Transformation in Trials
A podcast about the transformations in clinical trial. As life science companies are pressured to deliver novel drugs faster, data, processes, applications, roles and change itself is changing. We speak to people in the industry that experience these transformations up close and make sense of how the pressure can become a catalyst for transformation.
Transformation in Trials
Championing Diversity to Transform Clinical Research with Shelli Pavone
Join us for a conversation with guest Shelli Pavone, co-founder of Inlightened, to uncover the untapped potential of diversity in clinical trials. Discover how historical mistrust, structural barriers, and exclusion criteria continue to hinder diverse patient recruitment. Shelli sheds light on the transformative impact inclusive trials have on scientific integrity, safety, and the generalizability of results. By embracing diversity, not only do we align with regulatory expectations, but we also pave the way for innovation and trust in our healthcare systems. This episode promises to expand your understanding of why diversity in trial participation is a scientific necessity rather than just a moral obligation.
Explore the importance of diversifying clinical trial staff to boost trial success and enrollment rates. Shelli discusses breaking the mold of traditional investigator homogeneity by incorporating minority physicians, which fosters trust and enhances trial outcomes. Her insights into the creation of Inlightened reveal a passion for revolutionizing access to healthcare expertise, championing diverse voices, and pushing for equitable innovation. Uncover how Enlightened endeavors to challenge the constraints of conventional investment patterns and encourages the industry to embrace ideas that promise greater societal benefits.
This episode covers:
• Exploration of historical mistrust in clinical trials
• Challenges faced in diversifying patient recruitment
• Benefits of having diverse voices in clinical research
• The FDA's evolving stance on diversity in clinical trials
• The role of diverse investigators in influencing patient enrolment
• Strategies to reduce barriers and increase participation
• Shelli's journey and passion for healthcare innovation
• The overarching need for change in the clinical trial landscape
Shelli Pavone: https://www.linkedin.com/in/shelli-pavone-a729b2/
Inlightened: https://getinlightened.com/
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Reach out to Ivanna Rosendal
Join the conversation on our LinkedIn page
Welcome to another episode of Transformation in Trials. I'm your host, ivana Rosendahl. In this podcast, we explore how clinical trials are currently transforming so we can identify trends that can be further accelerated. We want to ensure that no patient has to wait for treatment and we get drugs to them as quickly as possible. Welcome to another episode of Transformation in Trials. Today we're going to focus on diversity in patient recruitment, and in the studio with me I have Shelley Pavone. Shelley, I'm so happy that you're here. Could you tell our guests a little bit more about yourself?
Speaker 2:Yes, thank you so much for having me. I am the president and co-founder of a company called Enlightened. Enlightened is a network of healthcare professionals and providers, and we connect them with healthcare companies of all stages and sizes to collaborate on innovation. They're giving their thoughts and opinions and expertise to innovators across the world to help them bring better products and solutions to light for patients. I've been in healthcare my entire career and I'm really excited about the subject that we have to discuss today.
Speaker 1:And you are the perfect person to discuss this subject with Shall. We just setting the stage for our listeners? Can you tell us more about what the challenges are in enrolling a diverse patient population into a clinical trial, as it is today?
Speaker 2:Yeah, absolutely. I think there are a lot of challenges and they're incredibly interconnected. And the list goes on, but I think some of the largest challenges are first, there's an issue of historical mistrust. Specifically in theS we've had some past unethical research practices. There's a study called the Tuskegee Syphilis Study that is often referenced in regard to the unethical research. But these things have led to deep-rooted sympathicism among certain populations, and that's particularly Black and Indigenous communities, and I think that because of these past offenses, there are many patients and their families that are hesitant to participate in clinical research due to concerns about exploitation or inadequate informed consent.
Speaker 2:And then there are also a lot of systemic and structural barriers as well. A lot of the clinical trial sites are concentrated in large academical medical centers, which which are not easily accessible to diverse communities. Peasants who live in rural or socioeconomically disadvantaged areas may lack access to trial sites or struggle with transportation, childcare or the ability to take off work to participate. And then, of course, you have language barriers as well. And then there are cultural considerations that can prevent effective outreach and engagement, exclusion and exclusion criteria and that, disproportionately, can exclude certain groups, whether it's due to comorbidities, medication use or other health conditions that are more prevalent in diverse populations, and so if the eligibility criteria are too rigid, it can create unintended but significant barriers to participation.
