Good Publication Practice 2: updating best practice
pharmafile | November 13, 2008 | Feature | Research and Development, Sales and Marketing |Â Â GPP, Good Publication Practice, clinical trials, ethics, journals, publicationÂ
Results from clinical trials are the very lifeblood of the pharmaceutical industry, representing the frontline in the search for new and more effective medicines.
That is why the confidence of all stakeholders in their scientific value, accuracy and trustworthiness is absolutely vital.
To respond to this need, work began on the first Good Publication Practice guidelines in 1998, eventually published in 2003.
This represented a major advance in building confidence and transparency in the field, and Good Publication Practice (GPP) is now firmly established as an indispensable aide for publication professionals. The guidelines are the first port-of-call for information about publishing clinical and pre-clinical information, especially when this information has been produced with the support of pharmaceutical, biotech or medical device companies.
But five years have passed since the GPP guidelines were published, and moves are now afoot to update them. Working with support from the International Society for Medical Publication Professionals (ISMPP), the GPP2 steering committee will open its global consultation on the first draft of its new guidelines towards the end of this year.
The first GPP
The first ideas for GPP were formed during a retreat of the Council of Biology Editors (now Council of Science Editors or CSE) a decade ago. After all the developments in the field since then, the time is right for GPP2: a new, revised version of Good Publication Practice.
James A. Gurr, director of publications and external communications, global medical affairs at Wyeth, is one of the members on the steering committee which will update the guidelines.
He says publications of results are under increasing scrutiny from regulators, journal editors, the media and the public, which makes the review of GPP guidelines a top priority.
“New mandates from the US government (FDAAA), journal editors (ICMJE) and others (e.g. the State of Maine, EUDRACT) have made it essential to revisit good publishing practices. GPP will provide direction for the development of publications in an ethical, transparent and responsible manner and in compliance with regulations and guidelines,” he says.
“Transparent interaction between pharma companies and investigators is especially important.”
Elizabeth Wager, first author of the original publication, says: “When we published GPP we always intended to revise it and keep it up to date, but we never found the time or funding for this. I’m still proud of what GPP has achieved, and I believe the underlying principles are still relevant today, but things have definitely moved on in the 10 years since it was first discussed. That’s why I’m delighted that ISMPP is taking a lead in developing GPP2.”
GPP2 will follow the mission laid out by the original GPP authors and “encourage responsible and ethical publication of the results of clinical trials sponsored by pharmaceutical companies”.
Like its predecessor, GPP2 will deliver ‘best practice’ ethical guidance about peer-reviewed publications and presentations at scientific meetings, as well as recommendations for ‘non-peer-reviewed scientific communications’.
New sections will provide guidance on recent developments in medical research and reporting, such as clinical trial registration and results disclosure.
You can help
Working with support from the International Society for Medical Publication Professionals (ISMPP) the GPP2 steering committee will open consultation on the first draft of its new guidelines.
“With all that’s happened over the years since the publication of GPP, this update could not be more timely,” says Gene Snyder, ISMPP president.
“ISMPP is proud to spearhead this initiative, which will serve to strengthen the credibility of industry-sponsored clinical publications.”
To contribute to the consultation you need over ten years’ experience in three or more of the following areas:
* Setting publication policies in commercial organisations
* Design, conduct and reporting of clinical trials
* Legal and regulatory requirements on conducting, registering and reporting clinical trials publications as part of a clinical development programme
* Common editorial and journal practices, including peer review
* Scientific or medical writing and editing
About ISMPP
The International Society for Medical Publication Professionals (ISMPP – pronounced ‘Izmap’) is a non-profit organisation dedicated to advancing medical publication planning and development, supporting medical publication professionals and ensuring ethical medical publication practices.
ISMPP promotes quality professional standards and practices, and encourages members to meet such standards. For more information visit: www.ismpp.org
Chris Graf is co-chair of the ISMPP Standards & Best Practices committee. He is associate editorial director at Wiley-Blackwell and publisher of the International Journal of Clinical Practice (www.IJCP.org).
To contribute to the GPP2 consultation contact Chris via e-mail at chris.graf@wiley.com or telephone +44 (0)1865 476 393
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