Project inspection priority evaluation method based on medical clinical test

Abstract

The invention discloses a project inspection priority evaluation method based on a medical clinical test, and the method comprises the steps: obtaining all sub-class information of a project for a test research condition, an applicant condition and an entrusted research institution experience condition, measuring the possible consequence of a risk according to the sub-class information, and carrying out the evaluation of the project inspection priority. The method comprises the steps of performing evaluation grading and score giving according to consequence severity, performing grading and weight giving on the risk-caused damage probability of each sub-category according to sub-category information, multiplying the score of each sub-category by the corresponding weight to obtain a corresponding score, adding all scores to obtain a final score, and determining the risk-caused damage probability of each sub-category according to the final score. And evaluating the priority of project inspection. According to the method, consequence severity grading and score and weight endowing are carried out through the sub-category information of different inspection items, the final score is obtained through calculation, the priority of the inspection items is judged, work key points and resources of inspection departments are inclined to the items with high priorities, and the project quality of companies is guaranteed.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical clinical trials, and in particular relates to a project audit priority evaluation method based on medical clinical trials. Background Art

[0002] Project audit in drug clinical trials is one of the important links to ensure the standardization of the research process, scientificity and reliability of the results. Audit refers to a systematic and independent inspection of clinical trial related activities and documents to evaluate whether the implementation of clinical trial related activities, the recording, analysis and reporting of trial data comply with the requirements of the trial plan, standard operating procedures and relevant laws and regulations.

[0003] The main purposes of the audit include: 1. Compliance assessment: Auditors will assess whether the organization and execution of clinical trials comply with GCP (Good Clinical Practice) and other relevant laws and regulations. 2. Ensure data quality: The audit aims to ensure that the data collected in clinical trials are accurate, complete, consistent, and consistent with the actual situation, thereby ensuring the reliability of the data. 3. Protect the rights and interests of subjects: The audit will check whether the rights and interests of subjects are fully protected, including safety and ethics during the trial. 4. Systematic and effectiveness evaluation: The audit will also evaluate the overall effectiveness of the clinical trial system, including process compliance, standardization of operations, etc.

[0004] Through these audit activities, sponsors and other participants can obtain independent assessments of the implementation of clinical trials, identify and correct existing problems in a timely manner, and thus improve the quality and efficiency of clinical trials.

[0005] A company often has multiple projects that need to be audited, but the audit department has limited resources and energy to mobilize, and cannot conduct on-site audits for all projects. In this case, it has become a common concern in the industry to evaluate the priority of project audits, identify projects with higher risk levels, determine the priority of project audits, and shift the focus and resources of the audit department to projects with higher priority, thereby ensuring the overall project quality of the company.

[0006] In the prior art, the priority of project audit is mainly roughly evaluated based on the project experience of the auditors, without a systematic and data-based quantitative indicator evaluation method. A rough evaluation based on the project experience of the auditors requires high experience from the auditors, has low reliability, and is prone to errors in the assessment of project audit priorities. In serious cases, it may even affect the quality of the entire clinical trial project. This rough empirical evaluation method can no longer meet the needs of clinical trial project audits. Summary of the invention

[0007] The purpose of the present invention is to provide a project audit priority assessment method based on medical clinical trials. The technical problem to be solved is that the existing technology performs a rough assessment based on the project experience of the auditors. This process requires high experience from the auditors, has low reliability, and is prone to errors in the project audit priority assessment. In severe cases, it may even affect the quality of the entire clinical trial project.

[0008] To achieve the above object, the present invention provides the following technical solutions: The present invention provides a project audit priority assessment method based on medical clinical trials, comprising: Obtain all sub-category information of the project based on the trial research situation, sponsor situation and commissioned research institution experience; Based on the sub-category information, measure the possible consequences of the risk, grade them according to the severity of the consequences, and assign scores according to the graded results; Based on the sub-category information, the probability of damage caused by the risk of each sub-category is graded and weights are assigned according to the grading results; Multiply the severity scores of each subcategory by the corresponding weight to get the score of each subcategory, and add up all the subcategory scores to get the final score; Based on the final score, the priority of project audit is evaluated.

