Patient involvement in publications: Top 5 tips
for Medical Affairs professionals

Authors:

Professor Karen L. Woolley, Global Lead, Patient Partnerships, Medical Affairs, Envision Pharma Group

Anne-Clare Wadsworth, Global Business Unit Head, Medical Affairs, Envision Pharma Group

Dr Dawn Lobban, Senior Scientific Lead, Medical Affairs, Envision Pharma Group

Dr Lauri Arnstein, Patient Partnership Liaison, Medical Affairs, Envision Pharma Group

Dr Joe Kohles, Chief Medical Officer, Medical Affairs, Envision Pharma Group

As a Medical Affairs professional, what do YOU think about the idea of involving patients in publications?

  1. Something that can’t be done (eg, peer-reviewed publications are written by, and for, the scientific community, not patients. Patients shouldn’t be involved).
  2. Something that could be done, but has no real value (eg, even if patients could get involved, they couldn’t contribute enough to be authors or understand the publications enough to really use them. Why bother?).
  3. Something that you always thought would be a good idea (eg, it took a while for others to see, but involving patients in planning, preparing, and sharing publications just makes sense. Patients should have a say in what’s published, as their lives can be affected by what’s published).

From our years of research on patient involvement in publications (1-8), as well as our first-hand experience of working WITH patients on planning, preparing, and sharing publications (9–15), we have progressed to the third stage. And just in time! With the support of leading journal editors and publishers, patients ARE, and will continue to be, involved in publications – there is no going back and many reasons to move forward. The aim of this article is to help MAPS members navigate the rewarding, but at times challenging, journey of involving patients in publications. We hope that by sharing our top 5 tips we can make that journey a faster, easier, and more rewarding one for our Medical Affairs colleagues and their patient partners.

Champions – don’t start unless you have champions

Involving patients in publications requires pioneering efforts, but progress will be faster and easier if you can work with champions – within and beyond your Medical Affairs department. Here are the types of champions who have allowed us to advance the cause of ethical and effective patient involvement in publications:


Patient advisors

  • Within the patient community, we have identified and worked with patient advisors around the world who have advocated for patient involvement in publications. They have guided us, partnered with us, and challenged us. As one of our patient partners said, “You should not have to justify why you should involve us in publications; you should have to justify why you have not!”. With their strong and collective encouragement, we are pursuing exciting initiatives with not-for-profit patient advocacy groups (e.g., Patient-Focused Medicines Development, European Patients’ Academy, International Alliance of Patients’ Organizations) and Medical Affairs teams to empower the patient voice in the publication ecosystem.

The C-suite

  • Within our organization, our Board of Directors and our Executive Leadership Team have championed the Envision the Patient initiative. Nothing happens without commitment and resources – we’ve been fortunate to have gained both. Without such support, we could not have funded our extensive research program (1–8), including the world’s first systematic review on patient involvement in publications, or invested in the practical tools required to help ensure ethical and effective involvement of patients in publications.

Early adopters

  • Within our client base, we have worked with ‘early adopters’ who have recognized the power of the patient voice. These clients collaborated with their peers in a pre-competitive atmosphere at our Envision the Patient Forum (London, 2018; Figure 1) and our Medical Affairs Roundtable (New York, 2018). These ‘early adopters’ are now leading efforts within their companies to challenge business practices (eg, publication planning, medical plan development) that have previously viewed patients as important, but passive, recipients rather than valuable partners.

Figure 1. Industry leaders worked pre-competitively and in collaboration with patient advisors to discuss patient involvement in publications at the Envision the Patient Forum (London, UK; 2018).

Compliance – trust and transparency always… old rules help, new rules needed?

Compliance concerns can be raised when Medical Affairs staff pursue innovation. That’s to be expected and welcomed. We’ve certainly had to work with our patient partners and clients to overcome compliance concerns as we have introduced innovative ways to involve patients in the publication ecosystem (e.g., patient authors, plain language summaries of conference abstracts).


In 5 years’ time, we predict the publication compliance landscape will look different to how it looks now.


We predict that more attention will have been paid to the section of the existing international industry Code of Practice that clearly differentiates communication with patients from promotion to patients (Figure 2). If the media and investors can be informed about the latest research findings, why can’t patients?

3 Pre-Approval Communications and Off-Label Use


No pharmaceutical product shall be promoted for use in a specific country until the requisite approval for marketing for such use has been given in that country.


