Research and Reporting Methods30 August 2022

Good Publication Practice (GPP) Guidelines for Company-Sponsored Biomedical Research: 2022 Update

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    Abstract

    Translations

    These updated Good Publication Practice (GPP) guidelines include recommendations for publishing company-sponsored biomedical research. The GPP guidelines apply to peer-reviewed or peer-oriented biomedical publications, such as manuscripts, meeting presentations, posters, and abstracts, as well as enhanced content, such as plain-language summaries. The current GPP guidelines incorporate guidance on ethics and transparency as well as the planning, development, review, and approval of biomedical publications and policies and procedures that describe these practices. Supplemental materials lay out processes for steering committees, publication plans, publication working groups, determining authorship, and documentation. Information about new topics, such as alliances and working with patients, has been included where appropriate within these supplemental materials. Incorporating the principles and best practices presented in these GPP guidelines will result in increased transparency and a firm ethical footing. This guidance is also intended to enable the compliant incorporation of new and emerging publication tools for the ethical publication of company-sponsored research.

    Transparency and accountability have become increasingly high priorities for publications of company-sponsored research (1, 2). Ethical publication planning should ensure that the design and results of clinical trials and other biomedical research studies are accurately reported in a timely and transparent manner (3). With these obligations in mind, these updated Good Publication Practice (GPP) guidelines are designed to guide publications of biomedical research conducted in collaboration with or sponsored by 1 or more companies.

    Good practice may refer to formal guidelines or generally accepted practices. The initial GPP guidelines (4) provided ethical and other principles for publications of company-sponsored biomedical research. As new trends emerged, additional GPP iterations (5, 6) and Good Practice for Conference Abstracts and Presentations (GPCAP) recommendations (7) followed to answer day-to-day questions. To align with practices such as Good Clinical Practice, this GPP update omits a version number; we recommend that this and future GPP updates carry the date of the update rather than a version number.

    As with the prior publications, we identify best practices based on existing guidance from organizations such as the American Medical Writers Association (AMWA) (8), the Council of Science Editors (9), the Committee on Publication Ethics (10), the European Association of Science Editors (11), the European Medical Writers Association (EMWA) (12), the International Committee of Medical Journal Editors (ICMJE) (3), the International Society for Medical Publication Professionals (ISMPP) (13, 14), Medical Publishing Insights and Practices (15), and the World Association of Medical Editors (16), as well as the many guidelines collected by the EQUATOR Network (2, 3, 17, 18). Sponsor-led initiatives by national and international groups, such as the International Federation of Pharmaceutical Manufacturers and Associations (19), Pharmaceutical Research and Manufacturers of America (20), the Association of the British Pharmaceutical Industry (21), the Advanced Medical Technology Association (22), and the Japan Pharmaceutical Manufacturers Association (23), also provide helpful advice. Thus, much of the presented guidance is based on our knowledge of such guidelines and aims to collect and interpret generally accepted principles. We endeavored to credit original sources; in cases where similar advice has appeared multiple times, it was treated as common knowledge in the field.

    As always, continual effort is needed to ensure that the GPP guidelines are followed widely. We encourage journals, conferences, and academic institutions to endorse these guidelines and help disseminate them throughout the research community. Prompt publication of biomedical research will increase the quality of health care, support education, and promote public health (24).

    Scope

    These GPP guidelines apply to publications of biomedical research conducted by or in collaboration with companies or company sponsors. Such research includes but is not limited to clinical research, translational and biomarker studies, nonclinical research, health economics, real-world evidence, and outcomes research.

    We define “publications” as peer-reviewed or peer-oriented biomedical publications, such as manuscripts, meeting presentations, posters, and abstracts, including enhanced content, preprints, and plain-language summaries (PLSs) of or about such publications. More detailed definitions are provided in Section A of the Supplement, and definitions of other terms used in the guidelines are provided in the Glossary.

    Glossary

    This GPP guideline update may also be adapted for additional situations, such as independent research funded by unrestricted grants from companies or clinical trials conducted through collaborations between other types of groups, such as government agencies and academic partners.

    Changes and Additions

    We intentionally retained many of the principles in prior GPP iterations and GPCAP (4–7). These principles have been reorganized and augmented. One rationale for this reorganization is the increasing scope of publications and professional functions potentially affected by GPP; another is to aid newcomers by providing an overview of different topics.

    Information has been added to reflect updates to key ethical documents, such as the ICMJE recommendations (3) and the Declaration of Helsinki (25); to reference an AMWA/EMWA/ISMPP joint statement on the role of professional medical writers (26); and to reflect advances in biomedical publishing, such as enhanced content, social media posting about peer-reviewed publications, and PLSs. Many minor updates have therefore been made in the supplemental materials.