[0009] By using the subcategory information of different audit projects, the severity of consequences is graded and assigned scores, the risk damage probability of each subcategory is graded and assigned weights, and the priority of the audit project is determined based on the score and weight calculation of each subcategory and compared with the priority table. The audit department's work focus and resources are tilted toward high-priority projects to ensure the company's overall project quality.

[0010] Optionally, the subcategories of the trial research situation include one or more of study scope, study phase, therapeutic area, planned number of centers and subjects, selection of research centers, subject recruitment, study process, SMO management, and other suppliers, and the trial research situation is divided into multiple subcategories for separate priority assessment.

[0011] Optionally, the subcategories of the sponsor's situation include one or more of company size and type, importance of the trial, and credibility of the sponsor, and the sponsor's situation is divided into multiple subcategories for separate priority assessment.

[0012] Optionally, the subcategories of the experience of the commissioned research institution include one or more of service scope, BD impact, project manager and project team, and the experience of the commissioned research institution is divided into multiple subcategories for separate priority assessment.

[0013] Optionally, the possible consequences of the risk are measured based on the subcategory information, the consequences are graded according to their severity, and scores are assigned according to the grading results, specifically including: High severity: subcategory issues have a significant impact on the project, which may cause serious delays in the project, have a significant impact on quality or compliance, completely unavailable data, or pose a major threat to the safety of the subjects, and are assigned a score of 5; Medium severity: subcategory issues have some impact on the project, but will not cause a major crisis, and are assigned a score of 3; Low severity: Subcategory issues have little impact on the project and are assigned a score of 1.

[0014] By evaluating and grading each subcategory according to the severity of the consequences, we can determine which risks have the most serious impact on the project, so that we can give priority to and deal with risks with high severity of consequences, allocate resources reasonably, improve the efficiency of risk management, and provide a basis for decision-making for project managers. When facing multiple risks, they can decide what response measures to take according to the severity level of the consequences, identify potential major problems in advance, take preventive measures, reduce the possibility of risks, meet supervision requirements and enhance communication and collaboration.

[0015] Optionally, the risk-causing damage probability of each subcategory is graded according to the subcategory information, and weights are assigned according to the grading results, specifically including: Obtain and analyze the frequency data on damage caused by specific risks in the company's previous similar projects, refer to the standards and specifications of the relevant industry, understand the frequency and impact of different risks in similar projects, invite experts with rich clinical trial experience to evaluate the probability of damage caused by different sub-categories of risks based on their professional knowledge and experience, obtain historical data of the audited units, analyze and calculate the frequency data after the occurrence of damage, and then invite experts to consider the nature of the risk, the characteristics of the project and the general situation of the industry for further evaluation.

[0016] Optionally, assigning weights according to the grading results includes: High probability: The risk often occurs in similar projects, and once it occurs, it may have a significant impact on the project schedule, quality or cost, requiring high attention and preferential treatment. In this case, it is given a weight of 3; Medium probability: The risk has a certain probability of occurrence and has a moderate impact on the project. It needs to be given proper attention and control in project management. In this case, it is given a weight of 2; Low probability: The risk is less likely to occur and has less impact on the project. It needs to be monitored during the project and is assigned a weight of 1.

[0017] By grading and weighting the risk damage probability, high-risk audit projects and subcategories can be identified more accurately. The audit department can focus limited resources on these high-risk areas, improve the pertinence of the audit, avoid waste of resources, and reasonably allocate work resources based on the comprehensive assessment results of risk probability and consequence severity. For high-priority projects, more manpower, time and funds can be allocated to ensure the adequacy and effectiveness of the audit work, which will help the project team better understand the risks faced by the project and formulate corresponding risk response measures in advance. Through scientific risk assessment and priority sorting, the audit of high-risk projects can be strengthened, and potential quality problems and compliance risks can be discovered and corrected in a timely manner, ensuring the smooth progress and quality safety of clinical trial projects.

[0018] Optionally, the final score is calculated by the following formula:

[0019] In the formula, p is the final score of the audit project, wi represents the graded severity score of the i-th subcategory under category i, xi represents the weight of the i-th subcategory under category i, wj represents the graded severity score of the j-th subcategory under category j, xj represents the weight of the j-th subcategory under category j, wk represents the graded severity score of the k-th subcategory under category k, and xk represents the weight of the k-th subcategory under category k.

