed, and publishing the report template to be reviewed; a reviewer performing online review on the report template to be reviewed, and adding online collaboration comments, such that the statistical analyst updates, on the basis of the online collaboration comments, the report template to be reviewed, so as to obtain a report template to be applied; an annotator annotating the report template to be applied, such that the clinical trial report generation platform constructs a corresponding SAS program on the basis of an annotation; and executing the SAS program, so as to obtain a clinical trial report to be applied. In the present application, by means of the method, automatic generation of a clinical trial analysis report is efficiently realized.

Description

Clinical trial report output method, device and medium for clinical trial data

[0001] This application claims priority to the Chinese patent application No. 202410411133.1, filed on April 8, 2024, and entitled "Clinical trial report output method, device and medium for clinical trial data", the whole content of which is incorporated herein by reference. TECHNICAL FIELD

[0002] The present application relates to the technical field of medical research and development data analysis, in particular to a clinical trial report output method, device and medium for clinical trial data. BACKGROUND

[0003] The medical research and development data analysis field is a complex work field across multiple disciplines such as medicine, statistics, computer science, etc. In China, it has been in the ascendant for more than 20 years, and there are few related majors in domestic universities. It needs compound talents, and most of the work still relies on manual work, resulting in a shortage of talents. Medical research and development data analysis has very high quality requirements and very low fault tolerance requirements, and the industry convention usually requires that all calculation results pass "independent double programming" quality control, i.e. two analysts independently write programs to operate, and the results of the two people must be 100% consistent to pass. Therefore, it is highly dependent on personnel, and a lot of work time is needed to write programs and operate and quality control.

[0004] In terms of clinical trial data submission, with the advent of the era of electronic submission, the European Union required pharmaceutical companies to submit in eCTD (Electronic Common Technical Document) format in 2014, and the US FDA also made a mandatory provision in 2016. CDISC (Clinical Data Interchange Standards Consortium) has developed a number of modules to support clinical data standards over the past 20 years: SEND / SDTM / ADaM / Define.xml. Along with these modules, clinical trial statistical reports based on SAP (Statistical Analysis Plan) are produced. The number of clinical trial reports varies depending on the complexity of the project, ranging from hundreds to thousands. Therefore, the above-mentioned several modules plus clinical trials have become the main and important work tasks of the statistical analysis team of pharmaceutical and CRO companies to respond to submission requirements. Therefore, how to efficiently realize the automatic output of clinical trial reports has become a technical problem to be solved. SUMMARY

[0005] Embodiments of the present application provide a clinical trial report output method, device and medium for clinical trial data, to solve the technical problem of how to efficiently realize automatic output of clinical trial reports.

[0006] In a first aspect, embodiments of the present application provide a clinical trial report output method for clinical trial data, the method comprising: creating, by a clinical trial report output platform, a clinical trial report output project corresponding to to-be-processed clinical trial data, and assigning corresponding roles and permissions to relevant processing personnel of the clinical trial report output project; wherein the relevant processing personnel include: statistical analysis personnel, review personnel, and labeling personnel; the statistical analysis personnel construct a to-be-audited report template based on a clinical trial design, and publish the to-be-audited report template; the review personnel perform online review on the to-be-audited report template, and add online collaborative annotations, so that the statistical analysis personnel update the to-be-audited report template based on the online collaborative annotations to obtain a to-be-applied report template; and the labeling personnel label the to-be-applied report template, so that the clinical trial report output platform constructs a corresponding SAS program based on the labeling; and the SAS program is executed to obtain a to-be-applied clinical trial report.

[0007] In an implementation manner of the present application, constructing the to-be-audited report template based on the clinical trial design comprises: determining a to-be-searched keyword based on the clinical trial design, and reading a report style knowledge base based on the to-be-searched keyword to determine whether there is a related template with a matching degree greater than a preset threshold; in a case where it is determined that there is a related template with a matching degree greater than the preset threshold, adjusting the related template based on the clinical trial design to obtain the to-be-audited report template; and in a case where it is determined that there is a related template with a matching degree less than the preset threshold, generating an empty template and constructing the to-be-audited report template based on the clinical trial design.

