My Favorite Case Study: Patient Centricity in Research
About the Advarra In Conversations With…
The future of healthcare innovation hinges on research and clinical trials. Advarra sits down with leading experts to dig into pressing issues and explore cornerstone solutions. Join us as we discuss topics and trends impacting the healthcare of tomorrow and advancing clinical research to be safer, smarter, faster.
About This Episode
In this episode of Advarra’s new series “My Favorite Case Study,” we discuss patient-centric strategies and solutions of real research programs at CSL Behring to improve the patient experience and retention in clinical trials./p>
Chapter 1: Patient Engagement
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Hi, everyone! Welcome back to Advarra In conversation with… Podcast Series. I’m your host for today’s podcast. My name is Aidan Gannon. I’m senior director of Client Services and innovation at Advarra, and today my guest is Ellyn Getz from CSL Behring. We’re going to be discussing some very interesting concepts around the CSL’s approach to patient engagement, patient centricity, retention on their clinical trials. So with that I’m going to hand it over to Ellyn to introduce yourself.
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All right. Hi Aidan, great to be here. I’m Ellen Getz, Director of R&D Patient partnerships here at CSL, which is a mid-sized global biotechnology company that includes CSL plasma, Sequirus, which is our vaccine arm and CSL Behring. And we focus predominantly on rare diseases, and we’re committed to putting patients first in discovering, developing and delivering biotherapeutics and vaccines.
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And here at CSL I gather input into our clinical development and operations from patients care partners, study participants, health care providers and researchers, and I have developed strategies and plans to support our patient engagement efforts and appreciation throughout the life cycle of our studies.
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Prior to CSL, I’ve just been here for about a year. I worked at the center for information and study on clinical research participation (CISCRP for short) I worked there for about eight years. It’s a global facing nonprofit where I wore many hats. I supported a grassroots outreach and community engagement as well as patient advocacy and education. So a lot of my remarks today will be based to a large extent on my understanding of the survey research that CISCRP has conducted regularly, and through the years, as well as feedback that CSL receives through our patient advisory boards that we conduct for our studies.
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Great perfect, I mean, seems that we’ve got a lot to discuss. So let’s get going. I’m gonna start with a big question. When I think about CSL, I think you guys have a slightly different take or opinion on patient engagement in that it’s very much a partnership. Do you agree? Am I right there? And could you expand on that a little bit if I am?
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Absolutely! Wow, I’m so pleased that we have that reputation, and that that mindset shines through. We believe that patient engagement is not just a set of standard practices. It really evolves over time as patients’ needs change, and as we aim to develop therapies that are effective and safe and meaningful across diversification populations as well as our study designs change, and as we pursue new therapeutic indications, so I’m so glad that you recognize that we see it also as a partnership with patients with care partners and their support communities.
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So we need to be able, as a company to pivot and adapt. So our R&D patient partnerships team ensures that the patient voice is embedded at every stage, and that patient engagement initiatives are considered well before they’re needed, and they’re fully ingrained in our planning and execution processes. So we work internally, especially between our R&D and commercial teams around connections that already exist in the organization and around potential engagement opportunities. We build relationships with community groups to understand unmet patient needs and areas of collaboration years before recruitment or engagement efforts are underway,
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And that is something that really resonates with me, and that I know our team is very mindful of is that research shows that patients really rely on the clinical research enterprise to be a very coordinated and open system of care. And so we’re always looking for ways to eliminate patient burden or participant burden and make information about our studies more accessible. We know that potential participants want to hear about trials from trusted individuals in their communities and care partners. So we have to do our part to make sure that these materials and tools allow these trusted individuals or ambassadors to evaluate opportunities for participants easily and confidently, and really enable them to serve as patient engagement facilitators
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Great. So that’s interesting. You mentioned the kind of prioritization, almost of the community well in advance of. Actually, you know, it begins. What can you provide a little more detail on what strategies you look to implement at that point?
