Article type
Year
Abstract
Background: The number of published 'randomized controlled trials (RCT)á, as reported by their authors, increased quickly in past years in China. Authors of this paper, found that only about 7% of those trials were authentic RCTs and that only about 0.2% were submitted to an ethics review committee.
Objective: Aiming to improve the quality of clinical trials in China, a series of strategies and measures have been developed and are being implemented by the authors.
Methods: 1. Promoting transparency of clinical trials in three ways: prospective registration of the trial before recruting participants, making the trial process transparent and promoting reporting on the quality of the trial. 2. Improvement ethics review committees and increase submission to these bodies.
Results: A clinical trials quality control system has been established and is functioning in China: 1. The Chinese Clinical Trial Registry (ChiCTR) was established in October, 2004 becoming a Primary Registry for WHOás ICTRP in July, 2007. Registration in ChiCTR is free. Up to 30 March, 2011, more than 1200 trials have been registered. 2. The 'Chinese Clinical Trial Registration and Publication Collaboration (ChiCTRPC)á was initiated in June 2006 amongst ChiCTR and 48 key Chinese medical journals aiming to promote a policy that would make trial registration mandatory in China. 3. The Clinical Trial eCRF System was established to offer management of raw data of clinical trial on a voluntary basis. In this system the case records and the real-time results of the trials are sent to a central deposit, the raw data and calculated data, except the private information of the participants, can be publicly accessed. 4. The Chinese Ethics Committee for Registering Clinical Trials (ChiECRCT) was established in 2008 to review trial registration. 5. Cooperation with the CONSORT group and EQUATOR has been established to promote the use of the CONSORT guidelines in China.
Conclusions: A comprehensive management system of clinical trials in China has been established by the authors.
Objective: Aiming to improve the quality of clinical trials in China, a series of strategies and measures have been developed and are being implemented by the authors.
Methods: 1. Promoting transparency of clinical trials in three ways: prospective registration of the trial before recruting participants, making the trial process transparent and promoting reporting on the quality of the trial. 2. Improvement ethics review committees and increase submission to these bodies.
Results: A clinical trials quality control system has been established and is functioning in China: 1. The Chinese Clinical Trial Registry (ChiCTR) was established in October, 2004 becoming a Primary Registry for WHOás ICTRP in July, 2007. Registration in ChiCTR is free. Up to 30 March, 2011, more than 1200 trials have been registered. 2. The 'Chinese Clinical Trial Registration and Publication Collaboration (ChiCTRPC)á was initiated in June 2006 amongst ChiCTR and 48 key Chinese medical journals aiming to promote a policy that would make trial registration mandatory in China. 3. The Clinical Trial eCRF System was established to offer management of raw data of clinical trial on a voluntary basis. In this system the case records and the real-time results of the trials are sent to a central deposit, the raw data and calculated data, except the private information of the participants, can be publicly accessed. 4. The Chinese Ethics Committee for Registering Clinical Trials (ChiECRCT) was established in 2008 to review trial registration. 5. Cooperation with the CONSORT group and EQUATOR has been established to promote the use of the CONSORT guidelines in China.
Conclusions: A comprehensive management system of clinical trials in China has been established by the authors.