关键词:

临床试验, 方案偏离, 研究者管理

Abstract:

Objective　To discuss the construction of management system for clinical trial investigators, in order to reduce the incidence of protocol deviation and improve the quality of clinical trials. Methods　By searching the reports about protocol deviation in the process of clinical trial implementation in China National Knowledge Network (CNKI), Wanfang data knowledge service platform, and VIP database till January 5, 2023, the data of protocol deviation were extracted, the deviation problems were classified and analyzed, and the treatment measures were tailored to reduce the incidence of protocol deviation. Results　A total of 122 literatures were retrieved, and 11 literatures meeting the inclusion/exclusion criteria were finally included, all of which were in Chinese. There were 89 clinical trial protocol deviation problems, which were classified into 8 categories according to the category of protocol deviation. Among them, the top 3 categories of problems with protocol deviation occurrence and incidence were experimental procedures (6 264 cases, 58.72%), management and use of investigational product (IP) (1 594 cases, 14.94%), and inclusion/exclusion criteria (1,362 cases, 12.77%). Conclusion　By establishing the investigator management system, we can standardize the management for investigators, reduce the incidence of protocol deviation, improve the investigators' clinical research level, ensure the subjects' safety and interests, and assure the quality of clinical trials.

Key words:

Clinical trials, Protocol deviation, Investigator management