The Systemic Lupus Erythematosus Interventional Trials in Mainland China: A Continuous Challenge

ObjectivesMore than a quarter of single-country systemic lupus erythematosus (SLE) interventional randomized clinical trials (RCTs) were conducted in China. To help develop management guidelines and set benchmarks for future SLE research, a systematic review of current trials is needed. MethodsWe searched systematically three databases and four registries to summarize the interventional RCTs in mainland China and identify factors associated with participant loss. The internal validity of trials was assessed using the Cochrane risk-of-bias tool for assessing risk of bias. The odds ratio (OR) was defined as the ratio of the odds of less than 10% loss to follow-up in the presence or absence of different factors. ResultsA total of 188 trials met our inclusion criteria, and 15 center dot 5% of trials conducted in mainland China ranked low risk of bias. Participant loss was significantly higher among trials that had a defined primary outcome or were registered {primary outcome identification (0 center dot 02 [0 center dot 00-0 center dot 23]) and registration (0 center dot 14 [0 center dot 03-0 center dot 69])}. Trials examining traditional Chinese medicine (TCM) pharmacological treatments had an 8 center dot 16-fold (8 center dot 16 [1 center dot 28-51 center dot 98]) higher probability of having low participant loss than trials examining non-TCM pharmacological treatment trials, and trials that did not report masking status had a 15 center dot 95-fold (15 center dot 95 [2 center dot 45-103 center dot 88]) higher probability of having low participant loss than open-label trials. In addition, published articles in Chinese also had higher probability of having low participant loss (5 center dot 39 [1 center dot 10-26 center dot 37]). ConclusionSLE trials conducted in mainland China were of relatively poor quality. This situation, including nonrigorous design, lack of registration, and absence of compliance reporting, needs to be ameliorated. To maintain the fundamental repeatability and comparability of mainland China SLE RCTs, transparency of the clinical trial process and complete reporting of the trial data are crucial and urgently needed.