The Greater Gift Recognition for Clinical Trial Participants - Lilly Skok Bunch

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HANNAH LIPPITT: Hello and welcome to the Totally Clinical podcast brought to you by Teckro. Totally Clinical is a deep dive into the freshest trends, big-time challenges, and most excellent triumphs of clinical trials. I'm Hannah, your host. Join me as I chat with industry experts, trailblazers, thought leaders and, most importantly, the people benefiting from clinical research. So tune in, settle back and don't touch that dial. It's time to get Totally Clinical.

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HANNAH LIPPITT: Greater Gift is a philanthropic organization with a unique mission in the clinical research space. Greater Gift highlights the heroic work of clinical trial participation and increases patient engagement in clinical trials through gifting those in need with a lifesaving gift. This has a double positive effect, honoring the sacrifices made by clinical trial volunteers and also helping to increase patient engagement. Here to explain more about how Greater Gift works is Lilly Skok Bunch, the company's executive director.

Lilly, thank you so much for joining the Totally Clinical podcast. Could you start by explaining what initially inspired you to set up Greater Gift and more about the company's mission?

LILLY BUNCH: Thank you. So happy to be with you today. Greater gift started almost 13 years ago with a simple idea that companies and those who do clinical research are not really effectively sharing the gratitude they feel for the patients that participate in clinical trials. And also, most importantly, clinical trial participants don't really understand the importance and the impact of their work. And so Jennifer Byrne, who was our founder and chair of the board for many years, founded Greater Gift as a way to provide industry leaders an opportunity to make a donation on behalf of their clinical trial participants, and Greater Gift would, in return, make donations in honor of those individuals of a vaccine or meal to a child in need to show the company's gratitude towards the work of the clinical trial participant.

So the whole premise of Greater Gift and its early beginnings was built on a concept that really, one plus one equals three, and that is that a clinical trial participant makes a contribution to the industry by agreeing to be a volunteer, and that warrants an expression of gratitude that can be expanded by making a donation in honor of those participants, and then in return, a child’s life is saved by the receipt of a vaccine that otherwise they would not be able to receive or a backpack full of food.

HANNAH LIPPITT: Taking part in a clinical trial isn't always an easy decision for participants. Can you highlight some of the key patient concerns and how you believe these could be best addressed?

LILLY BUNCH: I think it's important to understand, and particularly in the United States, only about, less than 10% of individuals would even consider participating in a clinical trial. And for many of those individuals, it's not even a barrier to being fearful or what have you, but really more of a situation where they just don't even understand what clinical research is. And they don't understand that it's that clinical research is the way in which we solve public health issues in the world, until COVID. And when COVID hit and across the news every night we heard about clinical trials and the trials that were taking place to try and come up with a vaccine reinforced for all of us that: "Ahh, I understand! Clinical trials are how we get these new drugs.” And we, for the first time understood that I think the quickest that any drug had ever come to market in the United States was six or seven years. And we were all sitting around saying, “Six or seven years: we're not going to be able to go to the office? Six or seven years: children won't be able to go to the classroom? Six or seven years: we won't be able to hug our grandparents and our parents and our grandchildren?” And we realized, at least in the United States, that this won't work. We must come up with a solution for COVID-19 in less than seven years.

And so Operation Warp Speed came on board and in the United States, we came up with a strategy where we could come up with a solution to a health care crisis in record speed, right, in eighteen months, we came up with a vaccine. And so, what we learned from that, I think, is a real shift in terms of what we used to think as the reason that individuals didn't participate in clinical trials was because they didn't know what clinical trials were and they didn't understand that was even something that they could do. I think since COVID-19, we learned that many people object to participating in clinical trials because they are fearful and distrustful of the health care industry. And this is, I think, a real shift for us in understanding at greater gift what initially was a belief that part of the reason individuals didn't participate in clinical trials was because we didn't do a good job in the industry of showing gratitude to a place where we recognize a very simple concept, which is that if you are not white, male, living in an urban center, generally speaking, East or West Coast in the United States and highly educated, you are likely not being represented in clinical research. So, we realized that there were a whole host of individuals who were not being represented, and this is what we call the unrepresented majorities that are not being represented in clinical research.

