Investigator Compliance Quality Analysis on Clinical Research of TCM Prevention and Treatment for Chronic Diseases / 中国中医药信息杂志

ABSTRACT

Objective To explore ways and means to improve the investigator compliance through the evaluation and analysis of the investigator compliance of TCM clinical research projects of chronic diseases. Methods Totally 28 studies from the project Chinese medicine clinical study on prevention and treatment of chronic disease started in 2010 or 2011 and ended in 2015 were collected. The investigator compliance was analyzed by the evaluation form, which were drafted by quality control core team of TCM projects of chronic diseases, as research method performance, compliance of subjects inclusion and exclusion, integrity, accuracy and normalization of case report form in final quality evaluation for TCM clinical research on chronic diseases. Results There were 19 excellent studies according to investigator compliance, accounting for 67.9%, including 3 studies with ten score, accounting for 10.7%. There were 8 good studies according to investigator compliance, accounting for 28.6%. There was 1 study up to standard, accounting for 3.6%. 11 studies included unreasonable changes in the record during the process of implementation. 12 studies included missing in the filling of research records during the process of implementation. Conclusion In general, 28 studies of TCM linical research projects for chronic diseases show high investigator compliance. The existing problems are mainly found in the integrity and normalization of research records.