Klinik araştırmadan yayın aşamasına geçen süre (İng)

From Clinical Trial to Publication Takes Close to 2 Years

Ricki Lewis, PhD

Mar 04, 2013 

Median time from completion of a clinical trial to publication of results in a peer-reviewed journal is 21 months, according to a study published online March 4 in JAMA Internal Medicine.

Past studies have shown that 50% to 75% of clinical trial results are published in peer-reviewed biomedical journals, most within 2 to 2.5 years. To update these findings, Joseph S. Ross, MD, from the Section of General Internal Medicine and Robert Wood Johnson Foundation Clinical Scholars Program, Department of Medicine, Yale University School of Medicine and the Center for Outcomes Research and Evaluation, Yale–New Haven Hospital, New Haven, Connecticut, and colleagues evaluated 1336 clinical trials listed at ClinicalTrials.gov that had been published in 2009. They imputed completion dates from participant enrollment dates and the longest follow-up allowed in assessing outcomes.

The clinical trials considered include all phases, different trial designs, and completion dates from 1998 to 2007. The dominant study conditions were cardiovascular diseases, cancers, and infections.

Median time to publication was 21 months, ranging from 13 to 32 months, and was shorter among trials enrolling 1000 or more participants. Time to publication was also shorter for trials published in journals with impact factors greater than 10.

Source of funding did not make a great difference in publication rates. The median for industry-sponsored trials was 24 months compared with 20 months for nonprofit organization and government funding.

The researchers conclude that the small differences among trial types indicate that “timely dissemination of research needs to be uniformly prioritized to enhance science.” They support current federal initiatives requiring reporting results within a year of completion of a clinical trial. However, the investigators point out how much must be accomplished during that year, including compiling data, performing statistical analysis, writing, preparing figures, and allowing time for peer review.

Limitations of the study are that it did not account for results presented in other ways, such as at professional meetings, or for results published in journals that do not require a ClinicalTrials.gov identifier.

“I heartily agree with the need to speed publication of clinical trial results. It’s not just academic, but directly impacts patient care decisions. All results, positive and negative, need timely reporting and discussion. This 1-year goal should be just a starting point,” Judy Stone, MD, an infectious disease specialist and author of Conducting Clinical Research: A Practical Guide for Physicians, Nurses, Study Coordinators, and Investigators, told Medscape Medical News.

Although the article avoids controversy, it is present, albeit between the lines.

“While Ross et al rightly point to the time necessary for careful assembly of a manuscript, and the vagaries of peer review, they inappropriately minimize differences across trial types, such as a new application of a drug vs use of gene transfer. Also, they fail to mention subjective factors influencing editorial decisions in high-impact journals, including personal notions of popularity or importance and a disdain of negative results,” Bruce Baum, PhD, DMD, director, National Institutes of Health Medical Research Scholars Program, told Medscape Medical News. The article also does not address risks of premature publication, such as not allowing time for an adverse effect such as cancer to show up.

Dr. Ross is on a scientific advisory board for FAIR Health Inc. One coauthor chairs a scientific advisory board for UnitedHealthcare, and one coauthor is a program analyst for ClinicalTrials.gov. Dr. Stone and Dr. Baum have disclosed no relevant financial relationships.

JAMA Intern Med. Published online March 4, 2013.