So I think the decision about participating in clinical trials, our understanding of what the barriers are of that participation has really shifted with COVID-19, and so too has the mission of Greater Gift shifted to begin to focus squarely around “What are the things that we as an industry, as a health care industry, need to do to ensure that those unrepresented individuals, those who are not represented in clinical trials, to make sure that they feel safe and they trust health care enough to participate in the clinical trials and therefore be represented adequately so that the medications and treatments that we come up with are really representative of the people who they are serving?”

HANNAH LIPPITT: Yeah, I think COVID certainly opened people’s eyes as to how clinical trials work and who they represent. What are the key issues of trust that you're concerned with?

LILLY BUNCH: Well, what we learned during COVID and what we certainly have been talking about for some time in the clinical research industry and in the health care industry, in the United States in particular, is that in my lifetime, we have examples during the Tuskegee trials and others where individuals participated unknowingly in clinical trials and were taken advantage of because of the color of their skin. We also know in the United States that the disparities in health and the lack of access to quality health care for Black and Brown individuals are significant. And so you get to a place where you can understand why Black and Brown people are less willing to, quote unquote, be Guinea pigs, which is a term I don't even want to use in the context of talking about clinical trials, but I think we need to recognize that Black and Brown people are fearful that they are being used as Guinea pigs as a part of clinical research, because by and large, they have been in the past.

And so part of what we need to do in this country – and I would argue in the rest of the world – is begin to recognize and accommodate the belief systems of folks and the fears that they have about clinical research, to understand the IRB process and what that means in terms of our protections as patients when we participate in clinical trials. And understand and validate, most importantly, the concerns that people have and not think, “Oh, they're silly, that they don't trust the health care system or that they don't want to participate in clinical trials.” I think we need to validate the concerns that people have and in some ways that then takes the oxygen out of the balloon, right? If we can say, “We know and we understand why you're fearful and here is documented reasons why we know that clinical research is now safe.”

So I think that our work at Greater Gift is to create space in the marketplace, to hear people's concerns, to validate them, and to share the information that we know that is correct about the safeguards that are in place so that we can build that trust on behalf of the organizations that are working with individuals who are unrepresented in clinical trials.

HANNAH LIPPITT: That makes a lot of sense. Could you go into more detail about some of the incentives and initiatives you have at Greater Gift to motivate people to take part in trials?

LILLY BUNCH: Absolutely well, it all stems from gratitude, right? One of the things that we talk a lot about in the industry is that participants in clinical trials oftentimes are in trials that span five, six, seven years. Oftentimes, patients who participate and volunteer in clinical trials never learn the outcome of the trial that they participated in. They might be in, say, a diabetes trial for a new drug – they don't necessarily even know the name of the new drug that is being tested – and then all of a sudden, here we are with a new drug that may be on the marketplace and they don't even know that that trial that they participated in and their volunteerism as a part of that trial was what allowed the marketplace to have a new drug on the market. And so our premise at Greater Gift is, again, to organize a mechanism for the industry to express gratitude to the patients that participate in clinical trials, all of whom receive a certificate from Greater Gift that says, say, one of our partners like Merck, which is one of our strong partners in the marketplace as a sponsor, that our certificate explains that Merck is honoring you as a clinical trial participant and as a volunteer, we're honoring you by making a donation on your behalf to a child in need who will receive a pentavalent vaccine in the third world in recognition of the contribution that you're making to the clinical trial.

HANNAH LIPPITT: Could you explain further about the impact that your program has on clinical research?

