The Good Publication Practice (GPP) guidelines were updated in August 2022. In this post, I summarize a recent presentation of the guidelines that may be of particular interest to medical writers.
What is GPP?
GPP outlines the principles and best practices for writing peer-reviewed or peer-oriented biomedical publications (eg, manuscripts, meeting presentations, posters, and abstracts) as well as enhanced content (eg, plain-language summaries [PLSs]) in order to increase transparency and a provide a firm ethical footing for scientific publications.
You can access the guidelines here. You will need to create an account with the Annals of Internal Medicine and then you should be able to access the guideline pdf. Make sure you have a look at the Supplement, which contains further information on the topics below.
In a broadcast from ISMPP, four of the guidelines authors, Lisa DeTora, Faith DiBiasi, Laura Dormer, and Fiona Plunkett, summarized the updates made in the most recent version of the guidelines. Below is the summary of the meeting and the Q&A session that I would be of particular interest to medical writers.
What’s new in GPP2022?
The first thing you'll notice about the new guidelines is the name change. The previous version was called GPP3, the new version is called GPP2022. “Why not GPP4?” people asked. The answer is that the authors of the guidelines didn’t want it to be treated as a sequel as it is more of an evolution or a progression of the previous version. In addition, they wanted it to be in line with the rest of the Good Practice guidelines, which do not use numbers.
While the core GPP principles were not changed markedly in the new version, the authors pointed to the following important updates:
Patients and patient advocates should be included in publication planning and development, where appropriate
Publications should be supported by plain language summaries (PLS)
Inclusivity of marginalized and minority groups should be a priority
Enhanced content and PLS should be used to reach lay audiences
Open access should be used whenever possible
All regions in which research is conducted should be represented
Policy and standard operating procedures (SOPs) should be developed and proper trancing on publishing practices provided to team members involved in communication of scientific information
The GPP guidelines also got a makeover in the form of detailed appendices for the key aspects of publication planning. The presenters did not cover details of each section, but they did provide helpful summaries of information found in each section and answered questions from the participants.
Publication types
This section presents definitions for differed publication types, their content, and timing of publishing. The publication types described include primary and secondary publications, reviews and meta-analyses, scientific conference presentations, and other publication types such as methodology articles and letters to editor.
Enhanced content and plain language summaries
Furthermore, the GPP2022 authors recommend that “publication might be augmented by enhanced content, including a PLSs or lay summary, presented in various formats such as text, video, audio, podcast, or infographic.” They cautioned that this “enhanced content” should never be promotional and must follow the same ethical and quality principles as the main publication. It is desirable to have all patient-facing materials peer-reviewed along with the main publication.
Pro tip: To avoid your PLS sounding like just another abstract involve patient authors in their production. They can help ensure accessible language and relevant content.
Though guidance on creating PLSs and enhanced content is beyond the scope of GPP2022, this information is available from the Patient Focused Medicines Development (PFMD) group here and in this practical guide by one of the authors of GPP2022 (Laura Dormer).
The presenters did give some useful advice on the PLSs and enhanced content. If a journal does not publish PLS along the main publication, GPP2022 supports its publication elsewhere. Alternatively, some journals may include it as a table, and they advised discussing this possibility with the editor. In terms of readability, the PLS should be accessible to its intended audience, which should be determined upfront (eg, non-specialist HCP/GPs, patients, general public). They also pointed out that there is a distinct advantage of involving patient authors, patient panels, or patient members of the publication working group in developing PLSs. They can ensure that the summary is written in accessible language and that the content is relevant.
Pro tip: If a journal does not publish the PLS along the main publication, discuss with the editor if you could include it as a table in the manuscript.
Another important consideration they brought up is budgeting for PLSs and enhanced content, as the cost range can be quite wide (eg, video production can be costly, while writing PLSs may be more cost-effective). They reminded the participants that the budget for enhanced content should be included in the publication plan.
Further guidelines for different publication types are available in Supplement Section A.
Publication professional roles and professional development
In this section, the authors offer recommendations for developing SOPs for scientific data presentation and recommend key organizations that can help with training publications teams.
This section is of particular interest to medical writers and those working with us. It outlines the guidelines for hiring publication professionals (ie, medical writers). The authors state that company-hired publication professionals:
Preserve the integrity of the publication process and advise authors, writers, internal reviewers, publication working groups, and steering committees
Manage the publication budget
Mediate or manage professional relationships
Educate team members on various aspects of publication management, ethics, and development
Develop relevant SOPs
They further clarify that external publication professionals “may be contracted to perform services that would typically be done by an in-house publication professional, as well as additional services, such as writing, editing, and publication plan management.” They specify that “properly trained and experienced medical writers” can:
Help authors develop publications
Enhance publication quality
Reduce the risk for retractions due to misconduct (Woolley et al 2011; Gattrell et al 2016)
Finally, the authors mention that medical illustrators and designers can contribute to the clarity of tables, figures, posters, presentations, and infographics (shout out to our med illustrator colleagues!).
