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PRESS RELEASES << Ghostbusting in medical research: latest guidelines reinforce the importance of ethics in scientific publications
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Ghostbusting in medical research: latest guidelines reinforce the importance of ethics in scientific publications
Published 30 November 2009
The European Medical Writers Association, EMWA, welcomes the affirmation of the role of medical writers in the updated guidelines on Good Publication Practice for Pharmaceutical companies (GPP2) in the British Medical Journal.
The guidelines reaffirm the legitimate role that professional medical writers can play in the publication of medical research, and echo EMWA’s own comprehensive guidelines on ethical publication practice. Both the EMWA and GPP2 guidelines aim to stamp out the practice of “ghostwriting” – where a pharmaceutical company pays a medical writer to write a paper without this arrangement being disclosed.
Medical writers are skilled communication professionals who can help ensure that research is presented clearly and effectively, and to rigorous scientific standards. Their role is to draft a concise scientific paper using the mass of highly detailed results generated by clinical trials. EMWA and GPP guidelines emphasise that this should always be done in close collaboration with the researchers who are named as the paper’s authors.
The coordinating role of the medical writer can speed up the publication process so that research is presented more quickly. But it is the named scientific authors who have control over – and responsibility for – the final published document. EMWA guidelines stress that to ensure transparency, the role of the sponsoring company in paying for medical writing should be clearly disclosed in the paper.
Recent research by EMWA (jointly with the American Medical Writers Association) has shown that ghostwriting has become substantially less common over the last few years, suggesting that the guidelines have been effective. GPP2 is the latest in a series of initiatives designed to ensure that publication of clinical research results by the pharmaceutical industry is done to the highest ethical standards. The original GPP guidelines, published in 2003, were written by a group of professional medical writers in response to criticisms that publications of clinical research sponsored by pharmaceutical companies had a commercial bias, at the expense of good science. Such criticisms were particularly likely when “ghostwriters” were used.
EMWA and the American Medical Writers Association have been at the forefront of initiatives designed to improve ethical standards in medical publications. EMWA published guidelines in 2005 which clarified the role of professional medical writers based on clear ethical principles. EMWA hopes that the GPP2 guidelines will help to ensure that ethical standards in medical publication continue to improve.
Notes
The European Medical Writers Association (www.emwa.org) is the main professional organisation for medical writers in Europe. It has almost 1000 members, working in pharmaceutical companies, contract research organisations, specialist medical writing companies, and as freelancers. It promotes good practice in medical writing through its extensive training programme in all aspects of medical writing, as well as being the official voice of medical writers in Europe.
The EMWA guidelines can be found at http://www.emwa.org/MembersDocs/GuidelinesCMRO.pdf
Details of the research showing that ghost writing is becoming less common can be found at http://www.emwa.org/JournalArticles/JA_V18_I2_Jacobs1.pdf
The latest version of the GPP guidelines (GPP2) can be found at: http://www.bmj.com/cgi/doi/10.1136/bmj.b4330
The original GPP guidelines (2003 version) can be found at http://www.gpp-guidelines.org/
For more information
Helen Baldwin, EMWA President, helen.baldwin@scinopsis.com, +33 4 94 83 90 20
Jo Whelan, EMWA Education & Professional Development Committee member, whelan.jo@gmail.com, +44 (0)1865 721881
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Feedback: Do you have any comments about this article? Contact the Publisher, Peter Llewellyn.
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