LILLY BUNCH: What we see as a result, the impact of our celebration program is, is very clear, and that is: when patients feel gratitude and when patients understand that the time that they are spending participating in a clinical trial actually is impacting global health and it's impacting in the near term because a donation is being made on their behalf, and it's also benefiting in the long term because we have a conversation with individuals about the meaningfulness of their participation in the clinical trial, then their overall engagement in the work increases significantly. So, retention in studies, which is consistently a problem for us in the industry, improves, and most importantly, as we all know, when people have a positive experience, they talk about it. And so, when they talk about their experience as a part of a clinical trial and talk about how meaningful it was, we know that others consider participation. And so that's how we at Greater Gift believe that we are increasing awareness overall. We are expressing gratitude to the medical heroes who we clinical research could not happen without and we are also encouraging individuals to stay enrolled in the studies that they have been involved with.

HANNAH LIPPITT: Going from purely focusing on gratitude to clinical trial participants, to being more actively involved in driving diversity and inclusion in clinical trials is a big shift. Can you talk us through how you took this decision?

LILLY BUNCH: As I mentioned earlier, the arrival of COVID-19, which was by and large a challenge for everyone, I think, for Greater Gift, made us realize that we had an opportunity. It made us realize that clinical trials being on the news provided us with a platform that we looked at each other and said, “If we can't really do this work now, if we can't really make a deep dive into increasing awareness of the importance of engagement in clinical research now, we never will be able to.” But we also realized it's not just engagement in clinical research that was important, but it was who was participating in clinical research. And we recognized at the same time that the George Floyd protests were going on in the United States, and we were having nightly conversations about equity, diversity and inclusion in all kinds of different ways. We realized that inclusion and the lack of equity in clinical research was integral to the conversation that we were having about the COVID vaccines. So, we made a strategic decision at greater gift to expand our mission from not only increasing awareness, but increasing awareness very specifically with those populations who are not being represented in clinical research: minorities, Black and Brown individuals being paramount.

And so, we recognized that we had a unique position in the marketplace. As you mentioned at the beginning of this podcast, Greater Gift is a nonprofit organization, we're a 501(c)(3), we do not have stockholders. We do not have products that we sell. We are a nonprofit that in the United States has a mission to do the work that we do and gain donations from our stakeholders in order to do it. So, in order to be a nonprofit organization, we have to show value to the community. And we recognize that our most important value we could show to the community was by leveraging our position as a nonprofit, by building relationships with other nonprofits who have deep relationships embedded in the Black and Brown community across the United States, and to have those folks be our mouthpieces to help build trust. So, we spent months and months in advance of any of the clinical trials that were happening with some of our partners, building relationship with community centers, with nonprofit free clinics, with Hispanic clinics, with food banks across the country that we had relationships with, that we were contributors to, and began to build networks of stakeholders who recognized the importance of the lack of representation of diversity in clinical trials, and said, “This really matters,” that, “We need to get the message out to our people – that their representation and clinical trials matter.”

HANNAH LIPPITT: Considering the various forms of inequity that are being discussed right now, how do you raise the urgency for clinical trial participation?

LILLY SKOK BUNCH: The way I have these conversations often with our stakeholders are is there are so many examples of inequity in the world and why should somebody care about the lack of equity in clinical research over the lack of equity in education or in access to food or in any of the other myriad of ways that inequities exist in the world? And my message to them is that by having lack of representation in clinical research, it is the first and foremost fundamental example of inequity in health care. Here's how it manifests: in the United States Black boys are three times more likely to die from asthma than white boys, and that is largely because Black children are not represented in clinical trials, and so inhalers and medications and treatments are not designed with their genetics in place. And so when we talk about health care disparities in the United States, having engagement of Black and Brown individuals in clinical research is a huge step forward in creating equity.

HANNAH LIPPITT: In your work I imagine you see barriers to participation that are related to more administrative types of issues. Can you give us an example?

LILLY BUNCH: We see high numbers of immigrants who are willing and eager to participate in clinical trials and there's a real simple barrier that exists that makes it difficult for them to participate. In the United States, you are required to fill out certain tax papers because you are not compensated but reimbursed for your time participating in clinical trials. That requires you as a participant to fill out a tax form so that the revenue that you receive from the clinical trial company is taxable. Now, if you're an unregistered immigrant in the United States without a tax ID number, you are immediately disqualified for participating in a clinical trial. So, we would argue, and many in the industry argue, that because we say very clearly that compensation received from clinical trials is not compensation, but rather reimbursement for your time, that that revenue should not be taxable and therefore should not require a Social Security number. We have very specific examples of members of the Hispanic community in particular who tried to participate in clinical trials and were not able to. They screen failed because they did not have Social Security numbers. This is atrocious. These individuals who want to give back to their community and want to participate should be allowed to participate and be able to waive compensation and waive the requirement of having a Social Security number.

