GPP 2022 (formally, the Good Publication Practice (GPP) Guidelines for Company-Sponsored Biomedical Research: 2022 Update) is the current industry-authored standard governing how pharmaceutical, biotechnology, and medical device sponsors plan, write, and publish research they fund. It was published in Annals of Internal Medicine on August 30, 2022 (DeTora LM, Toroser D, Sykes A, et al., DOI 10.7326/M22-1460), developed by a GPP Steering Committee working with the International Society for Medical Publication Professionals (ISMPP). This page is the full explainer of what GPP 2022 actually covers — its authorship rules, transparency and disclosure requirements, data-access provisions, and publication-planning obligations. For the narrower question of how to avoid ghost and honorary authorship specifically in an industry-sponsored study, see Industry-Sponsored Research Authorship: Avoiding Ghostwriting and Honorary Authorship; this page covers GPP 2022 itself, end to end.
What GPP 2022 is, and what it replaced
GPP began in 2003 as a response to well-documented cases of ghostwritten and honorary-authored industry publications, and has been revised roughly every six to seven years since: the original 2003 guidelines, GPP2 in 2009, GPP3 in 2015 (Battisti WP, Wager E, Baltzer L, et al., Annals of Internal Medicine, DOI 10.7326/M15-0288), and the current GPP 2022. Notably, the 2022 update deliberately dropped sequential version numbering — it is not called “GPP4” — in favor of naming updates by year, on the expectation that future revisions will follow the same convention. ISMPP describes GPP 2022 as reorganized relative to GPP3, restructured to give publication teams more directly usable, practical guidance rather than a purely narrative set of principles, with a supplement containing dedicated sections on steering committees, publication plans, publication working groups, authorship and contributorship determination, and publication processes.
GPP 2022 is a distinct document from COPE’s much older 1999 Guidelines on Good Publication Practice, which is a separate lineage from a separate organization (the Committee on Publication Ethics) that evolved into COPE’s Code of Conduct and, later, Core Practices. The two documents share a name by coincidence of history, not by common authorship — don’t conflate them when citing either.
Who GPP 2022 applies to
GPP 2022 governs the publication of company-sponsored biomedical research: industry-funded clinical trials, translational and biomarker studies, and real-world evidence research, wherever a commercial sponsor (pharmaceutical, biotechnology, or medical device company), often working through a contract research organization (CRO) and one or more professional medical writers, is involved alongside academic or clinical investigators. Its scope explicitly covers peer-reviewed and peer-oriented outputs — full manuscripts, conference abstracts, posters, and presentations — and extends to what GPP 2022 calls “enhanced content,” including plain-language summaries written for patients and the public. It is written for everyone with a role in that pipeline: sponsors, medical affairs and publications teams, CROs, medical writers, and the named academic and clinical authors themselves.
The core structure: five practical components
Rather than a single flat list of rules, GPP 2022 organizes its guidance around five operational components that a compliant sponsor publication process is expected to have in place:
- Steering committees — a governance body (sometimes a publication steering committee separate from the trial’s scientific steering committee) that oversees the overall publication strategy for a study or program.
- Publication plans — a documented plan, ideally established before or at trial initiation, that lays out what will be published, in what venues, and on what timeline — the mechanism GPP 2022 uses to operationalize its commitment against selective, outcome-driven publication.
- Publication working groups — the operational team (typically including named authors, sponsor representatives, and any professional medical writer) responsible for a specific manuscript or output.
- Authorship and contributorship determination — the process for deciding, and documenting, who qualifies as an author versus a non-author contributor, and on what basis.
- Publication processes — the practical workflow: drafting, internal and author review, approval sign-off, and submission.
Authorship criteria under GPP 2022
GPP 2022 does not invent its own authorship test; it requires that authorship on a sponsored publication be assigned strictly against the ICMJE four authorship criteria (substantial contribution to conception/design or data acquisition/analysis/interpretation; drafting or critically revising the work; final approval of the version to be published; and agreement to be accountable for all aspects of the work). Anyone who meets all four is entitled to be listed as an author, regardless of whether they are a sponsor employee, a CRO staff member, or an academic investigator. Anyone who contributed meaningfully but does not meet all four criteria — a statistician who ran the analysis but did not participate in drafting or approval, for instance — should be named in a contributorship or acknowledgments statement instead, not silently omitted and not added to the byline as a courtesy. This is the mechanism by which GPP 2022 is designed to prevent both failure modes that recur in company-sponsored research: ghost authorship (a substantial, undisclosed drafting contributor) and honorary or gift authorship (a byline credit given to someone who did not do author-level work). See Ghost Authorship vs. Gift Authorship for how the two are distinguished in practice, and COPE’s Flowchart for Suspected Ghost, Guest, or Gift Authorship for how an editor investigates a suspected case of either.
Transparency and disclosure requirements
GPP 2022 treats disclosure as a condition of a publication being compliant, not an optional courtesy. Three disclosures in particular are required:
- Funding source and sponsor role. The commercial funder must be named, along with a description of the sponsor’s actual role in study design, data analysis, and the decision to publish — so a reader can judge whether the sponsor had editorial control over the result.
