Changing Rules for Reporting Clinical Trial Results
With ongoing criticism that public health may be harmed because too many trial results remain hidden away, the U.S. Department of Health and Human Services has proposed new rules that require researchers in industry and academia to post findings of all studies funded by the federal government on a publicly available website.
In a bid to make clinical trial results more widely available, the proposal would strengthen existing requirements that findings must be submitted to the website, which is known as clinicaltrials.gov.
National Institutes of Health (NIH) officials wrote in the Journal of the American Medical Association:
“The scientific community has a disappointing track record for dissemination of clinical trial results. This is a serious issue and the proposed rule underscores the intent of NIH to take strong action to promote timely dissemination.”
According to one source, fewer than half of all trials funded by the NIH were published in peer-reviewed journals within 30 months of completion and a third of completed trials remained unpublished after nearly four years.
A cross sectional analysis was undertaken of registry entries for unpublished trials to determine whether results for these studies were available in the database. The study results concluded:
Of 585 registered trials, 171 (29%) remained unpublished. These 171 unpublished trials had an estimated total enrollment of 299,763 study participants. Non-publication was more common among trials that received industry funding (150/468, 32%) than those that did not (21/117, 18%). Of the 171 unpublished trials, 133 (78%) had no results available.
Among this group of large clinical trials, non-publication of results was common. A substantial number of study participants were exposed to the risks of trial participation without the societal benefits that accompany the dissemination of trial results. Participation in trials should be accompanied by a commitment of the investigators to follow through, complete the study and share the results. Releasing data is the “necessary ingredient” to demonstrate value. Moreover, it is important that studies that support the clinical and financial goals of business not be cherry-picked over other trials that may show less favorable results.
Multiple publications of clinical trials in peer-reviewed journals are the gold standard of evidence-based research. As a result of the proposed policy change, another 600 to 650 NIH-funded trials would be required to post summary results to the website. This is a significant step forward.