Abstract: In recent years, many new DMARDs have been emerging, mainly in bDMARDs and tsDMARDs. With the increasing number of clinical trials, it is of great significance to strengthen the quality control of clinical trials. This paper analyzes the key points and difficulties in practice that the investigator should pay attention to in the b/tsDMARDs clinical trials, as well as the quality control concerns of the clinical trials of such drugs. Some methods are put forward to solve questions above in order to help improve the quality of such clinical trials.

Key words: DMARDs, clinical trial, investigator, quality control