Kristen Mack*, PharmD, ISMPP CMPP™, Biogen, US, and Matthew Booth*, PhD, MEDiSTRAVA, UK
* The opinions expressed within are the author’s own and do not necessarily reflect the views of the author’s employer.
How many hours of your working week are spent sending reminders to authors for their review or approval of a publication?
Do you struggle to gain detailed input from authors given their busy schedules?
Many medical publication professionals will be familiar with the challenges posed with these questions. As medical publication professionals, a portion of our day-to-day job includes following up with authors for their critical review and feedback on publications, as well as their approval of the final draft. The external authors are often busy and have the primary daily responsibility of treating patients. In addition to patient care, they are often simultaneously involved in multiple research projects and publications with different, and several, pharmaceutical companies. This can result in publications becoming a lower priority than other daily activities, leading to a lack of author engagement on an abstract/presentation/manuscript. It is essential to strive to engage authors and to adhere to the International Committee of Medical Journal Editors (ICMJE) criteria for authorship (http://www.icmje.org/) and Good Publication Practice guidelines (GPP; https://annals.org/aim/fullarticle/2424869/good-publication-practice-communicating-company-sponsored-medical-research-gpp3; development of GPP4 is underway).
This article outlines some of the challenges with author engagement and discusses ways in which the challenges can be overcome.
Reinforce the importance of ICMJE and GPP3 to authors, particularly to those new to working on industry-sponsored publications
Include an overview of the ICMJE and GPP3 guidelines in the author agreement. Additionally, during the author “kick-off” call, explain these criteria and recommendations, and review potential consequences to industry and authors involved in the publication, for not adhering to them during publication development.
Attain meaningful comments on publications from authors
Obtain the authors’ review with meaningful feedback on at least one draft of the publication, as well as their approval of the final draft; these expectations are of paramount importance. When following up for comments, recommended techniques include:
- Host teleconference calls, which are essential to kick-start a publication; calls can also further help reduce email traffic and create efficiency during publication development.
- Remind authors of their obligations according to the ICMJE criteria and GPP3 guidelines during the “kick-off” call and via “reminder” emails for author review.
- Ask for detailed feedback on a section within the publication tailored to their area of expertise via specific queries within comment bubbles (using tracking tools provided by Microsoft® Word or Microsoft® PowerPoint).
- Track substantial contributions to the draft; consider providing a tracked changes version and a “clean” version of the draft publication for reviews.
- If authors remain non-responsive, consider asking the Medical Science Liaison for help with follow-up and access to the author.
Address conflicting comments
To resolve conflicting comments from authors, consider working with the lead author to address those comments when/if they arise during publication development or have a teleconference call with the conflicting authors or all authors, depending on the situation. Use of a collaborative authorship software tool to facilitate parallel reviews, with transparency for all authors, is also recommended.
Engage authors on different formats of a publication (e.g., congress abstract versus poster versus manuscript) on the same analysis of a study
In the initial author invitation for participation in the congress abstract, indicate expectations for their involvement in downstream activities by mapping out the communication plan and expected timings for the abstract, poster, and manuscript, as well as planned specific dates for review or approval of a publication. This action may help with scheduling and identifying potential out-of-office conflicts so that an alternative plan can be drafted without jeopardizing publication deadlines.
Engage authors on a final analysis publication that showed similar results to the interim/preliminary analysis of the same study
Authors should be engaged early and have access to the data, so that they are familiar with the results of the final analysis relative to the primary analysis. New data at the final report could include longer-term treatment experience, sustained response to therapy, long-term safety, or quality of life data; all of which are of significant medical value and warrant publication, according to GPP.
Engage lead/corresponding authors in an encore congress presentation
Within a well-developed publication plan, authors can be informed of planned encores during the development of the abstract for the first congress presentation. Additionally, author agreements may allow for encore abstracts to be submitted to congresses with the agreement from only the lead/corresponding authors. Emphasize the rationale for the encore to the lead/corresponding authors and demonstrate how it meets an educational need for a different audience, whether it is going to a more general audience, specialized audience, or a payer audience.
