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US to impose tougher rules on reporting clinical trial data

BMJ 2016; 354 doi: https://doi.org/10.1136/bmj.i5060 (Published 19 September 2016) Cite this as: BMJ 2016;354:i5060
  1. Michael McCarthy
  1. Seattle

Researchers conducting clinical trials in the US will be required to provide more information about their studies when they initially register their trials and more detailed results upon their trials’ completion under two sets of new rules.

The rules were released on 16 September by the US Department of Health and Human Services1 and the National Institutes of Health (NIH).2

Francis Collins, director of NIH, said that the new rules will help maximize the value of clinical trials and fulfill researchers’ commitment to trial participants. “Access to more information about clinical trials is good for …

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