[0020] Optionally, the final score of the audit project is compared with a preset project priority comparison table to obtain the priority of the project audit, and the audit plan is confirmed based on the priority of the project audit. The audit plan can be obtained by comparing the project audit priority with the preset comparison table.

[0021] Optionally, the project priority comparison table is represented by a mathematical set, specifically including: [a1, a2), if p is between [a1, a2), the project priority is low and no research center audit is performed; [a2, a3), if p is between [a2, a3), the project priority is general, and at least one research center will be audited; [a3, a4), if p is between [a3, a4), the project has a higher priority and at least two research centers will be audited; [a4, a5], if p is between [a4, a5], the project priority is high and at least 3 research centers will be audited.

[0022] By comparing the final score of the audit project with the preset project priority comparison table, the priority of the audit project is obtained. The audit department determines the focus of work and the order of resource allocation based on the comparison of the final score with the priority result.

[0023] Compared with the prior art, the present invention has the following beneficial effects: 1. The project audit priority assessment method based on medical clinical trials of the present invention classifies the severity of consequences and assigns scores to subcategories based on the subcategory information of different audit projects, classifies the risk damage probability of each subcategory and assigns weights, calculates the score and weight of each subcategory, and compares it with the priority table to determine the priority of the audit project, so as to ensure that the work focus and resources of the audit department are tilted toward high-priority projects and ensure the overall project quality of the company.

[0024] 2. The project audit priority assessment method based on medical clinical trials of the present invention obtains the priority of the audit project by comparing the final score of the audit project with the preset score. The audit department determines the work focus and the order of resource allocation based on the comparison between the final score and the priority result. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 It is a schematic diagram of the process of the present invention. DETAILED DESCRIPTION

[0026] The present invention will be further described below in conjunction with the accompanying drawings. The following embodiments are only used to more clearly illustrate the technical solution of the present invention, and cannot be used to limit the protection scope of the present invention.

[0027] An embodiment, such as Figure 1 As shown, a project audit priority assessment method based on medical clinical trials is provided, including: S10, obtain all sub-category information of the project based on the experimental research situation, the sponsor situation and the experience of the commissioned research institution.

[0028] The audit items in this embodiment are preferably analyzed from three situations: experimental research situation, sponsor situation and CRO (commissioned research organization situation).

[0029] Referring to Table 1 below, it can be seen that the subcategories of the experimental research situation in this embodiment include research scope, research phase, therapeutic area, planned number of centers and subjects, selection of research centers, subject recruitment, research process, SMO management, and other suppliers.

[0030] Referring to Table 2 below, it can be seen that the subcategories of the sponsor situation in this embodiment include company size and type, importance of the trial, and sponsor funding and credibility.

[0031] Referring to Table 3 below, it can be seen that the subcategories of the commissioned research institution situation in this embodiment include alarm service scope, BD impact, project manager and project team.

[0032] Table 1 shows the experimental research situation:

[0033] Table 2 shows the sponsor information:

[0034] Table 3 shows the commissioned research institutions

[0035] S11, based on the subcategory information, measure the possible consequences of the risk, evaluate and grade them according to the severity of the consequences, and assign points according to the grading results. For each subcategory information in Table 1, Table 2 and Table 3, if the subcategory problem has a great impact on the project, it may cause serious delays to the project, have a great impact on quality or compliance, the data is completely unavailable, or pose a major threat to the safety of the subjects, it is a high consequence severity and is assigned a score of 5. If the subcategory problem has a certain impact on the project but does not cause a major crisis, it is a medium consequence severity and is assigned a score of 3. If the subcategory problem has a small impact on the project, it is a low consequence severity and is assigned a score of 1.

[0036] More specifically, as shown in Table 1, in the case of experimental research, the scores assigned to specific categories are as follows: If the research scope is global, the score is 5; if the research scope is regional, the score is 3; if the research scope is domestic, the score is 1.

[0037] If the research phase is three phases, the score is 5; if the research phase is two phases, the score is 3; if the research phase is one phase, the score is 1.

[0038] If the therapeutic area is new and there is no experience, a score of 5 is assigned; if there is experience in the therapeutic area, a score of 3 is assigned; if there is extensive experience in the therapeutic area, a score of 1 is assigned.

