Current situation of Investigator-Initiated Clinical Trial quality management: A scoping review / 中华医学科研管理杂志

ABSTRACT

Objective:To systematically identify and summarizes the weaknesses of the key aspects of Investigator-Initiated Clinical Trial (IIT) quality management in China, and quantitatively assess these weaknesses with a synthesis of relevant evidence, thereby providing references for the subsequent establishment of a complete IIT quality management system in China.Methods:According to the Scoping review report checklist (PRISMA-ScR statement), we conducted a systematic literature retrieval and screening, data extraction, and result synthesis of IIT quality management issues after defining the research questions.Results:73 eligible studies were eventually included. It was found that the most frequently explored issues were a lack of guidance and support from methodological and statistical experts at the project initiation stage (60.9%), a lack of research funding or improper funding management at the project implementation stage (49.3%), mismanagement of archival materials at the project completion stage (70.0%). Meta-analysis results showed that after evidence synthesis, the incidence of irregular informed consent signing, untraceable raw data, delayed study progress, and protocol violation were all above 40%, but there was heterogeneity in the results.Conclusion:Some outstanding issues in IIT quality management need to be addressed. Future studies should conduct more practical research to obtain quantitative data, undertake demonstrative application of management protocols, further carry out pioneering exploration and research in the field of IIT quality management, and propose effective solutions and strategies to improve IIT quality.