研究者发起的临床研究风险评估与管控体系研究OA

Objective To construct and verify a full-process risk assessment and hierarchical control system for investigator-initiated trials(IIT)based on the risk management model.Methods Literature analysis was used to retrieve IIT-related literatures,research reports,and current management policies from databases including CNKI,WanFang,Web of Science,PubMed,and internet search tools,with the retrieval period from the establishment of each database to December 2023.A preliminary pool of IIT risk assessment standard items was established.Two rounds of expert consultations were conducted using the Delphi method to determine the final full-process IIT risk assessment indicators and hierarchical control system.Methodological evaluation was performed,and the practical effectiveness of the indicator system was verified by combining real-world study and Spearman correlation analysis.Based on the current status of IIT project management in prefecture-level hospitals,a classified and hierarchical control system was proposed according to different stages,assessment implementers,and risk levels.Results A Delphi expert consultation group consisting of 17 experts was formed,with the majority being female(12 cases,70.59%),having work experience>10 years(13 cases,76.47%),holding a master's degree(8 cases,47.06%),possessing senior professional titles(9 cases,52.94%),and serving as principal investigators in good clinical practice(GCP)(9 cases,52.94%).The positive coefficients(questionnaire recovery rate)of the two rounds of Delphi consultations were both 100%,the expert authority coefficients were 0.953 and 0.965,the expert opinion concentration degrees were 4.495 points and 4.709 points,and the coefficients of variation were 0.096 and 0.065,respectively.Finally,a full-process IIT risk assessment indicator system covering project approval,implementation,and conclusion stages was constructed,including 8 first-level indicators,20 second-level indicators,and 36 third-level indicators.Among the third-level indicators,there were 8 first-level risk points,21 second-level risk points,and 7 third-level risk points.Real-world verification showed that the constructed IIT risk assessment indicator system was significantly positively correlated with independent expert risk scores in the full process(ρ=0.894),project approval stage(ρ=0.706),implementation stage(ρ=0.761),and conclusion stage(ρ=0.780)(P<0.001).Differentiated control measures of"centralized management+hierarchical linkage"based on risk levels were proposed for prefecture-level medical institutions.Conclusion The constructed IIT risk assessment and control system has good practical effectiveness and evaluation consistency,which can provide standardized tool support for prefecture-level medical institutions in managing potential risk points of IIT and theoretical reference for regulatory authorities in formulating industry management norms.