More information on professional roles and professional development, including suggestions for SOP development and training of internal teams, is available in Supplement Section B.
Publication steering committees
This section offers detailed guidance on when and how to form a publication steering committee. The authors recommend forming a steering committee for each clinical program or research program, for clinical trials expected to generate multiple publications, or alternatively, by product, indication or for a specific region or specialty. The presenters clarified that while having a steering committee is recommended, it may be not be needed if only a small number of publications is expected.
The presenters advised that it is important to get the steering committee started early on in the process and to clearly set out expectations and roles in a charter. A question about what happens when a steering committee is formed early but the data end up not being publishable further highlighted the need for a detailed charter so that such issues are dealt with ahead of time. They also advised outlining schedules and communication plans so that the steering committee members are aware of the time commitment. An important point was made about the life cycle of a steering committee that specifies a clear end date so that the committee is not in place indefinitely.
More information on steering committees, including a handy graphic that outlines the life-cycle of a steering committee and the responsibilities at each step, is available in Supplement Section D.
Publication working groups
Publication working group consists of team members who “manage the authoring and submission of abstracts, presentations, and publications from the same study or predefined data analysis or a closely related studies or datasets.” They also ensure that development follows all guidelines and timelines set forth by the steering committee. The publication working group is operationally involved in the production of individual publications (as opposed to the steering committee, who oversee the whole publication development program for a study, product, or area). In some cases, steering committee may take on the role of the publication working group as well, but this needs to be defined upfront in the steering committee charter.
Definition: Steering committee oversees the whole publication development program for a study, product, or area. Publication working group is operationally involved in the production of individual publications.
The professionals who make up the working group might include internal publication leads, project managers, medical writers and editors, statistical leads and others. It is important to note that the members of the publication working group are not necessarily going to be listed as authors – they are contributors (see next section on authorship vs contributorship).
The guidelines state that the commercial colleagues “may not influence content development, review, or approval for biomedical publications.” However, regardless of the internal reporting structure and their job function, health economics and outcomes research (HEOR) and real-world evidence (RWE) colleagues should be classified as researches if their expert input is beneficial to the publication.
More information on publication working groups is available in Supplement Section F.
Authorship and contributorship determination
Author vs contributor
The difference between authors and contributors, as it relates to a peer-reviewed publications, was discussed in some detail. In a nutshell, an author needs to meet the criteria outlined in ICMJE, and a contributor is anyone (eg, in the study group or publication working group) who participates in the production of the manuscript but will not necessarily be listed as an author. The presenters advised that the criteria for contributorship and responsibilities of different contributors need to be defined in advance.
Definition: An author is an individual who meets the criteria outlined in ICMJE and other internally defined authorship criteria. A contributor is anyone who participates in the production of the manuscript (but may not be necessarily credited as an author).
The CRediT (Contributor Roles Taxonomy) was created to with the intention of recognizing individual author contributions, reducing authorship disputes and facilitating collaboration. Head over to Elsevier's CRediT author statement website for a handy tool for figuring out who should be attributed to which role (or click on the arrow).
CRediT (Contributor Roles Taxonomy)
Authorship criteria
The presenters discussed the main principles of authorship criteria, highlighting that International Committee of Medical Journal Editors (ICMJE) criteria should be fulfilled for all publications, with the exception of any congresses that have their own authorship criteria. They further specified that paid employment does not exclude someone from being an author (including medical writers), assuming they fulfil the ICMJE criteria (click on the arrow below to learn more).
ICMJE Authorship Criteria
The presenters encouraged the use of ORCID ID in order to increase transparency (click on the arrow below to learn more).
ORCID ID
Interestingly, the guidelines suggest that “authorship criteria should be applied consistently to all contributors, including patients and professional medical writers.” In my experience, it is rare that the medical writer would meet all 4 ICMJE authorship criteria and that the company would invite the medical writer to be an author. However, it is nice to see that in cases where medical writers are deeply involved in the analysis of the data and production of a manuscript we might start to get recognized as authors.
Assigning authorship
For authorship, setting expectations early is critical. The presenters advised to make all potential authors aware of the criteria for authorship and any issues related to authorship (eg, author order) at the start. They suggested that perhaps an internal publication group member can circulate a list of all proposed publications, and suggest that potential authors sign up for 2 or 3 that they find most interesting. The presenters also discouraged patient enrollment as a criterion for authorship, as this practice has fallen out of favour.
Pro tip: To avoid authorship drama, circulate a list of all proposed publications and suggest that each potential author sign up for 2 or 3 publications that they are most interested in.
