Government and Regulations

Despite requirement, only 13% of clinical trials report results


 

FROM THE NEW ENGLAND JOURNAL OF MEDICINE

References

Only 13% of the clinical trials legally required since 2007 to report their findings to ClinicalTrials.gov actually do so, according to a report published online in the New England Journal of Medicine.

The Food and Drug Administration Amendments Act requires sponsors of most clinical trials to register and report their basic summary results within 1 year of either completing data collection for the primary outcome or of terminating. Failure to report study findings is punishable by sanctions including civil penalties of up to $10,000 per day and loss of funding.

The reporting regulation “reflect[s] the ethical obligation of researchers and sponsors to respect human trial participants through fidelity to commitments made explicit in informed consent: namely, to make results of trials available to contribute to generalizable knowledge,” said Dr. Monique L. Anderson of the Duke Clinical Research Institute, Durham, N.C., and her associates.

The law was enacted because of public concern that sponsors and investigators were “selectively publishing trials that favored interests of the sponsors, and that journals were selectively reporting positive findings.” Among other detriments, the failure to report results could harm participants in similar studies by failing to warn them of possible risks, the investigators noted.

They assessed compliance with the law more than 5 years after it was enacted, using a National Library of Medicine algorithm to identify 13,327 eligible clinical trials that were either completed or terminated during 2008-2012.

Only 13.4% of them reported their results within 1 year, and only 38.3% reported their results at any time during the study period (N. Engl. J. Med. 2015;372:1031-9). Moreover, “despite ethical mandates, statutory obligations, and considerable societal pressure, most trials that were funded by the NIH or other government or academic institutions ... have yet to report results at ClinicalTrials.gov, whereas the medical-products industry has been more responsive to the legal mandate,” the researchers explained.

At 1 year, the rate of reporting was 17.0% for industry-sponsored trials, 8.1% for NIH-funded trials, and 5.7% for other government- or academically funded trials. The corresponding rates of reporting at 5 years were only slightly better, at 41.5%, 38.9%, and 27.7%, respectively.

Phase I, II, and III clinical trials were the less likely than phase IV trials were to report their results in a timely fashion. These earlier-phase studies “are primarily focused on proof-of-concept demonstrations and as such represent valuable, closely guarded intellectual property,” Dr. Anderson and her associates said.

Despite the regulation’s threat of penalties, no enforcement has yet occurred, the researchers noted, in part because this portion of the FDA Administration and Amendments Act is still under public discussion and hasn’t been finalized.

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