Skip to main content
Journal cover image

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

Publication ,  Journal Article
Pencina, MJ; Louzao, DM; McCourt, BJ; Adams, MR; Tayyabkhan, RH; Ronco, P; Peterson, ED
Published in: Am Heart J
February 2016

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.

Duke Scholars

Altmetric Attention Stats
Dimensions Citation Stats

Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

February 2016

Volume

172

Start / End Page

64 / 69

Location

United States

Related Subject Headings

  • Research Personnel
  • Humans
  • Clinical Trials as Topic
  • Cardiovascular System & Hematology
  • Biomedical Research
  • Access to Information
  • Academies and Institutes
  • 3201 Cardiovascular medicine and haematology
  • 1117 Public Health and Health Services
  • 1102 Cardiorespiratory Medicine and Haematology
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Pencina, M. J., Louzao, D. M., McCourt, B. J., Adams, M. R., Tayyabkhan, R. H., Ronco, P., & Peterson, E. D. (2016). Supporting open access to clinical trial data for researchers: The Duke Clinical Research Institute-Bristol-Myers Squibb Supporting Open Access to Researchers Initiative. Am Heart J, 172, 64–69. https://doi.org/10.1016/j.ahj.2015.11.002
Pencina, Michael J., Darcy M. Louzao, Brian J. McCourt, Monique R. Adams, Rehbar H. Tayyabkhan, Peter Ronco, and Eric D. Peterson. “Supporting open access to clinical trial data for researchers: The Duke Clinical Research Institute-Bristol-Myers Squibb Supporting Open Access to Researchers Initiative.Am Heart J 172 (February 2016): 64–69. https://doi.org/10.1016/j.ahj.2015.11.002.
Pencina, Michael J., et al. “Supporting open access to clinical trial data for researchers: The Duke Clinical Research Institute-Bristol-Myers Squibb Supporting Open Access to Researchers Initiative.Am Heart J, vol. 172, Feb. 2016, pp. 64–69. Pubmed, doi:10.1016/j.ahj.2015.11.002.
Pencina MJ, Louzao DM, McCourt BJ, Adams MR, Tayyabkhan RH, Ronco P, Peterson ED. Supporting open access to clinical trial data for researchers: The Duke Clinical Research Institute-Bristol-Myers Squibb Supporting Open Access to Researchers Initiative. Am Heart J. 2016 Feb;172:64–69.
Journal cover image

Published In

Am Heart J

DOI

EISSN

1097-6744

Publication Date

February 2016

Volume

172

Start / End Page

64 / 69

Location

United States

Related Subject Headings

  • Research Personnel
  • Humans
  • Clinical Trials as Topic
  • Cardiovascular System & Hematology
  • Biomedical Research
  • Access to Information
  • Academies and Institutes
  • 3201 Cardiovascular medicine and haematology
  • 1117 Public Health and Health Services
  • 1102 Cardiorespiratory Medicine and Haematology