KEY TAKEAWAY

• Open discussion between stakeholders is the key to maintaining transparency and reaching consensus.

Medical writers must often juggle multiple—and sometimes conflicting—requests from various stakeholders, all the while adhering to Good Publication Practice (GPP) guidelines. In a recent poll for their MAP newsletter, the International Society for Medical Publication Professionals (ISMPP) asked respondents how they would handle the resurrection of a two-year old real-world evidence (RWE) manuscript. The scenario required respondents to balance the new project owner’s desire to publish promptly with the lead author’s request for additional analysis and author list changes. Dr Eric Y. Wong (Johnson & Johnson Innovative Medicine) summarised and discussed the results of the poll.

The poll asked: You are the medical writer on a real-world evidence (RWE) manuscript that was initiated 2 years ago. The RWE analyses utilise the services of a third-party data analytics company. At first draft stage, the project was put on hold. The project owner has now left the organisation and the manuscript has been transitioned to a colleague. The lead author would like to perform additional analyses and include one of their colleagues as an author. Meanwhile, the new project owner/client would like to finalise and submit the article as soon as possible.

What would you do?

The results of the poll, which was answered by 131 people, were:

• 87.8% – Convene a conference call between all the authors and relevant internal stakeholders to take a consensus on the best way forward. If the new author is added, all authors need to agree, and the new author must review and approve the manuscript draft.
• 10.7% – Explain the value of performing additional analyses (and spending budget with the third-party analytics company) to the new project owner/client, although this will introduce further delays. Include the new author after aligning with all authors/stakeholders.
• 1.5% – Recommend to the lead author to continue with the manuscript in its current state, as the priority for the project owner is to publish as soon as possible and without inclusion of new author.
• 0% – The additional analyses look simple enough. Carry out the calculations in Excel and circulate the updated draft for final approval without including the new author.

Dr Wong concurred with the consensus opinion. A conference call would allow stakeholders—in this case authors and client leads—to discuss, deliberate, and document a range of options and reach consensus. Authorship changes are permissible so long as ICMJE criteria are met; however,  the project sponsor may lack the budget or timeline flexibility for additional analysis. Dr Wong emphasised that any limitations or mitigations (ie, authors agreeing to take on extra work to support the analysis, or timeline excursions) should be clearly documented.

Some respondents chose the option to explain the value of performing additional analysis (despite potential delays). Dr Wong acknowledged that this approach could be a precursor to a conference call. By contrast, he suggested that proposing that the lead author simply accept the manuscript be published as is would exclude other authors’ views. Dr Wong felt that the final option was inappropriate, invalid, and “off-the-cuff”, as only statisticians (or other appropriately trained professionals) should conduct calculations, which may or may not require a new author.

Dr Wong concluded by highlighting the role of the publication professional in stakeholder mediation. As ever, open discussion is the key to success.

————————————————