ClinicalTrials.gov Compliance: Absent Regs, Enforcement Of Reporting Still Lags
The National Institutes of Health is still drafting regulations, but Rep. Markey’s TEST Act, which would impose more extensive reporting requirements, has won praise from stakeholders for some of its definitional details. In an election season, its prospects for passing are slim, but aspects of the legislation could serve as a model for pending regulations.
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JAMA studies focus on the high number of terminated and unreported trials, plus discrepancies in publicly reported trial results. Publication comes as the Institute of Medicine consults stakeholders about trial data sharing and ahead of new reporting laws in Europe.
The global push towards clinical trial registration and transparency hasn’t ended the problem of “hidden trials,” the head of NIH’s ClinicalTrials.gov cautions. But the existence of registries helps better analyze the problem and offers some fairly simple steps to get closer to the goal of assuring that all clinical trials are available to the public.
Some advocates and researchers say that data availability could inform repurposing opportunities for products, but a GSK exec cautions that it could just as easily bring a flood of confusing information.