Speaker 2:And then, finally, I would say there's the issue of awareness and engagement. Many people really just don't know that clinical trials are an option for them. I live in Boston and everywhere you go there are signs about clinical trials, because I live in the epicenter of academic medical centers. But if you don't live in a city like Boston, medical centers but if you don't live in a city like Boston, your awareness and access to trials is probably extremely different than the experience that I have. And you know, I think historically, outreach efforts have not always prioritized diverse populations, and less building takes time. So I think it's another one of the larger challenges that persists here.
Speaker 1:Yeah, those are some major challenges that influence whole communities. Let's take a look at the other side of the coin. What are we, as an industry, missing out on from having a more diverse patient population in our trials?
Speaker 2:So there are a myriad of benefits from having more diverse patient population in our trials. So there are a myriad of benefits from having more diverse patient population in trials. And it's not just about equity, right, it's really, at the root, about scientific integrity, safety and better health outcomes for all patients, and I think that something that we need to understand and consider is that different populations can respond differently to treatments, due to whether it's genetic, environmental or socioeconomic factors, and so if we don't have diversity in clinical trials, we risk developing drugs and therapies that are optimized only for a very small subset of population, which leaves others exposed to unknown risks or also reduced efficacy. You know, as an example, research has shown that cardiovascular medications like beta blockers, for instance, can have a really different effectiveness across racial and ethnic groups, and similarly also certain chemotherapy drugs they metabolize differently based on genetic variations. Second, I think that having diversity in clinical trials leads to more generalizable and applicable data. So if the trial predominantly includes one demographic, its findings may not translate well to the broader population, and that can lead to disparities in treatment effectiveness and, of course, safety, which is a huge concern.
Speaker 2:And then I think another major benefit is building trust in medical research and health care systems. You know, because underrepresented communities have been excluded from clinical research historically, increasing that representation fosters transparency and inclusion and it helps to rebuild trust and encourage greater participation in the future. But also, if we establish more trust within these communities, we can also have a better impact on population health and the population as a whole, Because it's not just the trust around clinical trials, it's trust in the healthcare system in general. And so if we are doing the appropriate outreach and engaging in clinical trials, hopefully that will have an impact on trust across the industry as well. And then you know, from a regulatory industry standpoint, improving diversity aligns with the evolving expectations of agencies like the FDA. You know we like to see the FDA making moves towards more inclusion in clinical trials. They have their diversity action plan and there is a push for stronger representation in clinical trial research.
Speaker 2:And then I think one of the topics that I talk about all the time is that equitable representation in trials leads to improved healthcare innovation, which benefits everybody. If we fail to include diverse populations in early research phases, we can miss critical insights into disease progression, treatment responses and potential side effects that could ultimately shape better therapeutic strategies. So I think you know. In short, it's not just a moral imperative to have diversity in clinical trials, it's a scientific necessity. It ensures that we develop safer, more effective treatments for everyone, rather than just a select few.
Speaker 1:I am dwelling on the point that you make about inclusion in clinical trials, witnessing the early stages of drug development, helping also build awareness of how is treatment developed and mitigate some of the misinformation that there may be out there about treatment and how that might benefit the whole healthcare in a population in general. I don't think I've thought deeply about that specific chain of events, but I think you're absolutely right. Being excluded from the science means that it is harder to understand. Well, why does this work and what do we know about this drug exactly?
Speaker 2:Yeah, absolutely that is a really good point do we know about this drug exactly?
Speaker 1:Yeah, absolutely. That is a really good point. I would be curious would you know what is the FDA currently doing to encourage more inclusion in clinical trials?
Speaker 2:Yeah, Well today, with the new administration in the US, there's a little bit of opacity around what's going on, but I can say over the last couple of years the FDA has moved toward making more regulatory change that is specifically focused on diversity in clinical trials. They have put out guidance, they have put out guidelines and there have been a lot of organizations that have followed those guidelines. There have been organizations like the Digital Medicine Society who have taken those guidelines and put together tools and playbooks for organizations that are partaking in clinical trials to follow those guidelines, and so I think that the regulatory environment has moved slowly in that regard, but there has been a lot more guidance issued in the last couple of years and hope to see that continue as well.