[0039] If the planned number of centers and subjects is greater than 12 research centers or greater than 500 subjects, a score of 5 is assigned; if the planned number of centers and subjects is 6-12 research centers and 200-500 subjects, a score of 3 is assigned; if the planned number of centers and subjects is less than 6 research centers or 200 subjects, a score of 1 is assigned.

[0040] If more than 30% of the research centers are new cooperative institutions / majors and their project experience is limited, a score of 5 will be assigned. If 10%-30% of the research centers are new cooperative institutions / majors and their project experience is limited, a score of 3 will be assigned. If 10% of the research centers are new cooperative institutions / majors but their project experience is limited, a score of 1 will be assigned.

[0041] If subject recruitment is difficult, a score of 5 is assigned, if subject recruitment is moderate, a score of 3 is assigned, and if subject recruitment is easy, a score of 1 is assigned.

[0042] If the research process is very complex and difficult to control, a score of 5 is assigned; if the research process is complex, a score of 3 is assigned; if the research process is general and easy to control, a score of 1 is assigned.

[0043] If the SMO management does not use SMO / involves multiple SMO companies, a score of 5 is assigned; if the SMO management involves 2-5 SMO companies, a score of 3 is assigned; if the SMO management only involves 1-2 SMO companies, a score of 1 is assigned.

[0044] If other suppliers involve 2 or more suppliers, a score of 5 is assigned, if other suppliers involve only 1 supplier, a score of 3 is assigned, and if no supplier is used in the other supplier category, a score of 1 is assigned.

[0045] More specifically, as shown in Table 2, in the case of the sponsor, the scores assigned to specific categories are as follows: If the company size and type is a large or international company, a score of 5 is assigned; if the company size and type is a medium or Sino-foreign joint venture, a score of 3 is assigned; if the company size and type is a small or domestic company, a score of 1 is assigned.

[0046] If the importance of the trial is very important to the sponsor, a score of 5 is assigned; if the importance of the trial is important to the sponsor, a score of 3 is assigned; if the importance of the trial is not very important to the sponsor, a score of 1 is assigned.

[0047] The funding and credibility of the sponsor are as follows: if the sponsor has sufficient funding and high credibility, a score of 5 is assigned; if the sponsor has average funding and average credibility, a score of 3 is assigned; if the sponsor has weak funding and low credibility, a score of 1 is assigned.

[0048] More specifically, as shown in Table 3, in the case of a commissioned research institution, the scores assigned to specific categories are as follows: When the service scope is full service, the score is 5; when the service scope includes central monitoring and project management, the score is 3; when the service scope includes central monitoring, the score is 1.

[0049] When the BD impact is large, a score of 5 is assigned; when the BD impact is medium, a score of 3 is assigned; and when the BD impact is small, a score of 1 is assigned.

[0050] A project manager with limited experience is assigned a score of 5, a project manager with moderate experience is assigned a score of 3, and a project manager with extensive experience is assigned a score of 1.

[0051] If the project team is a new team with limited experience, a score of 5 is assigned; if the project team is a team with moderate experience, a score of 3 is assigned; and if the project team is an experienced team, a score of 1 is assigned.

[0052] S12, based on the sub-category information, the probability of damage caused by the risk of each sub-category is graded and weights are assigned according to the grading results.

[0053] In this embodiment, how to judge the probability of loss caused by risk can be considered from the following aspects: 1. Historical data: Analyze the frequency of actual damage caused by specific risks in similar projects in the past. That is, in past projects, if the complexity of a certain type of test plan has frequently led to inaccurate data or project delays, then the probability of damage caused by this risk is relatively high.

[0054] 2. Expert opinions: Invite experts with extensive clinical trial experience to assess the probability of damage caused by different sub-categories of risks based on their professional knowledge and experience. It should be noted that experts can consider factors such as the nature of the risk, the characteristics of the project, and the general situation of the industry.

[0055] 3. Industry standards and specifications: Refer to the standards and specifications of relevant industries (the references involved in this embodiment include "Good Clinical Practice for Drugs (No. 57 of 2020)" and "Key Points and Judgment Principles for Drug Registration Verification (Drug Clinical Trials) (Trial)") to understand the frequency and impact of different risks in similar projects, that is, trials involving people with certain special diseases may have higher risks because the physiological characteristics and treatment responses of such people may be more complex.

