be acknowledged, not listed as authors.

Avoiding Ghostwriting and Guest Authorship:

Two major violations in publication ethics are ghostwriting and guest (or honorary) authorship:

• Ghostwriting: Involves writing the manuscript without proper acknowledgment of the contributor, often in the context of commercial influence
• Guest authorship: Includes listing individuals as authors who did not make substantial contributions

Both practices are unethical and breach transparency guidelines. Journals are increasingly requiring author contribution statements to counter these issues.

To ensure transparency, authorship practices should be documented, ideally using SOPs for pharma SOP documentation that include ethical authorship as a defined process.

Clarifying Author Contributions with CRediT Taxonomy:

The Contributor Roles Taxonomy (CRediT) is a structured way to describe each author’s role, covering 14 contributor types such as:

• Conceptualization
• Methodology
• Formal analysis
• Investigation
• Writing – Original Draft
• Writing – Review & Editing
• Supervision
• Funding Acquisition

Including a CRediT statement with the manuscript increases accountability and clarifies contributions. Many journals now require it during submission.

Determining the Order of Authors:

Author order should reflect the relative contribution of each person. First authors typically perform most of the work and writing, while senior authors may appear last as supervisors or principal investigators. Intermediate authors contribute in various capacities.

Best practices include:

1. Discuss author order early in the project
2. Update order if roles change during manuscript development
3. Document agreement among all authors regarding order

Disputes often arise due to unclear expectations or lack of documentation—use internal SOPs or publication policies to avoid ambiguity.

Manuscript Approval and Accountability:

Before submission, all listed authors must:

• Review and approve the final manuscript version
• Confirm agreement with content, data integrity, and conclusions
• Accept responsibility for their contributions and ensure ethical compliance

This ensures that everyone is accountable and the publication is ethically sound. Journals may request confirmation of author approvals as part of submission requirements.

Managing Authorship in Multi-Sponsor and Multinational Trials:

Large-scale clinical trials often involve multiple institutions, CROs, or sponsors. Authorship must reflect true scientific contribution rather than organizational affiliation.

Best practices include:

• Use joint authorship committees or publication steering committees
• Follow a pre-agreed authorship plan, often outlined in the trial protocol
• Balance contributions from all involved stakeholders
• Avoid giving undue authorship to funding sponsors unless justified

For example, in accordance with EMA guidance, transparent authorship disclosures support scientific credibility in regulatory submissions.

Acknowledgments and Non-Author Contributions:

Contributors who do not meet ICMJE authorship criteria should be acknowledged appropriately. This includes:

• Medical writers (if not meeting full authorship criteria)
• Statisticians providing analysis but not intellectual content
• Study coordinators or technical support staff

Always obtain written permission from individuals before acknowledging them in a publication.

Handling Authorship Disputes and Corrections:

Despite precautions, disputes over authorship can occur. Institutions and research teams should have formal procedures in place to resolve conflicts. Corrective actions may include:

• Retraction of the manuscript
• Erratum or correction notices
• Reporting to journals or funding agencies

Using SOPs in accordance with GMP documentation standards can ensure consistency and fairness in resolution.

Ethical Publication Practices – Summary Checklist:

• Follow ICMJE’s four authorship criteria
• Avoid ghost and honorary authorship
• Use CRediT taxonomy for contribution disclosure
• Discuss and agree author order in advance
• Document all contributions and approvals
• Maintain transparency in multinational collaborations
• Acknowledge non-author contributors appropriately
• Resolve disputes through documented procedures

Conclusion:

Ethical authorship is a cornerstone of scientific integrity in clinical trial reporting. Pharma professionals must uphold these standards not just to comply with guidelines, but to foster a culture of trust and transparency. Incorporating authorship SOPs and aligning with platforms like pharma validation and pharma regulatory compliance ensures that manuscripts are credible, accountable, and ethically sound.