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Sure it really requires a lot of coordination and communication. I like to think of some pretty notable touch points for patient engagement activities, starting with very early planning stages, teams with leveraging market research conducted for insights into patient and care partner journeys. And at that point many of our product strategy teams are developing their patient engagement strategies along with folks in our clinical development teams to make sure that those strategies and tactical plans are really thinking about the entire patient or participant experience.
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So during our outline development and protocol design, we work with teams to conduct patient and health care, provider advisory boards for patient burden assessments to understand trial and treatment, challenges patient preferences and patient attitudes around the potential new therapy to confirm that our endpoints are meaningful and relevant, and we also encourage teams to receive patient feedback into informed consent development, and any decentralized clinical trial, remote or hybrid designs that are being considered.
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I work very closely with our clinical operations teams to incorporate these learnings and insights, and to make sure that we’re also trying to centralize what we’re hearing from other therapeutic areas and other indications in case that’s relevant for these teams, as they’re embarking on a new therapeutic areas and new indications.
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And then also, We suggest evaluating pre registry options to identify patient geographies and think about how we could even leverage pharmacies, clinics, doctors, practices that are local to patients when we’re assessing site feasibility and essentially activating our sites.
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We also work with study teams to implement patient support activities like Thank you Cards for all of our studies that direct our participants to plain language summaries after the study is concluded, and we are also building and working on a patient portal with study-specific information, prescreens, disease and study information and general education.
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And One more item I do want to mention Aiden is about community groups, because this is something that we include as part of our patient engagement strategies, recognizing that these community groups are a vital part of patient support systems, and that as we’re partnering with patients, we also think about working with their families, working with patient advocates in the broader, healthcare community as partners in this development process. Something that we’ve learned is that engaging with community groups early has been really helpful, like patient advocacy groups or patient organizations, especially to gauge their feedback as well as collaborate on educational campaigns.
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Some of the challenges I’ve heard and feedback I’ve gotten from our clinical development teams and clinical operations, teams is concerned that potentially even over promising, if we ultimately decide not to pursue a particular indication down the line. But we feel it’s really important to acknowledge these concerns and recognize that there are many stakeholders involved in these decisions. And so far we’ve found that, including our medical affairs teams early in these discussions has been really helpful to ensure alignment between our R. & D. Leaders and our commercial colleagues, so I always encourage teams to be fully transparent
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to share their earnest interests in a particular therapeutic area that we’re working on with a particular community group, even if it’s a new indication for us or early in development. We want to make sure these organizations know that we want to collaborate on this journey with them
Chapter 2: DCT Technology & Meeting Patients Where They Are
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Tell me a little more about how you’re using new technology to support those kinds of trials with thought about going to where the patients are at. Can you expand on that a little bit more?
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I think something that I’ve learned as I’ve entered the pharmaceutical industry is that many traditional approaches to patient engagement and recruitment are still utilized, like patient brochures, flyers, and other print materials. But I’ve also become very aware that recruitment and retention rates are at the lowest in their history, and especially within oncology and rare disease
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and drug development. Failure rates are higher than they’ve ever been, and the average duration of development program and a clinical trial are taking so much longer. So that’s a key area where I feel like our team can help to serve and bridge some of the gaps here, and the ways that we can try to innovate and approach our clinical trials, really thinking about that overall overarching journey, and try to build our trials around our patients. Our base really fit our trials into a patient’s routine rather than the other way around. So I know in some ways. Before I talk a little bit about technology could be reducing the burden on patient participation by getting patient feedback into a study design. And that’s something that we’re implementing across all our phase, two and three trials.