[0056] In this embodiment, the probability of damage caused by risk is divided into three levels: high, medium and low according to the evaluation results, as follows: High probability: The risk often occurs in similar projects, and once it occurs, it may have a significant impact on the project schedule, quality or cost, requiring high attention and preferential treatment. In this case, it is assigned a weight of 3.

[0057] Medium probability: The risk has a certain probability of occurrence and has a moderate impact on the project. It requires proper attention and control in project management and is assigned a weight of 2.

[0058] Low probability: The risk is less likely to occur and has less impact on the project. It needs to be monitored during the project and is assigned a weight of 1.

[0059] In this embodiment, taking a specific situation as an example, referring to the sponsor situation in Table 2 above, a weight is assigned to each subcategory, specifically: If small or domestic companies often appear in previous projects of company size and type, it is assessed as high probability and assigned a weight of 3. If medium or Sino-foreign joint ventures appear, it is assessed as medium probability and assigned a weight of 2. If large or international companies appear, it is assessed as low probability and assigned a weight of 1.

[0060] If in the previous items of the importance of the trial, it is often not very important to the sponsor, it is evaluated as high probability and assigned a weight of 3. If it is important to the sponsor, it is evaluated as medium probability and assigned a weight of 2. If it is very important to the sponsor, it is assigned a weight of 1.

[0061] In terms of the applicant's funding and credibility, if the applicant's financial strength is weak and its credibility is low, once a risk occurs, it will have a greater impact on the project, and it is assessed as high probability and assigned a weight of 3. If the applicant's funding is average and its credibility is average, and the impact of a risk on the project is medium, it is assessed as medium probability and assigned a weight of 2. If the applicant has sufficient funding and high credibility, and the impact of a risk on the project is small, it is assessed as low probability and assigned a weight of 1.

[0062] In this embodiment, only the sponsor's situation is illustrated, and the experimental research situation and the entrusted research institution situation can also be evaluated by experts according to this method, so it will not be repeated here.

[0063] It should be noted that in the actual application of this embodiment, it is necessary to continuously adjust and optimize the weight assignment according to the specific circumstances of the project and actual experience. That is, if it is found in a certain project that the actual impact of the risks of various categories is inconsistent with the initial assessment, its weight can be adjusted. In addition, it is necessary to regularly review and analyze the results of project audits, summarize the actual occurrence and impact of different risks, so as to update and improve the weight assignment. This will enable the evaluation method to more accurately reflect the actual risk status of the project and improve the pertinence and effectiveness of project audits.

[0064] S13, multiplying the severity scores of each subcategory by the corresponding weight to obtain the score of each subcategory, and adding up all the subcategory scores to obtain the final score.

[0065] The final score of the project audit in this embodiment is obtained by the following formula:

[0066] In the formula, p is the final score of the audit project, wi represents the graded severity score of the i-th subcategory under category i, xi represents the weight of the i-th subcategory under category i, wj represents the graded severity score of the j-th subcategory under category j, xj represents the weight of the j-th subcategory under category j, wk represents the graded severity score of the k-th subcategory under category k, and xk represents the weight of the k-th subcategory under category k.

[0067] S14. Evaluate the priority of project audit based on the final score.

[0068] In this embodiment, the final score of the project audit is compared with a preset project priority comparison table to obtain the priority of the project audit, and then the audit plan is confirmed based on the priority.

[0069] Referring to Table 4 below, it can be seen that when the final score P of the project audit is in the range of [a1, a2), the priority of the project audit is low and no research center audit is conducted. When the final score P of the project audit is in the range of [a2, a3), the priority of the project audit is general and at least one research center audit is conducted. When the final score P of the project audit is in the range of [a3, a4), the priority of the project audit is high and at least two research center audits are conducted. When the final score P of the project audit is in the range of [a4, a5], at least three research center audits are conducted. It should be noted that in this embodiment, a1, a2, a3, a4 and a5 are all integers.

[0070] Table 4 Project priority comparison table:

[0071] The embodiments of the present invention are described above in conjunction with the accompanying drawings, but the present invention is not limited to the above-mentioned specific implementation methods. The above-mentioned specific implementation methods are merely illustrative and not restrictive. Under the enlightenment of the present invention, ordinary technicians in this field can also make many forms without departing from the scope of protection of the purpose of the present invention and the claims, which all fall within the protection of the present invention.