Speaker 1:Well, fingers crossed for that general development. Yes, so fingers crossed for that general development. Yes, shelley. One of the topics we discussed during our pre-call before this recording was how staffing clinical sites with investigators who are more diverse could have a positive influence on trial enrollment. But maybe, before we dive into that topic, just for our listeners who may be a little bit new to this side of clinical trials who are these investigators and what is a trial?
Speaker 2:site.
Speaker 2:So in the clinical trial system there are principal investigators and sub investigators, and these are essentially the clinicians who would run the trial.
Speaker 2:And a clinical trial site is the place that the patients would go to in order to receive treatment for the trial and their evaluation and follow-up.
Speaker 2:And so, as I mentioned before, historically a lot of clinical trial sites would have been academic medical centers and so you would have a physician that works at the center who is overseeing the trial as a principal investigator and they would enroll patients into the trial and then, as patients are receiving the treatment or placebo rather maybe they would go to the trial and then, as patients are receiving the treatment or placebo, rather maybe they would go to the trial sites. They would be there for all of their follow-up, everything like that. Now today we are fortunate to have scenarios where we see decentralized clinical trials, so there is the ability for patients to go to, say, pharmacy retail trains as their trial site, and physician might work out of that site, maybe a day a week or they could be remote entirely, and so that really gives us a little broader access to individuals. But really, principal investigator and sub-investigator are just terms for the clinicians that are overseeing the trial, and then the site is really where the patients are going to receive the treatment.
Speaker 1:And, in general, how homogenous is the group of investigators in your experience?
Speaker 2:Traditionally very homogenous, and especially if we look at the nature of trials and the way that they were carried out at academic medical centers. And so there are reasons why the trial staff has been historically very homogenous. And, you know, one of the first reasons is just that limited access to clinical trial opportunities. So something that I've heard a lot in this industry is well, you know, maybe minority physicians don't want to participate in clinical trials, and that is not a true statement. There has been research done and minority physicians express interest in participating in clinical trials at similar rates as their white counterparts, but they are far less likely to be recruited, sponsored or supported to serve as PIs or sub-Is. And again, because these trials are historically run through academic medical centers, they have lower representation of minority physicians in leadership positions, and so it creates a little bit of a self-reinforcing cycle where the lack of diverse investigators leads to a lack of diverse trial participants, of course. And then the other thing is I see this so much in this industry Industry-funded trials tend to rely on established investigators with prior experience.
Speaker 2:They always want not only do they want a PI that has prior experience, they want them to have prior experience on industry-funded trials, which generally excludes minority physicians because they haven't had the opportunity to participate in previous trials. And so if there are not intentional efforts to break this cycle, the same limited pool of investigators continue to be selected, and then, you know, because they've relied on these familiar investigator networks, then we don't see minority physicians having the same connections within the industry or visibility or even mentorship opportunities that are needed to be selected for PI roles, and so it's a little bit of a vicious cycle, I think, where it becomes. Well, historically we have selected people from academic medical centers where there is less minority representation. Now we only want people who have experience. Those are the only people that have experience. And again and again, and again, and I think that that's a really frustrating scenario, and I've come across that a lot in the industry.
Speaker 1:Yeah, that is frustrating and I can just confirm that from the industry perspective, we usually do look for the familiar faces, the people that we know have recruited well for us before, so I can see that it can be a challenge to broaden that pool.
Speaker 2:Yeah, absolutely yeah, sorry.
Speaker 1:What can help with breaking some of this dynamic?
Speaker 2:Yeah, so I think that, um, first of all, we need to be more open to the CIs and sub-Is who have done training programs but maybe they haven't necessarily had the experience in a trial or an industry-funded trial. We need to make sure that we are evaluating a broad pool of individuals for their expertise, and the thing of it is is that having more PIs and sub-Is and clinical trial staff in general, who represent the populations that we need to study, is incredibly beneficial to the trial. And I think that it's about educating the sponsors, educating the organizations who are running these trials, on that simple fact that the racial and ethnic background of the trial investigator influences patient enrollment. And so when we can have a broader outreach and we get trial staff that reflects the background of the patients we're hoping to enroll, then we will have a more successful trial overall. We will have a more successful trial overall.
