Abstract:Objective To investigate the compliance status of subjects in drug clinical trials from multiple perspectives, analyze the influencing factors systematically, and establish a full-process subject protection system. Methods The data of 445 subjects from 40 clinical trials conducted in Zhongda Hospital Southeast University from June 2018 to June 2021 were enrolled and sorted out, and with clinical compliance and medication compliance as evaluation indicators， the influencing factors of subjects' compliance were analyzed from four aspects, including trial schemes, personal factors, treatment factors and others. Results Univariate analysis showed that the project type, number of follow-up, diary card design, treatment environment, and whether adverse events occurred were the influencing factors of the subjects' medication compliance (P<0.05)； the control design, age, and disease degree were the influencing factors of the subjects' clinical compliance (P<0.05)； and the trial stage, blinded design, trial cycle, route of administration, whether family members being accompanied or not, and whether serious adverse events occurred were the influencing factors of the subjects' clinical compliance and medication compliance (P<0.05). Conclusion Based on the analysis of the results, corresponding measures to improve the compliance of the subjects were summarized and put forward, such as optimizing the design of the trial scheme, perfecting the design of trial drugs, rationally screening the subjects, fully giving informed consent, establishing a good doctor-patient relationship, strengthening the compliance training of the subjects, and attaching importance to the management of the trial process.