US toughens rules for clinical-trial transparency

From Nature:

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New rules on reporting the results of clinical trials should bring more transparency to the process.

The disappointing results of clinical trials will no longer be able to languish unpublished, thanks to rules released on 16 September by the US Department of Health and Human Services (HHS) and the US National Institutes of Health (NIH).

The long-awaited changes to the HHS clinical-trial disclosure laws requires, for the first time, that researchers report the design and results of all clinical trials and empowers the government to enforce penalties for those that do not comply. The NIH rules apply only to work done through agency grants, and include stricter reporting requirements for phase I trials. If institutions don’t follow the rules, the NIH could withdraw their funding.

“I think a lot of major universities just miss the point that if you do an experiment on a person and get consent, you really have the obligation to make the results known,” says Robert Califf, head of the US Food and Drug Administration (FDA). “This is fundamentally an ethical issue.”

Both sets of rules are intended to crack down on the large number of clinical trials that are conducted but never reported. They go into effect on 18 January, and researchers will have 90 days to comply.

Under a 2007 law, researchers conducting trials with human subjects had to register their study with an HHS website called before they started their work. The site, which has more than 225,000 entries, is the largest such repository in the world. At the time, researchers had to include information about their methods and results, but there were so many exceptions and loopholes — such as trials that obtained FDA approval for their therapies could register after the fact — the law was hard to enforce.

That ambiguity …

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