BRIARCLIFF MANOR, N.Y., Nov. 30 /PRNewswire/ -- Good Publication Practice 2 (GPP2), a key guidance document for the publication of company-sponsored medical research, has been published online today by the British Medical Journal (BMJ). "The publication of GPP2 in BMJ is strong recognition of the importance of providing support and guidance for industry sponsored research and the publication of study results in the peer-reviewed medical literature," said Chris Graf, Associate Editorial Director, Wiley-Blackwell, lead author of GPP2 and member of the International Society for Medical Publication Professionals (ISMPP) Board of Trustees.
GPP2 is an update of the original Good Publication Practice (GPP) guidelines, which were published in 2003. In light of the increased scrutiny of pharmaceutical company involvement in publications and regulatory changes that have occurred over the past few years, the need to update GPP became readily apparent. ISMPP recognized this need and organized an international steering committee of 14 members who undertook the update. "A key expansion of GPP2 is providing guidance to medical device and biotechnology as well as pharmaceutical companies. More than 25 new recommendations, particularly guidance on the role of the professional medical writer, and two new checklists provide a balanced, up-to-date set of standards," said Yvonne E. Yarker, PhD, ISMPP Board of Trustees, GPP2 coauthor, and Senior Vice President, Medical Communications, Scientific Connexions, a division of KnowledgePoint 360. In addition to the steering committee, GPP2 had input from a large, diverse group of stakeholders. "The consulting process for GPP2 was very extensive with a global review from 116 individuals representing university academic medical centers, medical journal editors and publishers, professional organizations, pharmaceutical, medical device, and biotechnology companies, medical communication agencies, and medical writers," said Dr. Yarker.
Among the most important areas addressed in GPP2 are the responsibilities of authors, reimbursement and honoraria, recommendations for use of publication steering committees and how to assemble them, the role of the professional medical writer, and different types of manuscripts beyond the primary clinical trial results paper.
According to the authors, GPP2 benefits all stakeholders in medical publications - journal editors, publishers, academic universities, companies that conduct medical research, and ultimately patients and the public - through setting standards for adoption that will maintain integrity, completeness, transparency, and responsibility in peer-reviewed publications. GPP2 has been designed to work in concert with other guidelines, such as the International Committee of Medical Journal Editors authorship guidelines and Consolidated Standards of Reporting Trials. The publication includes a checklist that will help those developing medical publications apply the guidelines, and promote transparency and integrity in biomedical writing.
"With publication in the BMJ, and ISMPP taking a lead role in disseminating GPP2, broader adoption of best publication practices is anticipated across medical device, biotechnology, and pharmaceutical industries. Implementing current best publication practices will help promote integrity of medical research reporting within the rapidly evolving current environment," said Mr. Graf.
For more information on GPP2 and to view the publication, go to http://www.gpp-guidelines.org/
About the International Society for Medical Publication Professionals: ISMPP is an independent non-profit professional association with members from the pharmaceutical, medical device, and biotechnology industries; publication planning and medical communication companies; academia; and medical journal staff, including editors and publishers. Its goals are to support the educational needs of publication professionals and to develop best practices that ensure the rigorous maintenance of all ethical standards for reporting results of medical research. Additional information about ISMPP is available by contacting the organization's Executive Director, Kimberly Goldin (phone: 914-945-0507; e-mail: firstname.lastname@example.org), or online at http://www.ismpp.org.
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SOURCE International Society for Medical Publication Professionals
|SOURCE International Society for Medical Publication Professionals|
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