Doctors, researchers highlight importance of clinical trial data sharing

Data

The focus on sharing of clinical trial data is growing, and three recent perspective articles published in the New England Journal of Medicine this week break down the importance of transparency in the space and the direction in which the industry must go.

“As we work through these complex issues, we want to make it clear that the Journal is committed to making data sharing part of our everyday business,” NEJM editors write in a post introducing the perspectives.

Here’s breakdown of what each one addresses:

"Data Sharing at a Crossroads:" There must be a “simple one-stop shop for clinical trial data sharing,” say authors Frank Rockhold, Ph.D., Perry Nisen, M.D., Ph.D., and Andrew Freeman. Currently, they say, costs and resources for data sharing can be a major barrier for academic and smaller sponsors. They propose a system that would allow clinical trial data to be more easily shared. Study details and/or data, they say, would be sent to a third party, a “custodian,” who could manage scientific review and privacy. “This approach would require sponsors to give up their own effective systems but would realize economies of scale, helping to address cost barriers,” the doctors write.

"Toward a Shared Vision for Cancer Genomic Data:" The NCI Genomic Data Commons has the power to reshape the practice of precision oncology, the seven authors of this article write, and the commons must be embraced by healthcare players, including researchers, clinicians, regulatory agencies and patients. With the large amount of genomic data currently being collected, challenges can arise in storing and analyzing all the information; the GDC addressed those issues. It someday could expand to the point where collection of genomic data is routine in care, the authors say, and patients could become “cancer information donors” to allow their data to be shared through the commons.

"Incentives for Clinical Trialists to Share Data:" Among the barriers still at times holding back clinical data sharing is getting clinical trialists on board to do so, write Bernard Lo, M.D., and David L. DeMets, Ph.D. Many researchers are worried about sharing data, not wanting others to reap the rewards from their work. However, the authors say there are ways to address such concerns, including having funders and sponsors to offer resources of data sharing, incentives given to the trialists such as proper acknowledgment and rewards, even when the data is used by other researchers, and clarity on what secondary investigators’ responsibilities are when analyzing shared information.

In recent clinical trial data sharing efforts, the National Institutes of Health released a final rule to improve the transparency of clinical trial information and results. Last year the Institute of Medicine released a framework to further data-sharing for clinical trials.