[0008] In an implementation manner of the present application, the method further comprises: marking different field parts in a plurality of to-be-audited report templates or a plurality of to-be-applied report templates; determining any one of the plurality of to-be-audited report templates or the plurality of to-be-applied report templates as a to-be-operated report template, and determining other report templates as synchronous report templates; in a case where the to-be-operated report template is modified, triggering an update component of the corresponding synchronous report template to complete updating of the corresponding synchronous report template.

[0009] In an implementation manner of the present application, the labeling of the report template to be applied includes: determining a parameter report field to be labeled in the report template to be applied, and performing programmatic or natural language tagging annotation on the parameter report field; triggering a logic checking function to perform logic checking on the programmatic or natural language tagging annotation to determine whether the programmatic or natural language tagging annotation conforms to the writing specification; and in the case where it is determined that the programmatic or natural language tagging annotation conforms to the writing specification, completing the labeling of the report template to be applied.

[0010] In an implementation manner of the present application, the clinical trial report output platform constructs a corresponding SAS program based on the labeling, including: the clinical trial report output platform parses the labeling through a cross-platform computer programming language and SAS to convert the labeling into parameters corresponding to a SAS core calculation macro program and an automatic filling macro; and the parameters corresponding to the SAS core calculation macro program and the automatic filling macro are summarized to obtain the corresponding SAS program.

[0011] In an implementation manner of the present application, after the clinical trial report output platform parses the labeling through a cross-platform computer programming language and SAS, the method further includes: parsing the to-be-processed clinical trial data to convert the to-be-processed clinical trial data into variable units corresponding to filling parameters; and summarizing the labeling and the variable units to obtain an ADaM analysis data set derivation specification document.

[0012] In an implementation manner of the present application, after the SAS program is executed to obtain the clinical trial report to be applied, the method further includes: storing the clinical trial report to be applied and a SAS result data set generated by executing the SAS program.

[0013] In an implementation manner of the present application, the method further includes: when the reviewer performs online review on the report template to be audited and the clinical trial report to be applied and adds online collaborative annotations, generating and saving a communication log in real time.

[0014] In a second aspect, the embodiments of the present application further provide a clinical trial report output device for clinical trial data, the device comprising: at least one processor; and a memory in communication connection with the at least one processor; wherein the memory stores instructions executable by the at least one processor, and the instructions are executed by the at least one processor to enable the at least one processor to: create, through a clinical trial report output platform, a clinical trial report output project corresponding to to-be-processed clinical trial data, and assign corresponding roles and permissions to relevant processing personnel of the clinical trial report output project; wherein the relevant processing personnel comprise: a statistical analysis personnel, a review personnel, and a labeling personnel; the statistical analysis personnel constructs a to-be-audited report template based on a clinical trial design, and publishes the to-be-audited report template; the review personnel performs online review on the to-be-audited report template, and adds online collaborative annotations, so that the statistical analysis personnel updates the to-be-audited report template based on the online collaborative annotations to obtain a to-be-applied report template; and the labeling personnel labels the to-be-applied report template, so that the clinical trial report output platform constructs a corresponding SAS program based on the labeling; and the SAS program is executed to obtain a to-be-applied clinical trial report.

