Intelligent subject screening system for clinical test
The intelligent subject screening system has solved the problems of low efficiency and accuracy in subject screening, enabling efficient subject screening and accurate recruitment, thereby improving the quality of clinical trials and the speed of new treatment development.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2023-07-14
- Publication Date
- 2026-04-17
AI Technical Summary
Existing methods for screening participants are inefficient and inaccurate, making screening difficult and affecting the accuracy and efficiency of clinical trials.
An intelligent subject screening system is adopted, including a subject screening management terminal, an execution terminal, and a service terminal. Through modules such as setting research objectives, inclusion criteria, screening procedures, recruitment channels, information collection and verification, and exclusion criteria, the system achieves efficient screening and management of subject information.
This improved the efficiency and accuracy of subject screening, ensured the correct recruitment of the target population in clinical trials, enhanced the quality and representativeness of the results, and shortened the development cycle of new treatment methods.
Smart Images
Figure CN121885052A_ABST
Abstract
Description
Technical Field
[0001] This application relates to the field of clinical trial technology, and in particular to an intelligent subject screening system for clinical trials. Background Technology
[0002] Currently, after developing a new drug, pharmaceutical companies usually need to recruit patients to complete the clinical drug research. In the process of clinical trials, subjects are an important part of scientific research. The existing recruitment methods mainly involve recruiting internal recruitment specialists to visit hospitals, departments, and doctors, or directly visiting patients, or cooperating with other platforms to find suitable subjects, thereby achieving the recruitment goals of pharmaceutical companies.
[0003] However, the instability of the recruits' sources during the recruitment process led to low efficiency and accuracy in subsequent subject screening, making subject screening quite difficult and requiring improvement. Summary of the Invention
[0004] To reduce the difficulty of subject screening, this application provides an intelligent subject screening system for clinical trials.
[0005] This application provides an intelligent subject screening system for clinical trials, which adopts the following technical solution:
[0006] An intelligent subject screening system for clinical trials, comprising:
[0007] The subject screening management module includes a research objective setting module, an inclusion criterion setting module, and a screening procedure module. The research objective setting module is used to determine research objective information and subject characteristic information. The inclusion criterion setting module is used to set inclusion criteria based on the research objective information and subject characteristic information. The screening procedure module is used to determine eligible subjects based on the inclusion criteria.
[0008] The subject screening execution module includes a subject recruitment module, a subject screening module, and an exclusion criteria module. The subject recruitment module is used to recruit subjects through different channels. The subject screening module evaluates potential subjects through a screening procedure and collects and verifies the subjects' information according to the inclusion criteria to obtain screening results. The exclusion criteria module is used to formulate exclusion criteria after determining the eligible subjects to exclude subjects who are not suitable to participate in the study.
[0009] The subject screening server includes a subject selection module, a subject informed consent module, and a monitoring and tracking module. The subject selection module is used to select subjects who meet the inclusion criteria to participate in the study based on the screening results. The subject informed consent module is used to ensure that the subjects understand and agree to the study content. The monitoring and tracking module is used to monitor and track the subjects according to the research plan.
[0010] Preferably, the subject screening management terminal, the subject screening execution terminal, and the subject screening service terminal communicate with each other via a dedicated network, and the dedicated network is configured with communication permissions for designated personnel.
[0011] Preferably, the research objective formulation module includes a research objective formulation unit and a research objective formulation database unit. The research objective formulation unit is pre-set with a research objective question database and a research objective feature matching database, wherein the research objective feature matching database is divided into matching degrees based on the results of the subjects' answers to research questions in the research objective question database.
[0012] The research objective database unit is connected to the research objective unit and is used to store the matching degree data of the subjects after being calculated by the research objective feature matching database.
[0013] Preferably, the inclusion criterion development module includes a criterion development unit and an inclusion criterion database unit. The criterion development unit is configured with inclusion criterion information that is adapted to the research objective information and subject characteristic information. The inclusion criterion information includes age information, gender information, disease status information, medical history information, physiological indicator information, and drug use information. The inclusion criterion database unit is data-connected to the criterion development unit and is used to store the inclusion criterion information.
[0014] Preferably, the screening procedure module includes a screening procedure unit and a screening procedure database unit. The screening procedure unit formulates screening questionnaire procedures, medical examination procedures, and laboratory testing procedures based on inclusion criterion information. The screening procedure database unit is used to store the screening procedure information generated in the screening questionnaire procedures, medical examination procedures, and laboratory testing procedures, and to identify eligible subjects.
