Third of NHLBI-funded trials never see timely publication

More than one third of cardiovascular-related randomized controlled clinical trials funded by the National Heart, Lung, and Blood Institute (NHLBI) were published within 30 months of their completion, according to an analysis published Nov. 14 in the New England Journal of Medicine.

A team from NHLBI led by David Gordon, MD, PhD, evaluated publication results from 244 institute-funded cardiovascular trials that completed data collection between 2000 and 2011. All the trials were registered on ClinicalTrials.gov. They looked for publication dates for online or print, whichever appeared first, through March 31, 2012. They also reviewed citation counts through the end of 2012.

They determined that 57 percent of trials had primary endpoints published within 30 months after completing the trials. Trials that focused on clinical endpoints and that had higher costs were more likely to receive early publication. Trials with clinical endpoints and costs higher than $5 million had 82 percent of the total citations of papers reporting main results.

Failing to publish results shortchanges the public and medical community who would benefit from the knowledge gained, the authors emphasized. They wrote that investigators, funders, peer reviewers, journals and others share the blame for this problem.

They didn’t let the NHLBI off the hook, either.

“[W]e acknowledge that the NHLBI, working in concert with other parties, could play a more active role in better understanding the proximate and root causes of the delay in publication of trial results, in redirecting our funding priorities toward the trials that are most likely to be published quickly and to have high impact within the biomedical community, and, when appropriate, in communicating to grant and contract recipients our expectation of timely publication.”