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Shaping the Future of Clinical Trial Data Sharing

THE SPRINT CHALLENGE IS ON.  Opening on November 15, the SPRINT Data Analysis Challenge explores the potential of clinical trial data sharing by challenging individuals and groups to identify a novel scientific or clinical finding using the SPRINT article data. Entries will be judged by an expert panel of leaders in clinical research, data analysis/statistics, and patient advocacy and the three best will be presented at the Aligning Incentives for Sharing Clinical Trial Data summit in Boston, MA on April 3–4, 2017.

MedTech Boston sat down with Dr. Jeffrey Drazen, editor-in-chief at the New England Journal of Medicine to discuss the upcoming challenge.

What is the SPRINT data set and why did you decide to make it public?

The data are from the SPRINT article, “A Randomized Trial of Intensive versus Standard Blood-Pressure Control.”  In November 2015, we published the trial’s initial results. The trial was stopped early, in September 2015, because of a benefit to the patients who had the extra blood pressure lowering.

At that time, there was a call from the community for the data to be made public, but this couldn’t happen because the investigators hadn’t had a chance to analyze them. The SPRINT investigators and the National Heart, Lung, and Blood Institute (NHLBI) worked with us to make the data in the NEJM paper available to the public. It’s relevant to mention that this occurred a year earlier than the NHLBI rules currently require.

What are your goals for the challenge?

The community has an opportunity to shape the future of clinical trial data sharing. The SPRINT Challenge is a step toward that goal. Also, we look forward to seeing if new insights or ideas can come from this dataset.  We hope that a novel scientific or clinical finding that advances medical science can arise.

The challenge is followed by a two-day web event—Aligning Incentives for Sharing Clinical Data Trial Summit.  How is this event related to the challenge, and what do you hope participants will take away from this event?

The top three Challenge entrants will win an opportunity to present their results at the Aligning Incentives for Sharing Clinical Trial Data summit hosted by NEJM in April 2017.

We hope that the summit will bring together three disparate constituencies — clinical trialists, data analysts, and patient participants — for an open conversation on clinical trial data sharing, and identify areas where alignment of incentives for responsible sharing of clinical trial data is possible and sustainable.

How is the access to big data sets changing medical research? What do you think this will do to the pace of research? What do you think this will do to the quality of research?

Clinical trials offer a source of rich medical data, and the availability of increased computing power and many more people trained to interpret it makes possible even more creative and informative uses of these data. It’s safe to expect that independent analysts will find within data gathered for one reason even more compelling, unanticipated applications.

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