Karen King, PhD, ISMPP CMPPTM, CMC AFFINITY, Glasgow, UK; Katharine Howe, PhD, ISMPP CMPPTM, CMC AFFINITY, Macclesfield, UK; and Klaus-Uwe Kirchgaessler, MD, F. Hoffmann-La Roche, Ltd., Basel, Switzerland
“It takes a village to raise a child” is an African proverb meaning that a community of different people is needed to help a child grow and develop. The same could be said for “raising” a publication plan; insight and input are necessary from a myriad of internal stakeholders and external experts to develop a meaningful plan, which, in turn, guides the development of relevant and timely publications.
It is, however, one of the greatest challenges in good publication planning. Medical publication professionals may be familiar with cases of questionable practice in stakeholder engagement, plans that are developed without input from key groups or fail to answer vital questions, or a complete lack of planning altogether with publications appearing from nowhere. The importance of internal and external stakeholder involvement cannot be overstated, but what does best practice look like?
Gathering Insights from Internal Stakeholders
The functions that are involved in publication planning can vary by pharmaceutical company. In general, a cross-functional global medical team, consisting of a publication or scientific communications lead plus medical directors and clinical trial leads, needs to work with a variety of other internal stakeholders, including:
- Country and/or regional medical colleagues
- Medical science liaisons (MSLs)
- Health economics and outcomes research
- Research and development
- Team members responsible for interactions with patient organizations
For products in post-launch phases, medical information and real-world data teams may also be involved to gather insight on use of the product in clinical practice to inform knowledge gaps.
According to GPP3, commercial functions, such as marketing teams, should “neither direct publication planning or development nor be involved in publication review or approval.”1 However, commercial colleagues may be consulted during publication planning discussions, and publication plans tend to exist within a broader medical or communications plan that is not independent of product strategy. Market research may also be used to inform on gaps, which, in turn, may generate publication ideas; in some cases, the market research itself may warrant publication if robust methodology can be demonstrated, the publication is transparent about the intention of the research, and any potential bias is minimized and acknowledged.
Gathering insights from internal teams should begin as early as possible in the development of a new product; this usually happens around the end of Phase 2 clinical trials when clinical data support further investment. In an ideal scenario, the internal team should meet for a publication planning workshop and discuss insights gained from gap and competitor analyses, external experts, and patients to generate ideas for publications that can then be built into a detailed publication plan (see Figure 1 below). Finding the time and resources necessary to bring together multiple functions from different locations can be challenging, however; it may be necessary to hold a virtual meeting or to arrange several meetings with smaller groups whose insights can then be discussed by a core team. The use of surveys or asking specific questions can also be an important way of gaining insights from the wider team.
Another key challenge in publication plan development is balancing the global publication plan and the country- or regional-specific publication plans to avoid missing key topics or potential duplication of effort. Involving colleagues from key regions in development of the global plan may help to proactively determine the appropriate division of topics. In addition, a two-way dialogue should be established to enable sharing of the global plan with affiliates and review of the regional and country plans by the global team. MSLs may also be able to capture valuable insights to feed into the publication plan, so it is important to establish a process to make this possible; for example, some companies have international MSLs who can feed regional insights directly into the global team.
Once a publication plan is developed, it should be shared with internal stakeholders and regularly updated as new information on the product and/or disease area becomes available. Regular meetings with internal stakeholders should be held; however, it is important to ensure that these meetings are a forum to obtain insights that inform the plan, rather than a platform for notifying the group about progress in delivering publications. For example, publication updates could be provided via email, allowing regular meetings of internal stakeholders to focus on gathering new insights and ideas.
Enabling Insights from External Stakeholders
In terms of publication planning, external stakeholders primarily consist of health care professionals (HCPs) with expertise in the disease or therapy area in question. However, valuable insight can also be gained from HCPs practicing in the field, payers, and patients.
There are a number of ways in which external insight can be gathered and fed into the publication plan (Figure 1). Firstly, clinical trials with a publication steering committee (PSC) are in an ideal position to provide advice on the publication plan from an early stage. According to GPP3, PSCs should be formed before results are available to allow time for publication planning and should meet to review and update the plan as new data become available.1 The PSC should be guided by a charter detailing the roles and responsibilities of the members, and all study investigators should be informed about the role and membership of the PSC.1 Members of the PSC should also agree with the level of their involvement in the development of each publication, as membership in the PSC does not automatically confer authorship.1 Membership of the PSC usually involves study investigators and employees of the sponsor, but may also include contractors involved in conducting the study, medical publication professionals, and other therapy area experts.1
Advisory boards that gather groups of external experts, either in person or via a virtual platform, to discuss a disease or therapy area can also be utilized to stimulate ideas for publications by identifying knowledge gaps. Most typically, advisory boards involve HCPs, but payer advisory boards are also possible and may generate different ideas and priorities. HCPs may also contact the pharmaceutical company directly with ideas for analyses and publications. When it is important to gain insights from a larger group of practicing physicians, e.g. for a new indication in the primary care setting, conducting surveys using an HCP network (such as Medscape or M3 Europe) or physician Twitter polls can be beneficial.
The role of patients in clinical research is increasing as pharma companies and HCPs realize that working with patients results in better health outcomes (see The MAP article on “Patient Involvement: Current Practices in Medical Research; Driving Change in Medical publications,” published March 13, 2019). Best practice would involve patients or patient advocacy groups (PAGs) in the early planning of clinical research so they can provide input into research questions, trial design, and data interpretation, as well as contribute to publication planning and delivery. However, it is currently uncommon for patients or PAGs to have this level of early involvement, or to be involved in publication planning. However, the first opportunity that publication professionals could have to engage with patients would likely be during development of the publication plan. Working with PAGs is perhaps the easiest route to identify individuals who can contribute topics of interest to patients, which could be developed into publications. Inviting PAGs to advisory boards and/or PSCs may also be a useful way to gain patient insights, if permitted by the pharmaceutical company. Alternatively, it may be possible to speak directly to PAGs to gain an understanding of knowledge gaps from their perspective.
The current model for incorporating external insights into the publication plan tends to involve indirect input via an internal stakeholder, e.g. medical affairs colleagues providing a summary of HCP views collected during an advisory board. The key question for the future is whether publication teams should enable direct external input into publication planning workshops, giving HCPs, payers, and patients a seat at the table.
Finally, medical communication agencies working in close partnership with pharma clients and HCPs develop an excellent understanding of the field and data and can provide valuable insight. In addition to conducting gap and competitor analyses, agencies can develop lexicons to aid consistent communications by internal stakeholders, contribute ideas for publications based on their product knowledge and interactions with stakeholders, and bring expertise in good publication practice.
Gaining insights from a wide range of internal and external stakeholders is key to the success of a publication plan, but it comes with challenges. Best practice calls for early engagement involving all stakeholders, both internal and external (see Figure 2 below). A publication plan should never be final or static, but should serve as a living, breathing document that changes as new insights, data, and information become available; therefore, regular interaction with stakeholders is key. Incorporating patient views into publication planning will be of increasing importance as the industry moves towards developing medicines with patients and not just for patients. The “village” involved in publication planning needs to expand to welcome them!
- Battisti WP, Wager E, Baltzer L, et al. Good Publication Practice for Communicating Company-Sponsored Medical Research: GPP3. Ann Intern Med. 2015;163:461-464