HANNAH LIPPITT: Accessibility to clinical research is another barrier to clinical research in your scope. Can you tell us more about what you’re doing here?

LILLY BUNCH: Because principal investigators are required to be on site during clinical trials, oftentimes sites are located far from these locations with where minority participants live. If we had some legislative changes that would allow for clinical research to be embedded in some of the community centers that I talked about in some of the free clinics who are serving high percentages of Hispanic and minority and Black individuals that are serving high percentages of rural and lower education level individuals, if we could embed clinical research in those clinics, we would have many fewer barriers to participation for the populations that we are trying to include and research. And instead we allow for Uber certificates to provide transportation vouchers for individuals, but the reality is who in their right mind as a volunteer participating in a clinical trial would ride in an Uber for 45 minutes from where they live in the outskirts of Houston, into downtown Houston, where the clinical trial is being conducted without any regard to the time that it would take to do that? And so at Greater Gift, we are advocating very strongly to federal legislative changes to compensation guidelines that provide a barrier to those without Social Security numbers to participate, and secondly, to encourage the co-location of clinical trials within community centers where minorities live and play.

HANNAH LIPPITT: Continuing on the topic of diversity, what impact do you think that the new FDA guidelines will have when it comes to moving the needle on this topic?

LILLY SKOK BUNCH: Excellent question. And we at Greater Gift are extremely appreciative of the FDA for publishing their guidelines, which call for greater emphasis on diverse enrollment in clinical trials. The FDA guidelines, I think, speak to what the industry has been pushing for for a long time but this was the first time that the FDA really came out with some guidance on the topic. And I think I would say to my colleagues in the clinical research ecosystem that you all have been talking, we all have been talking about the importance of diverse enrollment, but we haven't really been listening to what the solutions can be. And unfortunately, oftentimes, as we know, the only way we solve problems is when they are federally regulated. And so perhaps this step of the FDA publishing guidelines on diversity will lead us in the direction of having greater regulation around requirements for certain minority representation. We are grateful to the FDA for submitting these guidelines, but we wish the FDA would go a little bit further in their guidelines. The first is we wish that they would provide some metrics in the guidelines to say that requirements in clinical studies must mirror the population that is affected by that disease. So, for example, if women are three times more likely to suffer from COPD, then they should be three times more represented in clinical trials. And so we encourage the FDA to apply some stronger metrics in their FDA guidance.

The second thing we encourage the FDA to do is also to put some pressure legislatively on making some changes to the compensation or the reimbursement of clinical trial participants to address this issue of providing a barrier to those who don't have a Social Security number for participation.

And the third, as I mentioned earlier, is relaxing some of the restrictions around the requirement for principal investigators or PIs to be on site during clinical trial visits and creating an environment where mobile clinics can be affordable and acceptable so that we can go to the people who we most want to build trust with and engage in clinical research instead of expecting them to come to us.

HANNAH LIPPITT: Let's look to the future now. If we think a couple of years from now, what would success mean to you at Greater Gift and how would if your goals would have had an impact?

LILLY BUNCH: Well, I love that question, and I can only answer that by saying what one of our board members from Parexel, Claire Grace, says every time we're in a board meeting, which is: “Success for me and success for Parexel is when every clinical trial participant in one of our trials participates is honored by Greater Gift, and that those that are honored by Greater Gift are representative of all of the individuals that make up the melting pot of the world in which we live.”

HANNAH LIPPITT: And that's your dose of Totally Clinical. You can download our podcast on Apple, Spotify and Google. Please subscribe and leave a rating and review so more people can find the show. See you on your next visit and remember to bring your friends. Thanks for listening! Goodbye!