Fed up with the lack of transparent clinical trial reporting, U.S. Rep. Tom Reed, a Republican from the state of New York, has introduced a bill that adds new teeth to requirements for trial results to be reported. The bill aims to require groups to publish both positive and negative results of cancer clinical studies, as part of a larger effort to find cures.
Drug developers often hide their clinical trial failures, and current rules for reporting results from federally funded research often aren't followed. But if Reed's bill became law, groups that fail to report the results of federally funded cancer studies would have to repay their grants to the Treasury and lose eligibility for future government research support, according to a statement. Good or bad, Reed wants the results published on ClinicalTrials.gov, the U.S. government's online directory of clinical trials.
Advocates for transparency in clinical trial outcomes argue that access to study results could help advance scientific knowledge and lead to faster development of new therapies. Reed's bill focuses on the largest area of drug development today--cancer treatment--and the premise of his bill is that wider sharing of study data could result in cancer cures. While this sounds like an oversimplification of efforts to combat a vastly complex disease, there's no denying that researchers often conduct redundant studies because they don't know about previous results of the same experiments.
"Public reporting of both positive and negative results will help other research be more effective and less duplicative," Reed said in a statement. "Enforcing the reporting requirement will not only lead to more available cancer research data, but also help every taxpayer dollar spent on research go further toward finding a cure."
- here's Reed's release
- check out Pharmalot's article
- and the report from FDA Law Blog