Reading the 2022 edition of Good Publication Practice
The 2022 edition of Good Publication Practice is a guideline to be applied with judgment, not a procedure to be followed clause by clause. Its principles sit in a short main body and its operational detail in a long supplement, it adds principles and topics that earlier editions lacked, and it was produced over more than three years with wide consultation.
What the guideline is
Good Publication Practice is a set of principles and recommendations for peer-reviewed or peer-oriented publications arising from research funded by or conducted in collaboration with industry sponsors, typically pharmaceutical, biotechnology and medical device companies. The edition appeared in the Annals of Internal Medicine (2022;175(9):1298–1304) and, like every edition before it, is free for the public to read. It was first called GPP4 and is named for its year, and current and future updates carry the date of the update rather than a version number, so that readers can track when an update happened.
The edition builds on previous practice rather than discarding it: many principles of the earlier editions remain, and the update continues to strengthen principles and refine practices to reflect a rapidly evolving field of biomedical publishing. It also takes guidelines for congresses into account. It draws its best practices from a wide range of existing guidance, including the ICMJE recommendations, reporting standards such as CONSORT and those collected by the EQUATOR Network, and the ethical principles of AMWA, EMWA, ISMPP, the Council of Science Editors and the World Association of Medical Editors, and it is meant to be a living document, revised as the field changes and expands.
A guideline, not a procedure
The guideline's authors are often asked to make it behave like a procedure, adding or removing a clause so that it matches an organisation's standard operating procedure (SOP). One of them holds that it is a guideline, not an SOP, and cannot include everything, so a team that approaches the work with ethical intent is following it. Like any guideline, it cannot answer every question that arises at work, and applying its principles to a particular case takes day-to-day judgment by publication professionals; where it gives no exact answer, its principles and processes may still provide an approach to a solution. One practitioner thinks that most organisations' publication SOPs probably carry more tick-boxes than the guideline recommends. Where litigation or a corporate integrity agreement applies, that legal guidance takes precedence over Good Publication Practice. The country a team works in may also determine what processes it must follow.
How the document is organised
The edition's format is similar to that of GPP3. The main body presents the Ethical Principles and the Practical Planning Principles together with the methods used to develop the edition, its scope and format, how to use it, and its conclusions and future directions; a detailed table summarises the key changes and additions since GPP3; and the principles call out specific supplement sections so that a reader can cross-reference quickly.
The supplement is where the detailed guidance sits, and it was much expanded and reorganised to set out, in a logical order, guidance on day-to-day work in the process steps of publication planning, development, review and approval. It was also reformatted to make its topics clearer and the document easier to read. The document, especially the supplement, holds a large amount of information, and it may be hard to read in one sitting or to remember in full, so it helps a publication team to know its structure and consult the relevant sections.
The supplement has nine sections, lettered A to I:
- A, publication types: primary and secondary publications, reviews and meta-analyses, conference presentations, and other types, among them enhanced content and plain language summaries.
- B, publication professional roles and professional development, with a table of the essential team-education events for clinical research publications and their timing.
- C, additional detail on the ethical principles, including special considerations for communicating with the public.
- D, publication steering committees, with a suggested life cycle for one.
- E, publication plans.
- F, publication working groups.
- G, authorship and contributorship determination, with suggested contents for an author agreement.
- H, the publication process, from journal and conference selection, data sharing and working with professional medical writers through kick-off, drafting, review and approval, acknowledgments and disclosures, submission, peer review and page proofs to post-publication activities, with an overview figure and a table of criteria for choosing journals and conferences.
- I, documentation.
Training of publication teams was raised many times during the update, and an important goal of the document is to help train them in best practice, both in principles and in day-to-day processes. The supplement's sections can be used as training: each can stand alone to explain a process and its best practice to publication stakeholders, and the supplement as a whole can serve to educate a publication team and, at some organisations, to guide the development of publication policies and procedures.
Practical guidance for a medical writer's day-to-day work is found in several supplement sections, among them B on professional roles and development, D on publication steering committees, F on publication working groups, G on authorship and contributorship determination, and H on the publication process. One coauthor judges that B, F, G and H hold the most information directly applicable to medical writing. Two flow diagrams, one of the publication steering committee and one of the publication process, and the supplement's tables can be pulled straight out and given to people as a quick reference. The publication-process diagram does not stop at submission but carries through into what happens after publication.
What the 2022 edition added
The edition reflects changes in the publication field and the changing, expanding role of the publications professional. It strengthens the guideline's core values: ethics, transparency, accountability and responsibility are long-standing values of the guideline, and inclusivity is a new focus in 2022.
The principles were augmented and strengthened. They cite updated key ethical documents, among them the ICMJE recommendations and the Declaration of Helsinki, and the AMWA–EMWA–ISMPP joint statement on the role of professional medical writers. The Ethical Principles now number 23 against GPP3's 10, divided into five areas: general principles for ethics and good publication practice, protecting research and data integrity, promoting transparency, supporting inclusivity, and authorship, contributorship and accountability. A set of Practical Planning Principles was added for the practical side of the work.
