There is growing appreciation of the benefits of patient involvement during the drug development process, from clinical trials to data dissemination and post-marketing activities. Consequently, patient involvement is increasingly being advocated in industry and journal policies and guidelines. Following her participation at the 2023 International Society for Medical Publication Professionals (ISMPP) EU meeting, The Publication Plan spoke to Christine Vanderlinden, Senior Director, Head Global Publications at GSK, to gain her insights on patient engagement within medical communications. Christine also discussed the latest update to the Good Publication Practice guidelines (GPP 2022), on which she was a co-author, and provided her thoughts on data dissemination and the use of social media within the pharmaceutical industry.
At the 2023 European Meeting of ISMPP you took part in a panel discussion which covered patient authorship of industry-sponsored publications. In your experience, what are the key benefits and challenges when involving patients as authors?
“Key benefits are addressing the needs of patients in scientific/medical publications and making complex scientific/medical content more understandable and accessible to an audience from diverse backgrounds. We can certainly demonstrate that patients and industry can work together in an effective way, while ensuring all ethical measures are in place. Enabling patients to directly report in a scientific manuscript their own personal experience to the medical and scientific community also increases confidence that publications address topics that have a real-world relevance. Finally, we provide a clear example of inclusion.”
“Enabling patients to directly report in a scientific manuscript their own personal experience to the medical and scientific community also increases confidence that publications address topics that have a real-world relevance.”
“Key challenges include ensuring the appropriateness of engaging patients as authors. This is an important consideration for companies looking to develop policies for working with patient authors and should be approached with a broader view of patient engagement at study level. We should also be very careful not to create the perception of engaging patients as authors to convey specific product messaging and we should ensure patient authors are fully engaged during the entire process of the publication to guarantee authorship.”
Patients may contribute to many aspects of the publication process, including but not limited to contributing as an author. For example, they may review materials or help to design clinical studies. Could you describe your experiences of working with patients in these or other roles? What are your key learnings from such experiences?
“Patient engagement should not be considered in silo for one activity but should be looked at from a broader perspective ie, considering the patient engagement journey as an end-to end activity from study design to publications. Considerations for patient engagement can also differ between therapy areas and different approaches may be required for example in rare diseases, and for therapeutic treatments versus prophylactic treatments. Patients as reviewers either of a whole publication or of a plain language summary included in a publication bring rich insights and make the research more tangible and accessible from an end-use perspective.”
“Patients as reviewers either of a whole publication or of a plain language summary included in a publication bring rich insights.”
The guidance in GPP 2022 surrounding compensation of patient participants and patient advocates is clear and does not preclude offering compensation for involvement with publications activities. Is this sufficient and/or should there be more guidance to industry in this area?
“This area is still very new overall in the publication world and each company needs to conduct their own risk assessment and determine their approach towards this topic. As such, patient authors should not be considered differently from other authors and any compensation needs to be aligned with the overall approach of each company and follow transparency principles.”
“Patient authors should not be considered differently from other authors and any compensation needs to be aligned with the overall approach of each company.”
At the 2023 European Meeting of ISMPP, you also discussed the use of independent platforms such as Figshare and industry-owned platforms for disseminating research. Could you briefly share your thoughts on the pros and cons of each of these platforms for sharing content? Does GSK currently use either method?
“I believe that accessibility of publications and publication content is key. Some of these platforms can be an interesting way to increase that accessibility by increasing the entry points to a publication and therefore increasing its discoverability. The downside of this is that we need to ensure full transparency and decrease complexity by linking all of the outputs generated from each data set/piece of research.
GSK is not systematically using Figshare for all publications but is using the platform to post publications enhancements when journals do not provide the option of hosting such content. In those cases, a link to the Figshare post is included in the main publication. Some journals also use the platforms to post appendixes and additional materials to the main publication.”
Thinking more broadly about data dissemination, what are your key considerations when making publication decisions with regards to publishing open access or using enhanced features such as plain language summaries or graphical or video abstracts?
“Our main considerations are linked to making the research data more discoverable, accessible, and understandable by the key target audiences and also making it more accessible for broader audiences and use. On the content of the publications itself, we need to specifically focus on the language use, the style, the way to present the information, the importance of visuals and podcasts to be considerate of this broad usually non-scientific, non-medical audience.”
“We need to specifically focus on the language use, the style, the way to present the information, [and ] the importance of visuals and podcasts…”
Has the GPP 2022 update or your involvement in its development changed your approach to any publication-related processes? Which aspects of the guidelines do you think will have the most impact on daily working practices?
“The GPP 2022 update has not changed my approach to publications related processes overall. None of the principles of GPP3 have been modified in GPP 2022. GPP 2022 is mainly focussed on new emerging trends and provides guidance and insights on those topics. For instance, I believe that the recommendations on patient involvement will support companies to align on this topic and encourage them to further develop patient engagement in research and research data communication.”
Do you feel social media should have a greater role within the medical communications industry, and if so, in which areas? Do you feel the mention of social media in the GPP 2022 update will encourage its use or is further guidance needed?
“Social media is fully embedded in our societal habits, including in scientific and medical communities. So, the use of social medial platforms needs to be considered carefully. Social media is a sensitive topic as it is subject to local regulations and there is a thin line in perception between what is considered scientific communication and what constitutes promotional activity. Hence why I believe that social media policies should remain in the scope of the external communication departments of companies who have a broader view and in-depth understanding of regulations in this regard and of journals who disseminate publications in a neutral way. GPP 2022 is not encouraging the use of social media for publication dissemination but rather deferring to the approach of individual companies as part of the broader topic of use of social media in external communications.”
Are there any new topics or areas which you feel could be expanded further in future iterations of GPP?
“I believe that with the rapid evolution and expansion of artificial intelligence, this topic will need more attention in the next iteration of GPP to provide aligned guidance and standard approaches in this field.”
Christine Vanderlinden is Senior Director, Head Global Publications at GSK and can be contacted via LinkedIn
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