Author groups/Collaborators
If there is a large number of authors or collaborators who cannot be all listed but need to be acknowledged, it is sometimes possible to use “on behalf of.” Another option is to list them as a “Study Group.”
It should be noted that collaborators in the "Study Group" will be indexed by name in PubMed. In response to the question on whether permission is needed from investigators to list them in a study group, the presenters advised that the best practice is to always ask for permission. Some journals may require written permission, but in other cases you can simply send an email stating that you intend to list them in a study group and that if you don’t hear back from them you will assume they agree.
Pro tip: To get a timely approval, send an email stating that you intend to list the individual in a study group and that if you don’t hear back from them you will assume they agree.
An interesting question was posed during the Q&A: What happens when there are multiple internal authors in the same function or if a person leaves the company and goes to a competitor? The presenters advised that this needs to be decided on the case-by-case basis. Perhaps it can be based on how well they qualify - if they developed the protocol, set up the study, or analyzed data, then they may need to be listed as authors. However, if the person is going to a competitor and new proprietary data come up, it would be best to consult the company’s legal department.
Patients as authors
The presenters discussed at some length the inclusion of patient authors. They encouraged the inclusion of patients as authors, where appropriate, to provide a previously underrepresented point of view. The advice was that patient authors should be shown the data in context and given ample time to review them and give intellectual input.
Pro tip: Always provide patient authors with the data along with explanations and context and budget ample time for them to review and provide input.
This prompted a question about the legality of sharing data with patient authors. The presenters acknowledged that privacy would need to be preserved and that some parts may need to be redacted. They advised to consult their internal company transparency rules about what can be shared and when. GPP2022 encourages companies to be as transparent as possible, while maintaining privacy rules and company transparency policies.
More information on authorship and contributorship, including guidance for author sequence and considerations for authorship agreements, is available in Supplement Section G.
Publication plans
Publication plans “help ensure that research is published and presented in a responsible, ethical, and timely manner.”
Key principles of publication plans are outlined in this section, including:
Publishing primary and secondary outcomes regardless of whether they are positive or negative
Publishing background information needed to contextualize clinical data (eg, new methods or techniques) before publishing the results
Including all publication components (including PLSs and enhanced content) in planning and budgeting
Selecting appropriate and realistic journals and conferences
Prioritizing open-access and free-to-access options
Notifying authors in a timely manner of their roles and responsibilities and giving them ample time to review the data
Respecting journal and conference embargoes
More information on publication plans, including a detailed table of the key principles of publication plans, is available in Supplement Section E.
Publication process
The section on publication process in the supplement is detailed and full of practical information (eg, how to choose a journal/conference, how to structure a kick-off meeting, how to deal with post-publication activities). However, here I wanted to focus on the section on working with professional medical writers. The guidelines state that general good practice would dictate that the following is indicated in writing in the author agreement:
The authors control and direct publication contents.
The writer must receive direction from the authors before they undertake any writing, including an outline.
All authors have agreed to the writer’s involvement.
All authors have a documented agreement with the sponsor that identifies their respective rights, roles, and responsibilities.
The authors will disclose, at a minimum, the writer’s name, professional qualifications, affiliation, funding source, and any other information required by the journal or conference.
Good publication practices will be followed (GPP2022).
These clauses are a welcome addition to the author agreements, dispelling any myths about medical writers influencing or biasing the outcomes we report. In reality, medical writers have little influence over the content and messaging, and would be expected to bring up with the group any issues related to ethics and guidelines.
Phew - that was longer than I intended. I hope this not-so-short summary is helpful and encourages you to explore the GPP2022 guidelines in more detail.
Do you have any further thoughts on these updates? Let me know in the comments!
Stay curious,
Resources at a glance
DeTora LM, et al. Good Publication Practice (GPP) Guidelines for Company-Sponsored Biomedical Research: 2022 Update. Ann Intern Med. 2022;175:1298-1304.
Authorship:
Determining authorship eligibility: ICMJE. Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals.
Determining authorship contributions: CRediT (Contributor Roles Taxonomy).
Authorship statement: Elsevier website.
PLS and enhanced content:
Patient Focused Medicines Development (PFMD) group guidance.
Dormer et al. A practical ‘How-To’ Guide to plain language summaries (PLS) of peer-reviewed scientific publications: results of a multi-stakeholder initiative utilizing co-creation methodology. Res Involv Engagem. 2022;8:23.
Roles and benefits of professional medical writers:
Wooley KL, et al. Lack of involvement of medical writers and the pharmaceutical industry in publications retracted for misconduct: a systematic, controlled, retrospective study. Curr Med Res Opin. 2011;27(6):1175-82.
Gattrell WT, et al. Professional medical writing support and the quality of randomised controlled trial reporting: a cross-sectional study. BMJ Open 2016;6: e010329.
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