[0015] In a third aspect, the embodiments of the present application further provide a non-volatile computer storage medium for clinical trial report output of clinical trial data, the medium storing computer executable instructions, and the computer executable instructions are configured to: create, through a clinical trial report output platform, a clinical trial report output project corresponding to to-be-processed clinical trial data, and assign corresponding roles and permissions to relevant processing personnel of the clinical trial report output project; wherein the relevant processing personnel comprise: a statistical analysis personnel, a review personnel, and a labeling personnel; the statistical analysis personnel constructs a to-be-audited report template based on a clinical trial design, and publishes the to-be-audited report template; the review personnel performs online review on the to-be-audited report template, and adds online collaborative annotations, so that the statistical analysis personnel updates the to-be-audited report template based on the online collaborative annotations to obtain a to-be-applied report template; and the labeling personnel labels the to-be-applied report template, so that the clinical trial report output platform constructs a corresponding SAS program based on the labeling; and the SAS program is executed to obtain a to-be-applied clinical trial report.

[0016] The clinical trial report output method, device and medium provided by the embodiment of the application have high online collaboration capability, greatly reduce the communication cost in the review and update process, the project status is clear at a glance, repeated communication confirmation is not required, and all communication records are retained and can be exported for record. The WYSIWYG novel method used by the application can eliminate the inconsistency in cognition between the reviewer and the programmer. The final result of the clinical trial report must be consistent with the report template style seen by the reviewer. The SAS program and ADaM analysis dataset derived statement document are simultaneously output by the machine after the annotation analysis is summarized, breaking the original process of first writing the dataset statement document, generating the dataset, and then writing the clinical trial program. What is needed for subsequent analysis is done by the ADaM analysis dataset, and the relationship between the two modules is one-to-one, avoiding a large number of redundant variables that are not needed in the back end, and there will be no situation that the variables needed for the clinical trial report are not created in the dataset before the SAS program is executed. The machine replaces the traditional manpower to automatically generate the SAS program, which is efficient, has stronger detail control (including format and layout), has low risk of rework or revision, reduces repetitive work, and guarantees consistency and quality. The application stores the to-be-applied clinical trial report and the SAS result dataset generated by executing the SAS program, so that the comparison between different versions of the clinical trial report can be accurately positioned to the changed position, the results of the previous version are displayed, and the line error problem is solved. BRIEF DESCRIPTION OF DRAWINGS

[0017] The accompanying drawings, which are included to provide a further understanding of the application and constitute a part of this application, illustrate certain illustrative embodiments of the application and together with the description serve to explain the application. In the drawings:

[0018] FIG. 1 is a flowchart of a clinical trial report output method for clinical trial data provided by an embodiment of the application;

[0019] FIG. 2 is a schematic diagram of the internal structure of a clinical trial report output device for clinical trial data provided by an embodiment of the application. DETAILED DESCRIPTION

[0020] To make the objectives, technical solutions and advantages of the application clearer, the technical solutions of the application will be described below in conjunction with the specific embodiments of the application and the corresponding drawings. Obviously, the described embodiments are only some of the embodiments of the application, not all the embodiments. Based on the embodiments in the application, all other embodiments obtained by those of ordinary skill in the art without making creative efforts fall within the scope of protection of the application.

[0021] According to the data collected by the clinical research plan, the statistical analysis work is to use SAS (a professional statistical analysis software recommended in the field of life sciences, all calculation modules of which are certified) to generate the data sets (SDTM, ADAM) required by the regulatory department in accordance with the CDISC standard and hundreds of clinical trial reports for the writing and submission of clinical research reports (CSR).

[0022] Before submission, designing clinical trial report forms and generating statistical analysis reports according to SAP is a key task for statisticians, and pharmaceutical companies and CRO companies need to invest a lot of manpower and resources in statistical analysis teams.

[0023] The following problems exist:

[0024] 1. Report complexity: Clinical trial reports are usually revised frequently in terms of content and format based on different clinical trials or different stages of the trial, and contain a large amount of data and statistical analysis results. During the report production and review process, based on actual data, it may need to be generated and updated multiple times, and due to the lack of preparation of the previous data set, it may also be returned for modification of the data set, which makes the report finalization process complex and requires the statistical analysis team to invest more time and effort.