- Professional medical writing support. Any professional medical writer’s involvement must be named and their contribution disclosed, typically in the acknowledgments section, along with who funded that support. GPP 2022’s position is that using a professional medical writer is legitimate and common practice — the compliance failure is not using one, it is failing to disclose it. See Medical Writing in Clinical Trials for how that role is defined and where it sits relative to authorship.
- Conflicts of interest. Named authors’ financial and professional relationships to the sponsor must be disclosed per the target journal’s own conflict-of-interest policy.
Data access and author control
A GPP 2022–compliant publication requires that named authors have full access to the underlying study data, or at minimum a data summary sufficient for them to vouch for its accuracy and take responsibility for the reported results, and that authors retain genuine control over the manuscript’s interpretation and conclusions. A manuscript drafted by a sponsor’s medical writer and merely routed to academic authors for a signature, without meaningful opportunity to review the underlying data or challenge the interpretation, does not meet this bar even if the writer is fully disclosed and every named author independently meets ICMJE’s four criteria on paper.
Publication planning: the commitment against selective publication
A defining GPP requirement, carried through every version since 2003, is a documented intent to publish results regardless of outcome — including negative, inconclusive, or commercially unfavorable findings. This is the guideline’s direct response to publication bias in sponsor-funded research: a publication plan created at or near trial initiation, rather than after results are known, is the evidentiary mechanism GPP 2022 relies on to demonstrate that a sponsor did not simply decide not to publish an unfavorable result after the fact.
What’s new or expanded in the 2022 update
Relative to GPP3 (2015), GPP 2022 broadens its scope to reflect how sponsor-funded evidence generation has changed over the intervening seven years. It explicitly extends its guidance to translational and biomarker research and to real-world evidence studies, alongside traditional interventional clinical trials. It formalizes guidance on plain-language summaries as a distinct publication output requiring the same transparency principles as a full manuscript. And it addresses newer dissemination channels — preprints and social media — that did not have established norms at the time GPP3 was written. Sponsors and publication professionals who were operating under GPP3 practices should treat these as genuine scope expansions, not just a restatement of prior guidance.
How GPP 2022 relates to ICMJE and COPE
GPP 2022, ICMJE, and COPE are complementary but distinct. ICMJE sets the underlying authorship criteria that GPP 2022 adopts wholesale rather than modifying; ICMJE’s recommendations apply to all biomedical research, sponsored or not. COPE is a membership organization for journal editors and publishers, providing case-based ethics guidance and flowcharts for editors investigating suspected misconduct, including suspected ghost or gift authorship. GPP 2022 is the only one of the three written specifically for the sponsor side of the relationship — it operationalizes ICMJE’s authorship criteria and journals’ disclosure expectations into a concrete internal process (steering committee, publication plan, working group, sign-off) that a commercial sponsor and its publication professionals can actually run.
Frequently asked questions
Is GPP 2022 a legal requirement?
No. GPP 2022 is an industry self-regulatory standard, not a law or regulation. It has no independent enforcement mechanism of its own. Its practical force comes from journals, editors, and increasingly sponsor internal compliance policies expecting adherence to it, and from the reputational and scientific-integrity consequences of a publication that is later shown not to meet it.
Is GPP 2022 the same as GPP3?
No. GPP 2022 supersedes GPP3 (2015) as the current version. The two are related revisions of the same guideline lineage, but GPP 2022 expands scope (real-world evidence, translational/biomarker research, plain-language summaries, preprints, social media) and reorganizes the guidance into more directly actionable sections. Cite the 2022 version, not GPP3, for anything published or planned from 2022 onward.
Does GPP 2022 apply to academic-only research with no commercial sponsor?
No. GPP 2022’s scope is company-sponsored biomedical research specifically. Purely academic or investigator-initiated studies without commercial funding are governed by ICMJE’s general authorship criteria and their target journal’s own policies, not by GPP 2022, although many of its transparency principles are good practice regardless of funding source.
Who is expected to follow GPP 2022 — the sponsor, the medical writer, or the named authors?
All of them. GPP 2022 is written for the whole publication team: the sponsor (through its medical affairs or publications function), any CRO or medical communications agency involved, the professional medical writer, and the named academic or clinical authors, each of whom has a distinct compliance responsibility — the sponsor for transparency and planning, the writer for disclosure of their own role, and the authors for verifying they genuinely meet all four ICMJE criteria before accepting a byline.
Does using a professional medical writer violate GPP 2022?
No, and this is one of the most common misreadings of the guideline. GPP 2022 explicitly treats professional medical writing support as legitimate, provided it is disclosed. The compliance failure is non-disclosure (ghost authorship), not the use of a writer itself.
Related CASRAI pages
For the practical safeguards this guideline supports, see Industry-Sponsored Research Authorship: Avoiding Ghostwriting and Honorary Authorship. For the underlying concepts, see the dictionary entries for Good Publication Practice (GPP), Ghost authorship, Gift authorship, ICMJE, and Medical Writing in Clinical Trials. For how to distinguish the two authorship failure modes GPP 2022 is designed to prevent, see Ghost Authorship vs. Gift Authorship and COPE’s Flowchart for Suspected Ghost, Guest, or Gift Authorship.
