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Volume 25, Issue 2 - Medical Communication

EMWA News

Abstract

EMWA team responds to ICMJE requirements on sharing clinical trial data

In January 2016, the International Committee of Medical Journal Editors (ICMJE) proposed requirements on sharing clinical trial data, in Darren Taichman’s editorial, Annals of Internal Medicine.1 The ICMJE stated its belief “…that there is an ethical obligation to responsibly share data generated by interventional clinical trials because participants have put themselves at risk. In a growing consensus, many funders around the world – foundations, government agencies, and industry – now mandate data sharing”. The editorial outlined ICMJE’s proposed requirements to help meet this obligation, and encouraged feedback on the proposed requirements at www.icmje.org by 18 April 2016.

References

  1. Taichman DB, Backus J, Baethge C, Bauchner H, de Leeuw PW, Drazen JM, et al. Sharing clinical trial data: A proposal from the International Committee of Medical Journal Editors. Ann Intern Med. 2016;164(7): 505-506.
  2. Retraction Watch. Sharing data is a good thing. But we need to consider the costs. [cited April 2016]. Available from: http://retractionwatch.com/2016/01/28/ sharing-data-is-a-good-thing-but-we-needto- consider-the-costs/
  3. LinkedIn. European Medical Writers Association. Available from: https://www.linkedin.com/grp/post/ 2717752-6102832116159049732
  4. LinkedIn. The Publication Plan. Available from: https://www.linkedin.com/groups/ 1886265/1886265-6130063859827957764
  5. TransCelerate BioPharma Inc. Common Protocol Template [cited 2016 Apr 1]. Available from: http://www.transceleratebiopharmainc.com /initiatives/common-protocol-template/
  6. U.S. Food and Drug Administration. FDA and NIH release a draft clinical trial protocol template for public comment [cited 2016 Apr 1]. Available from: http://blogs.fda.gov/fdavoice/?s=protocol

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  • Victoria White (Tampa, Florida, USA)
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  • Amy Whereat (SpeaktheSpeech Consulting, Asnieres sur Seine, France)

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