Many NIH-funded clinical trials go unpublished over two years after completion

In a study that investigates the challenges of disseminating clinical research findings in peer-reviewed biomedical journals, Yale School of Medicine researchers have found that fewer than half of a sample of trials primarily or partially funded by the National Institutes of Health (NIH) were published within 30 months of completing the clinical trial.

These findings appear in the January issue of the , which focuses on the topic of unpublished evidence.

"When research findings are not disseminated, the scientific process is disrupted and leads to redundant efforts and misconceptions about ," said Joseph Ross, M.D., first author of the study and a Yale assistant professor of medicine. "Such inaction undermines both the trial in question and the evidence available in peer-reviewed medical literature. This has far-reaching implications for , and even institutional review board assessments of risks and benefits associated with future research studies."

Ross and co-authors performed a cross-sectional analysis of NIH-funded clinical registered within ClinicalTrials.gov, a trial registry and results database maintained by the U.S. National Library of Medicine. All trials in the study sample were registered after September 30, 2005 and completed by December 31, 2008, allowing at least 30 months for publication following completion of the trial.

They found that overall fewer than half of NIH-funded trials in the sample were published in a peer-reviewed, MEDLINE-indexed biomedical journal within 30 months of trial completion. They also found that one-third of trials remained unpublished 51 months after completion.

Ross said that there may be many reasons for lack of publication, such as not getting accepted by a journal or not prioritizing the dissemination of research findings. Still, he said, there are alternative methods for providing timely public access to study results, including the results database at ClinicalTrials.gov that was created in response to Federal law.

"Steps must be taken to ensure the timely dissemination of publicly funded research so that data from all those who volunteer are available to inform future research and practice," Ross said.

While this study was focused on trials funded by NIH, Ross said that similar problems with non-publication and delayed publication of research findings have been described among trials funded by the pharmaceutical and medical device industries, as well as by non-profit organizations.

"This suggests that the current culture of research needs to prioritize the timely public dissemination of research findings, ideally via peer-reviewed journals, for research funded by both public and private sources," said Ross. "More work needs to be done to better understand impediments to publication."

More information: Brit. Med. J. doi: 10.1136/bmj.d7292

Related Stories

Half of trials supporting FDA applications go unpublished

Sep 23, 2008

Over half of all supporting trials for FDA-approved drugs remained unpublished 5 years after approval, says new research published in this week's PLoS Medicine. The most important trials determining efficacy, and those with s ...

Extensive publication bias for Phase I drug trials

Feb 18, 2009

A study published in this week's issue of the open-access journal PLoS Medicine suggests that, in comparison to other types of trials, the results of Phase I drug trials are far less likely to be published.

Recommended for you

Cold cash just keeps washing in from ALS challenge

9 minutes ago

In the couple of hours it took an official from the ALS Association to return a reporter's call for comment, the group's ubiquitous "ice bucket challenge" had brought in a few million more dollars.

Medtronic spends $350M on another European deal

15 hours ago

U.S. medical device maker Medtronic is building stronger ties to Europe, a couple months after announcing a $42.9 billion acquisition that involves moving its main executive offices across the Atlantic, where it can get a ...

Mind over matter for people with disabilities

Aug 26, 2014

People with serious physical disabilities are unable to do the everyday things that most of us take for granted despite having the will – and the brainpower – to do so. This is changing thanks to European ...

Ukraine's former world's tallest man dies

Aug 25, 2014

Ukraine's tallest man, who briefly held the world record but gave it up to live as a recluse, has died due to complications from the condition that saw him never stop growing, local media reported Monday.

User comments