PharmaWrite at the 12th Annual Meeting of ISMPP
HOW TO RESOLVE "REAL-LIFE" AUTHORSHIP CHALLENGESCompiled for you by PharmaWrite.
In the course of developing scientific publications, medical writers and publication professionals often face three primary author-related challenges. These specific issues, as defined recently at the 12th annual meeting of the International Society of Medical Publication Professionals (ISMPP), are non-responsive authors, late addition of authors, and situations where internal authors depart the company.
At the ISMPP, a distinguished panel of industry experts identified and then discussed these common authorship issues – and then offered guidance and best practices to resolve and even evade them.
I. Non-Responsive Authors
It is always problematic and costly when authors are non-responsive to requests to review manuscript drafts. There are often multiple reasons for this non-responsiveness, including:
- Busy schedule
- Lack of interest
- Authorship inappropriately identified
- Difficulty with online review platforms (eg. DataVision)
These variant circumstances often drive difficult decisions on whether or not the author met ICMJE criteria - or whether they should be removed from the author byline altogether.
To avoid these situations, there are various strategies that can help ensure or elicit responsiveness. These strategies may include:
- Setting expectations and timelines in advance (preferably on a kickoff call)
- Using regional or local MSLs or ex-US staff to help elicit a response
- Being flexible about how comments are received
- For example, if the author will not send back written comments, consider capturing comments on the phone and documenting the exchange)
- Asking an author specific questions during the review process, to help elicit a substantive response
It is also important to consider when in the process an author becomes non-responsive. While an author who is non-responsive from the beginning may not meet authorship criteria, if an author comments on the first two drafts and then becomes unresponsive, it is often possible (according to the current guidelines) to continue without additional feedback. If, however, the decision is ultimately made to remove an author from the byline, keep in mind that an acknowledgment is still required if that author contributed to the study.
Of note, there was audience-stimulated discussion regarding an assumption of "no comment" if an author did not respond during a review cycle. While most felt some input was needed to meet ICMJE criteria, a few felt that such demands constituted imposing "Western standards" on culture-influenced investigators (eg, authors from Asia) – authors who would be reticent to offer input that might contradict a more senior author.
II. Late Addition of Authors
At ISMPP, Michael Platt of MedVal noted that there are circumstances where an author could be added later in the process of manuscript development. He cited an example where a group of authors decided that specific safety context was required for a manuscript, and recommended an academic author be added with expertise in the topic. The development process was stopped while the new author was invited to participate, was brought up to speed on the development of the paper, and offered his input. Michael noted that proper documentation was important for transparency.
When the situation calls to add late authors, there are a number of questions to consider:
- Does the author meet ICMJE criteria or would acknowledgment be more appropriate?
- Who is requesting the addition and why? (Often, authors are added at a late stage of development for poor reasons, such as guest authorship.
- Where is the publication in development? If in late-stage, will getting comments delay timelines?
- Do all the other authors approve of the addition?
If the decision is made to add a late author, always ensure that:
- The author had access to all data and minutes of all previous discussions about the publication
- There was adequate re-education about authorship criteria
- All rationale for why the author was added was properly documented
III. Internal Authors Who Depart
Many companies have policies in place regarding internal staff who are identified as authors on a manuscript and depart for a new position at another company. Such guidance is critical to avoiding authorship disputes. Often, such employees may not be retained as authors if development of the paper has not commenced.
An exception might include a departing medical director, whose knowledge of the clinical trial is needed for coherent development of the manuscript. If retaining an author who has departed the company, it is prudent to obtain an authorship agreement similar to the agreements a company has with external authors.
To mitigate this situation, the following questions should always be considered when authors depart the company:
II. Is the author still interested in maintaining authorship?
III. What is the status of the publication?
IV. Did the author go to a competitor company?
For your convenience, and for your reference, the PharmaWrite staff has compiled a detailed meeting summary of the ISMPP event, including session descriptions, key takeaways, and valuable speaker comments and quotes. The summary includes valuable in-depth information, like the material presented here, on all of the topics discussed at ISMPP. Please fill out the form below to request this comprehensive summary.