Good Publication Practice (GPP) guidelines for company-sponsored biomedical research from the point of view of the diverse authors involved in its publication

Less than two years ago, the 2022 update to the Good Publication Practice (GPP) guidelines for company-sponsored biomedical research was published in the Annals of Internal Medicine¹. This new version of GPP has generated correspondence^2–4, further commentary^5,6, and has been translated into Chinese and Japanese (see https://www.ismpp.org/gpp-2022). The first version of GPP appeared in 2003 in the pages of Current Medical Research & Opinion⁷, with subsequent iterations^1,8,9 created under the auspices of the International Society for Medical Publication Professionals (ISMPP), a not-for-profit organization founded in 2005¹⁰.

Work on the GPP 2022 update began in April 2019, with the creation of a “GPP4” steering committee through ISMPP from among volunteers representing different geographic regions (Europe, North America, and Asia) and professional specialties (pharmaceutical, biotechnology, and device companies; medical communication companies; journal editors; publishers; and academics). Not all of the SC members were current members of ISMPP. A full description of the work processes can be found in the principal publication¹. Box 1 provides a list of the different guidance topics covered by GPP 2022.

Box 1 Guidance topics covered in GPP 2022.

• Publication types

• Publication professional roles and professional development

• Ethical principles

• Publication steering committees

• Publication plans

• Publication working groups

• Authorship and contributorship

• Publication process

• Documentation guidelines

Prior iterations of GPP focused on clinical studies, whereas the new, expanded scope of GPP 2022 reflects the need for responsible publication planning and management at all stages of clinical development and all types of biomedical research. Enhanced attention to ethics, standards, and inclusivity is promoted. Inclusivity is usually thought of in terms of subject demographics (like race, sex, or gender), the participation of patients in publications, and appropriate representation from world regions. However, inclusivity also can involve authors, investigators, investigator site personnel, IRB/EC members, and regulators. GPP affects all of these people as well as ultimately all those who benefit from the results of research.

Members of the GPP steering committee were asked to opine about the GPP 2022 update from the point of view of their individual professional roles.

Role of GPP for biopharmaceutical companies

Along with the ICMJE guidelines (see https://www.icmje.org/), the GPP guidelines serve as the foundation of many biopharmaceutical companies’ internal publication policies. They help to foster a consistent industry-wide approach to the development of publications based on company-sponsored research, grounded on high standards of ethics and transparency. This latest iteration of GPP addresses advances in publications that have taken place in the past few years, including enhanced publication content, plain language summaries and preprints. By providing guidelines and recommendations on these topics, GPP will serve as the basis of how many companies will incorporate requirements for these items into their standard operating procedures. GPP addresses the important issue of involving patients in the publication planning, development, and review process. GPP will hopefully result in companies taking more steps to appropriately collaborate with patients on the generation of publications and plain language summaries. GPP also establishes the central role the publication professional plays in defining and implementing a company’s publication policy and educating and advising colleagues on best practices.

Updates to the GPP guidelines are often keenly anticipated because they touch on multiple “new” items that have become topical since the last iteration (GPP3) that was published in 2015⁹. As expected, during the development of these GPP guidelines, many contacted the steering committee to ask about its status with their motivation being to update their company publications SOP and processes according to the new GPP publication. As already noted, GPP guidelines are often a cornerstone for pharmaceutical companies’ publications SOPs that regulate internal publication processes. In addition, GPP is often used in the education of company employees on both the medical and commercial side in good publication practice.

Conducting a transparent and compliant publication process is a top priority for the industry. It can be challenging to develop best practices that work across varied areas e.g. diagnostics, biotech, small, medium, and large pharma companies. The resources available and the timelines for development vary drastically between these different entities. In addition, there is no college curricula where you can major in publication management, so publication professionals have varied backgrounds and experiences. Creating best practices that are easy to follow and flexible enough to work across all industry models was an important goal. This version of GPP is meant to convey the basic principles of an ethical process. The supplement is where the roadmap for managing publications resides. This more detailed guidance is meant to provide practical insight into managing the day-to-day processes for the publication professional. It is a new tool that can be used to train new staff, explain the process to our authors, partners, and other non-publication professionals, to help to facilitate following best practices.

