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 leading the strategic publications and data communication portions of business planning with your medical affairs and real-world outcomes teams. Your marketing colleagues have requested a seat at the table during these discussions, which would be a first, and your medical affairs/real-world outcomes colleagues do not feel comfortable but defer to you on how to proceed.
A. Recommend to the marketing colleague that they follow-up individually with the medical affairs and real-world outcomes teams prior to the meeting to provide input that can be discussed in the meeting, but the marketing team should not be in attendance at the meeting
B. Reassure medical affairs/real-world outcomes colleagues that it is appropriate for marketing colleagues to attend this medical affairs business planning meeting and provide input into the discussions
C. Explain to the marketing colleagues that while it is appropriate for marketing to hear and provide input into the medical strategy from a strategic point of view, marketing colleagues should not be involved in guiding the publication plan or reviewing the content of any publication
D. Hold a separate meeting with the marketing team to present the strategic publications and data communication portions of the business plan for their information only
A total of 115 people replied to this poll (including 2 who only provided a comment).
Multiple business functions utilize and/or have significant interest in the data that come out of company-sponsored studies: R&D/clinical; medical affairs (including field-based, continuing education, internal training staff); medical information; real-world health economics and outcomes; regulatory; public affairs; and commercial, just to name a few. The timing and nature of milestones, such as publications, are important for many different and critical business activities; even so, it is important to ensure business functions act appropriately within their own lanes and follow best practices and local regulations.
According to Good Publication Practice 3 (GPP3), “Commercial functions should neither direct publication planning or development nor be involved in publication review or approval” . This means the timing, authorship, submission targets, and (most importantly) content of publications should not be driven by the goal of commercial success and are owned by the R&D/clinical and medical affairs functions. However, to ensure efficient and successful execution of commercial initiatives, the timing of publications and data availability should be communicated to commercial colleagues. Moreover, commercial is frequently engaged with healthcare providers, relevant stakeholder organizations, patients, advocates, and market research data, and R&D/clinical and medical affairs teams can benefit from commercial insights about unmet needs and knowledge gaps to consider in the publication plan.
Option C adheres to GPP3 guidance and enables high-level strategic discussions among functions without allowing for commercial to direct publications or plans. Option B is not as clear as to whether the restrictions on commercial input into publications or plans are in place. Options A and D may be the preferred approaches for organizations with strict firewalls between commercial and medical functions, but including commercial in publications planning meetings is probably acceptable practice as long as commercial does not direct publications or plans; in fact, there may be value for cross-functional business partners to access commercial insights directly.
Medical publication professionals should review and understand their company policies and local regulations to determine the best approach for each individual situation. Additional details about publication planning can be found in this article in The MAP: It Takes a Village: The Value of Publication Planning with Functional Partners and External Stakeholders.
Eric Y. Wong, PhD, MBA, ISMPP CMPPTM, Janssen Global Services, 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 Global Services, 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.