Wendy P. Battisti, PhD; Elizabeth Wager, PhD; Lise Baltzer; Dan Bridges, PhD; Angela Cairns; Christopher I. Carswell, MSc; Leslie Citrome, MD, MPH; James A. Gurr, PhD; LaVerne A. Mooney, DrPH; B. Jane Moore, MS; Teresa Peña, PhD; Carol H. Sanes-Miller, MS; Keith Veitch, PhD; Karen L. Woolley, PhD; Yvonne E. Yarker, PhD
Note: Inquiries about the GPP3 guideline can be made at firstname.lastname@example.org.
Disclaimer: The opinions expressed in this guideline by the authors do not necessarily represent those of their employers.
Acknowledgment: The authors and steering committee thank the reviewer panel for their review and comments and Wasim Rashid, Victoria Lacy, and Elizabeth Ward (all from Ashfield Healthcare Communications) for their assistance in collating the reviewer comments and reviewer demographic information. Further, the authors thank the International Society for Medical Publication Professionals (ISMPP), which helped ensure that the GPP3 was updated appropriately through administrative (nonfinancial) assistance.
Disclosures: Dr. Battisti is an employee of Janssen Research & Development and reports nonfinancial support from the ISMPP outside the submitted work. Dr. Wager reports personal fees from various universities, scholarly societies, drug companies, and publishers for training and consultancy outside the submitted work. Ms. Baltzer is an employee of Novo Nordisk and owns stock in the company. Dr. Bridges is an employee of Nucleus Global, which provides medical education services, including medical writing and publication planning, to the pharmaceutical industry; he is a member of the Board of Trustees of ISMPP, which is a not-for-profit organization that is focused on the ethical and effective publication of medical research to inform treatment decisions. Ms. Cairns is an employee of Ashfield Healthcare Communications, which provides services, including publication planning and professional medical writing, to pharmaceutical, medical device, and diagnostics industries and authors; she has served on several ISMPP committees, including the Certification Board of Trustees. Mr. Carswell is a salaried employee of Springer Science+Business Media. Dr. Citrome reports personal fees from Actavis (Forest), Alexza Pharmaceuticals, Alkermes, Bristol-Myers Squibb, Eli Lilly, Forum Pharmaceuticals (EnVivo), Genentech, Janssen, Jazz Pharmaceuticals, Lundbeck, Merck, Medivation, Mylan, Novartis, Noven Pharmaceuticals, Otsuka, Pfizer, Reckitt Benckiser, Reviva Pharmaceuticals, Shire, Sunovion Pharmaceuticals, Takeda Pharmaceutical Company, Teva Pharmaceutical Industries, and Valeant Pharmaceuticals International for consultancy; personal fees from Actavis (Forest), AstraZeneca, Janssen, Jazz Pharmaceuticals, Lundbeck, Merck, Novartis, Otsuka, Pfizer, Shire, Sunovion Pharmaceuticals, Takeda Pharmaceutical Company, and Teva Pharmaceutical Industries for work as a speaker; other items (stocks [small number of shares of common stock] and long-term ownership) from Bristol-Myers Squibb, Eli Lilly, Johnson & Johnson, Merck, and Pfizer outside the submitted work; and is the Editor-in-Chief of the International Journal of Clinical Practice. Dr. Gurr reports work with MedImmune and Bristol-Myers Squibb under a contract with Aerotek Scientific outside the submitted work and holds Pfizer stock. Dr. Mooney is a Pfizer employee, holds Pfizer stock, and is on the Board of Trustees and a steering committee member of the Medical Publishing Insights and Practice initiative. Ms. Moore is a member of ISMPP; she is an employee and shareholder of Medtronic. Dr. Peña reports stock awards from Bristol-Myers Squibb and AstraZeneca outside the submitted work; she is an employee of Bristol-Myers Squibb and the Board of Trustees chair for ISMPP. Ms. Sanes-Miller reports employment at AstraZeneca from 2008 to 2012 and stock in the company. She is currently employed at Baxalta and has stock in the company. She was a member of the ISMPP Certification Board of Trustees from 2010 to 2014 and chair from 2013 to 2014; she is currently a member of ISMPP. Dr. Veitch is a freelance consultant in medical publications, having previously managed publication groups at GlaxoSmithKline Biologicals, Sanofi Pasteur, and Novartis Vaccines and Diagnostics; he has recently been a paid consultant for Takeda Vaccines and the Bill & Melinda Gates Foundation and is a member of the ISMPP European Union committee. Dr. Woolley reports personal fees from ProScribe (Envision Pharma Group) outside the submitted work; she is actively involved in not-for-profit organizations that encourage ethical medical publication practices. Dr. Woolley voluntarily serves on the Board of Trustees of ISMPP, which has sponsored the development of GPP3. She conducts research on the value and integrity of medical publication professionals and provides ethical medical writing support and training courses, particularly to authors from low- and middle-income countries. Dr. Yarker reports nonfinancial support from ISMPP and Ashfield Healthcare during the conduct of the study; she is the chair elect of the ISMPP Board of Trustees, past chair of the ISMPP Ethics Committee, and past treasurer of the ISMPP Board of Trustees. In addition, Drs. Battisti, Bridges, Gurr, Woolley, and Yarker; Ms. Cairns; Ms. Moore; and Ms. Sanes-Miller are ISMPP Certified Medical Publication Professionals. Further details about contributorship and the steering committee for GPP3 can be found in Appendix 2 and Appendix 3, respectively. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M15-0288.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that she has no financial relationships or interests to disclose. Darren B. Taichman, MD, PhD, Executive Deputy Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer.