Academia

For people working in academic settings as teachers and as researchers, GPP would be applicable to any biomedical research publication, as the principles of ethics, transparency and timeliness are equally relevant to academic research as to company-sponsored studies. Although the GPP guidelines were developed with company sponsored biomedical research publication practice in mind, the advice provided can be broadly applied. A challenge could be that academic researchers have less access to publication professionals or professional medical writers, and may thus be less aware of GPP. At Danish universities, for instance, the university library offers support and services to the researchers, including publication support. In this setting, the GPP could be a useful addition to the toolbox.

The GPP 2022 guidelines and supplements can directly benefit university and institutional researchers, who are increasingly encouraged to engage beyond academia and collaborate and partner with industry. They will also benefit educators including mentors/supervisors, research integrity advisors, communication skills trainers, and professionals who support researchers (e.g. authors’ editors and statisticians). In addition, learned societies and practitioner associations (e.g. for research and innovation officers, ethics trainers, or copyeditors) can refer to, endorse, or incorporate GPP to enhance their professional development or train-the-trainer programs. GPP can be used not only to promote research and publication ethics, but also increase awareness of best practices in planning, documentation, and reporting to maximize transparency, accountability, quality, and societal impact of industry-sponsored biomedical research. Beyond dealing with traditional researcher concerns of authorship credit for journal papers and conference presentations, GPP outlines practical considerations of open research and open science, such as data sharing, content and language accessibility, and the use of social media. The guidelines thus align well with the growing global momentum in universities’ “third mission” of knowledge transfer or exchange, and involvement in industry consultancy and contract research projects. As such, the audience for GPP is potentially broader than the primary users, and the recommendations could be readily adopted and adapted for industries, sponsors, and disciplines beyond life sciences.

Medical communications agencies

It is common practice for pharmaceutical and medical device companies to engage with external agencies to assist with their medical communication needs. As such, the GPP 2022 guidelines have also been eagerly awaited by medical communications agencies. GPP documents are a key tool in training staff, and since the prior iteration of GPP, much has changed in our world that requires novel approaches. While the basic principles of ethical publications have remained the same, there are many new ways of communicating a message to multiple audiences. Plain language summaries and other enhancements/extenders have become common deliverables. However, the community is still figuring out how to best approach them, and the new GPP provides guidance on when and how they can be ethically developed, while leaving plenty of room for the creative process. Medical communication companies also use GPP guidelines to educate clients. GPP 2022 aims to facilitate the updating of internal processes that agencies need to follow, also when working with alliances. The structure of the 2022 GPP update makes it easier to reference sections that are most relevant to specific situations, saving time and making the publication planning process less complex.

Publishers and editors

Lastly, publishers and editors are often called upon to provide guidance to authors on best practice. Sometimes this is directly – fielding questions at the various stages of a publication, from pre-submission enquiries, throughout the publication process, to post-acceptance and beyond. In addition, they must ensure that their information for authors and publishing processes align with best practice. For example, this can include the gathering of author disclosure information, the sharing of publications on social media, the inclusion of digital features, and more. Given the high volume of papers with industry involvement, the GPP guidelines are a valuable resource as an educational tool for the publishing and editorial staff themselves, and as a resource to point authors towards to provide the context for a particular requirement. Since the initial publication of GPP in 2003, and the most recent prior iteration in 2015, the publishing environment has advanced in many areas, including the proliferation of digital features; the growth of social media as a tool to drive awareness of published papers; the inclusion of patients as authors, amongst others. Publishers and editors can drive these developments forward, and the updated GPP guidance provides them with a tool to ensure this is done ethically and in line with industry best practice.

