A requirement by leading medical journals for clinical trials to be registered before their results can be published has been an outstanding success and changed the culture of the research community, their editors have claimed.
The International Committee of Medical Journal Editors, representing 12 publications including the Medical Journal of Australia, introduced their policy in 2005. It aimed to ensure that information about the existence and design of clinical trials was publicly available - an ideal espoused by leaders in evidence-based medicine for decades.
The editors said their policy precipitated much angst amongst researchers and sponsors, who were worried that registration would be a burden and would stifle competition. "Yet, the response to this policy has been overwhelming," they said.
Many other journals has since adopted the requirement, and the number of registered trials had grown dramatically. There were about 13,000 trials listed in the largest of five approved registries (ClinicalTrials.gov) before the policy, growing to 22,000 a month afterwards and 40,000 by April 2007. About 200 new trials were added every week.
The World Health Organization was now providing an international clinical trial registry platform that would assist in providing reliable access to trial details, and standardise the information that was available. It would accept information from a growing range of primary registries, provided they were operated by not-for-profit organisations and attained the required quality standards.
Registration requirements applied to any research study that prospectively assigned human subjects to one or more health-related interventions and evaluated their effect on health outcomes. Interventions included not only medications, but also surgical procedures, devices, behavioural treatments, dietary interventions, and changes in processes of care. Purely observational studies did not require registration.
"Three years ago, trials registration was the exception; now it is the rule," the editors said. "Registration facilitates the dissemination of information among clinicians, researchers and patients, and it helps assure trial participants that the information that accrues as a result of their altruism will become part of the public record."
Reference
Laine, C. Horton, R. et al. 2007, 'Clinical trial registration. Looking back and moving ahead.' Medical Journal of Australia published online.
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