    A list of major changes, deletions, and additions is provided in the Table.

    Table. Good Publication Practice Guidelines 2022 Update: List of Changes

    Table.

    Format

    As with GPP3 in 2015 (6), the main principles are presented, and more detailed recommendations and process steps appear in Sections A (Publication Types) through I (Documentation Guidelines) of the Supplement. A table of contents is provided in the Supplement, and each of the specific sections of the Supplement is referenced in principles detailed below. The Supplement sections are intended to cover topics in a logical order for an individual team. Each section of the Supplement is also intended to be useful as a standalone document that might, for instance, be provided to potential members of steering committees (SCs) (Section D of the Supplement) or publication working groups (Section H of the Supplement) to help explain the nature of the work being requested or overseen.

    Information on alliances, the role of patients, preprints, enhanced content, and PLSs has been included where appropriate in Sections D (Publication Steering Committees) through I (Documentation Guidelines) of the Supplement. A statement on the use of social media is included in Section C of the Supplement (Ethical Principles: Additional Detail).

    Using GPP

    Not all day-to-day realities of working situations can be anticipated in guidelines. Problem solving and challenging conversations will continue to be necessary. Hence, we attempt to highlight the leadership potential of publication professionals and others who support and plan publications (2, 10, 27). Information about team education and developing standard operating procedures and policies is included in Section B of the Supplement (Publication Professional Roles and Professional Development).

    Methods

    SC Selection and Guideline Drafting

    In April 2019, ISMPP invited its members to apply to serve on a “GPP4” SC. From 74 applications, an 11-member SC was chosen by ISMPP leadership and the then-designated SC chairpersons (D.B. and L.B.), based on professional experience, service to the profession, and publishing record. The chosen members represent different geographic regions (Europe, North America, and Asia) and professional specialties (pharmaceutical, biotechnology, and device companies; medical communication companies; journal editors; publishers; and academics). Each SC member has extensive experience working in various regional and global settings as well as a substantive record of professional service. Membership in ISMPP was not a requirement for SC selection. An SC chairperson (D.B.) identified a colleague (F.J.P.) to assist with administrative activities. All SC members and F.J.P. qualified for authorship based on ICMJE criteria.

    The SC, assisted by F.J.P., initially self-selected into cross-functional subgroups by topic. Subgroups suggested necessary changes and additions, which were reviewed by the full SC. Additional refinements and additions were developed as needed and reviewed by the full authoring group. Consensus was achieved through discussion. The draft sections were compiled and edited for consistency, completeness, accuracy, and readability by a single author (L.M.D.) who was asked to assume leadership responsibilities in June 2021.

    All contributors and authors volunteered their time in a personal capacity.

    Reviewer Panels

    Two review panels were organized to obtain feedback before journal submission. The review panels are described in the Figure. For the expert review, ISMPP was asked to provide contact information for some of the desired reviewers. For the volunteer review, ISMPP created a portal and delivered comments to the SC via a Microsoft Excel spreadsheet.

    Figure. Good Publication Practice Guidelines 2022 Update: review panels.

    ISMPP = International Society for Medical Publication Professionals; SC = steering committee.

    The SC attempted to take in all comments that were feasible and within the scope of GPP. Comments that were very specific to a company setting or therapeutic area and those that were potentially inconsistent with regulatory requirements were not accepted (volunteers work in various countries, therapeutic areas, and study settings and may not be familiar with regulatory requirements in other settings). Conflicting editorial suggestions were not followed.

    Ethical Principles

    See Section C of the Supplement (Ethical Principles: Additional Detail) for further information about ethical principles.

    General Principles for Ethics and Good Publication Practice

    1. Biomedical publications and the research they report must adhere to appropriate accepted ethical research principles (28). Principles outlined in the Declaration of Helsinki (25) and country-specific works, such as the Belmont Report (29), should be consulted.

    2. Publication of biomedical research in peer-reviewed journals is an ethical responsibility.

    3. Publication development should be conducted solely for the purposes of scientific exchange and should follow best practices to meet public health and medical needs, in keeping with the principles of research ethics (25) as well as applicable laws (30) and guidelines (3, 20, 24, 31). See Section C of the Supplement for more detail.

    4. Consistent with journal guidelines (3), sponsors and communications agencies (32, 33), as well as individuals, have a duty to adhere to ethical practices for all publication activities (19, 23, 25, 30). This duty includes the responsibility to ensure that medical writers and other colleagues who support publications are treated ethically and enabled to follow the ethical practices of the field.

    5. Publication professionals, authors, and SCs have a responsibility to seek out and share knowledge on relevant standards and guidelines (17) and to educate their teams on an ongoing basis. See Section B of the Supplement (Publication Professional Roles and Professional Development).