Claims

1. A project audit priority assessment method based on medical clinical trials, characterized in that: include: Obtain all sub-category information of the project based on the trial research situation, sponsor situation and commissioned research institution experience; Based on the sub-category information, measure the possible consequences of the risk, grade them according to the severity of the consequences, and assign scores according to the graded results; Based on the sub-category information, the probability of damage caused by the risk of each sub-category is graded and weights are assigned according to the grading results; Multiply the severity scores of each subcategory by the corresponding weight to get the score of each subcategory, and add up all the subcategory scores to get the final score; Based on the final score, the priority of project audit is evaluated.

2. A project audit priority assessment method based on medical clinical trials according to claim 1, characterized in that: The subcategories of the trial research situation include one or more of the study scope, study phase, therapeutic area, planned number of centers and subjects, selection of study centers, subject recruitment, study process, SMO management, and other suppliers.

3. A project audit priority assessment method based on medical clinical trials according to claim 2, characterized in that: Subcategories of the sponsor status include one or more of company size and type, significance of the trial, and reputation of the sponsor.

4. A project audit priority assessment method based on medical clinical trials according to claim 3, characterized in that: The subcategories of the experience of the commissioned research institution include one or more of service scope, BD influence, project manager and project team.

5. A project audit priority assessment method based on medical clinical trials according to claim 4, characterized in that: Based on the sub-category information, the possible consequences of the risk are measured, and the severity of the consequences is evaluated and graded. Points are assigned according to the grading results, including: High severity: subcategory issues have a significant impact on the project, which may cause serious delays in the project, have a significant impact on quality or compliance, completely unavailable data, or pose a major threat to the safety of the subjects, and are assigned a score of 5; Medium severity: subcategory issues have some impact on the project, but will not cause a major crisis, and are assigned a score of 3; Low severity: Subcategory issues have little impact on the project and are assigned a score of 1.

6. A project audit priority assessment method based on medical clinical trials according to claim 1 or 5, characterized in that: Based on the sub-category information, the probability of damage caused by the risk of each sub-category is graded and weights are assigned according to the grading results, including: Obtain and analyze the frequency data on damages caused by specific risks in the company's previous similar projects, refer to the standards and specifications of relevant industries to understand the frequency and impact of different risks in similar projects, and invite experts with rich clinical trial experience to evaluate the probability of damages caused by different sub-categories of risks based on their professional knowledge and experience.

7. A method for evaluating project audit priorities based on medical clinical trials according to claim 6, characterized in that: The weighting is assigned according to the grading results, including: High probability: The risk often occurs in similar projects, and once it occurs, it may have a significant impact on the project schedule, quality or cost, requiring high attention and preferential treatment. In this case, it is given a weight of 3; Medium probability: The risk has a certain probability of occurrence and has a moderate impact on the project. It needs to be given proper attention and control in project management. In this case, it is given a weight of 2; Low probability: The risk is less likely to occur and has less impact on the project. It needs to be monitored during the project and is assigned a weight of 1.

8. A project audit priority assessment method based on medical clinical trials according to claim 7, characterized in that: The final score is calculated by the following formula: In the formula, p is the final score of the audit project, wi represents the graded severity score of the i-th subcategory under category i, xi represents the weight of the i-th subcategory under category i, wj represents the graded severity score of the j-th subcategory under category j, xj represents the weight of the j-th subcategory under category j, wk represents the graded severity score of the k-th subcategory under category k, and xk represents the weight of the k-th subcategory under category k.

9. A method for evaluating project audit priorities based on medical clinical trials according to claim 8, characterized in that: Compare the final score of the audit project with the preset project priority comparison table to obtain the priority of the project audit, and confirm the audit plan based on the priority of the project audit.

10. A project audit priority assessment method based on medical clinical trials according to claim 9, characterized in that: The project priority comparison table is represented by a mathematical set, specifically including: [a1, a2), if p is between [a1, a2), the project priority is low and no research center audit is performed; [a2, a3), if p is between [a2, a3), the project priority is general, and at least one research center will be audited; [a3, a4), if p is between [a3, a4), the project has a higher priority and at least two research centers will be audited; [a4, a5], if p is between [a4, a5], the project priority is high and at least 3 research centers will be audited.

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