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So that’s one way. But we’re trying to seek additional like advocacy group support patient feedback through advisory panels and put into that design and our informed consent. But also I’ve been recognizing, especially at CSL and across other companies, the growing role of mobile technologies and use of social media and healthcare. So some of those new recruitment strategies like the use of mobile apps and smartphones, Text messages, as well as social media forums, have been recognized to be fairly effective,
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especially use of registries and electronic health records. These methods, I think, are very, very intriguing, and ones that we’re piloting and really evaluating effectiveness. But I think the other piece here is, how do we make sure that our trials are as personalized as possible, or as customized for patients and their families? I think that will engender additional trust in the research enterprise and make our trials more accessible. So some of the supportive services and flexible study visit options that we’ve been thinking about are, how can we bring in home health care? How can we increase direct to patient shipments of the of the potential new therapy or the study drug? How can we think about Telemedicine as a way to increase patient retention in our trials? And I know our study operations and clinical development teams have been really interested in these new opportunities, and we’re working to really track the effectiveness.
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Another area is that study portal that I was describing before. This is one we’ve been working on with long books, and we’re really excited to be rolling this out across studies. It offers pre-registry. It also has a chance for potential participants to learn about the study itself, to look at where sites are based, and to receive disease management information, too, That’s something we’ve been hearing from our patient advisory boards is really important
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to make sure that we’re not just providing study related information as we’re recruiting, but also information about disease management or the importance of um of managing a disease and preventing infection down the line. And what that could mean is just an example. So those are some areas we’ve been piloting and launching, and I’m really excited to be able to even come back to this podcast in the future and talk about some of our key learnings here.
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Absolutely. That would be great. I mean You’ve given some really insightful thoughts there as to how you guys are approaching patient centricity. I know that’s a loaded term, but you know, putting the patients first, and making them certainly a part of the whole entire journey from development
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of the Protocols right through to, you know, being their guides through the study and giving that information on the condition and their medications. And I want to touch on that because I know you mentioned before about showing appreciation to participants. One thing that that always resonated with me is, I used to actually live quite close to one of our biggest recruiting sites. When I was working on a global phase, three oncology study, and I ended up meeting a lady in the park when I was with my kids, who, long story short, she was actually on that trial that I was working on, and she didn’t realize that.
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Yeah, she didn’t realize that the drug that we were developing that she participated in that that study which was the primary registration study actually results in that. So they get that drug getting
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approval. She never realized that that was the fact. So a big passion of mind is making sure that we provide that feedback to the patients at the end of the trial as well as their appreciation. Do you have any ideas or strategies around making sure that patients are informed, post-trial as well as during the trial?
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Definitely, I think the Thank you Cards and offering plain language summaries across all of our studies is crucial, and I’m so pleased to see that the industry has been moving more in this direction, offering these kinds of transparent and ah! Additional information. I think we owe it to patients, not just to show our appreciation for their involvement, but also recognizing them as partners. So this is something that I know as a standard practice, that CSL been offering um before I even came to join the team, and I’ve been really
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really pleased to see this. So that’s one area, and then also really making sure we’re including patient organizations and advocacy groups sharing out whether it’s a manuscript that’s patient
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friendly language and making sure we’re offering culturally sensitive educational content and information about our studies, so that we can continue to build trust and continue that conversation. Well, after this study has concluded. So we’ve been establishing these relationships with patient organizations. We also mentioned that we’ll share out our learnings from the study after it’s concluded with them too, that they can share with their constituency.
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That’s really great. I mean, I think that’s the least we can do, and we need to be as an industry much better at doing that. I’m glad to see that you guys among many others, are certainly factoring that in the conversation loop is closer than the patients feel, not only appreciate it, but feel informed about what the benefit that they provided to the particular city that they spent, You know,
sometimes quite a lot of their time and lives being part of
Chapter 3: Building Patient Trust
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This is not an easy question, but since the pandemic, I feel like the mistrust of Pharma is becoming a little bit more obvious. do you agree with that firstly, and what steps do you think we need as an industry to address this and make people more aware of what we’re actually trying to do, and what the objective of drug development is?
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I do agree with that. And it’s so unfortunate because that lack of trust really threatens future innovations and advances in medicines that rely on clinical research. And I think, in addition to what you’ve already mentioned, that that weighs into that lack of trust. I think also, the fact that our health care system, especially in the US is extremely siloed, and there are major gaps between clinical care and clinical research, and I do hear in other countries, from our advisory boards of patients. Many patients have to advocate for themselves due to this lack of coordination between providers and specialists and many patients don’t hear about clinical trials from their doctors directly, and really have to advocate for themselves to find them.