[0025] 2. Data quality issues: Data quality is crucial to the quality and accuracy of clinical trial reports. However, in actual operation, data errors, omissions, inconsistencies, etc. may cause the report production process to be slow, and even affect the final results.

[0026] 3. Communication and coordination: Clinical trial report production involves multiple departments and teams, including data management, statistical analysis, medical writing, etc. Therefore, communication and coordination become crucial. If not properly handled, it may lead to design and requirements not meeting, excessive consumption of resources, and ultimately affect the quality of the report.

[0027] 4. Time pressure: Clinical research usually has strict time limits, so the statistical analysis team needs to complete the production of clinical trial reports in a short period of time, which may lead to overtime work for team members and increase work pressure.

[0028] 5. Compliance and quality control: Clinical trial reports are an important part of clinical research reports and need to meet the requirements of relevant regulations and standards.

[0029] Therefore, the statistical analysis team needs to pay attention to compliance and quality control during the report production process to ensure the accuracy and reliability of the report.

[0030] The embodiment of the present application provides a clinical trial report output method for clinical trial data, a device and a medium, to solve the technical problem of how to efficiently realize automatic output of clinical trial analysis report.

[0031] The technical solutions provided by the embodiment of the present application are described in detail below with reference to the drawings.

[0032] FIG. 1 is a flowchart of a clinical trial report output method for clinical trial data provided by the embodiment of the present application. As shown in FIG. 1, the clinical trial report output method for clinical trial data provided by the embodiment of the present application specifically includes the following steps:

[0033] Step 101, creating, by a clinical trial report output platform, a clinical trial report output project corresponding to to-be-processed clinical trial data, and assigning corresponding roles and permissions to relevant processing personnel of the clinical trial report output project.

[0034] In an embodiment of the present application, to realize the clinical trial report output method for clinical trial data, first, a user needs to create, by a clinical trial report output platform, a clinical trial report output project corresponding to to-be-processed clinical trial data. After the application is created, corresponding roles and permissions are assigned to relevant processing personnel of the clinical trial report output project. Different roles have different task permissions, which can avoid misoperation of other personnel on the document.

[0035] It should be noted that the relevant processing personnel include: statistical analysis personnel, review personnel, and labeling personnel.

[0036] Step 102, the statistical analysis personnel constructs a to-be-audited report template based on clinical trial design, and publishes the to-be-audited report template.

[0037] In an embodiment of the present application, after creating the clinical trial report output project and assigning corresponding roles and permissions to relevant processing personnel of the clinical trial report output project, the statistical analysis personnel constructs a to-be-audited report template based on clinical trial design.

[0038] Based on the clinical trial design, the to-be-searched keywords are determined, and based on the to-be-searched keywords, the report style knowledge base is read to determine whether there is a related template with a matching degree greater than a preset threshold; in the case where it is determined that there is a related template with a matching degree greater than a preset threshold, the related template is adjusted based on the clinical trial design to obtain the to-be-audited report template; in the case where it is determined that there is a related template with a matching degree less than a preset threshold, an empty template is generated, and the to-be-audited report template is constructed based on the clinical trial design.

[0039] According to the WYSIWYG novel method, all the text and format on the to-be-audited report template are parsed by cross-platform computer programming languages and SAS, including titles, footnotes, column titles, displayed text of each paragraph, line breaks between paragraphs, presentation of small numbers, etc., and finally presented on the final clinical trial report. The platform can also export other formats of clinical trial reports (such as word, PDF) to meet the different needs of the project team for filing.

[0040] Further, the statistical analyst publishes the to-be-audited report template.

[0041] Step 103, the reviewer reviews the to-be-audited report template online and adds online collaborative comments, so that the statistical analyst updates the to-be-audited report template based on the online collaborative comments to obtain the to-be-applied report template.

[0042] In an embodiment of the present application, after the statistical analyst publishes the to-be-audited report template, the reviewer reviews the to-be-audited report template online and adds online collaborative comments.

