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To explore the potential of clinical trial data sharing, the New England Journal of Medicine (NEJM) is hosting a challenge: use the data underlying a recent NEJM article to identify a novel clinical finding that advances medical science.
Clinical trials drive medical advances and have a direct impact on health outcomes. Thoughtful, transparent systems for the responsible sharing of data are important in maximizing the contribution of the patients who put themselves at risk by participating in clinical trials.
The New England Journal of Medicine (NEJM) is hosting a summit on Aligning Incentives for Sharing Clinical Trial Data on April 3–4, 2017, in Boston, MA. As a respected global leader in publishing clinical trial results, NEJM seeks to initiate an open conversation among the three key constituencies — clinical trialists, data analysts, and patient participants — as well as government and funding agencies, to identify areas where alignment of incentives for responsible sharing of clinical trial data is possible and sustainable.
Leading up to the summit, NEJM is hosting a SPRINT Data Analysis Challenge to explore the potential benefits of sharing data from clinical trials. Individuals and groups are invited to analyze the dataset underlying the SPRINT article — A Randomized Trial of Intensive versus Standard Blood-Pressure Control (N Engl J Med 373: 2103-2116) — and identify a novel scientific or clinical finding that advances medical science.
The data in question are from the SPRINT clinical trial, which was sponsored by the National Heart, Lung, and Blood Institute (NHLBI). The trial was also sponsored by the National Institute on Aging (NIA), the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and the National Institute of Neurological Disorders and Stroke (NINDS).
The trial compared intensive management of systolic blood pressure (BP) (target, <120 mm Hg) with standard management (target, <140 mm Hg). The trial was stopped early because the rate of cardiovascular events was significantly lower with intensive management.
Trial results were published in NEJM in print on November 26, 2015. The dataset that underlie that publication will become available on November 1, 2016. Participants can register with the NHLBI and apply for the data beginning on September 15, 2016, and should allow sufficient time to complete data use agreements and other needed administrative tasks.
The winning entries will be those that provide the most clinically useful or novel information either from the SPRINT data alone, or the SPRINT data and any other publicly available dataset. For example, the derived information might allow health care professionals to improve the care of patients with hypertension, or might serve as the basis for a novel clinical trial to test a new hypothesis about the care of such patients.
Entries will be judged by a panel of experts representative of the clinical trial community on the basis of:
Additionally, all submissions will be open to the public for crowdvoting. Those who follow the SPRINT Challenge will be allowed to cast their crowdvote for their favorite entry.
The SPRINT dataset underlying the published article must be used in the formulation of every entry. Other publicly available datasets may also be used. It is acceptable to use datasets that require application for use to the dataholder as long as such application can be made by anyone.
The winning entries will be judged by a panel of experts representative of the clinical trial community.
Prizes will be as follows to the winning individual or team:
All three (3) prize packages also include the option of a trip for one representative to attend the Aligning Incentives for Sharing Clinical Trial Data summit on April 3–4, 2017, in Boston, to present their findings. See Official Rules for complete details.
Challenge Round participants will be notified of results on or about March 1, 2017.