Note: Inquiries about the GPP3 guideline can be made at [email protected].
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 (available at annals.org), respectively. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M15-0288.
Requests for Single Reprints: Elizabeth Wager, PhD, Sideview, 19 Station Road, Princes Risborough, Buckinghamshire HP27 9DE, United Kingdom; e-mail, [email protected].
Current author addresses and author contributions are available at www.annals.org.
For author affiliations, see end of text.
This article was published online first at www.annals.org on 11 August 2015.
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. Peña, 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. Peña, 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. Peña, 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. Peña, 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. Peña, 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. Peña, 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. Peña, C.H. Sanes-Miller, K. Veitch, K.L. Woolley, Y.E. Yarker.
