Medical Writing Medical Communication EMWA News

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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Editor-in-Chief

Raquel Billiones

Co-Editors

Evguenia Alechine

Jonathan Pitt

Managing Editor

Victoria White

Deputy Managing Editor

Alicia Waltman

Associate Editors

Anuradha Alahari

Jennifer Bell

Clare Chang

Barbara Grossman

Joselita T. Salita

Amy Whereat

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Nicole Bezuidenhout 

Digital Communication

Somsuvro Basu

EMWA News       

Aurélie Gobet / Paolo Rega

Gained in Translation

Raquel Billiones

Getting Your Foot in the Door

Wendy Kingdom / Amy Whereat

Good Writing Practice

Alison McIntosh / Stephen Gilliver

In the Bookstores

Maria Kołtowska-Häggström

Lingua Franca and Beyond

Phil Leventhal

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Lisa Chamberlain-James

Medical Communications/Writing for Patients

Namrata Upadhyay

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Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

Laura Kehoe

Out on Our Own

Jennifer Clemens

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Claire Gudex

Teaching Medical Writing

Kimi Uegaki

The Crofter: Sustainable Communications

Karim Montasser

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Phil Leventhal

Lay out Designer

Chris Monk