Medical publication policies and guidelines offer a framework for best practices, but there may be situations when more than one approach seems reasonable. The primary purpose of “What Would You Do?” is to explore examples of such situations. With the limited information provided to interpret the scenarios, you may find yourself agreeing with one, more than one, or none of the proposed actions. And that’s the point ‒ you should debate, contemplate, and communicate (with a comment) before selecting your “best” answer.
Now let’s find out how you responded and read through some commentary (for context only; not meant to be comprehensive) to the below scenario:
You are the medical writer on a real-world evidence (RWE) manuscript that was initiated 2 years ago. The RWE analyses utilize 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 organization 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 finalize and submit the article as soon as possible.
A. 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.
B. 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.
C. 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.
D. 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.
A total of 131 people replied to this poll.
Option C describes the likely optimal path forward. By bringing the authors and relevant stakeholders together, multiple options and opinions can be shared openly, mutually agreed upon, and documented in a single discussion. It is not uncommon to have multiple contributors acting on behalf of a single entity (eg, scientists/analysts employed by, or working on behalf of, the sponsor) attend publication calls, and it is usually beneficial for this group to connect in advance to align on a position prior to the call. If there are new individuals involved to conduct additional analyses or contribute to the interpretation of data, changes in authorship are allowed based on Good Publication Practice and ICMJE criteria if all other authorship criteria are met. It is appropriate to provide clarity and describe author involvement and contributions at the end of the manuscript.
It is possible the sponsor no longer has the budget or resources to pursue the updated analysis. In this case, unless an alternative solution is reached (eg, authors are willing to support or take on the work directly), an updated analysis will likely not be possible. Companies or organizations may also have policies in place that dictate the timeframe for when data analyses meant for publication must be published, and there should be individuals who track these timelines to ensure the publication is executed according to policy (or exceptions put in place). Any limitations or considerations such as the examples provided here should be clearly communicated and documented to authors during project kickoff calls to avoid any misunderstandings down the line.
Option B is an action that can be taken by the sponsor prior to the approach described in Option C, as discussed above.
Option A may not necessarily account for the lead author’s feelings about the future of the analysis, nor does it give an opportunity for other authors to chime in. This approach may be considered if the sponsor cannot continue with the project, and then the status should be shared with all authors.
Option D seems a bit off-the-cuff; calculations should be conducted in a validated fashion with the involvement of statisticians and those who understand how to interpret the analysis, and it is unclear whether a new author may be needed for this purpose.
As publication professionals, the ability to lead, facilitate, and pull through action items from several different stakeholders are key ingredients for transparency. Broad, inclusive discussions involving all authors and relevant stakeholders is the recipe for success.
Eric Y. Wong, PhD, MBA, ISMPP CMPP™, Johnson & Johnson Innovative Medicine
This article was prepared by the author in his personal capacity. The opinions expressed within are the author’s own and do not necessarily reflect the views of Johnson & Johnson Innovative Medicine.
References
- Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals (updated May 2022): http://www.icmje.org/icmje-recommendations.pdf