NIH cites European precedent in call for disclosure of clinical trial data

NIH Director Francis Collins

The push for publication of more clinical trial data has made the leap beyond Europe. If the U.S. National Institutes of Health (NIH) gets its way, any researcher it funds will have to publish a summary of their results and adverse events, regardless of whether the trial succeeded or failed.

The NIH views the proposal as a way to start correcting publication bias--which results in the public never seeing negative trial results--and maximizing the value of the clinical data it helps to generate. Data from trials that failed could help researchers avoid repeating unsafe or unsuccessful trials, while also giving them guideposts for designs of future studies. The NIH has already mandated the sharing of other types of results--such as data from genomics projects it funds--but clinical trial disclosure has lagged behind.

Efforts in Europe to make companies disclose more clinical trial data cleared some of the obstacles the NIH was facing. "We believe that if clinical trial results information is available via another publicly accessible data bank (such as [European database] EudraCT), a number of the concerns that have been expressed about disclosure in ClinicalTrials.gov would no longer be applicable," the NIH wrote in the proposed rule.

The actions taken by European politicians have shifted the tone of the transparency debate. And the harmonization of common data elements between EudraCT and ClinicalTrials.gov lessens the validity of one of the technical objections to the NIH proposal. The NIH thinks it should be relatively simple for any organization that is adding data to the European system to also submit files to ClinicalTrials.gov.

The NIH is accepting feedback on the proposal until February 19.

- read the proposal
- check out Bloomberg's take
- and FierceBiotech's coverage

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