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 publication steering committee of a company-sponsored pivotal phase 3 clinical trial has selected investigators to serve as authors, but the committee and authors are having difficulty in deciding the order of authorship. During discussions, multiple authors believe that they have equal rights to the first author position based on their contributions.
- Assign first author position to the author who is most experienced and renowned in the field
- Suggest that the company sponsor should decide the authorship order
- Systematically list out the contributions of each author, with an objective weight assigned to each contribution, and use the weighted score to determine authorship order
- Propose to authors that the journal attributes lead authorship to the multiple authors by stating that they all “contributed equally” to the article, with names listed alphabetically on the byline
A total of 89 respondents replied to this poll.
In general, publication steering committees not only provide input into publication planning, determine key results to include within each publication, and identify secondary analyses, but committee members are also asked to align on and assign roles in the development of each publication, including authorship. Given the importance of these decisions, it is critical that the committee members and chairs have a solid understanding of Good Publication Practice (GPP3) guidelines1, International Committee of Medical Journal Editors (ICMJE) authorship criteria2, and company sponsor policies pertaining to authorship, or access to a medical publications professional who can explain and consult on these topics.
Whether or not a publication steering committee exists for the study and its resulting publications, it is considered best practice to assign roles and determine the authorship group and order early in the process before publication development begins. Positions such as lead or senior author are often given to the contributors who conceive, design, and make the study possible, and/or those who have the background and experience to analyze or interpret the findings so that results are accurately conveyed, have maximal impact, and are optimally communicated to the readership. Other positions on the author byline are assigned to select contributors who are expected to fulfill ICMJE criteria. There is currently no single widely accepted methodology to make authorship order decisions, but the process should be done in a thoughtful and transparent manner so that all authors understand the rationale for the decisions (even if they do not necessarily agree).
Ultimately, all authors should align on the authorship group and order. In the event that there are significant deviations to the expected contributions by assigned authors (eg, an author departs an institution and no longer wants to be involved, or does not contribute sufficiently to warrant the role assigned, or contributes much more than initially planned), the authorship group can agree to modify the byline as publication development progresses. It may also be a good idea to include in the publication steering committee charter, which all participants sign and agree to prior to membership, language about how authorship disagreements will be adjudicated (eg, final decisions are made by the committee chair(s)).
With these points in mind, we can now explore the different options:
Assign first author position to the author who is most experienced and renowned in the field (0% of responses)
The authorship group must agree on who will contribute sufficiently to the publication to warrant the lead author position according to ICMJE criteria. And although the authorship group may decide that the author with the most experience/renown does meet the criteria to serve as lead author, that author’s previous accomplishments, reputation, and/or title alone should not be used as justification for this publication.
Suggest that the company sponsor should decide the authorship order (0% of responses)
It is the responsibility of the authorship group to decide authorship order. If employees of the company sponsor are also authors, then they may provide input as members of the authorship group, but it is not the role of the sponsor to make authorship decisions.
Propose to authors that the journal attributes lead authorship to the multiple authors by stating that they all “contributed equally” to the article, with names listed alphabetically on the byline (35% of responses)
This is an option if the authorship group agrees that multiple individuals contributed equally and if the target journal allows for it. This approach is not very common in medical research, and, in most cases, the equal contribution is shared among only 2 or 3 authors.
Systematically list out the contributions of each author, with an objective weight assigned to each contribution, and use the weighted score to determine authorship order (65% of responses)
This is probably the most common and objective approach to assign authorship order. Often this involves the authorship group talking through and documenting the contributions made or expected of each author to justify given positions on the byline. Others may choose to be more formal and utilize a predefined scorecard with a checklist of activities to assess relative contributions of each author up until the time the publication is approved for submission. There is currently no single universally accepted approach, but transparency to the decision-making process is paramount.
As an additional note, the ISMPP Author Algorithm Task Force is developing a standardized framework for identifying and documenting author contributions in a consistent and rational manner. The Task Force plans to share its findings and recommendations this year.
Eric Y. Wong, PhD, MBA, ISMPP CMPPTM, 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.
- Good Publication Practice for Communicating Company-Sponsored Medical Research: GPP3: Ann Intern Med. 2015 Sep 15;163(6):461-4. doi: 10.7326/M15-0288.
- Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals (updated December 2019): http://www.icmje.org/icmje-recommendations.pdf