Transparency of clinical trial in China: strategy and foresight

Article type
Authors
Yang X, Zhuo Q, Zeng X, Yuan Y, Wu T
Abstract
Background: In June 2007, as the Ministry of Health of China sponsored national clinical trial register, the Chinese Clinical Trial Register (ChiCTR) joined the WHO International Clinical Trial Registry Platform (ICTRP) to one of five Primary Register, which symbolizes the founding of a clinical trial registration system with consolidated international standards in China. Strategies: In order to enhance the transparency of clinical trials, we initiated and implemented strategies as follows: (1) Pushing the registration of clinical trials for the purpose of promoting the trials quality at the protocol stage. Chinese EBM Center initiated the Chinese Clinical Trial Registration System in collaboration with 52 key medical journals in China and established Chinese Clinical Trial Registration and Publishing Collaboration (ChiCTRPC) with the Joint Statement of Establishing ChiCTRPC. This system is inaugurated to facilitate the public accessibility of the information on all clinical trials. We are calling on more key medical journals to join the ChiCTRPC and are contemplating to declare that only registered trials can be published in China. Hitherto, nearly 70 clinical trials have been registered and conducted under the guidance and supervision of ChiCTR. (2) Making consolidated international standards for reporting clinical trials aiming to promote the trial quality at the publication stage. In 2005, Chinese EBM Center was entrusted to lead Consolidated Standards for Reporting Trials of Traditional Chinese Medicine (CONSORT for TCM). We have launched the series of research on it and have provided the global standards for reporting trials of TCM. The establishment of CONSORT for Acupuncture is also on processing. (3) EBM education for medical staffs and dissemination of the medical practice model. EBM education will bring them evaluation standards and methods as well as the philosophy and behavior model of medical practice. The physician team which meets the international clinical medicine standard is the guarantee for quality improvement and sustainable development. We have offered EBM courses to several medical universities and research institutions. Transparency of clinical trials is a grand enterprise which calls for general concern, joint efforts and rigorous attitude. We firmly believe that an efficient, independent and transparent registry will be eventually established in China.