Supporting open access to clinical trial data for researchers: The Duke Clinical Research Institute-Bristol-Myers Squibb Supporting Open Access to Researchers Initiative

详细信息    查看全文

• 作者：Michael J. Pencina ; PhD^a ; ^{michael.pencina@duke.edu" class="auth_mail" title="E-mail the corresponding author} ; Darcy M. Louzao ; PhD^a ; Brian J. McCourt ; BA^a ; Monique R. Adams ; MS ; PhD^b ; Rehbar H. Tayyabkhan ; MBA^b ; Peter Ronco ; BA^b ; Eric D. Peterson ; MD ; MPH^a
• 刊名：American Heart Journal
• 出版年：2016
• 出版时间：February 2016
• 年：2016
• 卷：172
• 期：Complete
• 页码：64-69
• 全文大小：360 K

文摘

There are growing calls for sponsors to increase transparency by providing access to clinical trial data. In response, Bristol-Myers Squibb and the Duke Clinical Research Institute have collaborated on a new initiative, Supporting Open Access to Researchers. The aim is to facilitate open sharing of Bristol-Myers Squibb trial data with interested researchers. Key features of the Supporting Open Access to Researchers data sharing model include an independent review committee that ensures expert consideration of each proposal, stringent data deidentification/anonymization and protection of patient privacy, requirement of prespecified statistical analysis plans, and independent review of manuscripts before submission for publication. We believe that these approaches will promote open science by allowing investigators to verify trial results as well as to pursue interesting secondary uses of trial data without compromising scientific integrity.