Use of GPP3 for ethical guidance – Pubrica

1. Use of GPP3 for Ethical Guidance Dr. Nancy Agnes, Head, Technical Operations, Pubrica sales@pubrica.com In-Brief GPP3 is a revision of the original Good Publication Practice (GPP) standards, which were first published in 2003 and last revised in 2009. The ISMPP GPP3 Steering Committee has revised the 2009 edition of the Good Publication Practice Guidelines (GPP2) to emphasise integrity and transparency in industry-sponsored publication planning and development in today's environment. I. INTRODUCTION GPP3 is a revised version of the Good Publishing Practice (GPP) guideline that offers guidelines organisations involved in disseminating research findings funded or assisted by pharmaceutical, medical device, diagnostics, and biotechnology industries. The guidelines are meant to help organisations adhere to legal and regulatory standards while ensuring fair and open publishing activities. These guidelines apply to peer-reviewed journal publications and oral and poster presentations at science conferences. Author payment and repayment are now more explicitly described. Clarification of the words "ghost fiction" and "guest authorship." Professional medical writers: what they do and how they help Advice on how to exchange data acceptably. II. GPP HISTORICAL ARCHIVE GPP2 Guidelines, 2009 International Publication assembled a Steering Committee to produce an updated Good Publication Practice guide, now known as "GPP2," to discuss regulatory, guidance, and ethical changes since 2003 and to affirm the goals of the initial 2003 publication(4). Society Professionals for Medical (ISMPP) for persons and individuals and GPP Guidelines, 2003 The critical Good Publication Practice (GPP) guidelines, released in 2003, aimed to ensure that "clinical trials funded by pharmaceutical firms responsibly and ethically." GPP3 for ethical guidelines, 2015 The resulting guideline adds new parts (Principles of Good Publication Practice for Company-Sponsored Data Sharing, Studies That Should Be Published, and Plagiarism). It builds on are published The following are some of the latest subjects discussed in GPP3: The most recent ICMJE authorship conditions are explained (2013) Authorship problems that are frequently found Medical Research, 1 Copyright © 2021 pubrica. All rights reserved

2. authorship requirements and widespread authorship concerns established by the International Committee of Medical Journal Editors., Expand details on the position of medical writers and explain appropriate author payment and Individuals and organisations can embody honesty, transparency, and obligation for reliable, complete, and transparent reporting in their publications and presentations by adopting good publishing (including GPP3). principles section and quick reference tables addressing authorship criteria and joint authorship issues guidance on We use the terms "publications" and "presentations" interchangeably guideline to refer to the wide variety of formats presented in peer-reviewed journals (for example, original research papers, brief reports, analyses, or letters to the editor) and "abstracts," "posters," and slides for oral presentations at scientific "Sponsors" are organisations that offer primary resources for a study, such as funding. Professional medical researchers, publishing designers, administrators are known as "publication practitioners," and they work in or with businesses. Regulatory documents, medical education services, and marketing and promotional materials are governed or accredited by various national or state bodies and are not protected by this guideline. reimbursement. in the practices congresses. and publication III. WHAT IS NEW IN GPP3 Guidance on updated ICMJE 2013 authorship criteria Advice on everyday issues about authorship Author payment and compensation guidance and clarification Further definitions of what creates guest or ghost invention Information on the position and benefits of licenced medical authors has been expanded Advice for appropriate data sharing Overall simplification of language and format with a new guiding IV. ROLE OF ISMPP ISMPP was the energetic force behind the adoption of the GPP3 guideline. By supplying logistical research paper support, giving access to the mailing list of ISMPP participants, sending out e-mails to members 2 Copyright © 2021 pubrica. All rights reserved

3. and prospective reviewers, maintaining the database of respondents, setting up the reviewer Web site, and reviewing the GPP3 steering committee, the sponsor was able to assist in the formation of the GPP3 steering committee. Several members of the steering committee also sit on the ISMPP Board of Trustees. They did, however, contribute to GPP3 as entities, not on behalf of ISMPP. The quality of this guideline was not guided or regulated by the ISMPP employees. V. FUTURE SCOPES We hope that GPP3 will add to the many valuable guidelines and recommendations that are already available (such as those from the American Medical Writers Association, Council of Science Editors, Committee on Publication Ethics, European Association of Science Editors, European Medical Writers Association, International Federation of Pharmaceutical Manufacturers & Associations), ISMPP, Medical Publishing Insights and Practices, and the World Association of Medical Editors) all promote responsible publishing practices and research. VI. CONCLUSION Because of advancements in regulatory, medical, and journal understanding of the publishing environment has changed. The GPP3 guideline has been amended to keep up with the changes. The role, reimbursements, responsibility of MWs in the process have been identified and elaborated to a greater extent. Necessitates MW staying current with current trends specialised training from known institutions to improve understanding and formulate a proper strategy. It is required to produce high-quality documentation and the bridging of the gap between research conduct and reporting. Avail Publication support services from Pubrica. REFERENCES 1. Battisti WP, Wager E, Baltzer L, Bridges D, Cairns A, Carswell CI, et al. Good Publication Practice for Communicating Company-Sponsored Research: GPP3. Ann Intern Med. 2015;163:461-464; doi:10.7326/M15-0288 Glasziou P, Altman DG, Bossuyt P, Boutron I, Clarke M, Julious S, et al. Reducing waste from incomplete or unusable reports of biomedical research. Lancet. 2014;383:267-76. [PMID: 10.1016/S0140-6736(13)62228-X Wager E, Field EA, Grossman L. Good publication practice for pharmaceutical companies. Curr Med Res Opin. 2003;19:149-54. [PMID: 12814125] Graf C, Battisti WP, Bridges D, Bruce-Winkler V, Conaty JM, Ellison JM, et al; International Society for Medical Publication Professionals. Research Methods & Reporting. Good publication communicating company sponsored medical research: the GPP2 guidelines. BMJ. 2009;339:b4330. [PMID: 19946142] doi:10.1136 /bmj.b4330 Wager E, Woolley K, Adshead V, Cairns A, Fullam J, Gonzalez J, et al. Awareness and enforcement of guidelines for publishing industry-sponsored medical research among publication professionals: the Global Publication Survey. BMJ Open. 2014;4:e004780. [PMID: 24747794] doi:10.1136/bmjopen-2013- 004780 Medical 2. 24411647] doi: 3. 4. practice for 5. ICMJE, standards, our and increased and undergoing 3 Copyright © 2021 pubrica. All rights reserved