Speaker 2:You know, my company Enlightened, specifically, one of the things that we focus on heavily is making sure that we have diverse physicians in range as the PIs and sub-Is in clinical trials. There are organizations that we work with that are very interested in this. There are, you know, steps being taken to make sure that we have more diverse clinical trial staff, and I think we have to get rid of the notion that somebody can only be a successful PI or sub-I if they have experience with that specific kind of study, because it's just not the truth.
Speaker 1:Right, yeah, but I can also see how it would solve one of our industry problems, which is it is difficult to find the patients that we need, and we are scrambling to find those good trial sites that actually give us the numbers of patients that we need to run a trial.
Speaker 2:Yeah, absolutely more diverse clinical staff at the trial site? How do they find the more diverse patient population? So, first off, I think that missions in general are more likely to participate in clinical trials when they see investigators that they trust and relate to right, someone that understands their experiences, the cultural context and their healthcare challenges. You know, one of the first things that we talked about was one of the reasons that we don't see patients from racial and ethnic backgrounds enrolling in trials is because there is a mistrust of the system, and so having a professional from a similar background helps to, I think, generate more trust in that area. And then there are also language barriers, and medical jargon can be intimidating to all of us, particularly, though, for non-native English speakers, and so when clinical trial staff speak the same language or dialect as potential participants, they can explain procedures, risks and benefits in a way that resonates more. And then, I think, also, diverse staff are more likely to understand cultural norms and values, and that can heavily influence patient's participation decision. So, for example, there are some communities that prioritize family decision making over individual consent, and so if there are staff that realize this, they can engage family members more appropriately.
Speaker 2:Some patients are unfamiliar with clinical research or hesitant due to cultural beliefs about medicine.
Speaker 2:There are ways that diverse staff can help navigate those concerns, concerns, um. And then you know, ultimately having a diverse trial staff helps to reduce the implicit bias in patient recruitment. Um implicit bias can unintentionally shape who's offered trial participation. Um research has broadly shown that black and Hispanic patients are less likely to be invited to participate in clinical trials. So it's not just that these populations are less likely to want to participate, they are not invited. And then when the trial teams include diverse staff members who actively advocate for equitable recruitment, they help ensure that everyone has the same opportunity to participate. And then you know again, the hope is that the FDA and other industry diversity expectations continue to codify and they continue to increase the emphasis on the importance of diversity in clinical trials. And so sponsors, knowing that they risk delays in drug approval or if they need additional post-market studies if they haven't enrolled diverse patient populations, hopefully they understand that having diverse staff from the outset can help them meet their diversity targets and ultimately they'll be generating stronger, more representative data as well.
Speaker 1:That makes sense. Well, Shelley, you are clearly very passionate about this specific topic. I would be curious to learn more about how did you venture into this space. Well, Shelley, you are clearly very passionate about this specific topic. I would be curious to learn more about how did you venture into this space. What was your journey for finding this passion?
Speaker 2:Yeah, I mean my journey was definitely not a straight path. I had been in healthcare for my entire career. I worked for large pharmaceutical and medical devices. Early in my career, I established a deeper understanding of healthcare and really a passion for innovation space, and I also, unfortunately, got a firsthand look at some of the inefficiencies in healthcare. And when I started Enlightened, my focus was very heavily on how we're accessing expertise and leveraging that expertise in clinical research as well as innovation and healthcare. So what I saw across the board was that the same voices were being elevated repeatedly, and this goes for the clinical trial piece of it, but also just general healthcare innovation.
Speaker 2:When we would launch something for a company that I worked with, it was the same individuals from large academic institutions or people that had very well-connected networks and equally qualified but less visible. Experts like women and minority physicians were generally overlooked. Experts like women and minority physicians were generally overlooked, um, and we were creating our own echo chamber in that regard. Right, talking to the same people over and over again, um, you know, in the pharmaceutical space are these people known as key opinion leaders? And it's the same people that are giving advice and they're representing a very broad swath of physicians and then you know the process of, I think, finding and screening and engaging those experts was cumbersome and slow. So even if you were an innovator and you were trying to engage other individuals, it was kind of hard to find those people, hard to understand their backgrounds, hard to know what their expertise was. But I also saw that health care professionals were very eager to contribute their expertise beyond patient care but there just weren't as many clear or accessible opportunities for them to do that.