[0043] The reviewer can review the to-be-audited report template online and add comments or modification opinions in real time, and the status is updated in real time, and emails and Feishu messages are sent to relevant personnel in real time. After receiving the comments, the statistical analyst can update or reply based on the online collaborative comments, without back-and-forth email and other communication methods. Through this online collaboration method, the communication cost between workers is greatly reduced.

[0044] In an embodiment of the present application, when the reviewer reviews the to-be-audited report template online and adds online collaborative comments, a communication log is generated and saved in real time, avoiding unnecessary disputes.

[0045] In an embodiment of the present application, to realize batch rapid update of report templates, the present application can also mark different field parts in a plurality of to-be-audited report templates or a plurality of to-be-applied report templates when generating the to-be-applied report template; determine any one of the plurality of to-be-audited report templates or the plurality of to-be-applied report templates as a to-be-operated report template, and determine other report templates as synchronous report templates; in the case of modification of the to-be-operated report template, trigger the update component of the corresponding synchronous report template to complete the update of the corresponding synchronous report template.

[0046] Step 104, the annotator annotates the to-be-applied report template, so that the clinical trial report output platform constructs the corresponding SAS program based on the annotation.

[0047] In an embodiment of the present application, after obtaining the to-be-applied report template, the annotator will first annotate the to-be-applied report template.

[0048] The parameter report field to be labeled is determined in the to-be-applied report template, and the parameter report field is labeled with a program language or a natural language; a logic checking function is triggered to check the logic of the program language or the natural language label, to determine whether the program language or the natural language label meets the writing specification; and in a case where it is determined that the program language or the natural language label meets the writing specification, the labeling of the to-be-applied report template is completed.

[0049] Further, the clinical trial report output platform constructs a corresponding SAS program based on the labeling.

[0050] The clinical trial report output platform parses the labeling by using a cross-platform computer programming language and SAS, to convert the labeling into parameters corresponding to a SAS core calculation macro program and an automatic filling macro; and the parameters corresponding to the SAS core calculation macro program and the automatic filling macro are summarized to obtain a corresponding SAS program.

[0051] It should be noted that, in a specific application, R language or a cross-platform computer programming language can be used instead of SAS to perform core operations related to statistical analysis.

[0052] In an embodiment of the present application, after the clinical trial report output platform parses the labeling by using a cross-platform computer programming language and SAS, the method further includes: parsing the to-be-processed clinical trial data to convert the to-be-processed clinical trial data into variable units corresponding to filling parameters; and summarizing the labeling and the variable units to obtain an ADaM analysis dataset derivative specification document.

[0053] It should be noted that, after the labeling and parsing, the data are also parsed into variable units by a background, and are summarized together with all the labels in the same project; finally, the results of the summarization are combined with a CDISC standard to automatically output an ADaM analysis dataset derivative specification document, which contains all the dataset and variable information required for generating a clinical trial report. There is no need to manually create a blank specification document and fill in the information one variable at a time.

[0054] Step 105: executing the SAS program to obtain a to-be-applied clinical trial report.

[0055] In an embodiment of the present application, after the corresponding SAS program is constructed, the SAS program is executed to obtain a to-be-applied clinical trial report.

[0056] Further, after the SAS program is executed to obtain a to-be-applied clinical trial report, the to-be-applied clinical trial report and a SAS result dataset generated by executing the SAS program are stored.

[0057] It should be noted that the SAS result data set and the clinical trial report generated by each execution of the SAS program are saved in the designated folder, facilitating the saving of different versions and the comparison of versions, and the differences (additions, deletions, and modifications) are intuitively displayed in the clinical trial report and highlighted in color.

[0058] Modification: Direct results of different versions have changes, are marked in red and display the previous results. New: New result row compared with the comparison version, marked in green.

[0059] Delete: New result row compared with the comparison version, marked in gray and placed at the end.