Requests for Single Reprints: Elizabeth Wager, PhD, Sideview, 19 Station Road, Princes Risborough, Buckinghamshire HP27 9DE, United Kingdom; e-mail, email@example.com.
Current Author Addresses: Dr. Wager: Sideview, 19 Station Road, Princes Risborough, Buckinghamshire HP27 9DE, United Kingdom.
Ms. Baltzer: Novo Nordisk A/S, Novo Alle 1, DK-2880 Bagsværd, Denmark.
Dr. Bridges: Nucleus Global, Admiral House, 76–78 Old Street, London EC1V 9AZ, United Kingdom.
Ms. Cairns: Ashfield Healthcare Communications, Victoria Mill, Windmill Street, Macclesfield, Cheshire SK11 7HQ, United Kingdom.
Mr. Carswell: Adis International, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, Auckland, New Zealand 0754.
Dr. Citrome: New York Medical College, 11 Medical Park Drive, Suite 106, Pomona, NY 10970.
Dr. Gurr: MedImmune, 1 MedImmune Way, Gaithersburg, MD 20878.
Dr. Mooney: Pfizer, 235 East 42nd Street, New York, NY 10023.
Ms. Moore: Medtronic, 8200 Coral Sea Street, Mail Stop MVS-66, Mounds View, MN 55112.
Dr. Peña: Bristol-Myers Squibb, Route 206 and Province Line Road, Mail Stop J43-05, Princeton, NJ 08543.
Ms. Sanes-Miller: Baxalta, 1 Baxter Parkway, Deerfield, IL 60015.
Dr. Veitch: Keithveitch Communications, Pieter Aertszstraat 48-3, 1073 SP Amsterdam, The Netherlands.
Dr. Woolley: ProScribe-Envision Pharma Group, Level 1, 6-10 Talavera Road, Macquarie Park, NSW 2113, Sydney, Australia.
Dr. Yarker: Medicite, 1493 Scarlet Oak Road, Yardley, PA 19067.
Author Contributions: Conception and design: W.P. Battisti, E. Wager, D. Bridges, A. Cairns, C.I. Carswell, L. Citrome, J.A. Gurr, T. Peñ, C.H. Sanes-Miller, K. Veitch, K.L. Woolley, Y.E. Yarker.
Analysis and interpretation of the data: W.P. Battisti, E. Wager, L. Baltzer, D. Bridges, A. Cairns, C.I. Carswell, J.A. Gurr, L.A. Mooney, T. Peñ, C.H. Sanes-Miller, K. Veitch, K.L. Woolley, Y.E. Yarker.
Drafting of the article: W.P. Battisti, E. Wager, L. Baltzer, D. Bridges, A. Cairns, C.I. Carswell, L. Citrome, J.A. Gurr, L.A. Mooney, T. Peñ, C.H. Sanes-Miller, K. Veitch, K.L. Woolley, Y.E. Yarker.
Critical revision of the article for important intellectual content: W.P. Battisti, E. Wager, L. Baltzer, D. Bridges, A. Cairns, C.I. Carswell, L. Citrome, J.A. Gurr, L.A. Mooney, B.J. Moore, T. Peñ, C.H. Sanes-Miller, K. Veitch, K.L. Woolley, Y.E. Yarker.
Final approval of the article: W.P. Battisti, E. Wager, L. Baltzer, D. Bridges, A. Cairns, C.I. Carswell, L. Citrome, J.A. Gurr, L.A. Mooney, B.J. Moore, T. Peñ, C.H. Sanes-Miller, K. Veitch, K.L. Woolley, Y.E. Yarker.