Future directions

What’s next? No doubt the next iteration of GPP will include a discussion of artificial intelligence. Currently, guidelines by some top publishers and journals on the use of generative artificial intelligence by authors are lacking¹¹. A series of position statements have been published in Current Medical Research & Opinion¹² from ISMPP¹³, the Healthcare Communications Association¹⁴, and the World Association of Medical Editors¹⁵. Presently, artificial intelligence is partially addressed in a GPP FAQ document (see https://www.ismpp.org/gpp-2022-faq). Of note is the launch of a new monthly journal from NEJM Group, NEJM AI (https://ai.nejm.org/about). Another area that might receive more attention is the role of patients, from the patient perspective. More to come!

Transparency

Declaration of funding

No external funding or writing assistance was utilized in the production of this editorial.

Declaration of financial/other relationships

Leslie Citrome has served as consultant to AbbVie/Allergan, Acadia, Adamas, Alkermes, Angelini, Astellas, Avanir, Axsome, Biogen, BioXcel, Boehringer Ingelheim, Cadent Therapeutics, Cerevel, Clinilabs, COMPASS, Delpor, Eisai, Enteris BioPharma, HLS Therapeutics, Idorsia, INmune Bio, Impel, Intra-Cellular Therapies, Janssen, Karuna, Lundbeck, Luye, Lyndra, MapLight, Marvin, Medavante-ProPhase, Merck, Mitsubishi-Tanabe Pharma, Neumora, Neurocrine, Neurelis, Noema, Novartis, Noven, Otsuka, Ovid, Praxis, Recordati, Relmada, Reviva, Sage, Sumitomo/Sunovion, Supernus, Teva, University of Arizona, Vanda, Wells Fargo, and one-off ad hoc consulting for individuals/entities conducting marketing, commercial, or scientific scoping research; speaker for AbbVie/Allergan, Acadia, Alkermes, Angelini, Axsome, BioXcel, Eisai, Idorsia, Intra-Cellular Therapies, Janssen, Lundbeck, Neurocrine, Noven, Otsuka, Recordati, Sage, Sunovion, Takeda, Teva, and CME activities organized by medical education companies such as Medscape, NACCME, NEI, Vindico, and Universities and Professional Organizations/Societies; owns stock (small number of shares of common stock) in Bristol-Myers Squibb, Eli Lilly, J & J, Merck, Pfizer purchased > 10 years ago, and stock options in Reviva; earns royalties/publishing income from Taylor & Francis (Editor-in-Chief, Current Medical Research & Opinion, 2022-date), Wiley (Editor-in-Chief, International Journal of Clinical Practice, through end 2019), UpToDate (reviewer), Springer Healthcare (book), Elsevier (Topic Editor, Psychiatry, Clinical Therapeutics).

Lisa M DeTora in the last 12 months has served as a consultant to Boston University, the Regulatory Affairs Professionals Society, and Harvard Medical School.

Dikran Toroser is an employee of Merck & Co Inc and owns Merck stock.

Angela Sykes is an employee of Pfizer and owns Pfizer stock.

Trevor Lane is a Council Member and Trustee of the Committee on Publication Ethics, and has recently served as a consultant to Edanz Group, AsiaEdit, Springer Nature, Hong Kong Academy of Medicine, City University of Hong Kong, and Chinese University of Hong Kong.

Eline Hanekamp is an employee of Excerpta Medica B.V. and a member of the ISMPP Board of Trustees.

Laura Dormer is a co-owner of Becaris Publishing Ltd. She undertakes paid and unpaid consultancy for stakeholders in the healthcare industry (including pharmaceutical companies and medical communication agencies) and the academic publishing industry. She receives an honorarium from ALPSP as a journal Editor-in-Chief (Learned Publishing).

Faith DiBiasi is an employee of AstraZeneca and owns AstraZeneca stock.

Lise Baltzer has no disclosures.

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.