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 a company medical publication professional. The lead author of a manuscript in development was key in acquiring data for the study and actively engaged in the initial discussions that shaped the outline for the paper. However, he/she was slow to send feedback on the first draft, and the second draft has been with him/her for more than 2 months, despite exhaustive attempts to get in touch through multiple channels (via co-authors, field medical staff, etc.). Some of the other authors have contributed equally to the design of the study, and direction and revisions of the paper. Several of them have indicated that they want to remove the lead author as an author on the manuscript because of the delays. Another co-author has suggested “demoting” the lead author to another position on the byline.

What would you do?

A total of 60 respondents replied to this poll.

Remove the lead author and acknowledge his/her contributions so that the team can immediately proceed with manuscript development to make up for the delays. (0% of responses)

It would not be appropriate for the medical publication professional to take this action based on the information given. When faced with a decision of whether to remove an author, all (not just several) authors must be looped in on the rationale and agree to the change. In addition, the lead author has not yet failed to fulfill ICMJE criteria for authorship to warrant removal.

Keep authorship as is and continue to follow up with the lead author until a response is received. (16.5% of responses)

This could be an acceptable approach if:

  1. The manuscript is not about pivotal new clinical trial or safety data that should be published promptly to help inform safe and appropriate use of a therapy.
  2. There were significant changes between the first and second drafts of the manuscript, especially around content specifically suggested by the lead author.

It is generally correct to push manuscript development along in order to ensure timely publication of data and meet publication plans.

Agree to demote the lead author to another position, send an email to the lead author to explain the decision, and continue to follow up until he/she responds. (20.0% of responses)

A change in authorship positions may be warranted if a co-author contributes significantly enough to leapfrog the contributions of the lead author, and if all authors agree to this change. It is questionable whether a delayed response to a second draft manuscript alone warrants a demotion in authorship position.

Address comments from all other authors and send the final manuscript for all author approval by a given deadline, stating firmly but politely that any authors not responding by the deadline would be removed from the manuscript. (63.5% of responses)

This approach pushes manuscript development along to ensure timely publication of data, and the proposal to remove any authors who do not provide final approval is aligned with ICMJE criteria. Up to this point, the lead author has provided enough input into the development and review of manuscript drafts such that a final approval would support authorship.

Key Takeaways

Early in the publication development process, such as within the authorship agreements and during kickoff calls, the roles, responsibilities, and expectations of each author should be clearly outlined and agreed upon. This would include the expectation of timely reviews in adherence to proposed development timelines (especially if expedited timelines are anticipated), and the consequences of not meeting them (ie, potential removal as an author).

Eric Y. Wong, PhD, MBA, ISMPP CMPP™, Janssen Scientific Affairs, LLC
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 Janssen Scientific Affairs, LLC.

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