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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.
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.
Individuals and groups are invited participate in the SPRINT Data Analysis Challenge by analyzing the dataset underlying the SPRINT article — A Randomized Trial of Intensive versus Standard Blood-Pressure Control (N Engl J Med 373: 2103-2116) — and identifying novel scientific or clinical findings that advance medical science.
The SPRINT Challenge will have two rounds: a Qualifying Round and a Challenge Round. Participants must complete the Qualifying Round to become eligible to enter the Challenge Round.
SPRINT Challenge opens: September 15, 2016
NHLBI Applications for SPRINT data opens: September 15, 2016
SPRINT data available from NHLBI: November 1, 2016
Qualifying Round open: November 15, 2016 – January 20, 2017 at midnight EST
Challenge Round open: December 1, 2016 – February 14, 2017 at midnight EST
Judges review and crowdvoting period: February 15–28, 2017
Challenge participants notified: March 1, 2017
Aligning Incentives for Sharing Clinical Trial Data summit: April 3–4, 2017
Step-by-step instructions are provided below. Have any questions or comments?
Register to 'Follow' the SPRINT Challenge and stay informed of news, updates and important deadlines. Comment on submissions during the Challenge Round and cast your crowdvote for the best entry.
The NHLBI data repository will make the SPRINT dataset that underlie the published NEJM article available for download on November 1, 2016. Early attention to IRB or ethics committee approval and other administrative tasks is advisable. For additional information, please reference the BioLINCC handbook on accessing the NHLBI data repository.
Go to biolincc.nhlbi.nih.gov to register with BioLINCC, the NHLBI data repository coordinating center.
Apply for an approval letter/certificate or exemption certificate, which will be required with your application for the data.
Go to the SPRINT Primary Outcome Paper (SPRINT-POP) page. Look for the study listed as ‘SPRINT-POP’ on the BioLINCC website which differentiates the trial data that underlie the NEJM article from the full SPRINT study data (to be released in November 2017).
Click the “Request Data” button found at the bottom and upper right corner of the page. Fill out the Data Request Form, and upload your IRB/Ethics Committee approval or exemption certificate.
Your request will be reviewed by BioLINCC and confirmed within 1-2 business days.
You will receive an email when your request is approved from BioLINCC asking you to complete key fields for the Data Use Agreement (termed a Research Materials Distribution Agreement or RMDA).
Have the Data Use Agreement signed by the designated Principal Investigator and an Institutional Business/Signing Official.
Upload a scan of the signed Agreement to the ‘RMDA’ tab on your request page. A representative of the NHLBI will sign the agreement, and BioLINCC will post a comment notifying you when this copy is available.
Receive a data download link to the “comments” tab of your request from BioLINCC when the SPRINT dataset is available on November 1, 2016.
The Qualifying Round will be open from November 15, 2016 to January 20, 2017. Participants will be required to submit the answer to one of two qualifying questions as follows:
QUESTION 1: What is the log likelihood ratio statistic for the Cox proportional hazards model described in Table 2 of the NEJM article for the primary outcome (first occurrence of myocardial infarction, acute coronary syndrome, stroke, heart failure, or death from cardiovascular causes)?
QUESTION 2: What is the sample size and the mean for the systolic blood pressure at the last recorded [post-baseline] study visit for each participant by treatment arm (Intensive and Standard)?
The submission form is on the Newsfeed page.
Please allow up to one week from submission for our team to review your entry to the Qualifying Round.
The Challenge Round will be open from December 1, 2016 to February 14, 2017. As participants pass the Qualifying Round, they will be notified of the details for how to submit an entry to the Challenge Round. Participants will be required to submit the following information:
The SPRINT dataset must be used in the formulation of every entry. Other publically 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.