[0015] Preferably, the subject recruitment module includes a subject recruitment unit and a subject recruitment database unit. The subject recruitment unit recruits subjects through hospitals, clinics, community advertisements, and online platforms. The subject recruitment unit judges the reliability of different channels and adjusts the evaluation criteria of the subject screening module based on the reliability of different channels. The lower the reliability, the higher the evaluation criteria. The subject recruitment database unit is used to store the reliability of subjects recruited through different channels.
[0016] Preferably, the subject screening module includes a subject screening unit and a subject screening database unit. The subject screening unit is used to evaluate potential subjects in the screening process and to collect and verify subject information based on the reliability of subjects from different channels. The subject screening database unit is used to store subject screening information.
[0017] Preferably, the exclusion criteria module includes an exclusion criteria unit and an exclusion criteria database unit. The exclusion criteria unit is used to exclude subjects who are not suitable to participate in the study, in addition to the inclusion criteria. The exclusion criteria may include other diseases, specific drug use, and allergic reactions. The exclusion criteria database unit is used to store exclusion criteria information.
[0018] Preferably, the subject selection module includes a subject selection unit and a subject selection database unit. The subject selection unit is used to select subjects who meet the inclusion criteria to participate in the study based on the screening results, and randomly assign the subjects to different treatment groups or control groups to obtain subject selection information. The subject selection database unit is used to store the subject selection information.
[0019] Preferably, the informed consent module for research subjects includes an informed consent unit for research subjects and an informed consent database unit for research subjects. The informed consent unit for research subjects is used to ensure that research subjects understand the purpose, process, risks and benefits of the research before the research begins, and to sign an informed consent form to obtain the informed consent information of the research subjects. The informed consent database unit for research subjects is used to store the informed consent information of the research subjects.
[0020] In summary, this application includes at least one of the following beneficial technical effects:
[0021] 1. The goal of this system is to improve the efficiency and accuracy of subject screening to ensure that the target population of clinical trials can be correctly recruited and included in the study. Through the intelligent subject screening system, clinical trial researchers can identify and recruit subjects who meet the trial inclusion criteria more quickly and efficiently, improve the speed and quality of trial recruitment, reduce the difficulty of subject screening, and help ensure the accuracy and representativeness of trial results, and accelerate the research and development and promotion of new treatment methods. Attached Figure Description
[0022] Figure 1 This is a schematic block diagram illustrating the intelligent subject screening system for clinical trials, which is the main embodiment of this application.
[0023] Figure 2 This is a schematic block diagram illustrating the subject screening and management terminal, which is the main embodiment of this application.
[0024] Figure 3 This is a schematic block diagram illustrating the subject screening execution end of the embodiments of this application.
[0025] Figure 4 This is a schematic block diagram illustrating the subject screening server, which is the main embodiment of this application.
[0026] Figure labeling: 1. Subject screening management terminal; 11. Research objective setting module; 12. Inclusion criterion setting module; 13. Screening procedure module; 2. Subject screening execution terminal; 21. Subject recruitment module; 22. Subject screening module; 23. Exclusion criteria module; 3. Subject screening service terminal; 31. Subject selection module; 32. Subject informed consent module; 33. Monitoring and tracking module. Detailed Implementation
[0027] The following is in conjunction with the appendix Figure 1-4 This application will be described in further detail.
[0028] This application discloses an intelligent subject screening system for clinical trials.
[0029] Reference Figure 1 A smart subject screening system for clinical trials includes a subject screening management terminal 1, a subject screening execution terminal 2, and a subject screening server terminal 3. The subject screening management terminal 1, the subject screening execution terminal 2, and the subject screening server terminal 3 communicate with each other via a dedicated network. The dedicated network is configured with communication permissions for designated personnel, such as through an encrypted company intranet.
[0030] In this embodiment, the subject screening management terminal 1 includes a research objective setting module 11, an inclusion criterion setting module 12, and a screening procedure module 13. The research objective setting module 11 is used to determine research objective information and subject characteristic information; the inclusion criterion setting module 12 is used to set inclusion criteria based on the research objective information and subject characteristic information; and the screening procedure module 13 is used to determine eligible subjects based on the inclusion criteria.
[0031] The research objective formulation module 11 includes a research objective formulation unit and a research objective formulation database unit. The research objective formulation unit pre-sets a research objective question bank and a research objective feature matching bank. The research objective feature matching bank classifies the matching degree based on the subjects' answers to research questions in the research objective question bank. The research objective formulation database unit is data-connected to the research objective formulation unit and is used to store the matching degree data of subjects after calculation by the research objective feature matching bank.
