Academic journal article
By Adams, Martin
Bulletin of the World Health Organization , Vol. 85, No. 9
Medical research--Information management
Medical research--International aspects
Clinical trials--Information management
Clinical trials--International aspects
Registries (Medicine)--International aspects
China's acceptance, along with India, into the new WHO International Clinical Trials Registry Platform will help spur greater transparency and registration of research involving human's in the world's most populous country. But much work is needed to bring China's trial standards up to standard.
Chinese scientists for years have conducted unregistered clinical trials on humans that have raised concerns about the level of controls and transparency in place, as well as the kinds of safety standards available to trial subjects.
But the World Health Organization's July 2007 addition of recently launched Chinese and Indian registers into its new global clinical trial network has raised hopes that medical research standards would start benefiting from greater scrutiny.
The WHO International Clinical Trials Registry Platform was launched in May 2006 to bring different clinical trials registers from around the world into one network. It aims to increase the transparency and accountability of clinical research conducted by companies and institutions, and thus boosts public trust and confidence in that research. The initiative follows a number of high-profile cases in developed countries, where negative research results were withheld from the public.
Chinas new state-backed registry, known as the Chinese Clinical Trial Register, was launched in 2005 in response to calls for greater transparency of the clinical trial process in the world's most populous country. It is run by the Chinese Evidence-Based Medicine Centre, sponsored by institutions such as the state-run Sichuan University and Chinese Ministry of Health, and was designated by the government to join the WHO platform.
Associate Professor Taixiang Wu, administrator of the register, estimated at least 30 000 clinical trials were performed annually in China, but information on them is limited. Since 2006, some Chinese researchers have been registering their trials at http://www.ClinicalTrials.gov, a web site run by the United States of America National Institutes of Health, or at the International Standard Randomised Controlled Trial Number scheme sponsored by the Medical Research Council in England, which aims to simplify trial identification and improve reporting traceability. But despite this recent trend, most trials in China remain unregistered, Wu said. Fewer than 300 current Chinese trials have been recorded in international registers that contributed research to WHO.
The new Chinese register "aims to help trialists (i.e. researchers) correctly report their trials to let the public know how the trial was planned and detail its results", Wu told the Bulletin.
Its aim is to encourage widespread trial registration within China, a country where millions live in far-flung regions and where close scrutiny and consumer activism for improving medical procedures are weak. The Chinese register faced a "very big challenge", Wu acknowledged.
Dr Davina Ghersi, WHO platform coordinator, said bringing China and India into the network was "extremely important because of the vast populations in those two countries, the amount of research that is being done there, and the need to meet the needs of the populations of the two countries". …