When considering an encore for a regional or local congress, choose a presenting author who is local to the region to communicate the study’s findings within their medical community. This planning should be considered at the time of the original abstract to ensure the local author is involved in the initial abstract and presentation. If the local author was not included in the original abstract, consult the congress and author group about the option to add a name to the author list to present on behalf of the group (https://annals.org/aim/fullarticle/2424869/good-publication-practice-communicating-company-sponsored-medical-research-gpp3).
Address geographic/time diversity of authors
With global publications, and the possibility that authors may span multiple time zones, considerations need to be given to appropriate hours and deadlines. Consider using a “poll” to obtain availability for an author “kick-off” call or discussion call. If it becomes impossible to gather all authors on a call, be sure to share meeting minutes of calls with all authors. Finally, don’t expect a publication approval from an author in the middle of the night.
Reduce the volume of publication-related emails received by the authors
A publication professional should set expectations of authorship in an initial email and encourage participation during publication development. Try to avoid overwhelming the authors with multiple emails for multiple projects and try to avoid the constant emails at submission deadlines.
Instead, we recommend the following approach:
- In the first email to authors requesting their participation in a publication outline or draft, emphasize the ICMJE criteria for authorship.
- Include the timeline for publication development, stressing the submission deadline.
- If the author is simultaneously involved in more than one publication, clearly outline what is needed from the author using a bulleted list (in order of priorities) within a single email for all publications.
- When using a publication planning and tracking software tool, such as DatavisionTM (https://www.emwa.org/Documents/Freelancer/Technical/Datavision%20for%20publication%20planning.pdf), inform authors on how they can view other authors’ comments within the system. This approach can also drastically reduce the volume of emails, as the author can directly comment within the system whilst being aware of co-author feedback.
Employ other technology mediums to keep authors engaged
Cloud-based document storage and editing tools can be used to engage authors to make their edits on a “live” draft of the publication, ensuring that they are editing the latest draft and making it easier for them to respond to comments promptly. However, before using these tools, publication professionals and medical writers would need to assure they are compatible with respective companies’ data security systems. These editing tools incur additional fees, usually require secure access permission, and many are compatible with Microsoft Office. In the future, incorporation of these cloud-based editing programs into publication planning and tracking software tools would strongly enhance publication development.
To conclude, it is essential to understand the challenges with engaging authors on publications and how to take practical and necessary steps to improve their participation in current and future collaborations. Table 1 below summarizes common challenges with author engagement and outlines suggested steps to handle them.
Table 1. Common challenges with author engagement and suggested approaches for addressing them
|Author commitment||– Reinforce commitments according to ICMJE criteria and GPP3 guidelines in the “kick-off” call and within the author agreement|
– Reinforce the timeline for publication development
– Track substantial contributions to the draft; consider providing a tracked changes version and a “clean” version for reviews
|Addressing conflicting comments||– Consider working with the lead author on conflicting comments during development|
– Consider a teleconference call or collaborative authorship software tool for facilitating parallel reviews, with transparency for all authors
|Engagement on/attendance for an encore presentation||– Select a presenting author who can disseminate the study’s findings to their region’s medical/scientific community; aim to do this at the time the original abstract is developed|
– If the local author cannot attend the congress, consider asking him/her and the congress if a local non-author expert can present on the author’s behalf
|Geographic/time diversity of authors||– Technology may offer a compliant and practical alternative|
– Share summaries of teleconference calls
|Ensuring author input and approval||– Include specific questions for authors on the article draft (tailored to their area of expertise, if possible) to encourage feedback|
– Post compliance information/publication drafts on a collaborative website (e.g., Google Docsa) or publication tracking software tool (e.g., Datavision™)
Writing and editing assistance for this article was provided by Sally Hassan, PhD, ISMPP CMPP™, Parexel International, UK.