[0032] Specifically, during the process of the subjects answering questions, the research objective question bank will pre-recommend question types that match the current subjects' basic information, and classify the subjects' scores based on the subjects' answers to the research questions in the research objective question bank to determine whether the subjects are matched with the current research objective.
[0033] The inclusion criteria module 12 includes a criteria setting unit and an inclusion criteria database unit. The criteria setting unit sets inclusion criteria information that is adapted to the research objective information and subject characteristic information. The inclusion criteria information includes age information, gender information, disease status information, medical history information, physiological indicator information, and drug use information. The inclusion criteria database unit is connected to the criteria setting unit and is used to store the inclusion criteria information.
[0034] The screening procedure module 13 includes a screening procedure unit and a screening procedure database unit. The screening procedure unit formulates screening questionnaire procedures, medical examination procedures and laboratory testing procedures based on the inclusion criteria information. The screening procedure database unit is used to store the screening procedure information generated in the screening questionnaire procedures, medical examination procedures and laboratory testing procedures and to identify eligible subjects.
[0035] Reference Figure 3 The subject screening execution terminal 2 includes a subject recruitment module 21, a subject screening module 22, and an exclusion criteria module 23. The subject recruitment module 21 is used to recruit subjects through different channels. The subject screening module 22 evaluates potential subjects through a screening procedure and collects and verifies the subjects' information according to the inclusion criteria to obtain the screening results. The exclusion criteria module 23 is used to formulate exclusion criteria after determining the eligible subjects to exclude subjects who are not suitable to participate in the study.
[0036] The subject recruitment module 21 includes a subject recruitment unit and a subject recruitment database unit. The subject recruitment unit recruits subjects through hospitals, clinics, community advertisements, and online platforms. The subject recruitment unit judges the reliability of different channels and adjusts the evaluation criteria of the subject screening module 22 based on the reliability of different channels. The lower the reliability, the higher the evaluation criteria. The subject recruitment database unit is used to store the reliability of subjects recruited through different channels.
[0037] The specific reliability criteria are selected based on the actual situation. For example, if subjects are recruited through cooperating hospitals or clinics, the reliability can be appropriately increased. The specific judgment logic is not limited here.
[0038] The subject screening module 22 includes a subject screening unit and a subject screening database unit. The subject screening unit is used to evaluate potential subjects in the screening process and to collect and verify subject information based on the reliability of subjects from different channels. The subject screening database unit is used to store subject screening information.
[0039] The exclusion criteria module 23 includes an exclusion criteria unit and an exclusion criteria database unit. The exclusion criteria unit is used to exclude subjects who are not suitable to participate in the study, in addition to the inclusion criteria. The exclusion criteria may include other diseases, specific drug use, and allergic reactions. The exclusion criteria database unit is used to store exclusion criteria information.
[0040] Reference Figure 4 The subject screening server 3 includes a subject selection module 31, a subject informed consent module 32, and a monitoring and tracking module 33. The subject selection module 31 is used to select subjects who meet the inclusion criteria to participate in the study based on the screening results. The subject informed consent module 32 is used to ensure that the subjects understand and agree to the study content. The monitoring and tracking module 33 is used to monitor and track the subjects according to the research plan.
[0041] The subject selection module 31 includes a subject selection unit and a subject selection database unit. The subject selection unit is used to select subjects who meet the inclusion criteria to participate in the study based on the screening results, and randomly assigns the subjects to different treatment groups or control groups to obtain subject selection information. The subject selection database unit is used to store the subject selection information.
[0042] The informed consent module 32 for research subjects includes an informed consent unit for research subjects and an informed consent database unit for research subjects. The informed consent unit for research subjects is used to ensure that research subjects understand the purpose, process, risks and benefits of the research before the research begins, and to sign an informed consent form to obtain informed consent information from research subjects. The informed consent database unit for research subjects is used to store informed consent information from research subjects.
[0043] The above are all preferred embodiments of this application, and are not intended to limit the scope of protection of this application. Therefore, all equivalent changes made in accordance with the structure, shape and principle of this application should be covered within the scope of protection of this application.
