Updated Good Publication Practice Guidelines: What to Expect in 2023
Lisa DeTora
Hofstra University
@HofstraU
Dikran Toroser
Merck & Co. Inc.
@Merck
Leslie Citrome
New York Medical College
@nymedcollege
T

he newest iteration of the Good Publication Practice Guidelines for Company-Sponsored Biomedical Research (GPP) appeared in September 2022 in Annals of Internal Medicine. These guidelines build on prior GPP iterations that bolstered the credibility of publications of company-sponsored research and helped establish the publications profession as a routine function within company-sponsored research.

What is Good Publication Practice?

Elizabeth Wager and coauthors intended the original GPP to be a “one-stop” guide for professionals seeking to publish the results of industry-sponsored clinical research. GPP built on advice given by journal editors, such as the International Committee of Medical Journal Editors requirements and the CONSORT statement. However, editors cannot always predict the specialized circumstances and logistical pressures that may occur in specific company settings. The original GPP guideline filled this gap by considering publication bias, appropriate authorship practices, transparency, the process for developing publications, and other key issues for company-sponsored research.

The International Society for Medical Publication Professionals (ISMPP) adopted the original GPP and sponsored subsequent GPP updates. These iterations refined the methods for appropriate and auditable planning, authoring, reviewing, and publishing of high-quality publications of company-sponsored research. Some measures advised establishing steering committees to guide publication planning and developing formal publication plans. Advice was also given for managing day-to-day challenges in authorship, the role of professional medical writers in publications, and data sharing with authors and journals.

What’s New in the 2022 Update?

While the newest iteration (GPP 2022) retains the basic principles of prior GPP iterations, many changes have been made. The most significant change is in scope: As the publication profession has expanded, more industry and agency professionals are managing publications of nonclinical and biomarker research, health economics and outcomes research, real-world evidence, and patient-reported outcomes. GPP 2022 therefore reinforces the need to incorporate relevant guidelines from the EQUATOR Network (e.g., CONSORT) and adhere to publication standards in various scientific areas.

In addition, the publications remit has expanded from abstracts, posters, presentations, and manuscripts to encompass plain language summaries (PLS) and other forms of enhanced publication content that expand access to scientific information. Another major update is a focus on inclusivity: GPP now explicitly encourages inclusivity at all stages of research and publication planning and management. For instance, authoring groups and steering committees might also include patients, who provide needed expertise in understanding the day-to-day relevance of clinical findings.

The format of GPP also changed in 2022 to build upon the idea of a “one-stop” solution that provides advice not only about the publication process but also process leadership, such as developing policies and procedures and conducting team training. The GPP principles are presented in the main manuscript, while a supplement provides detailed information about specific process steps and practices. This detailed process information addresses activities such as writing an author agreement, determining authorship of a publication, or writing a charter for a steering committee. Overall, GPP 2022 now provides an overview of publications planning and management suitable for education and training purposes. Anyone curious about the field can learn the basics by reading this one resource.

GPP: Publications and Beyond

Like DIA, GPP is committed to promoting dissemination of accurate information about medicinal products to many different groups. Peer-reviewed publications provide supporting evidence for many forms of medical communication and promotional activities. Such activities must still conform with applicable regulatory frameworks and provide accurate, balanced information that adequately discloses the risks and benefits of medicinal products, vaccines, biologics, and devices. Peer-reviewed publications, for example, contextualize the benefits and risks observed in a specific study relative to the rest of the published literature in the view of the authors.

Reading GPP can help forward the goal of communicating medical information by helping various stakeholders understand the principles and process by which company-sponsored research should be published. Insights into how publications of company-sponsored research are planned and developed can help professionals like medical science liaisons, medical information professionals, and medical communicators translate that research for their target audiences.

Some areas of additional interest for medical communicators and others include information about including patients in the publication process, working with alliances, compensating various stakeholders in the publication process, and use of social media. Information about these topics is embedded as needed within various sections of the supplement, which describe steering committees, publication plans, authorship considerations, publication working groups, and the overall publication process.

When considering patient involvement in publications, the main message of GPP 2022 is that patients should be treated as equal stakeholders in whatever publication activity they participate in. Patient, caregiver, and patient advocate members of steering committees and publication working groups should be regarded as experts who provide necessary knowledge and advice for publication planning and development regarding their lived experience with the illness being discussed.

GPP 2022 also provides a series of suggested practices for obtaining advice that could be adapted for use in various other settings. For instance, steering committees might be helpful for developing many different types of communications. Unlike advisory boards, which may be a one-time event, the steering committee is a standing group that can provide as-needed advice and consultation.

Future Directions

Drug development has seen many changes during the COVID-19 pandemic. For instance, convergence and harmonization have become increasingly important as companies and regulatory bodies seek to bring needed products into clinical use.

We expect that more PLS will appear, which will help medical communicators tailor messages to various audiences. Additional publication enhancements, like short videos and infographics, can also support the work of medical communications groups by providing context and focusing on important messages.

The new focus on inclusivity in GPP can have positive impacts for many stakeholders, including and especially members of marginalized groups. Attention to diversity, equity, and inclusion can help patients, caregivers, and communities gain better access to medical information and medicinal products.

A focus on treating patients as equal stakeholders in the publication process is also important as various initiatives and regulatory bodies seek to include patients in more aspects of research. As GPP 2022 encourages greater inclusivity in publications, it is likely that more and more helpful peer-reviewed information will become available for medical communicators.

Acknowledgements and disclosures: We thank the members of the GPP 2022 authoring group for reviewing this work. All views are those of the three byline authors.
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