9.1 Good Publication Practice 2022: Principles, Scope & Application

Good Publication Practice 2022: Principles, Scope & Application

Scope

GPP 2022 applies broadly to company-sponsored biomedical research, including clinical, observational, health-economic, real-world, preclinical, and other research communicated through scientific publication. It also offers practices that can be useful beyond commercial sponsorship.

It is not a checklist for advertising, a clinical-trial conduct standard, or a guarantee that a journal will accept a manuscript. Apply it with:

• current ICMJE recommendations or the venue's authorship standard;
• EQUATOR reporting guidelines appropriate to the design;
• ethics and trial-transparency requirements;
• journal and congress policies;
• regional law and regulation;
• organizational procedures and agreements.

Prospective Publication Planning

Good practice begins before drafting. A publication plan should identify data that warrant dissemination, audiences with scientific information needs, intended outputs, approximate timing, dependencies, and responsibilities. It should include negative or inconclusive findings and should be updated as the evidence and external environment change.

Prospective planning does not mean deciding the results or conclusions in advance. It creates an accountable route for timely, complete communication.

Agreements and Responsibilities

For company-sponsored work, establish written expectations early. Relevant agreements may address:

• contributor and anticipated author roles;
• access to protocols, SAPs, analyses, and reports;
• author review and approval;
• sponsor factual, legal, regulatory, intellectual-property, or compliance review;
• target-venue decision processes;
• dispute escalation;
• publication timing;
• professional writing support;
• compensation and expense reimbursement;
• funding and disclosure;
• archiving.

The details depend on the project and applicable contracts. GPP does not supply a universal 30-day review period, 60-day patent delay, voting rule, or author-payment formula.

Authors and Contributors

Authorship requirements set by the journal or conference take precedence. GPP 2022 uses the ICMJE criteria as a default where an appropriate venue standard is absent. Under ICMJE, all four criteria are required.

Contributor discussions should begin early but remain conditional on actual work. A steering-committee appointment, senior title, funding acquisition, patient recruitment, or general supervision does not automatically guarantee authorship. Individuals who meet authorship criteria should be offered authorship; those who do not should receive appropriate nonauthor recognition with permission.

CRediT roles can describe who did what, but assigning a role does not by itself decide byline eligibility.

Professional Medical Writers

Professional writing support is legitimate and can improve clarity, reporting-guideline use, and project management. Authors must remain actively involved and accountable. Disclose the nature of support, the accountable writer, relevant qualification and affiliation, and funding as recommended by the Joint Position Statement and required by the venue.

A professional writer who meets all authorship criteria should be considered for authorship. Employment by a sponsor or agency does not automatically disqualify that person.

Sponsor and Company Involvement

A sponsor may have legitimate responsibilities for data accuracy, confidentiality, intellectual property, regulation, safety, and legal compliance. Sponsor employees may qualify as authors or contributors based on their work. Appropriate review should be defined and time-limited.

The ethical boundary is improper influence, not organizational identity. Sponsors should not:

• suppress unfavorable or inconclusive findings;
• force conclusions unsupported by the analyses;
• choose authors for commercial value;
• condition publication on promotional timing;
• exercise an undisclosed editorial veto;
• disguise promotional messaging as independent science.

Authors should consider factual comments and remain responsible for the content. A commercial function should not direct scientific conclusions or use publication planning as a marketing campaign, but a guide should not invent a rule that commercial personnel may never see any publication material under any circumstance. Governance, purpose, and influence matter.

Data Access and Final Checks

Authors need timely access to the information required to understand and verify the work. That does not always mean unrestricted access to identifiable participant-level data. Use privacy-protective, controlled access suited to the role.

Named authors responsible for integrity should perform the final data check. A professional writer may support or supervise quality control before that check. Reconcile the draft to validated outputs and explain material deviations from the protocol, registry, or SAP.

Compensation and Expenses

GPP 2022 and its official FAQs reject payment for guest authorship—money for lending a name—or compensation intended to buy a favorable view. They do not state that every author or contributor must always work without compensation.

Reasonable compensation may be offered for legitimate activities, subject to fair-market-value principles, law, institutional rules, contracts, corporate-integrity obligations, Open Payments or other transparency reporting, and journal or conference disclosure. The terms should be clearly communicated, ideally in the agreement.

Compensation neither establishes nor defeats authorship. Apply the criteria separately. Reimbursement of reasonable travel or presentation expenses can also be permissible under applicable rules.

Complete and Balanced Reporting

Reports should be accurate, complete, balanced, and traceable. Distinguish prespecified analyses from exploratory work. Report limitations and harms. Avoid duplicate publication and unjustified fragmentation.

When multiple publications use one dataset, each should have a distinct scientific question, cross-reference related work where appropriate, and avoid double counting or misleading readers about the amount of evidence.

New and Evolving Formats

GPP 2022 addresses an expanded publication landscape that can include:

• preprints;
• plain-language summaries;
• enhanced or digital content;
• data sharing;
• patient and public involvement;
• social media or post-publication communication.

For a preprint, obtain appropriate author and sponsor agreement, disclose funding and interests, make the non-peer-reviewed status clear, check target-journal and server policies, protect privacy and intellectual property, and link or update the record when a peer-reviewed version appears where possible.

For AI tools, the GPP FAQ directs stakeholders to applicable government, editorial, and conference policies. AI cannot take accountability as an author. Human authors remain responsible for accuracy, confidentiality, originality, and disclosure.

Applied Decision Framework

When a scenario invokes GPP 2022, ask:

1. Is the work within company-sponsored biomedical research publication?
2. Which venue, law, reporting guideline, ethics rule, and agreement also apply?
3. Are roles and review rights clear?
4. Are authors qualified and accountable?
5. Are nonauthor contributions and funding transparent?
6. Can authors understand and verify the data?
7. Is the report complete, balanced, and non-promotional?
8. Is compensation for real work, reasonable and disclosed, or is it payment for a name or influence?
9. Is any disagreement documented and escalated without suppressing the scientific record?