Karen King

Welcome to the Medical Affairs Professional Society Patient Centricity Focus Area Working Group’s, two part podcast series on publication plain language summaries. And this first podcast we will discuss key learnings from a farmer perspective in relation to developing publication in plain language summaries. I’m Karen King, and I’ll be the moderator for this podcast. I currently serve as a member of the patient centricity focus area working group, and I’m head of medical strategy at CMC Affinity, a medical communications agency. I’m also a researcher published author on publication plain language summaries. So just to see the views expressed in this recording are those of the individuals and do not necessarily reflect the opinions of MAPS or the companies with which they are affiliated. And this presentation is for informational purposes only. It’s obviously not intended as legal or regulatory advice. So we encourage everyone to engage in conversations about plain language summaries with other MAPS members via the community portal on the MAPS website. Simply log in with email address and password associated with your maps account and click on the discussion tab. Then you can scroll down to evidence generation to post a question or to look at other questions and review other answers. So the podcast objectives are to explain for publication plain language summaries are and their value, and also specifically to share farmer experience of developing plain language summaries, including how to overcome some specific farmer challenges. So please refer to the content hub on the maps website for an accompanying elevate article which does cover this topic in a lot more detail. And I’d like to thank today’s panelists Dheepa Chari, from Pfizer for sharing her expertise with the MAPSmembership. Dheepa, could you please introduce yourself?

Dheepa Chari

Thank you, Karen. I’d be happy to. My name is Dheepa Chari and I’ve been in the pharmaceutical industry for nearly 20 years now in various clinical research and medical communications roles. Over the last few years, I’ve been leading the global scientific publications team within Pfizer Oncology, responsible for scientific communication activities for medical congresses and journals across the entire oncology portfolio. In addition to pub planning, we work on a number of different initiatives covering digital innovation, and patient centric activities to broaden the reach of our data dissemination. Prior to my time at Pfizer, I worked at Novartis oncology and Amgen in similar medical communication functions and also in clinical research.

Karen King

Thank you Dheepa. So we’re just going to move on and start with a quick definition of some of the terms that we’re going to use in this podcast. So there are two different types of these summaries. The first is clinical trial summaries. And the second is publication plain language summaries. So clinical trial summaries are now obviously a legal requirement in Europe. And these are typically templated summaries, often hosted on the clinical trial databases. And they typically summarize the results of the trial in plain language for patients and their target audiences, obviously, their patients or perhaps were involved in that particular trial publication plain language summaries or summaries which accompany manuscript publications, which can be in different formats and styles, and also hosted in different locations, including on the journal site. So this also includes summaries in plain language of Congress abstracts, which are often displayed on Congress posters. And today, we’re going to focus on our experience with publication plain language summaries. So some really limited guidance on this topic. And we often get a lot of questions around this topic. And it’s clearly an area of interest and has been increasing over the years. So now that we’ve covered that Dheepa, I wondered if you could possibly outline Pfizer’s recent experience with developing plain language summaries for Congress abstracts, which was shared on scientific posters at ASCO and some of the other oncology meetings.

Dheepa Chari

Sure, Karen. So in June of 2018, my team initiated a pilot to develop short summaries of research results from our scientific abstracts written in plain language at the ASCO annual meeting. These abstract plain language summaries or apls, as you just described, or shared during the Congress, alongside poster and oral presentations, with the primary objective of helping other non scientific audiences better understand the latest developments around cancer research as well. therapeutic options in a timely and credible manner. As you know, cancer patients regularly attend oncology conferences, as they actively seek emerging scientific information that may impact their care. However, the availability of publications and non scientific language is very limited. The project that we embarked on represented a significant investment of time and resources since it was piloted without precedent within the pharmaceutical industry. There were a number of compliance challenges to address around sharing emerging data, including that on unapproved products and indications to ensure appropriate facilitation of scientific exchange with non scientific audiences in a way that was not promotional or misleading. In addition, the potential benefit and impact of the project were initially unclear since there was no guarantee that the apls would be used by the intended audience. However, the unmet need voiced by patients and others for more accessible information on emerging research was a priority to address. And our decision to proceed was rooted in Pfizer’s long standing patients first commitment. The apls pilot at ASCO was successful demonstrating that apls is were accessed and used widely, and that inclusion of patient perspectives add a substantial value to their development and readability. Since the initial pilot Pfizer has continued to share apls is at medical conferences globally, and now other pharmaceutical companies are following suit.

Karen King

That’s really interesting, Dheepa in my experience of working with other clients in this field that can sometimes be a reluctance from the legal and compliance team, which I know you mentioned regarding developing publication plain language summaries. Was that the same within Pfizer and how did you overcome that challenge?