    6. Company policies and other procedural documents for publication planning and authorship should include ethical principles. Sponsor and communications agency policies do not supersede journal or scientific guidelines or requirements (3, 9, 10, 24). See Section B of the Supplement.

    7. Detection of serious problems (such as plagiarism, duplicate publication, or inadequate disclosures) must result in swift action to correct or retract the work.

    8. Ethical standards for individual publications do not alter during public health or other emergencies. Publication activities may be adjusted in response to emerging health care situations to align with medical and public health needs and ethics (34).

    Principles for Protecting Research and Data Integrity

    1. Appropriate controls should be put in place to protect the integrity of research and data reported in publications; commercial interests should not be permitted to influence such integrity or the publications process (3).

    2. Publication planning, development, review, and approval should preserve research integrity by including only colleagues with appropriate qualifications (for example, medical, scientific, professional, or relevant experience) for their respective roles (24). Sections D (Publication Steering Committees), E (Publication Plans), F (Publication Working Groups), G (Authorship and Contributorship Determination), and H (Publication Process) of the Supplement contain additional detail on publication planning and processes.

    Principles to Promote Transparency

    1. Publication is only one form of data transparency, which also includes appropriate protocol and data sharing with authors and journals (35) and posting to trial and results registries.

    2. Data transparency associated with publication activities must be achieved in such a way as to protect patient privacy.

    3. Publications must include the role, if any, of any funding sources and disclose other interests of authors and sponsors, such as the role of the sponsor in research and publication activities and competing financial or other author interests.

    4. Publications should support communication of scientific information to lay audiences through PLSs and other accessible formats (36).

    5. Open-access or free-to-access options for publications should be used whenever possible, and funds for this purpose should be factored into publication budget planning.

    Principles to Support Inclusivity

    1. Attention should be paid to inclusivity and addressing the needs of marginalized or minority groups worldwide. Cultural differences must also be recognized and respected. Regional publication planning may address some inclusivity issues.

    2. Inclusivity should be considered in publication SCs and working groups by including colleagues from different geographic regions and job roles and with varied demographic characteristics (for example, sex or gender, race, and national origin).

    3. Inclusivity also applies to author bylines; ICMJE encourages inclusion of coauthors and collaborators from the region(s) where research is conducted (3).

    4. Patients and patient advocates may be included in publication planning and development, including as authors or contributors to publications, as appropriate to the topic or therapeutic area.

    Principles for Authorship, Contributorship, and Accountability

    See Section G of the Supplement (Authorship and Contributorship Determination) for further detail.

    1. Publication planning and development should reflect the collaborative nature of biomedical research and the full range of skills required to conduct, analyze, interpret, and report research findings. Authorship criteria should be considered at the start of research.

    2. Authors must be enabled to make informed decisions and should therefore have access to adequate study data and other relevant information to enable them to be accountable for publication contents and take public accountability for accuracy and integrity of the work (37).

    3. Author bylines and acknowledgments should follow relevant authorship criteria, using ICMJE as a default, to accurately reflect all contributions (3).

    4. Before publication preparation begins, the rights, roles, requirements, and responsibilities of contributors and authors should be confirmed in writing.

    Practical Planning Principles

    1. Steering committees and publication working groups should convene before study data are available; member responsibilities should be described in writing. See Sections D (Publication Steering Committees) and E (Publication Plans) of the Supplement.

    2. Publication plans should be developed with the input of appropriate contributors. See Section F of the Supplement (Publication Working Groups).

    3. Best practices for publication planning will anticipate problems; therefore, policies and procedures should provide built-in arbitration, escalation, and mediation processes that are clearly articulated and communicated to teams before work begins on relevant publications (26). See Section B of the Supplement (Publication Professional Roles and Professional Development).

    4. Policies, standard operating procedures, and working instructions should guide the work of biomedical publication planning and development and should be consistent with the current iteration of GPP. See Section B of the Supplement.

    5. The publication development process, publication plans, and data sharing should be documented following auditable methods. Regular self-audits are recommended. See Sections F (Publication Working Groups), H (Publication Process), and I (Documentation Guidelines) of the Supplement.

    Conclusion and Future Directions

    These GPP guidelines represent a continuation of prior work to establish and refine the concept of good publication practice (4–7). However, the publications field continues to evolve. One of the limitations of the process followed to develop the current document is that user feedback was not requested until late-stage drafts were developed. Input from members of ISMPP resulted in a radical redrafting of the existing document. Hence, user input should be solicited during the planning stages of any further major updates to GPP.

    The authors anticipate that over the next several years, advances in artificial intelligence, preprint servers, and online media will continue to enhance communication possibilities. We anticipate that ongoing discussions and refinements will be needed. As such, we suggest that a GPP task force may continue to be necessary to provide guidance within the field. Such a task force should include independent voices and maintain a balance of representatives from academia, publishers, communications agencies, editors, and industry representatives.

