Transparency of Chinese trials: The results are fully published after registered in WHO primary registries?

Article type
Authors
Xuemei L1, Li Y1, Senlin Y1, Shangqi S1
1Chinese Cochrane Centre, Chinese Evidence-Based Medicine Center,West China Hospital of Sichuan University, Chengdu, Sichuan, China
Abstract
Background: Full result publication is one of the main way to improve trial transparency. Objective: To investigated the result publication rate of Chinese trials registered in WHO primary registries. Method: We searched 11WHOprimary registries to screen the registration record of Chinese trials. The progress of each trial was analyzed. We searched the results full texts by tracing the result publication citations in the registration record. For completed trials without citation, we searched PubMed, EMbase, Chinese Biomedical Literature Database (Chinese), China Knowledge Resource Integrated Database,Chinese Science and Technology Periodicals Database by key words and registration number to find the result publication. We called the authors of completed trials of unavailable results publication by systematic search to ask for the results publication. Results: A total of 1294 Chinese trials records were identified. We analyzed the results publication of 1171 (428 in ChiCTR and 743 in clinicaltrials.gov) records. The results publication rates of Chinese trials in clinicaltrials.gov and ChiCTR were 36.6% (53/145) and 36.3% (89/245) respectively. The results publication rate of trials sponsored by industry was lower than sponsored by non-industry(24.1% vs. 42.1%). Publication rate of non-randomized trialswas higher than randomized trials (23.7% vs. 19.6%). Publication rate of interventional study was higher than observational study(38.5% vs 32.1). Conclusion: Result publication rate of registered Chinese trial was low with no significant difference between ChiCTR and clinicaltrials.gov. Effective mechanism is needed in China to promote the result publication based on trial registration system.