This provision is not intended to prevent the right of the scientific community and the public to be fully informed concerning scientific and medical progress. It is not intended to restrict a full and proper exchange of scientific information concerning a pharmaceutical product, including appropriate dissemination of investigational findings in scientific or lay communications media and at scientific conferences. Nor should it restrict public disclosure of information to stockholders and others concerning any pharmaceutical product, as may be required or desirable under law, rule or regulation.


https://www.ifpma.org/wp-content/uploads/2016/01/IFPMA_Code_of_Practice_2012_new_logo.pdf

Figure 2. Extract of Section 3 from the Code of Practice issued by the International Federation of Pharmaceutical Manufacturers and Associations (bolding by the authors of this article).

We advise Medical Affairs professionals to ensure internal stakeholders (e.g., compliance, regulatory, legal) have re-checked Section 3 of the Code. Doing so may help Medical Affairs staff and their patient partners negotiate how to meet public demands for timely, credible, accessible, and understandable information about the company’s latest medical research. As one of our patient advisors reminded industry participants at the Envision the Patient Forum, “…it’s important to realize that patients aren’t waiting for you. Patients are…sharing information that they have picked up….not all of which is useful or helpful or even safe…”. As we recently posted on the MAPS Community portal (15), when it comes to compliance in the real-world, we can’t ignore the risks of ignoring patients.


We also predict that the next version of the industry’s Good Publication Practice guidelines (GPP4) will cover patient involvement in publications. MAPS members can share their ideas of what should be included via Twitter (#GPP4). These new guidelines should reflect that leading general medical and patient-focused journals (e.g., The BMJ, Research Involvement and Engagement) are already welcoming publications authored by patients, and that the number of journals publishing plain language summaries of original research articles is rapidly increasing (the journal database in Datavision™, the publication planning software used by 28 of the top 30 pharmaceutical companies, now identifies journals that accept plain language summaries).

Patient partners – unique, substantial, and valuable insights for publications and medical plans

From our systematic review on the effects of patient involvement in publications (1) and research conducted with patient partners, we know that patients can offer unique, substantial, and valuable insights.


We have experienced this first hand during manuscript development calls with our patient and academic co-authors. The comments from patient authors often get the biggest exclamation marks in the meeting notes because they have raised points and interpreted data in ways that other authors have not. As one of our patient advisors reinforced at the Envision the Patient Forum, “…the value that patients or the public bring is their perspective…they are not scientists, they are not researchers, they are not your business colleagues, they are patients who bring a different perspective…”.


We have seen clients start to shift their thinking about involving patients as authors, especially when leading journal editors, including those from the International Committee of Medical Journal Editors, have said they see no reason why patients can’t be authors if they meet recognized authorship criteria. This view was evident from an exchange at the Envision the Patient Forum. (Industry): “Do you see any role for a patient author on a clinical paper?” (Patient and journal editor): “Yes. Yes. Yes. Who is going to deny that? Absolutely yes.” This view was also shared during a ’Patient involvement in publications’ session at the 14th Annual Meeting of the International Society for Medical Publication Professionals (National Harbor, USA; 2018). When asked whether patients should be more involved in publications, the majority of the audience clearly agreed (Figure 3).

Figure 3. Publication professionals voted “yes” for greater involvement of patients in publications during a patient-focused plenary session at the 14th Annual Meeting of the International Society for Medical Publication Professionals (National Harbor, USA; 2018).

From our research (1–8) and experience (9–15), we are now encouraging Medical Affairs colleagues to consider involving patients as authors of papers that report patient-relevant outcomes. To facilitate compliance discussions, we have developed a decision tree to help our clients understand which research studies may be most suitable to involve patients as authors, rather than contributors. We have also developed a plain language summary of the industry’s Good Publication Practice guidelines to help patient authors understand their rights AND responsibilities as authors. Working with patients as authors works best when there is trust and transparency. As one of our patient partners noted, “…much of this is about clarity, about expectations upfront, about having a role description …agreeing on rights and responsibilities…”.

First ‘easy’ wins – early success by early adopters benefits many

There is truth in the adage that success begets success. Although there are many innovative ways to involve patients in each stage of the publication lifecycle, we advise medical affairs professionals to start with the ‘easy’ first steps within each stage (Figure 4). For example, early adopters, like the leaders at UCB Pharma, have demonstrated how feasible and valuable it can be, for both patients and doctors, to access plain language summaries of publications.(16)

Figure 4. Patients can be involved throughout the publication lifecycle. Examples of ‘easy’ first steps within each stage are shown in the dark boxes.