    References

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    Robert Reinhard29 August 2022
    Participation of patient or research participant representatives in GPP drafting

    Thank you for publishing the very helpful revised GPP. In light of the principles for transparency and the mentiion of principles for inclusivity, a concerted effort to include patient or research participant representatives and advocates in the experts assembled to draft the GPP itself would be a welcome development. It does not appear from the methods or the information in the Supplement that this was the case. Please add these essential perspectives in GPP development.

    Lisa DeTora, Angela Sykes, Faith Di Biasi, Dikran Toroser for the GPP authors2 September 2022
    Author Response to Reinhard

    Thank you for this thoughtful comment.  We agree that more patient voices are needed in all areas of biomedical publications development, especially in the context of clinical trials and other studies that rely on patients to generate data. Patients should be considered as eligible, and important, participants in all aspects of biomedical publications planning, authoring, and management and should be respected and accommodated equitably with other stakeholders. 

    From its inception, the "GPP 4" steering committee included members who present and publish on patient engagement—and engage with patients—in the publications process.  As authors, we made the first mention of patient participants in the publications process in a GPP guideline, and we therefore opted to keep our advice general to create more space for authentic patient voices now and in the future. Our advice is, as we’re well aware, only a first step. Additional guidance is needed from experts in patient engagement, such as patients, patient advocates, and trial participants.   

    Of course, no one-size-fits all accommodation for “patients” in “publications” will ever exist. Important differences must be considered across various clinical settings, disease states, countries, regions, and communities. Individual patient authors, reviewers, and publication steering committee members will also have thoughts and opinions [1]. It would have been impossible to do justice to each of these voices in a single document, especially one that covers so many logistical elements. 

    We welcome and encourage patients, patient advocates, and clinical trial participants to voice their views.  We envision a vibrant series of exchanges and invite patient groups to issue their interpretations of the GPP 2022 principles from their own perspectives.  

    REFERENCES

    [1] Feighery L, Moutet A, Bharadia t, et al. Establishing a patient publication steering committee: A case study with insights for medical writers. Medical Writing 2020; 29 (4): 32-38. Available at: https://journal.emwa.org/writing-for-patients/establishing-a-patient-publication-steering-committee-a-case-study-with-insights-for-medical-writers/

    Disclosures:

    We are the authors of the paper commented on by Dr. Reinhard

    Farah Asif12 October 2022
    Inclusivity matters

    Revised GPP is helpful and its publication is appreciated. We thank the authors for paying attention to inclusivity and addressing the needs of marginalized or minority groups. The initiative of considering inclusivity in publication SCs and working groups by including colleagues from different geographic regions and job roles and with varied demographic characteristics (for example, sex or gender, race, and national origin), is very insightful. However, it should be kept in mind at all times that members from marginalized groups, LMICs, and women might still struggle to qualify as SC members, given the highly competitive nature of selection process. The representatives of above mentioned groups may not have access to similar specialized trainings or roles and other opportunities to make them a suitable candidate. It would be helpful to see what actions can be taken to effectively include these groups in publication SCs and working groups. Secondly, inclusivity of a wide range of populations in company sponsored biomedical research also calls for attention. GPP should include a note on how efforts were made to ensure a global representation of population which was studied to allow generalizability, where applicable, or an account of if wider population representation was not warranted or feasible. It is expected to prevent underrepresentation of large communities in company sponsored biomedical research.

    Lisa DeTora, Faith Di Biasi and Leslie Citrome on behalf of the GPP 2022 authors2 November 2022
    Author Response to Asif

    We thank Dr. Asif for the kind words regarding GPP 2022 and we agree with the main idea presented in this comment. We believe that inclusivity is important at all stages of the research process, and that the publication process may very likely be too late to ensure true inclusivity in research design.  We also agree that, when considering groups such as women and/or researchers in low- and middle-income countries that barriers to inclusivity may exist in inequitable access to education and training to even enable qualification to serve as an author or steering committee member. 

    When considering company-sponsored research, we hope that the groups that advise companies and their collaborators on the design of research, such as the International Committee on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and various medicines agencies and regulators, may help to promote research inclusivity on various levels.  And while we agree that GPP 2022 should endorse inclusivity, the more specific measures suggested, such as requiring comments on generalizability, might be better included in the guidelines included under the EQUATOR network, especially such guidelines as SPIRIT and CONSORT, or in the International Committee of Medical Journal Editors Recommendations.  Our reason for this response is that while GPP describes good practice for publications, other groups, especially journal editors, are responsible for mandating the contents of publications.