US Government Cracks Down on Clinical-Trials Reporting

Hiding negative results and harmful side effects that occur in clinical trials would become harder in the United States under regulations proposed on 19 November by the US National Institutes of Health (NIH) and the Food and Drug Administration (FDA).

One proposal would require companies seeking the FDA’s approval of a new drug or therapy to post all clinical-trial results to the government website ClinicalTrials.gov, even if the treatment being tested is never approved; current law mandates this only for drugs that are approved. Companies and researchers that do not comply with the deadlines set out in the proposal could face fines of US$10,000 per day.

The second proposal would require that any NIH-funded research on interventions, not just drugs, be registered and reported on ClinicalTrials.gov. The rule would apply to surgical techniques and behavioural interventions such as anti-smoking programmes.

And for the first time, federally funded researchers will be required to post the results of their phase I clinical trials. Noncompliant institutions could have their NIH funding withdrawn.

The regulations are intended to close a loophole in...