Ethical review reporting of Chinese trials records in World Health Organization primary registries

Article type
Authors
Xuemei L1, Li Y2, Shangqi S3, Shawna W3
1Chinese Journal of Evidence-Based Medicine, West China Periodicals Press, West China Hospital of Sichuan University, Chengdu, China
2Chinese Evidence-Based Medicine Center, West China Hospital of Sichuan University, Chengdu, China
3West China School of Medicine Sichuan University, Chengdu, China
Abstract
Background: Ethic review reporting in trial registration record is one of way to improve the transparency of trials to protect the participants. Objective: To investigate the report rate of ethical review in the registered Chinese trials records. Methods: We identified Chinese trials record in WHO primary registries and clinicaltrials.gov to July 14, 2009. We calculated the report rates of ethical review and each of the 20 items in WHO s Trial Registration Data Set. We assessed correlation of the item s report rate with the ethical review report rate. We also searched PubMed, EMBASE, CNKI, and CBM (from the establishment of each database to July 14, 2009) to collect the full texts of completed trials to calculate the report rate of ethical review in the result publications. Results: A total of 1247 records were identified, and 687 (55.1%) reported ethical review. The records reporting secondary sponsor(s), contact for public queries, and key secondary outcomes were more likely to report ethical review information (66.3% vs. 44.3%, 38.1 vs. 28.5%, 53.9 vs. 51.8%). The ethical review report rate of trials sponsored by industry was lower than those sponsored by non-industry (40.9% vs. 51.9%).The report rates of ethical review for self-supported trials (83.5%) and trials with unidentified sources of monetary or material support (66.7%) were lower than the average ethical review report rate for records in the Chinese Clinical Trial Registration Center (ChiCTR). The ethical review report rate was not high in the result publications (84.3% in clinicaltrials.gov, 50.0% in ChiCTR). Conclusion: Registered Chinese trials record report ethic review inadequately. Incomplete registration is correlated with not reporting ethical reviews. Medical Journal should inspect ethic review more critically.