[0060] The technology used by this function is that a separate Key variable is defined for the results of the clinical trial report (the row and column coordinate information, text information, i.e., the input data set, variable name, variable value or label, condition, etc., are stored for each cell of the clinical trial report), which is used to identify each row, and when comparing versions, the problem of difficult comparison results caused by incorrect rows can be avoided.

[0061] The above is the method embodiment of the present application. Based on the same inventive concept, the present application also provides a clinical trial report output device for clinical trial data, the structure of which is shown in FIG. 2.

[0062] FIG. 2 is a schematic diagram of the internal structure of a clinical trial report output device for clinical trial data provided by an embodiment of the present application. As shown in FIG. 2, the device includes:

[0063] at least one processor 201;

[0064] and a memory 202 in communication connection with the at least one processor;

[0065] The memory 202 stores instructions executable by the at least one processor, and the instructions are executed by the at least one processor 201 to enable the at least one processor 201 to:

[0066] Through the clinical trial report output platform, a clinical trial report output project corresponding to the to-be-processed clinical trial data is created, and corresponding roles and permissions are assigned to relevant processing personnel of the clinical trial report output project; wherein the relevant processing personnel include: statistical analysis personnel, review personnel, and labeling personnel;

[0067] The statistical analysis personnel construct a to-be-audited report template based on the clinical trial design, and publish the to-be-audited report template;

[0068] The review personnel perform online review on the to-be-audited report template and add online collaborative annotations, so that the statistical analysis personnel update the to-be-audited report template based on the online collaborative annotations to obtain a to-be-applied report template;

[0069] The annotator annotates the to-be-applied report template, so that the clinical trial report output platform constructs the corresponding SAS program based on the annotation;

[0070] The SAS program is executed to obtain the to-be-applied clinical trial report.

[0071] Some embodiments of the present application provide a non-volatile computer storage medium for clinical trial report output of clinical trial data corresponding to FIG. 1, which stores computer executable instructions, and the computer executable instructions are configured to:

[0072] Through the clinical trial report output platform, a clinical trial report output project corresponding to the to-be-processed clinical trial data is created, and the relevant processing personnel of the clinical trial report output project are assigned corresponding roles and permissions; wherein the relevant processing personnel include: statistical analysis personnel, review personnel, and annotators;

[0073] The statistical analysis personnel construct a to-be-audited report template based on the clinical trial design, and publish the to-be-audited report template;

[0074] The review personnel perform online review on the to-be-audited report template, and add online collaborative annotations, so that the statistical analysis personnel update the to-be-audited report template based on the online collaborative annotations to obtain a to-be-applied report template;

[0075] The annotator annotates the to-be-applied report template, so that the clinical trial report output platform constructs the corresponding SAS program based on the annotation;

[0076] The SAS program is executed to obtain the to-be-applied clinical trial report.

[0077] Each of the embodiments in the present application is described in a progressive manner, and the same and similar parts of each embodiment can be referred to each other. Each embodiment focuses on the difference from other embodiments. In particular, for the Internet of Things device and medium embodiments, since they are basically similar to the method embodiments, the description is relatively simple, and the relevant parts are described in the method embodiment.

[0078] The system and medium provided by the embodiments of the present application are one-to-one corresponding to the method, so the system and medium also have similar beneficial technical effects as the method. Since the beneficial technical effects of the method have been described in detail above, the beneficial technical effects of the system and medium will not be described here.

[0079] Those skilled in the art will appreciate that embodiments of the present application can be readily used as software, hardware, or a combination of software and hardware. In a typical configuration, a computing device includes one or more processors (CPUs), input / output interfaces, network interfaces, and memory.

[0080] The computer program instructions can also be loaded onto a computer or other programmable data processing apparatus to cause a series of operational steps to be performed on the computer or other programmable apparatus to produce a computer implemented process such that the instructions which execute on the computer or other programmable apparatus provide steps for implementing the functions specified in the flowchart block or blocks or in conjunction with the flowcharts described above.