Our research survey of industry and agency publication professionals (2) showed that one of the main barriers to involving patients in publications is that patients are rarely, if ever, considered. This is clearly amenable to change! We have found that focusing on some of the ‘easy’ first steps helps clients take the first steps – successfully. When these initial projects are widely applauded, internally and externally, it is easier to gain additional resources to expand patient involvement in other areas. Further, as more clients take these first steps, there is room for industry-wide collaboration. For example, we are now working with clients and the not-for-profit patient organization, Patient-Focused Medicines Development, on an initiative to enhance the quality, consistency, and accessibility of plain language summaries of publications. As one of our patient advisors at the Envision the Patient Forum highlighted “…a [plain language summary] is not something that you put in one or two places...in this digital age you embed it on websites, with patient organizations, link it back to the original publication…that will increase the visibility [of the publication].”


As Medical Affairs professionals achieve success with patient involvement in publications, attention is likely to turn to other areas where patient involvement may add unique, substantial, and valuable insights. We have highlighted ‘easy’ first steps where patients may be involved in each stage of the medical plan lifecycle (Figure 5). Again, ‘early adopter’ clients are already navigating their way, with support from their internal and external champions, to ensure their medical plans take into account the needs of their ultimate customers, the patients.

Figure 5. Patients can be involved throughout the medical plan lifecycle. Examples of ‘easy’ first steps within each stage are shown in the dark boxes.

Sharing – build the evidence base for best practice, together

Medical Affairs professionals and patients have a vested interest in knowing how to involve patients in publications in a way that maximizes benefits and minimizes harms. Our systematic review (1) has shown that the evidence base to guide best practice is limited, but it is emerging. As Tessa Richards (Senior Editor and Leader of the Patient Partnership Initiative at The BMJ) noted at the Envision the Patient Forum, “…we are on the early part of a curve here of a new science [patient involvement in publications]…we are in a steady process of learning and evaluation…there’s a whole science, which we need to collaborate on to define best practice.”

Medical Affairs professionals who have partnered, or will soon partner, with patients as authors could make a timely and useful contribution to the evidence base. Their publication plans could include patient-authored research articles, as well as a companion paper about the effect of patient authorship (eg, on the patient authors, their co-authors, and the research itself). Richard Stephens, a leading patient advocate and co-editor of the journal, Research Involvement and Engagement, has called upon industry to support these companion papers to help build a stronger and broader evidence base. Medical Affairs teams should follow the GRIPP2 guidelines when publishing these companion papers.(17)

While the evidence base is building, Medical Affairs professionals can share their insights about current best practices for publishing research. Major medical conferences are now providing dedicated tracks for patient advocates, and presentations (in plain language!) on how to publish, ethically and effectively, are likely to be well received. We were recently invited to share our publication insights during the Patient Advocacy Capacity Building Meeting at the 23rd Congress of the European Hematology Association (Stockholm, Sweden; 2018). The impact of this training quickly became evident on social media, with patient advocate attendees valuing this very practical and, where possible, evidence-based training (Figure 6).

Figure 6. Dr Dawn Lobban presented the first training session on ‘traps and tips’ for publishing research to patient advocates at the 23rd Congress of the European Hematology Association (Stockholm, Sweden; 2018).

All of us working within medical affairs will have felt the transformative power of the patient voice in recent years. Medical strategy relies on expert insights and the insights from Patient Advocacy Groups and ‘expert’ patients are becoming as important as those from other experts (e.g., clinical experts). Understanding what matters to patients and their support networks is critical as we work to develop best-in-class and cost-effective healthcare solutions. Our strong belief is that medical publications support effective and evidence-based patient care; publications should not be quarantined from patient involvement. With appropriate support and training, patients can bring unique value to the publication lifecycle. We welcome the growing groundswell of support for this view, and the willingness of Medical Affairs professionals and patients to work together as publication partners.


Authors:

Professor Karen L. Woolley, Global Lead, Patient Partnerships, Medical Affairs, Envision Pharma Group

Anne-Clare Wadsworth, Global Business Unit Head, Medical Affairs, Envision Pharma Group

Dr Dawn Lobban, Senior Scientific Lead, Medical Affairs, Envision Pharma Group

Dr Lauri Arnstein, Patient Partnership Liaison, Medical Affairs, Envision Pharma Group

Dr Joe Kohles, Chief Medical Officer, Medical Affairs, Envision Pharma Group



Disclosures:

All authors are paid employees of Envision Pharma Group. Professor Woolley serves on the the MAPS Executive Leadership Committee for Japan and Asia Pacific. Dr Kohles serves on the MAPS Standard and Guidance (Product/TA Planning Excellence) Working Group.