Medical Writing Medical Writing Education Implications of clinical trial data sharing for medical writers

Volume 22, Issue 1 - Medical Writing Education

Implications of clinical trial data sharing for medical writers

Abstract

Major clinical research funders are increasingly adopting policies supporting or mandating data sharing. These moves should improve the transparency and availability of clinical trial data and are likely to impact the work and responsibilities of medical writers. Medical writers are likely to play a prominent role in standardising policies and procedures and have the opportunity to lead the development of an efficient and feasible system for promoting clinical trial data sharing. These efforts will ensure that the research community can derive the full benefit from the enormous resources devoted to human clinical trial research and will help build patient trust in the research process.

Download the full article

References

  1. National Institutes of Health (NIH). Final NIH statement on sharing research data. 2003. Available from: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html
  2. Medical Research Council (MRC). MRC policy on research data-sharing. Available from: http://www.mrc.ac.uk/Ourresearch/Ethicsresearchguidance/datasharing/Policy/index.htm
  3. Bill and Melinda Gates Foundation. Our commitment to sharing information. Available from: http://www.gatesfoundation.org/global-health/Pages/our-commitment.aspx
  4. Hampton T. European drug agency works to improve transparency, but skepticism remains. JAMA 2012;308(9):850–1.
  5. Krumholz HM, Ross JS. A model for dissemination and independent analysis of industry data. JAMA 2011;306(14):1593–4.
  6. Loder E. Liberating Clinical Trial Data. 2012; Available from: http://blogs.bmj.com/bmj/2012/10/09/elizabeth-loder-liberating-clinical-trial-data/
  7. Thomas K. Glaxo opens door to data on research. New York Times, 11 October 2012.
  8. Ross JS, Madigan D, Hill KP, Egilman DS, Wang Y, Krumholz HM. Pooled analysis of rofecoxib placebo-controlled clinical trial data: lessons for postmarket pharmaceutical safety surveillance. Arch Int Med 2009;169(21):1976–85.
  9. Ross JS, Mulvey GK, Hines EM, Nissen SE, Krumholz HM. Trial publication after registration in ClinicalTrials.Gov: a cross-sectional analysis. PLoS Med 2009;6(9):e1000144.
  10. Ross JS, Tse T, Zarin DA, Xu H, Zhou L, Krumholz HM. Publication of NIH funded trials registered in ClinicalTrials.gov: cross sectional analysis. BMJ 2012;344:d7292.
  11. Chan AW, Hrobjartsson A, Haahr MT, Gotzsche PC, Altman DG. Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles. JAMA 2004;291(20):2457–65.
  12. Dwan K, Altman DG, Arnaiz JA, Bloom J, Chan AW, Cronin E, et al. Systematic review of the empirical evidence of study publication bias and outcome reporting bias. PloS one 2008;3(8):e3081.
  13. Gotzsche PC. Why we need easy access to all data from all clinical trials and how to accomplish it. Trials 2011;12:249.
  14. Ross JS, Gross CP, Krumholz HM. Promoting transparency in pharmaceutical industry-sponsored research. Am J Public Health 2012;102(1):72–80.
  15. Ross JS, Lehman R, Gross CP. The importance of clinical trial data sharing: toward more open science. Circul. Cardiovasc Qual Outcomes 2012;5(2):238–40.
  16. DRYAD Available from: http://datadryad.org/
  17. Hrynaszkiewicz I, Norton ML, Vickers AJ, Altman DG. Preparing raw clinical data for publication: guidance for journal editors, authors, and peer reviewers. BMJ 2010;340:c181–0.
  18. U.S. National Institutes of Health. ClinicalTrials.gov. 2009 Available from: http://www.clinicaltrials.gov/
  19. Zarin DA, Tse T, Williams RJ, Califf RM, Ide NC. The ClinicalTrials.gov results database–update and key issues. N Engl J Med 2011;364(9):852–60.
  20. Institute of Medicine of the National Academies. Sharing clinical research data: a workshop. Available from: http://www.iom.edu/Activities/Research/SharingClinicalResearchData.aspx
  21. Hrynaszkiewicz I, Altman DG. Towards agreement on best practice for publishing raw clinical trial data. Trials 2009;10:17.
  22. Vickers AJ. Whose data set is it anyway? Sharing raw data from randomized trials. Trials 2006;7:15.

Search

Articles

Medical writing education
Message from the President
EMWA's position on ghostwriting
Essential modules for teaching publication writers
Combined workshops on medical writing and publication ethics for Japanese postgraduate students and faculty members
Teaching scientific writing to non-native English speakers
A field guide to medical writing training
Teaching scientific writing using the learner-centred approach
On educating the medical writer
Learning and teaching clinical writing
Your professional association: A great way to expand your skills and advance your career
Pleasing the reader by pleasing the eye—Part 2 Page layout and readability
Implications of clinical trial data sharing for medical writers
In the Bookstores
Journal Watch
The Webscout
Manuscript Writing
Regulatory Writing
Medical Journalism
Medical Communication
Out On Our Own
The Light Stuff

Member Login

Links

The Write Stuff Archive Contact Instructions for Authors Article Template (Word) Journal Policies

Editoral Board

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

Daniela Nakagawa

Joselita T. Salita

Petal Smart

Amy Whereat

Section Editors

Nicole Bezuidenhout 

Digital Communication

Somsuvro Basu

EMWA News       

Aurélie Gobet / Paolo Rega

Gained in Translation

Ivana Turek

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

Manuscript Writing

Lisa Chamberlain-James

Medical Communications/Writing for Patients

Namrata Upadhyay

Medical Devices

Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

Laura Kehoe

Out on Our Own

Tiziana von Bruchhausen

Pharmacovigilance

Jennifer Clemens

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Claire Gudex

Teaching Medical Writing

Kimi Uegaki

The Crofter: Sustainable Communications

Jennifer Bell / Louisa Marcombes

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Phil Leventhal

Lay out Designer

Chris Monk