Administrative, technical, or logistic support: W.P. Battisti, A. Cairns, B.J. Moore, T. Peñ, K. Veitch, Y.E. Yarker.
Collection and assembly of data: W.P. Battisti, L. Baltzer, D. Bridges, C.I. Carswell, J.A. Gurr, L.A. Mooney, B.J. Moore, T. Peñ, C.H. Sanes-Miller, K. Veitch, K.L. Woolley, Y.E. Yarker.
This updated Good Publication Practice (GPP) guideline, known as GPP3, builds on earlier versions and provides recommendations for individuals and organizations that contribute to the publication of research results sponsored or supported by pharmaceutical, medical device, diagnostics, and biotechnology companies. The recommendations are designed to help individuals and organizations maintain ethical and transparent publication practices and comply with legal and regulatory requirements. These recommendations cover publications in peer-reviewed journals and presentations (oral or poster) at scientific congresses. The International Society for Medical Publication Professionals invited more than 3000 professionals worldwide to apply for a position on the steering committee, or as a reviewer, for this guideline. The GPP2 authors reviewed all applications (n = 241) and assembled an 18-member steering committee that represented 7 countries and a diversity of publication professions and institutions. From the 174 selected reviewers, 94 sent comments on the second draft, which steering committee members incorporated after discussion and consensus.
The resulting guideline includes new sections (Principles of Good Publication Practice for Company-Sponsored Medical Research, Data Sharing, Studies That Should Be Published, and Plagiarism), expands guidance on the International Committee of Medical Journal Editors' authorship criteria and common authorship issues, improves clarity on appropriate author payment and reimbursement, and expands information on the role of medical writers. By following good publication practices (including GPP3), individuals and organizations will show integrity; accountability; and responsibility for accurate, complete, and transparent reporting in their publications and presentations.
Table. What Is New in GPP3?
Methods used to develop GPP3.
GPP = Good Publication Practice; ISMPP = International Society for Medical Publication Professionals.
Appendix Table 1. Authorship Criteria
Appendix Table 2. Common Issues About Authorship
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Julia Donnelly, Art Gertel, Cindy W. Hamilton, Jackie Marchington, Serina Stretton, Karen Woolley [The Global Alliance of Publication Professionals (www.gappteam.org)]
Julia Donnelly, PhD; Julia Donnelly Solutions Ltd, Ashbourne, UK; Art Gertel, MS, President, MedSciCom, LLC, Lebanon, New Jersey, USA, Senior Research Fellow, Centre for Innovation in Regulatory Scien
August 19, 2015
Conflict of Interest:
All authors declare that: 1) all authors have provided or do provide ethical medical writing services to academic, biotechnology, or pharmaceutical clients, 2) KW’s husband is also an employee of Proscribe – Envision Pharma Group and AG’s wife works for Johnson & Johnson; all other authors’ spouses, partners, or children have no financial relationships that may be relevant to the submitted work; and 3) all authors are active in national and international not-for-profit associations that encourage ethical medical writing practices. No external sponsors were involved in the preparation of this manuscript, and no external funding was used.<br/><br/>KW is a co-author of GPP3
GPP3 - A welcome addition to publication guidelines
We, the Global Alliance of Publication Professionals (GAPP; http://www.gappteam.org; http://www.ismpp.org/gapp), would like to congratulate both Battisti et al and Ann Intern Med on the e-publication of the GPP3 guidelines. Although the previous GPP guidelines (published in 2003 and 2009) and substantial efforts by medical journal editors, the pharmaceutical industry, and communication professionals have led to an improvement in publication ethics and transparency, questions persist about the publication of company-sponsored medical research. Lack of awareness and confusion can lead to unintended consequences, such as poor publication practices and, worse, delayed publication of research findings. Publication of the GPP3 guidelines in a widely disseminated, respected journal will help to clarify the complex areas surrounding authorship, data sharing and the role of professional medical writers. Indeed, by following these guidelines, there should be no accusation of ghost-writing directed at ‘properly acknowledged professional medical writers’. Clarification regarding the rare occasions when medical writers qualify for authorship, the approach for specific publication types and acknowledging the main reporting standards are also welcome.These important guidelines are relevant to the many professionals involved in the communication of company-sponsored medical research, who wish to publish their findings ethically and efficiently. As GPP and GPP2 before, GPP3 will become an essential point of reference.
Battisti WP, Wager E, Baltzer L, Bridges D, Cairns A, Carswell CI, et al. Good Publication Practice for Communicating Company-Sponsored Medical Research: GPP3. Ann Intern Med. 2015;163:461-464. doi: 10.7326/M15-0288
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Published: Ann Intern Med. 2015;163(6):461-464.
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