Claims
1. An intelligent subject screening system for clinical trials, characterized in that, include: The subject screening management terminal (1) includes a research objective setting module (11), an inclusion criterion setting module (12), and a screening procedure module (13). The research objective setting module (11) is used to determine research objective information and subject characteristic information. The inclusion criterion setting module (12) is used to set inclusion criteria based on the research objective information and subject characteristic information. The screening procedure module (13) is used to determine eligible subjects based on the inclusion criteria. The subject screening execution end (2) includes a subject recruitment module (21), a subject screening module (22), and an exclusion criteria module (23). The subject recruitment module (21) is used to recruit subjects through different channels. The subject screening module (22) evaluates potential subjects through a screening procedure and collects and verifies the subjects' information according to the inclusion criteria to obtain screening results. The exclusion criteria module (23) is used to formulate exclusion criteria after determining the subjects who meet the conditions in order to exclude subjects who are not suitable to participate in the study. The subject screening server (3) includes a subject selection module (31), a subject informed consent module (32), and a supervision and tracking module (33). The subject selection module (31) is used to select subjects who meet the inclusion criteria to participate in the study based on the screening results. The subject informed consent module (32) is used to determine whether the subject understands and agrees to the research content. The supervision and tracking module (33) is used to supervise and track the subjects according to the research plan.
2. The intelligent subject screening system for clinical trials according to claim 1, characterized in that: The subject screening management terminal (1), subject screening execution terminal (2), and subject screening service terminal (3) communicate with each other via a dedicated network. The dedicated network is equipped with communication permissions for designated personnel.
3. The intelligent subject screening system for clinical trials according to claim 1, characterized in that: The research objective formulation module (11) includes a research objective formulation unit and a research objective formulation database unit. The research objective formulation unit is pre-set with a research objective question bank and a research objective feature matching bank. The research objective feature matching bank is divided into matching degrees based on the results of the subjects' answers to the research questions in the research objective question bank. The research objective database unit is connected to the research objective unit and is used to store the matching degree data of the subjects after being calculated by the research objective feature matching database.
4. The intelligent subject screening system for clinical trials according to claim 1, characterized in that: The inclusion criteria development module (12) includes a criteria development unit and an inclusion criteria development database unit. The criteria development unit is configured with inclusion criteria information that is compatible with the research objective information and subject characteristic information. The inclusion criteria information includes age information, gender information, disease status information, medical history information, physiological indicator information, and drug use information. The inclusion criteria development database unit is connected to the criteria development unit and is used to store the inclusion criteria information.
5. The intelligent subject screening system for clinical trials according to claim 1, characterized in that: The screening procedure module (13) includes a screening procedure unit and a screening procedure database unit. The screening procedure unit formulates screening questionnaire procedures, medical examination procedures and laboratory testing procedures based on the inclusion criteria information. The screening procedure database unit is used to store the screening procedure information generated in the screening questionnaire procedures, medical examination procedures and laboratory testing procedures and to determine the eligible subjects.
6. The intelligent subject screening system for clinical trials according to claim 1, characterized in that: The subject recruitment module (21) includes a subject recruitment unit and a subject recruitment database unit. The subject recruitment unit recruits subjects through hospitals, clinics, community advertisements, and online platforms. The subject recruitment unit judges the reliability of different channels and adjusts the evaluation requirements of the subject screening module (22) based on the reliability of different channels. The lower the reliability, the higher the evaluation requirements. The subject recruitment database unit is used to store the reliability of subjects recruited through different channels.
7. The intelligent subject screening system for clinical trials according to claim 1, characterized in that: The subject screening module (22) includes a subject screening unit and a subject screening database unit. The subject screening unit is used to evaluate potential subjects in the screening process and to collect and verify subject information based on the reliability of subjects from different channels. The subject screening database unit is used to store subject screening information.
8. The intelligent subject screening system for clinical trials according to claim 1, characterized in that: The exclusion criteria module (23) includes an exclusion criteria unit and an exclusion criteria database unit. The exclusion criteria unit is used to exclude subjects who are not suitable to participate in the study in addition to the inclusion criteria. The exclusion criteria may include other diseases, specific drug use, and allergic reactions. The exclusion criteria database unit is used to store exclusion criteria information.
9. The intelligent subject screening system for clinical trials according to claim 1, characterized in that: The subject selection module (31) includes a subject selection unit and a subject selection database unit. The subject selection unit is used to select subjects who meet the inclusion criteria to participate in the study based on the screening results, and randomly assigns the subjects to different treatment groups or control groups to obtain subject selection information. The subject selection database unit is used to store the subject selection information.
10. The intelligent subject screening system for clinical trials according to claim 1, characterized in that: The informed consent module (32) for the subjects includes an informed consent unit for the subjects and an informed consent database unit for the subjects. The informed consent unit for the subjects is used to ensure that the subjects understand the purpose, process, risks and benefits of the study before the start of the study, and to sign an informed consent form to obtain the subjects' informed consent information. The informed consent database unit for the subjects is used to store the subjects' informed consent information.