The strategies and measures of promoting improvement of the quality of clinical trials in China

Article type
Authors
Wu T1, Abudou M1, Yang X1, Zen X1, Wang Q1, Hao Y1, Kong X1, Li Y1
1Chinese Cochrane Centre, Chinese Clinical Trial Registry, Chinese Evidence-Based Medicine Centre, INCLEN Resource and Training Center in West China Hospital, West China Hospital, Sichuan University
Abstract
Background: Numbers of authors so called randomized controlled trials (RCT) were published and grown quickly in past years in China. We have found that only about 7% of them were authentic RCTs; we also found that only about 1% clinical studies were reviewed by ethics committee. There is potential risk of misleading health care providers, patients, health policy decision makers and systematic review authors by the false information. For the purpose of improving the quality of clinical studies of China, we have developed and are practicing series strategies and measures. Methods: 1. Promoting transparency in three stages of clinical trials: register the trial before beginning of a trial, transparent the processing of trial, promoting good reporting practice of the trial. 2. Promoting improvement and practicing of the ethics review system in China. Results: A clinical trials quality control system has been constructed and working in China: 1. We established Chinese Clinical Trial Registry (ChiCTR) in October, 2004, register free clinical trials. ChiCTR jointed WHO ICTRP to be a Primary Registry from July, 2007. Up to now, 810 trials have been registered. 2. We initiated Chinese Clinical Trial Registration and Publication Collaboration (ChiCTRPC) in June 2006 by ChiCTR and 48 key Chinese medical journals aim to promote using of mandatory policy of trial registration in China. 3. We established a voluntary use ChiCTR eCRF System for providing a free service of management of clinical trial raw data. In which system, the case records and the real-time results of the trials to be sent to the central depositor, the raw data and calculated data except the private information of the participants can be public accessed. 4. We established Chinese Ethics Committee of Registering Clinical Trials (ChiECRCT) in 2008 to review the registering trials those do not be reviewed by other ethics committees.