[0081] These computer program instructions can also be stored in a computer readable memory that can direct a computer or other programmable data processing apparatus to function in a particular manner, such that the instructions stored in the computer readable memory produce an article of manufacture including instructions which implement the function specified in the flowchart block or blocks or in conjunction with the flowcharts described above.

[0082] These computer program instructions can also be loaded onto a computer or other programmable data processing apparatus to cause a series of operational steps to be performed on the computer or other programmable apparatus to produce a computer implemented process such that the instructions which execute on the computer or other programmable apparatus provide steps for implementing the functions specified in the flowchart block or blocks or in conjunction with the flowcharts described above.

[0083] In a typical configuration, a computing device includes one or more processors (CPUs), input / output interfaces, network interfaces, and memory.

[0084] The memory can include non-persistent memory and / or volatile memory, such as random access memory (RAM) and / or cache memory, non-volatile memory, such as read-only memory (ROM), EPROM, and / or flash memory, etc. The memory is an example of computer readable media.

[0085] Computer-readable media includes permanent and non-permanent, movable and non-movable media that can implement information storage by any method or technology. The information can 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, compact disc read-only memory (CD-ROM), digital versatile disc (DVD) or other optical storage, magnetic cassette, magnetic tape, magnetic disk storage or other magnetic storage devices, or any other non-transmission medium that can be used to store information accessible to a computing device. According to the definition herein, computer-readable media does not include transitory media such as modulated data signals and carriers.

[0086] It should also be noted that the terms "comprising", "containing", or any other variant thereof are intended to cover a non-exclusive inclusion, such that a process, method, article or apparatus that comprises a list of elements does not only include those elements, but can also include other elements not expressly listed or inherent to such process, method, article or apparatus. Without more limitations, the element defined by the statement "comprising a" does not exclude the presence of additional identical elements in the process, method, article or apparatus that includes the element.

[0087] The above only describes the embodiments of the present application and is not intended to limit the present application. For those skilled in the art, the present application can have various modifications and changes. Any modification, equivalent replacement, improvement, etc. within the spirit and principle of the present application shall be included in the scope of claims of the present application.

Claims

1. A method for producing clinical trial reports for clinical trial data, wherein: The method comprises: Create a clinical trial report output project corresponding to the pending clinical trial data through the clinical trial report output platform, and assign corresponding roles and permissions to the relevant processing personnel of the clinical trial report output project; wherein, the relevant processing personnel include: statistical analysts, reviewers, and annotation personnel; The statistical analyst constructs a report template to be reviewed based on the clinical trial design and publishes the report template to be reviewed; The reviewer reviews the report template to be reviewed online and adds online collaborative annotations, so that the statistical analyst updates the report template to be reviewed based on the online collaborative annotations to obtain the report template to be applied; The annotator annotates the report template to be used, so that the clinical trial report output platform constructs a corresponding SAS program based on the annotation; Execute the SAS program to obtain the clinical trial report to be applied.

2. A method for producing clinical trial reports for clinical trial data according to claim 1, wherein: Based on the clinical trial design, a report template to be reviewed is constructed, including: Determine keywords to be searched based on the clinical trial design, and read a report style knowledge base based on the keywords to be searched to determine whether a relevant template has a matching degree greater than a preset threshold; If it is determined that there is a related template with a matching degree greater than a preset threshold, adjusting the related template based on the clinical trial design to obtain a report template to be reviewed; When it is determined that there is a related template with a matching degree less than a preset threshold, an empty template is generated, and a report template to be reviewed is constructed based on the clinical trial design.

3. A method for generating clinical trial reports for clinical trial data according to claim 1, wherein: The method further comprises: Mark several similar report templates to be reviewed or different field parts in several report templates to be applied; Determining any one of the plurality of report templates to be reviewed or the plurality of report templates to be applied as a report template to be operated, and determining the other report templates as synchronous report templates; When the report template to be operated is modified, the update component of the corresponding synchronization report template is triggered to complete the update of the corresponding synchronization report template.