Speaker 2:And so I started Enlightened because I knew there had to be a better way to do this. I knew so many brilliant physicians and I had come across a ton of amazing innovations and I wanted to just connect the two sides for better collaboration and communication and I wanted to use technology to do that. And so that's really what led to the launch of Enlightened. I co-founded the company with the goal of kind of revolutionizing how healthcare expertise is accessed, making it faster, more equitable and more impactful in the industry.
Speaker 2:And I think there's a really natural translation of that to clinical trials, because that is really the beginning of healthcare innovation. And so when I started Enlightened, we worked very heavily focused on later stage innovation right Once something was developed talking about patient journeys and engaging clinicians on the user experience of certain tools, but I think that using the things that I've learned from that and applying them in the clinical trial space was a natural evolution. And again, as we see, if the right voices are included very early on in the process, we have the opportunity for better outcomes later on, and so I think that that's you know, really, really how this came to be and why I'm so passionate about diversity in the innovation process in general, but specifically in clinical trials there are more people to discuss innovation with than these narrow key opinion leaders that we all gravitate towards.
Speaker 1:There's so much more expertise out there than in our effort to simplify things, we're also stifling development. Yes, that's awesome. Well, shelley, as we start rounding off this episode, we always ask our guests the same question towards the end, and that is if I gave you the transformation trials magic wand that has the ability to change one thing in our industry, what would you wish to change?
Speaker 2:One thing is a difficult ask here, but you know we've talked a lot about healthcare innovation, and the process of innovation and the way that we engage people develops because there are investments that are made into particular companies or modalities that help even get them to the point where they're able to be participating in clinical trials right, and I think that a lot of the companies and the ideas that receive investment and backing in health care aren't always the ones that will have the biggest impact or help the most people.
Speaker 2:There's a pattern it's a very heuristic approach that investors and decision makers follow when choosing where to allocate resources, and it goes back to what we talked about before they look for familiarity, recognizable names or models that have succeeded before, rather than, I think, truly assessing which ideas are the most transformative or which innovators are closest to the real problems that need solving and, as a result, innovation in healthcare can be more about pattern recognition than real problem solving recognition than real problem solving and funding goes to companies that fit a certain mold, not necessarily to those with the deepest insights, the most practical solutions or the greatest potential to create meaningful change, and I think that means we're missing out on a lot of incredible breakthroughs simply because they don't look like what has worked in the past.
Speaker 2:And over the last couple of years with Enlightened, I have had the opportunity to be exposed to amazing organizations that have really focused on making changes for people that have not historically had the research and backing in healthcare, specifically women and minorities and the founders of these organizations don't look like the traditional founders in healthcare and so they do not get as much attention or investment and elevation as their Ivy League white male counterparts and elevation as their Ivy League white male counterparts. And so to me, I would like to you know, change about the industry is our ability to kind of break tradition from following a specific pattern. And you know, really look at people who have the ability to make distinct change and innovation in this industry. And you know, I understand that we have a system of investment that is very convoluted and tied up in the expectation of making money off of this right, but there has to be more of a focus on solutions that are going to be for the greater good in the industry.
Speaker 1:I love that wish. I hope it is granted, and it's time for us as an industry to let go of the mold that we've been used to using. Yeah, absolutely Well, Shelley. If our listeners have follow-up questions or want to get in touch with you, where can they find you?
Speaker 2:So I can be found at Enlightened. So I can be found at email, shelley. At getenlightenedcom. Also Enlightened is we have our website, so it's wwwgetenlightenedcom. We have our website, so it's wwwgetenlightenedcom. And we can be found on Twitter and LinkedIn at Get Enlightened. So you know, we're often talking a lot about diversity in clinical trials and innovation in general. We also have a lot of the experts that are involved in the Enlightened Network who are sharing their stories via our social media channels. We talk a lot about innovations that come out of the work that we do, and so I think there are a lot of interesting resources that can be found by engaging with our website and social media and content.
Speaker 1:Thank you so much, shelly. It's been an absolute pleasure having you on the show. Thank you so much. Thank you so much, shelly. It's been an absolute pleasure having you on the show. Thank you so much. Thank you for having me. You're listening to Transformation in Trials. If you have a suggestion for a guest for our show, reach out to Sam Parnell or Ivana Rosendahl on LinkedIn. You can find more episodes on Apple Podcasts, spotify, google Podcasts or in any other player. Remember to subscribe and get the episodes hot off the editor.
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