Last week, the Journal of the American Medical Association ran a Viewpoint article from Francis Collins, MD, PhD, director of the National Institutes of Health and Kathy Hudson, PhD, deputy director of NIH, about the U.S. Health and Human Services’s plans to beef up transparency of clinical trials of FDA-regulated drugs and devices.
As they write, the rate of results-sharing for clinical trials is fairly dismal. Some of the reasons for this go beyond researchers; for example, it’s extremely difficult to get negative results published in scientific journals. Collins and Hudson point out that another avenue exists for sharing summary results: NIH’s ClinicalTrials.gov website. But even there, less than one-third of researchers had shared results within four years of the end of their studies. Collins and Hudson are critical of this lapse in data sharing:
Without access to complete information about a particular scientific question, including negative or inconclusive data, duplicative studies may be initiated that unnecessarily put patients at risk or expose them to interventions that are known to be ineffective for specific uses. If multiple related studies are conducted but only positive results are reported, publication bias can distort the evidence base. Incomplete knowledge can then be incorporated into clinical guidelines and patient care. However, one of the greatest harms from nondisclosure of results may be the erosion of the trust accorded to researchers by trial participants and, when public funds are used, by taxpayers.
The new rules make the expectations to report some summary details about clinical trials, including adverse events, explicit. Although NIH has always encouraged sharing of summary results, the rules haven’t always been explicit. Now that there will be detailed guidance, the penalty for not complying will be harsher:
Thus, with the implementation of clearer requirements, augmented support materials and resources, and facilitated reporting, the NIH expects that investigators and sponsoring organizations will have the necessary tools to provide accurate, complete, and timely trial results submissions. However, for grantees who are subject to the amendments act and fail to comply after sufficient notification, the law is clear that NIH and other federal funders of clinical trials must then withhold further funding for the grant and any future grant to the grantee. In addition, the timely reporting of clinical trials will be taken into consideration during review of subsequent applications for funding.
The proposed changes to the regulations are currently in the public comment period, which will end in a few weeks, on February 19. After a review of the comments (and possible revisions), a final rule will likely be issued in a few months time. Once the rule goes into effect, it will be interesting to watch how this changes the research process for new NIH and FDA-regulated studies.
Previously: Shake up research rewards to improve accuracy, says Stanford's John Ioannidis, Re-analyses of clinical trial results rare, but necessary, say Stanford researchers, How important is it to publish negative results?, Researchers call for "democratization" of clinical trials data and A critical look at the difficulty of publishing "negative" results
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