RESUMEN
Objectives: Quality can be a challenge for Investigator initiated trials (IITs) since these trials are scarcely overseen by a sponsor or monitoring team. Therefore, quality assessment for departments managing clinical research grants program is important and urgently needed. Our study aims at developing a handy quality assessment tool for IITs that can be applied by both departments and project teams. Methods: The framework of the quality assessment tool was developed based on the literature studies, accepted guidelines and the Delphi method. A total of 272 ongoing IITs funded by Shanghai non-profit organizations in 2015 and 2016 were used to extract quality indexes. Confirmatory factor analysis (CFA) was used to further evaluate the validity and feasibility of the conceptual quality assessment tool. Results: The tool consisted of 4 critical quality attributes, including progress, quality, regulation, scientificity, and 13 observed quality indexes. A total of 257 IITs were included in the validity and feasibility assessment. The majority (60.29%) were Randomized Controlled Trial (RCT), and 41.18% were multi-center studies. In order to test the validity and feasibility of IITs quality assessment tool, CFA showed that the model fit the data adequately. (CMIN/DF = 1.868, GFI = 0.916; CFI = 0.936; TLI = 0.919; RMSEA = 0.063; SRMR = 0.076). Different types of clinical studies fit well in the tool. However, RCT scored lower than prospective cohort and retrospective study in enrollment progress (7.02 vs. 7.43, 9.63, respectively). Conclusion: This study established a panoramic quality assessment tool based on the Delphi method and CFA, and the feasibility and effectiveness of the tool were verified through clinical research examples. The use of this tool can help project management departments effectively and dynamically manage research projects, rationally allocate resources, and ensure the quality of IITs.
