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Bumps and bridges on the road to responsible sharing of clinical trial data.

Publication ,  Journal Article
Berlin, JA; Morris, S; Rockhold, F; Askie, L; Ghersi, D; Waldstreicher, J
Published in: Clin Trials
February 2014

BACKGROUND: Sharing data from clinical trials could assist with the advancement of science and medicine, potentially providing a better understanding of both the benefits and risks of medicines and other treatments. Sharing data also allows for questions to be addressed at the meta-analysis level that cannot be addressed within individual studies. PURPOSE: In this article, we offer some practical recommendations that will allow researchers to readily combine datasets from different studies and sources, thereby enabling meta-analyses that could have significant impact on advancing medicine. METHODS: The authors relied on their collective experience in the conduct and reporting of clinical trials to define the areas of potential concern related to responsible sharing of clinical trial data. We conducted a review of the literature and engaged in an iterative consensus-building process. RESULTS: To further the goal of responsible sharing of clinical trial data, collaboration on a consistent set of data standards and methods across both industry and academia is sorely needed. Protection of participant privacy is a paramount principle. The additional questions of who maintains, funds, and oversees databases of participant-level data will be important to resolve. Requiring researchers to register their requests for participant-level data and to provide details of their intended research would allow others to evaluate the proposed research plan, consistent with the principles of science and transparency. LIMITATIONS: The recommendations represent the views of the individual authors. We recognize that other approaches to data sharing that have been advocated are also based on sound ethical and scientific principles.

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Published In

Clin Trials

DOI

EISSN

1740-7753

Publication Date

February 2014

Volume

11

Issue

1

Start / End Page

7 / 12

Location

England

Related Subject Headings

  • Statistics & Probability
  • Social Responsibility
  • Meta-Analysis as Topic
  • Information Dissemination
  • Humans
  • Cooperative Behavior
  • Consensus
  • Confidentiality
  • Clinical Trials as Topic
  • Access to Information
 

Citation

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Berlin, J. A., Morris, S., Rockhold, F., Askie, L., Ghersi, D., & Waldstreicher, J. (2014). Bumps and bridges on the road to responsible sharing of clinical trial data. Clin Trials, 11(1), 7–12. https://doi.org/10.1177/1740774513514497
Berlin, Jesse A., Sandra Morris, Frank Rockhold, Lisa Askie, Davina Ghersi, and Joanne Waldstreicher. “Bumps and bridges on the road to responsible sharing of clinical trial data.Clin Trials 11, no. 1 (February 2014): 7–12. https://doi.org/10.1177/1740774513514497.
Berlin JA, Morris S, Rockhold F, Askie L, Ghersi D, Waldstreicher J. Bumps and bridges on the road to responsible sharing of clinical trial data. Clin Trials. 2014 Feb;11(1):7–12.
Berlin, Jesse A., et al. “Bumps and bridges on the road to responsible sharing of clinical trial data.Clin Trials, vol. 11, no. 1, Feb. 2014, pp. 7–12. Pubmed, doi:10.1177/1740774513514497.
Berlin JA, Morris S, Rockhold F, Askie L, Ghersi D, Waldstreicher J. Bumps and bridges on the road to responsible sharing of clinical trial data. Clin Trials. 2014 Feb;11(1):7–12.
Journal cover image

Published In

Clin Trials

DOI

EISSN

1740-7753

Publication Date

February 2014

Volume

11

Issue

1

Start / End Page

7 / 12

Location

England

Related Subject Headings

  • Statistics & Probability
  • Social Responsibility
  • Meta-Analysis as Topic
  • Information Dissemination
  • Humans
  • Cooperative Behavior
  • Consensus
  • Confidentiality
  • Clinical Trials as Topic
  • Access to Information