Good Publication Practice for Communicating Company-Sponsored Medical Research: GPP3

Incomplete, inaccurate, misleading, or delayed reporting of medical research may result in poorly informed decision making and reduce the efficiency and quality of health care (1). Therefore, scientific and clinical research should be reported in a complete, accurate, balanced, and timely manner. Such research is often initiated by, or involves collaboration with, commercial organizations, such as pharmaceutical, biotechnology, medical device, and diagnostics companies. This updated Good Publication Practice guideline, known as GPP3, is designed primarily to help individuals and organizations maintain ethical practices when they contribute to the communication of this type of research. The principles of GPP3 apply to all research, however, so we expect that this guideline will be applicable to all medical and health care professionals involved in publications. The GPP guideline, published in 2003 (2) and updated in 2009 (as GPP2) (3), has been widely adopted. In an international survey of almost 500 people involved in publishing industry-sponsored research, more than 90% of respondents said they routinely referred to GPP2, which is a similar proportion to those who reported using International Committee of Medical Journal Editors (ICMJE) guidelines (4). The GPP guidelines have also been endorsed by medical journals (5) and cited in their instructions to authors. The latest revision, GPP3, reflects changes in the medical publications environment and aims to clarify and strengthen the principles and practices described in earlier versions. This guideline also reflects some important changes from GPP2 (Table). Table. What Is New in GPP3? Throughout the guideline, we use the term "publications" to include the full range of formats published in peer-reviewed journals (for example, original research articles, short reports, reviews, or letters to the editor) and "presentations" to include abstracts, posters, and slides for oral presentations at scientific congresses. "Sponsors" are organizations that provide primary support, which may include funding, for a study. "Publication professionals" are professional medical writers, publication planners, and publication managers, usually working either in or for companies. This guideline does not cover regulatory documents, medical education programs, or marketing or advertising materials, all of which are regulated or accredited by specific national or regional authorities. Methods In August 2013, an e-mail invitation was sent to more than 3000 professionals from around the world, including International Society for Medical Publication Professionals (ISMPP) members (n= 1630); persons invited to review GPP2 (n= 288); and a distribution list from the Medical Publishing Insights and Practices initiative that included approximately 1400 investigators, researchers, and journal editors. Candidates were invited to volunteer as members of the GPP3 steering committee or reviewers (or both). Eight GPP2 authors screened the applications (n= 241). Of 118 steering committee applicants, 11 were chosen and joined 7 of the former GPP2 authors to provide a broad range of perspectives (from 7 countries, including employees of pharmaceutical, biotechnology, medical device, and medical communication companies; freelance writers; journal editors; and publishers). From that first round of invitations, 153 applicants agreed to participate as reviewers. Personal invitations from steering committee members added 21 editors and academics to the reviewer list (Figure). Figure. Methods used to develop GPP3. GPP = Good Publication Practice; ISMPP = International Society for Medical Publication Professionals. The steering committee used a repeated survey process to reach consensus on the scope, title, and format for the new version. After agreement on the outline, subcommittees updated or developed specific sections. The draft GPP3 guideline was circulated to the reviewer panel after a first full draft was developed, edited, reviewed, and approved by the steering committee (Figure). The 94 sets of responses, comprising more than 2100 comments, were anonymized, collated, assessed, and ranked by steering committee members based on the frequency of comments received on a particular section, whether reviewers had marked the comment as critical (that is, a substantive disagreement) or beneficial (that is, a clarification or suggestion), and the steering committee members' interpretation of the importance of the comment. The list of ranked comments was then reviewed and discussed by the steering committee. Subcommittees for each section also evaluated all comments relating to their section and revised that section accordingly. Role of ISMPP The development of the GPP3 guideline was initiated and sponsored by ISMPP. The sponsor provided the resources to help assemble the GPP3 steering committee by providing administrative assistance, granting access to the mailing list of ISMPP members, sending out e-mails to members and potential reviewers, managing the database of respondents, setting up the reviewer Web site, and updating the GPP Web site. Several of the steering committee members are also members of the ISMPP Board of Trustees. However, they acted as individuals, and not on behalf of ISMPP, in contributing to GPP3. The ISMPP staff did not direct or control the content of this guideline. Principles of Good Publication Practice for Company-Sponsored Medical Research 1. The design and results of all clinical trials should be reported in a complete, accurate, balanced, transparent, and timely manner. 2. Reporting and publication processes should follow applicable laws (for example, Food and Drug Administration Amendments Act of 2007) and guidelines (for example, ICMJE recommendations and reporting guidelines found on the Enhancing the QUAlity and Transparency Of health Research [EQUATOR] Network). 3. Journal and congress requirements should be followed, especially ethical guidelines on originality and avoiding redundancy (that is, duplicate publication). 4. Publication planning and development should be a collaboration among all persons involved (for example, clinicians, statisticians, researchers, and publication professionals, including medical writers) and reflect the collaborative nature of research and the range of skills required to conduct, analyze, interpret, and report research findings. 5. The rights, roles, requirements, and responsibilities of all contributors (that is, authors and any nonauthor contributors) should be confirmed in writing, ideally at the start of the research and, in all cases, before publication preparation begins. 6. All authors should have access to relevant aggregated study data and other information (for example, the study protocol) required to understand and report research findings. 7. The authors should take responsibility for the way in which research findings are presented and published, be fully involved at all stages of publication and presentation development, and be willing to take public responsibility for all aspects of the work. 8. Author lists and contributorship statements should accurately reflect all substantial intellectual contributions to the research, data analyses, and publication or presentation development. Relevant contributions from persons who did not qualify as authors should also be disclosed. 9. The role of the sponsor in the design, execution, analysis, reporting, and funding (if applicable) of the research should be fully disclosed in all publications and presentations of the findings. Any involvement by persons or organizations with an interest (financial or nonfinancial) in the findings should also be disclosed. 10. All authors and contributors should disclose any relationships or potential competing interests relating to the research and its publication or presentation. For the complete GPP3 guideline, please see Appendix 1. Future Directions We hope that GPP3 will complement the many useful guidelines and recommendations that are available (for example, those from the American Medical Writers Association, Council of Science Editors, Committee on Publication Ethics, European Association of Science Editors, European Medical Writers Association, ICMJE, International Federation of Pharmaceutical Manufacturers & Associations, ISMPP, Medical Publishing Insights and Practices, and World Association of Medical Editors) and encourage adherence to and further research on responsible publication practices. We recognize that, to be effective, guidelines must be evidence-based, well-understood, and widely followed. This requires active research, promotion, education, and monitoring. Awareness and knowledge of publication guidelines are generally high among publication professionals, especially those working in biopharmaceutical and medical communication companies and those who belong to organizations, such as ISMPP, American Medical Writers Association, and European Medical Writers Association (4). However, work is needed to ensure that good practice is followed in all sectors and all world regions. We encourage journals, congresses, and academic institutions to endorse GPP3 and help disseminate it throughout the research community.