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Establishing the Chinese Clinical Trial Registration and Publishing Collaboration

Date: Thursday 1 November 10.45–12.15
Source: Forum 11
Authors: Li Youping, Director, Chinese Evidence-Based Medicine Centre, West China Hospital, Sichuan University, People's Republic of China
with Taixiang Wu, Guanjian Liu and Jing Li

Abstract

The global clinical trial registration system has been established by the World Health Organization but most Chinese clinical trials are conducted with poor methodology and reporting. This situation reflects the need to establish a special system to improve trial registration in the country.

The establishment of the Chinese Clinical Trial Registration and Publishing Collaboration (ChiCTRPC) has been initiated. The collaboration consists of three functional groups: 1) Chinese Clinical Trial Register (ChiCTR): registers trials, gives advice on writing trial protocols and articles, trains editors of medical journals, performs centre randomization, and acts as a quality controller for design and methodology at the beginning of trials; 2) Chinese Evidence-Based Medicine Centre/ Chinese Cochrane Centre/INCLEN CERTC Local Centre: offers a technical support platform, and acts as an expert resource; 3) Medical journals: publish only registered trials, publish articles according to their actual design and performance quality, act as quality controller for reports, to reflect the real situation at the end of trials.

The latest outcomes of these combined initiatives are as follows: 1) ChiCTRPC was established (April, 2006) by the following members: 48 medical journals, ChiCTR and the Chinese Cochrane Centre, the Chinese Evidence-Based Medicine Centre, and INCLEN CERTC Local Centre. Four more journals have since joined the journal group (currently 52 key Chinese journals); 2) A Joint Statement on Establishing the Chinese Clinical Trial Registration and Publishing System (Chengdu Statement) has been published; 3) The Chengdu Statement includes a declaration that from 1 January 2007, member journals of ChiCTRPC shall preferentially publish registered trials, and will gradually phase out publication of non-registered trials.