Data Sharing, Year 1 — Access to Data from Industry-Sponsored Clinical Trials

Since May 2013, researchers have been able to request access to deidentified patient-level data from GlaxoSmithKline–sponsored clinical trials, subject to oversight by an independent review panel. The initiative has been a productive first step in transparency. There has been considerable interest o...

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Bibliographic Details
Published in:The New England journal of medicine Vol. 371; no. 22; pp. 2052 - 2054
Main Authors: Strom, Brian L, Buyse, Marc, Hughes, John, Knoppers, Bartha M
Format: Journal Article
Language:English
Published: United States Massachusetts Medical Society 27.11.2014
Subjects:
Access to Information
Clinical trials
Clinical Trials as Topic - statistics & numerical data
Conflict of Interest
Drug Industry
Humans
Information Dissemination
Information sharing
Proposals
Research Support as Topic
Review boards
Websites
ISSN:0028-4793, 1533-4406, 1533-4406
Online Access:Get full text
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Summary:Since May 2013, researchers have been able to request access to deidentified patient-level data from GlaxoSmithKline–sponsored clinical trials, subject to oversight by an independent review panel. The initiative has been a productive first step in transparency. There has been considerable interest of late in increasing the transparency of clinical trials, including increasing access to the raw data from trials sponsored by the pharmaceutical industry. 1 Since May 2013, investigators have been able to request access to deidentified patient-level data from clinical trials sponsored by GlaxoSmithKline, 2 subject to review and oversight by an independent review panel (https://clinicalstudydatarequest.com/Default.aspx). As the members of this panel, we now have more than 12 months of experience with this initiative — and can report that it has been a productive and successful first step. The system was launched on May 7, 2013, and . . .
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ISSN:0028-4793
1533-4406
1533-4406
DOI:10.1056/NEJMp1411794