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I also think, with mass media coverage and the popular depictions of clinical research. And they’re typically very negative and an unbalanced view. So I think that the fact that those are focusing really largely on risks and human error and questionable motives among researchers that does not help the image that the pharmaceutical industry has. And then, on top of this, with our protocols becoming even more complex and eligibility criteria being even stronger. I think we’re often ruling out individuals that are really
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interested in participating. But we don’t always have the bandwidth to go back to them and explain. You may not have been eligible for this trial, but here’s another one that might be suitable for you. I think. Just do that to the lack of time and bandwidth that that our teams have. Um, you know, with among our sites, and that we have to be able to follow up. So I think, on top of all that clinical trials.gov is just so difficult to navigate.
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So there are a number of ways that we can try to approach this as an industry. I think there’s so much work to be done, and the areas that we can immediately address. I think educational initiatives are so important, that grassroots effort and I know there are a number of patient organizations and nonprofits out there that are trying to go into communities, to talk about clinical research, to engage with the public and address their concerns. I know we sponsor a number of those initiatives not just looking at it as a recruitment vehicle. Because we we’re really going out there just to raise awareness about research in general. Another area is how we can offer clinical trial navigators perhaps that can support patients, and something that we’re rolling out with a vendor called “my tomorrow’s” is a chance for individuals that are interested in a trial, if they take a look on our website and have questions about it. They can speak with a
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third-party navigator directly, a health professional who can talk to them about the study itself, make sure that they are ineligible, if that’s what they believe, and if they are ineligible, they also can present other options available outside of what CSL offers, and we feel we really owe it to patients and future participants to be able to be fully transparent, and make sure that they have the information that they need to be empowered about clinical research participation.
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So before trials begin, I think this is another area we’re thinking about. How can we raise awareness about risks and benefits? Um. The purpose of clinical research in general, and also about our studies directly. I think that a patient portal we’re developing with a study web page has a lot of that information available trying to make it really accessible about the kinds of procedures that would be required, and confidentiality protection. I think that can help patients or and future participants, and they’re thinking about how we’re being fully transparent and how they’ll be fully informed about the research process before they get involved.
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Then, also sharing back like we talked about the result summaries, individualized results as well, and keeping patients informed of future studies, as well as more information about disease management and updates about the drug as it hopefully moves to market, I think, is another way that we can continue to rebuild trust in the research enterprise.
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And then, lastly, something that I’m very mindful of and I know our teams are here at CSL are making sure that our study materials and educational materials are culturally sensitive and really tailored to diverse communities, and that they’re offered at all literacy levels. That’s another I think, major way that we’re trying to make sure that the information we provide is as accessible as possible.
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Wow. Well, you make me realize we’ve you know we have come a long way. We still have a lot to do, but I think ultimately, being thoughtful and open is key, and you speak to that. Ellyn, thank you very much, and thank you for joining this week’s episode of the Advarra in Conversations podcast.
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I really appreciate it. And thank you for giving us insights into what you guys are doing at CSL Behring, and I definitely will hold you to the offer of following up in a few months, and another episode of the podcast
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Would love that Aidan. And I’ll just mention something that I haven’t had an opportunity to talk about on this, just because it’s a very recent research project that I’d love to talk about in the next few months with you on the next podcast
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would be the self-assessment tool that we’ve been developing in tandem with Tufts and the DIA to really try to measure the impact of patient engagement, and I’d love to be able to share some of the learnings from that and metrics. I know we ran out of time, but perhaps we can add that to our list for the next.
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Definitely, it’s already on the list. Thanks, Ellyn. Awesome.
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Thank you so much. Thanks for including me, and it’s a pleasure speaking with you today.
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Thanks again, and, thanks to you all for listening. That’s it for this week’s episode. If you enjoyed this podcast, you’ll find more information about the series on our socials and on Advarra.com. Thank you.