Good Publication Practice, or GPP 2022 for short, is a guideline for the publication of company-sponsored biomedical research. The third update of the original Good Publication Practice was issued by the International Society for Medical Publication Professionals. It provides stakeholders with practical principles for the responsible planning, development, and communication of medical publications.
Scope of Company-Sponsored Research
GPP 2022 does not apply to every scientific publication regardless of its context, but specifically to biomedical research funded by companies. The focus is on publications whose creation can involve multiple stakeholders: scientific authors, medical departments, external service providers, sponsors, and, if applicable, patients or patient organizations. The guideline thus addresses publication practice after or alongside research, not the approval of a clinical study.
The 2022 version follows the original guideline from 2003 and its revisions from 2009 and 2015. It was published in the Annals of Internal Medicine at the end of August 2022. ISMPP describes it as a guide for ethical practice, inclusivity, transparency, and responsible publication planning; supplementary materials cover topics such as steering committees and the creation of publications.
Planning and Development of Publications
GPP 2022 requires early, evidence-based publication planning. The selection of publication format, target audience, and timeline should not lead to selective communication of results. Rather, responsible planning involves presenting relevant study results in an appropriate sequence and with clear disclosure of funding and relationships.
The guideline addresses current working methods, such as collaboration in alliances and the potential role of patients as authors or contributors. It also points to expanded content such as plain language summaries. The benchmark remains that the scientific statement of a publication accurately reflects the results of the underlying research and that the roles of all contributors are openly declared.
Distinction: Supplement to ICMJE, Not a Substitute for Authorship
GPP 2022 supplements the ICMJE authorship criteria but does not replace them. The ICMJE criteria answer, on a person-by-person basis, who may be named as an author of an individual work. GPP 2022 broadly regulates how a company-sponsored publication program should be planned and ethically implemented, including transparency, collaboration, and recognition of contributions.
Even GPP-compliant publication planning does not create scientific justification for a study protocol, endpoint selection, or evaluation procedure. CONSORT, SPIRIT, PRISMA, and STROBE are study-type-specific reporting standards. GPP 2022, in contrast, provides the organizational and ethical framework for publications from the corporate environment, regardless of which reporting guideline applies to a specific article.
The principle does not apply solely to journal articles. Depending on the evidence and publication plan, congress contributions, abstracts, digital content, or summaries for different target groups may be produced. GPP 2022 draws attention to the fact that these formats should not generate different versions of the same evidence with contradictory statements. Planning must therefore consider data maturity, author involvement, scientific review, and appropriate disclosures in every intended format.
GPP 2022 does not require identical author lists for all formats of a project. Which individuals merit authorship continues to be evaluated for each individual publication based on their contributions. Rather, the guideline helps to ensure that this decision-making process does not begin only with the finished manuscript. A traceable pre-planning can reveal where expertise is lacking, when authors are to be involved, and which data basis is suitable for the planned statement.
A central practical point is transparent collaboration between the sponsor and external authors. GPP 2022 does not permit a sponsor to obscure its role in funding, data access, or editorial support. At the same time, support does not mean that independent scientific judgment is excluded. The involved authors must be able to review the submitted data, contribute to the argumentation, and take responsibility for the published version.
Relevance for clinical trials
In a clinical development program, multiple publications often arise from a single study or drug: primary results, subgroup analyses, safety data, review articles, and accessible accompanying formats. Without a coordinated plan, publications can clash chronologically, contributions may remain unclear, or partial results may be communicated in isolation from the overall study. GPP 2022 therefore links the publication strategy with documented roles, author processes, and the complete evidence picture.
Full-service CROs like Mediconomics support GPP 2022 by creating and maintaining a publication plan, coordinating author meetings, and tracking conflict of interest and author approvals. Medical writing can prepare evidence tables, manuscript drafts, and plain language accompanying texts in such a way that sources and contributors remain identifiable. Project management connects these processes with the timings for database lock, statistical analysis, and regulatory communication.
Frequently Asked Questions (FAQ)
Is GPP 2022 a legal obligation for every study publication?
GPP 2022 is a professional guideline, not a legal regulation. However, for the publication of company-sponsored biomedical research, it sets a recognized framework of good practice.
Does GPP 2022 also cover publications with patient involvement?
Yes. The update includes information on the potential role of patients as authors or contributors and on the inclusive development of biomedical publications.
What role does CONSORT play alongside GPP 2022?
GPP structures responsible publication practice. CONSORT specifies the study-specific reporting elements for the results report of a randomized study.
Regulatory References
- GPP 2022 — Guideline for publications of company-sponsored biomedical research.
- ICMJE Recommendations — Define authorship, contributors, and publication responsibility.
- CONSORT 2025 Statement — Applies to the reporting of randomized trials.
- PRISMA 2020 Statement — Applies to the reporting of systematic reviews.