Publication of NIH-funded Clinical Trials Lags

Less than half of a sampling of trials funded by the National Institutes of Health (NIH) were published within 30 months of completion, Yale School of Medicine researchers have found.

The researchers conducted a cross-sectional analysis of NIH-funded clinical trials registered online at ClinicalTrials.gov after September 30, 2005 and completed by December 31, 2008, allowing at least 30 months for publication.

In all, the researchers found that less than 50% of these trials were published in a peer-reviewed, MEDLINE-indexed biomedical journal within 30 months of completion. In one-third of the trials, publication still had not taken place 51 months after completion.

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

Ross noted that publication delays could be due to numerous factors, such as not getting a study accepted by a journal or not prioritizing the dissemination of research findings, but pointed out that there are alternative ways to make trial results available to the public, including simply uploading them to the database at ClinicalTrials.gov.

“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.

The study appears in the January issue of BMJ.