Dheepa Chari

Absolutely, Karen. So as I mentioned, our pilot at ASCO 2018, represented the first time that plain language summaries of scientific content had been developed at a major scientific Congress. Therefore, we did encounter a few challenges in navigating compliance guardrails around patient directed communication, and even navigating challenges with the Congress itself to ensure that we were embarking on this activity compliantly. So this ultimately resulted in the need to develop a new governance process internally that would allow for the apls is to be written in a compliant manner, and appropriate for use with a non scientific audience. In addition, we determined that both internal and external other groups would need to be educated on the initiative overall, and why their involvement was important since it would result in added workload related to Congress’s overall. So we were able to overcome these obstacles through close collaboration with our medical and clinical teams, the lead authors, our agency partners and our patient partners. With their collective feedback, we were able to ensure that the apls is were developed with comprehensible reading level requirements, and relevancy to the patient perspective, while ensuring an accurate reflection of the of the original scientific content.

Karen King

Thank you, Deepa. And can I also ask, was there any key learnings regarding the best format for the pls? And that came out of all the discussions, as well as what should be included?

Dheepa Chari

Yes, we certainly do have a few. So first, we learned that it’s important to display information in a visual manner whenever possible and appropriate to help audiences understand more complex information. For example, using infographics and helpful way can communicate key points in a simplified manner. And this is especially beneficial when it comes to presenting data. The use of color is also important, along with different text styles and formats to ensure that the most important information in the abstract is easy to find. We also found that having audio phonetics available on the document can really help with the pronunciation of disease terms and drug names. And finally, it’s important to note that there is internal alignment on the appropriate leading reading level based on health literacy principles and guidelines. All of this has shown to help with reader retention and engagement.

Karen King

And it’s very interesting, deepen Connect, can I ask what the optimal review process was? And did you include patient reviewers in that?

Dheepa Chari

Yes, we did include patient reviewers as we thought that that was a very important step. So each of our apls is follows a code development process consisting of content development by a trained apls Medical writer, followed by reviews from our medical and clinical teams, lead authors and patient partners. Their feedback aligns the apls with the comprehensible reading level requirements and relevancy to the patient perspective. And overall, with all their feedback, we can ensure an accurate reflection of the original scientific content

Karen King

That’s interesting debunking is quoted Pfizer actually measure success and reach to patients because that’s a question we get asked over and over about metrics, can you maybe give me some more information on that?

Dheepa Chari

Absolutely, this is certainly one of the more challenging aspects of what we do. So apls is, as mentioned earlier, are available at the Congress. And specifically, this is done by viewing or downloading a queue after you scan a QR code on a scientific poster or oral presentation and you’re able to view or download that apls. And what that does is direct the patient or non scientific audience number two, a microsite that’s available throughout the Congress and for a duration of time after the Congress ends. And this microsite is actually set up to collect quantitative metrics on the usage of the summaries. So what we’ve captured today is that we have collected around 10,000 views or downloads across our 300 ACLs that have been developed since June of 2018. And in addition to that, we’ve received a lot of positive feedback from patient advocacy organizations on the importance of this activity, which was conducted through smaller meetings. We’ve also partnered with patient advocates in focus groups, to obtain more qualitative feedback on ways to enhance the development and the delivery of ACLs is, and also to ensure that we are making these as useful as possible for the broader patient community. This will continue being a work in progress. There’s a lot happening externally, there are a lot of health literary literacy principles that are evolving. And so this will help us adapt our plain language summaries accordingly.

Karen King

Thank you to 10,000 views and downloads is very impressive, particularly for your sort of initial pilot studies. So lastly, to finish if you had just three key recommendations for your other farmer colleagues who might be considering developing publication, plain language summaries, could you perhaps outline what they would be?

Dheepa Chair

Absolutely. So, as I mentioned, there may be some initial challenges in socializing the process internally. So first, I would suggest showing the importance of the activity to patients, and how it enables more transparency with pharmaceutical research. The second thing I would recommend is getting feedback from patients on the development process, as well as on the initiative overall, as their input will ensure that this activity meets the broader needs of the patient community. And finally, sometimes it’s easier to start on a smaller scale, like the pilot that we did, which will help demonstrate value. And then you can broaden the initiative over time. Taking a gradual approach like this will allow you to also make changes and adjustments along the way to the process. And then you’ll eventually be able to scale it up to the level that you’d like it to when you and your organization are ready to do so.

Karen King

That’s really helpful Dheepa, thank you. So it’s certainly clear that patients attending the patient tracks at these congresses really valued having these summit summaries that could be clearly understood, on the most up to date clinical research very relevant to them. So we’ve outlined experience from Pfizer, and how to overcome some of the perceived pharma challenges regarding developing publication plain language summaries. So I’d like to thank our speaker Deepa Sherry for sharing her expertise. And this has been the first podcast of two on publication plain language summaries. The next podcast will discuss the patient perspective on plain language summaries. And please also remember if you’re looking for more detail on this there is an accompanying elevate article on the content hub of the maps website. So if you are a maps member, thank you for your support. And if you’re not yet a maps member and would like access to additional resources in this area, please do visit the maps website to explore joining today at Medical Affairs.org slash membership. And this concludes the podcast Thank you