4. A method for generating clinical trial reports for clinical trial data according to claim 1, wherein: Marking the report template to be applied includes: Determining parameter report fields to be annotated in the report template to be applied, and annotating the parameter report fields using programmatic or natural language marking; triggering a logic check function to perform a logic check on the program or natural language markup annotation to determine whether the program or natural language markup annotation complies with writing specifications; When it is determined that the programmatic or natural language markup annotation complies with the writing specification, the marking of the report template to be applied is completed.

5. A method for generating clinical trial reports for clinical trial data according to claim 1, wherein: The clinical trial report output platform constructs a corresponding SAS program based on the annotation, including: The clinical trial report generation platform parses the annotations using a cross-platform computer programming language and SAS to convert the annotations into SAS core calculation macro programs and parameters corresponding to the auto-fill macros; Parameters corresponding to the SAS core calculation macro program and the automatic filling macro are summarized to obtain a corresponding SAS program.

6. A method for generating clinical trial reports for clinical trial data according to claim 5, wherein: After the clinical trial report generation platform parses the annotations using a cross-platform computer programming language and SAS, the method further includes: Parsing the clinical trial data to be processed to convert the clinical trial data to variable units corresponding to the filling parameters; The annotations and the variable units are aggregated to obtain a derived description document of the ADaM analysis dataset.

7. A method for generating clinical trial reports for clinical trial data according to claim 1, wherein: After executing the SAS program to obtain a clinical trial report to be applied, the method further includes: The clinical trial report to be applied and the SAS result data set generated by executing the SAS program are stored.

8. A method for generating clinical trial reports for clinical trial data according to claim 1, wherein: The method further comprises: When the reviewer reviews the report template to be reviewed and the clinical trial report to be applied online and adds online collaborative annotations, a communication log is generated and saved in real time.

9. A clinical trial report output device for clinical trial data, wherein: The device comprises: at least one processor; and, a memory communicatively coupled to the at least one processor; The memory stores instructions that can be executed by the at least one processor, and the instructions are executed by the at least one processor to enable the at least one processor to: Create a clinical trial report output project corresponding to the pending clinical trial data through the clinical trial report output platform, and assign corresponding roles and permissions to the relevant processing personnel of the clinical trial report output project; wherein, the relevant processing personnel include: statistical analysts, reviewers, and annotation personnel; The statistical analyst constructs a report template to be reviewed based on the clinical trial design and publishes the report template to be reviewed; The reviewer reviews the report template to be reviewed online and adds online collaborative annotations, so that the statistical analyst updates the report template to be reviewed based on the online collaborative annotations to obtain the report template to be applied; The annotator annotates the report template to be used, so that the clinical trial report output platform constructs a corresponding SAS program based on the annotation; Execute the SAS program to obtain the clinical trial report to be applied.

10. A non-volatile computer storage medium for producing a clinical trial report for clinical trial data, storing computer-executable instructions, wherein: The computer executable instructions are configured to: Create a clinical trial report output project corresponding to the pending clinical trial data through the clinical trial report output platform, and assign corresponding roles and permissions to the relevant processing personnel of the clinical trial report output project; wherein, the relevant processing personnel include: statistical analysts, reviewers, and annotation personnel; The statistical analyst constructs a report template to be reviewed based on the clinical trial design and publishes the report template to be reviewed; The reviewer reviews the report template to be reviewed online and adds online collaborative annotations, so that the statistical analyst updates the report template to be reviewed based on the online collaborative annotations to obtain the report template to be applied; The annotator annotates the report template to be used, so that the clinical trial report output platform constructs a corresponding SAS program based on the annotation; Execute the SAS program to obtain the clinical trial report to be applied.

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