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Clinical Trial Tell-All

Unsuccessful clinical trials almost never see their results published, but new rules from the US Department of Health and Human Services and the NIH are going to change the fate of these disappointments, Nature News says.

In a bid to increase transparency around clinical trials conducted in the US, the agencies now say that the design and results of all clinical trials must be disclosed, regardless of their success or failure, Nature News reports. Further, the government now has the power to enforce penalties for non-compliance. "The NIH rules apply only to work done through agency grants, and include stricter reporting requirements for phase I trials," Nature News says. "If institutions don't follow the rules, the NIH could withdraw their funding."

Trials must now be registered on within 21 days of patient enrollment, Nature News reports — researchers will no longer be allowed to wait for results before reporting data. Further, there are now more stringent requirements for researchers to report in detail how they will conduct trials, including which stats they'll use in analyzing the results. This should cut down on the problems of p-hacking, Nature News says.

"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," Robert Califf, head of the US Food and Drug Administration (FDA), tells Nature News. "This is fundamentally an ethical issue."

The new rules go into effect on Jan. 18.