Many clinical trial results not shared, creating ‘blind spot’
Less than 40% of the results of clinical trials conducted at leading academic medical centers were shared within two years of completion, Yale School of Medicine researchers report in a new study published in the current issue of the British Medical Journal.
"Not only was performance poor, but there was significant variation across the academic medical centers we studied," said Dr. Nihar Desai, assistant professor of medicine, section of cardiology at Yale School of Medicine and a researcher at the Yale Center for Outcomes Research and Evaluation.
Desai said randomized clinical trials are the gold standard in terms of testing the efficacy and safety of drugs, devices, and treatment strategies, so disseminating the results is of vital importance.
"Researchers also have an ethical responsibility to the patients enrolled in the study to make the results available," he said. "Providers and patients will never be able to make evidence-based health care decisions if the data is not in the public domain. In addition, future research cannot benefit from what other researchers have already done if results are not reported and/or published in a timely fashion."
Desai and his co-authors previously studied the rates of results reporting and publication of clinical trials sponsored by the National Institutes of Health and by pharmaceutical companies. They decided to extend that prior work by looking at the dissemination of clinical trial results across leading academic institutions. The team reviewed over 4,300 clinical trials and examined how many were published or had results reported on ClinicalTrials.gov within 24 months of the studies' completion.
The team saw a three-fold variation in performance, with some institutions disseminating 16% of their completed clinical research, while others disseminated 55%.
"This is yet another blind spot in the clinical research enterprise, and we hope our findings will serve as a call to action," said Desai. "Academic medical centers are uniquely positioned to lead this effort. They are dedicated to generating knowledge to improve health and health care. We hope our study will lead to a renewed commitment to our professional values and the mission of academic centers to not only conduct rigorous scientific investigation, but to share the results in a timely and transparent fashion."
Other authors on the study included first author Ruijun Chen, Joseph S. Ross, Weiwei Zhang, Katherine H. Chau, Brian Wayda, Karthik Murugiah, Daniel L. Lu, Amit Mittal, and senior author Harlan M. Krumholz.
Karen N. Peart