[Preliminary development of a competency evaluation framework for experts in investigator-initiated trials quality...

This study employed literature review and brainstorming methods, informed by practical experience in the quality evaluation of clinical research within the infectious diseases domain, to preliminarily establish an assessment framework titled "Investigator-Initiated Trials (IIT) Quality Evaluation - Expert Evaluation Status" for the construction of an expert database. Two rounds of Delphi consultation were conducted with 15 experts. The final framework for evaluating expert competency was determined based on the experts' familiarity with IIT project evaluation indicators, clinical research methodology, regulatory requirements for IITs, as well as their domain knowledge and awareness of cutting-edge developments. The finalized framework consisted of four primary indicators, eleven secondary indicators, and thirty-one tertiary indicators. The reliability of the consultation process and the validity of the framework were assessed using a Likert 5-point scale combined with predefined screening criteria. The positive coefficients for both rounds of expert consultation exceeded 90%, and the expert authority coefficients were 0.92 and 0.87, respectively. Kendall's coefficient of concordance indicated statistically significant consensus among the experts. The IIT quality evaluation expert competency assessment framework was demonstrated to be scientific, reliable, and practical. It provides an effective tool for standardizing expert database management and enhancing the quality of evaluation activities, thus supporting the high-quality development of investigator-initiated trials.