Among the established principles, one coauthor singles out as strongly affecting the medical writer that results are published in a balanced, accurate, complete and timely way in a peer-reviewed journal, that planning happens before the data are available, and that roles and responsibilities are set out in writing. Other established principles include avoiding commercial interest, promoting transparency, disclosing financial and other interests, supporting author accountability, sharing data, and complying with the law. Among the principles added in 2022 are to include patient voices in planning and authoring where appropriate, to support communication to lay audiences, to support inclusivity and consider marginalised or underrepresented groups, to use enhanced content to reach those audiences, to use open and free-to-access options wherever possible as a further way of promoting inclusivity by giving people access, to reflect all the regions in which the research was conducted at every stage of the publication, and to exhibit leadership through training activities and policy development.
The scope is wider. GPP3 leaned heavily on CONSORT and was focused on the clinical trial publication, while the 2022 edition extends across all scientific areas, naming translational and biomarker studies, nonclinical research, health economics, real-world evidence and outcomes research beside clinical research. The edition also reflects advances in publishing, such as enhanced content, plain language summaries, preprints, and social media posts about peer-reviewed publications, and gives some guidance on social media and guidance on plain language summaries and enhanced content. It expands the term "publications" to include plain language summaries and enhanced content such as videos, audio and infographics, and supports their use to augment a publication and increase its reach. Supplement Section A defines these publication types, and guidance on planning and developing them runs through other sections, among them B, E and H. The guideline emphasises that they should be developed to the same ethical and quality principles as the main publication. One of its coauthors adds that teams new to them would need to work with stakeholders in their own organisations to build good practice into daily work, and that it is important to consult the journals and congresses concerned on their policies and requirements for them.
Inclusivity is recommended both in publication activities, such as attention to cultural differences and region-specific needs, and in the people involved, such as the make-up of steering committees, author groups and publication teams. The edition addresses the potential role of patients in publication activities. One patient partner reports that it says patients can be paid for contributions such as co-authoring, reviewing drafts and sharing lived experiences to inform content. Its new material also covers working with alliance partners, putting together a better author agreement, which was a recurring question under GPP3, and clearer guidance on the timing of data sharing.
One of its coauthors gives, among many reasons for the update, changes in the field, in its audience and in the research it publishes. The field had been changing extraordinarily fast: with enhanced content a publication is no longer just a black-and-white piece in a journal, and the pandemic, by keeping people from travelling to conferences, created a huge need for digital enhancements such as audio and video recordings that can be reached virtually and on demand. The audience now includes people who are not experts in the field, who are not experts at all, who are short of time, or who are in other parts of the world. The wider scope reflects increasingly complex research: health economics and outcomes research matters for informing unmet need and for payers' policy and decisions, and real-world data and evidence play a growing part in decisions by regulators such as the US Food and Drug Administration. Because the research process and methods of these studies differ, the cadence of their publication activities may differ from that for clinical research, and complex data or analyses add the challenge of making the publication understandable and meaningful to its audience.
How the 2022 edition was produced
By March 2020 development of the new version, then called GPP4, was underway, with a steering committee established and working on revisions. As for every edition since GPP2, a steering committee was invited and formed with ISMPP's support, and its members, who typically also form the author group, wrote the guideline and managed review of the drafts by selected expert reviewers or a wider pool of volunteers. The 2022 author group represented Asia, Europe and North America and included members from pharmaceutical, biotechnology and device companies, medical communication agencies, journal editors and publishers, academic institutions and conference organisers, and the draft was reviewed by volunteers from the public before it was submitted, so feedback came from a wide range of perspectives in both the writing and the review.
One of its authors holds that the guideline has grown stronger as the community became involved in it, and that the growing consultation, with external review of the 2022 edition, has made it a robust guideline that fits what practice needs today. The same author notes that some of the feedback concerned practicality, and holds that this comes through in the 2022 edition. Another coauthor puts the number of people who reviewed the draft at somewhere between 500 and 600.
The work started in April 2019, before the pandemic, and took more than three years. That was much longer than its authors anticipated, and one of them thinks the pandemic disrupted the work, which the authors were doing in their own time, while priorities within companies changed, at least at first. The document also grew: the authors began thinking GPP3 was great and needed little change, but the document kept changing shape, and at one point the supplement ran to 26,000 words because it seemed logical for sections to be expansive.
Accounts of when the edition appeared differ by a month: an overview and an editorial give August 2022, while two other accounts give September 2022.
How it is being taken up
The guideline has become a cornerstone of the principles and standards for publishing company-sponsored biomedical research, and of publication processes and procedures in industry, especially at large companies. Its audiences beyond publication professionals and teams appear to include journal editors, conference organisers, academic institutions, and the wider research community and public. One of its coauthors expects it to be more and more widely accepted by journals, congresses and the academic research community; links had been built with the Asian Council of Science Editors, and ISMPP was working with the Medical Affairs Professional Society and the Drug Information Association to discuss and disseminate the update. Disseminating the edition and building it into daily work takes continued effort, and further dissemination and discussion are expected among publication professionals, medical writers, authors, journal editors and publishers, and other stakeholders. One of its coauthors holds that everyone can contribute through discussions with colleagues and stakeholders at professional development activities and in day-to-day work. The same coauthor encourages AMWA members involved in publications to get closely familiar with it. Besides the published document, two webinars introduce it: ISMPP's "Introducing GPP 2022" on 21 September 2022, and EMWA's "Good Publication Practice 2022: Focus on Medical Writing" on 8 March 2023.