The new requirements for mandatory registration of clinical trials in the Food and Drug Administration Amendments Act of 2007 signed into law by US President George Bush on 27 September represent “a critical advance in making clinical trials of new treatments public knowledge”, says an editorial in the latest New England Journal of Medicine.
Under Section 801 of the Act, trial sponsors are required to lodge details of all ‘controlled clinical investigations’, other than Phase I studies, of compounds subject to the Federal Food, Drug, and Cosmetic Act in clinicaltrials.gov, the existing on-line registry run by the US National Institutes of Health. Previously, only federally and privately funded studies of experimental treatments for “serious or life-threatening diseases and conditions” had to be included, while registration of any other trials was voluntary. The expanded NIH registry will also incorporate elements of clinical trial results.
Writing in the NEJM, editor Dr Jeffrey Drazen and colleagues welcome the broader scope of mandatory trial registration while acknowledging that some aspects of the provisions, such as the non-inclusion of Phase I studies, are “not ideal”. Nonetheless the new legislation does bring the US more into line with the International Committee of Medical Journal Editors, which demands that trials be registered before they are considered for publication, and the World Health Organisation’s International Clinical Trials Registry Platform, they note.
“A decade ago a clinical trial could be conducted in secret,” the editorial comments. “The trial’s sponsor, claiming proprietary rights, could keep all information about it, including its very existence, private. Thus, if a drug had important adverse effects, this information might never be made public. Legislators believed that such a possibility was not in the best interests of the American people.”
The greatest risk
With the new Act, Drazen et al say, the US has joined other other countries “in recognising that the human volunteers needed to complete a trial are more precious than the money required to mount it. Between study subjects and financial sponsors, it is easy to see who is taking the greater risk.”
Moreover, “fully open clinical trials will lead to more effective and safer treatments for patients”, they argue, pointing out that with “several recent blockbuster drugs, including rofecoxib [Vioxx], telithromycin [Ketek], and rosiglitazone [Avandia], serious breakdowns in the communication of trial results kept safety concerns from doctors and patients”.