Analysis on common problems and reporting standards of clinical trial protocols in China

Objective To provide a suggestion for physicians participating clinical research of how to write a clinical trial protocol correctly and standardly in the course of clinical trial design. Methods By exploring clinical trial protocols, we analyzed their common problems in the methodological details and the reporting standards with respect to typical cases. Results The common problems in the clinical trial protocols are: lack of clear outline when selecting the research subject; incorrect selection of research type; lack of comprehensiveness and accuracy of PICO elements; inappropriate application of methodologies in randomization and blinding; absence of statistical analysis plan; incorrect calculation of sample size; non-standard format of the protocol etc. Conclusions Many clinicans do not have enough understanding of the key points in designing the clinical trial and writing the protocol. However, the quality of the clinical trial protocol determines success or failure of the whole study. Therefore, carefully handling the technical details of PICO elements, methodology and statistics application, and writing the protocol in accordance with the CONSORT (Consolidated Standards of Reporting Trials) 2010 and SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 Statements, are the key points that each clinical researcher should pay attention to. Key words: Clinical trial; Protocol; Reporting standards