Abstract: Objective: To evaluate the quality of clinical trials in domestic and foreign enterprises during 2016-2020, and to provide reference for the standardization construction of clinical research on psoriasis in China. Methods: The drug clinical trials of psoriasis treatment were researched from Clinicaltrial.gov, Registration and Information Disclosure Platorm of Cencer for Drug Evaluation of China Food and Drug Administration and Chinese Clinical Trial Registry from January 1, 2016 to December 31, 2020. The standardization, methodological design and endpoint index of the study were analyzed. Results: A total of 123 and 314 clinical trials at home and abroad were collected. The rate of random allocation in domestic studies was 91.9%, which was higher than that in foreign studies (77.4%). Howerver, the rate of cases fewer than 100 in domestic studies was 49.6%, which was higher than foreign studies (43.9%). Parallel control was the most common method at home and abroad. In foreign countries, 32.2% of clinical trials were the four-blind design, and 44.7% of domestic clinical trials were double-blind. PASI as evaluation methods to access the efficacy in 19.5% of domestic studies and 28.0% of foreign studies. Conclusion: The quality of clinical trials in China has been greatly improved, but there is still a gap compared with the international advanced level. Attention should be paid to the design and implementation of clinical trials in China to improve the overall quality of clinical trials in China.

Key words: psoriasis, clinical trial, norm, quality evaluation, systematic analysis