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Breaking Barriers for Diversity in Clinical Trials with Sam Whitaker · Lab to Lives

• 0:13
  Speaker 1: You're listening to Transformation in Trials.
• 0:16
  Speaker 1: Welcome to Transformation in Trials.
• 0:23
  Speaker 1: This is a podcast exploring all things transformational in clinical trials.
• 0:27
  Speaker 1: The podcast is about the clinical trials community.
• 0:30
  Speaker 1: We're your hosts, ivana and Sam.
• 0:35
  Speaker 1: Welcome to another episode of Transformation in Trials.
• 0:39
  Speaker 1: Today we're going to dive into the topic of ensuring representation in clinical trials of patients from lower income backgrounds.
• 0:45
  Speaker 1: In the studio with me I have Sam Whitaker.
• 0:49
  Speaker 1: Hi, sam, hey, thanks for having me.
• 0:54
  Speaker 1: Sam is on a mission to identify and eliminate the barriers for people to participate in clinical trials, it's the perfect guest for this specific topic, sam, setting the stage for us.
• 1:01
  Speaker 1: Can you tell us more about which background the typical clinical trials patient has?
• 1:05
  Speaker 1: Yeah, I think that there's two parts to that answer?
• 1:15
  Speaker 2: I think the first is current state.
• 1:16
  Speaker 2: If we're thinking about who is actually involved in clinical trials today and we're trying to profile or generalize 80% of trial participants in the US, almost all of the statistics that I'll reference are US specific, but in the US 80% are white, most are men and there is a predisposition to be able to or willing to participate in a trial if you earn over $50,000 a year.
• 1:47
  Speaker 2: So I guess the inverse of that would be BIPOC communities that are earning less than $50,000 a year and when we think about what this does for the clinical trials that we run, what are some of the problems with having this specific type of population that typically has a specific trial.
• 2:20
  Speaker 2: So I don't think that the issue really revolves around income directly.
• 2:26
  Speaker 2: The larger issue that has been, I think, brought to the surface as a result of COVID and the vaccine studies is that having participants concentrated in a single group, like let's call them white Americans earning over $50,000, is great for white Americans earning over $50,000.
• 2:55
  Speaker 2: Drugs are tested on that patient population and, if approved and they make it to market, we know that they are safe and effective for that sub-segment of our broader American population.
• 3:10
  Speaker 2: The issue that is not, I think, not like a obscure one is that a lack of diversity in trials essentially erodes the integrity of the drug development process for all Americans.
• 3:26
  Speaker 2: More simply stated and I think that there's a quote on the FDA's website, I'm going to paraphrase it we essentially have to test new pharma products in the patient population that is essentially going to use them.
• 3:45
  Speaker 2: Otherwise, how can we be certain that they're effective or safe?
• 3:50
  Speaker 2: I think oftentimes we also.
• 3:55
  Speaker 2: So this is ultimately a conversation about diversity and I think as we get into this conversation we'll start to make some really clear connections between income levels and the lack of diversity that are in trials.
• 4:10
  Speaker 2: Diversity is a complicated issue in our country and I think that that concept or that term is almost instantly associated with racial diversity, which is certainly a component of this conversation, but it is not limited to simply an inclusion of certain racial or ethnic groups.
• 4:38
  Speaker 2: We also are attempting to also include people with a diverse set of medical conditions, mental health statuses, pregnant women, people who suffer from a substance abuse problem, and so on, and I think that excluding or effectively not actively excluding, but effectively boxing out a significant number of Americans as a function of low income also prevents us from testing new products on their patient population.
• 5:24
  Speaker 1: That makes sense.
• 5:25
  Speaker 1: A curious point is that we often compensate patients for participating in a clinical trial.
• 5:30
  Speaker 1: Why do we do that and how does this impact this challenge?
• 5:35
  Speaker 2: So on the surface, I think that most people probably assume that any sort of payment that's made to a participant is an exercise in incentivizing them to participate.
• 5:48
  Speaker 2: If you listen to the radio or you see an advertisement, oftentimes you'll hear at the end that you might be compensated for time and travel, which is like a very general statement that deliberately excludes or navigates around the concept of incentive.
• 6:09
  Speaker 2: But those are marketing advertisements that are trying to feed the top of the recruitment funnel and I think that the idea of offering up compensation is like a carrot to help, and I think over the years there's just been a general lack of critical thought around payments and what their purpose really is and how they impact the broader drug development process.
• 6:39
  Speaker 2: So I think that on the surface it seems like it's incentives, but actually, if you dig into this, the vast majority of participants are operating at a net loss and I think that, generally speaking, in the context of a conversation about payments, I'll like slide phase one studies aside and we can talk about that later or another time.
• 7:06
  Speaker 2: I think I'm specifically talking about the larger populations that are going to be enrolled in studies beyond phase one.
• 7:14
  Speaker 2: Most patients are operating at a net loss If you think through all of the possible expenses that are associated with being a participant, beyond the very superficial parking garage expense or gas or even mileage, there's quite a lot, including childcare, tolls.
• 7:41
  Speaker 2: There may be hotel expenses that were not contemplated by a study team when they were constructing the ICF, or other expenses.
• 7:54
  Speaker 2: I think that the interesting thing about how we construct essentially a framework for each study is that we don't consider the individual circumstances of a participant, so your expenses associated with participation in mind are almost guaranteed to be different.
• 8:15
  Speaker 2: They might be profoundly different, but it's probably unlikely that they're exactly the same.
• 8:21
  Speaker 2: But the payment schedules that are provided to within the ICF that are ultimately delivered to patients and the caregivers if there's a payment at all are the same across the board.
• 8:36
  Speaker 2: And if we dig into that more, right so like, not.
• 8:40
  Speaker 2: So.
• 8:41
  Speaker 2: First, payment is not required.
• 8:43
  Speaker 2: So there is no requirement that a participant receives any form of payment at all, whether it comes in the form of a reimbursement or what we would typically think of as stipend.
• 8:54
  Speaker 2: And if I back up for a second, I'll tell you that payments aren't uncommon in clinical trials and they typically get bifurcated into two different types Reimbursements, which, as you as it implies, is a reimbursement of expense incurred and stipends, which is kind of like this like catch all concept.
• 9:17
  Speaker 2: In clinical trials that is typically a flat amount that is provided to a participant for the completion of like a defined milestone and most commonly it would be a site visit.
• 9:28
  Speaker 2: The issue with stipends is that they are also synonymous with income as far as the IRS is concerned.
• 9:38
  Speaker 2: So all of the funds that you receive in the form of reimbursement would not be taxable, but all of the funds that you receive in the form of stipend.
• 9:46
  Speaker 2: A stipend will be aggregated and you will be responsible for reporting that from dollar one and you will get a 1099 from the payer after you exceed $600.
• 10:04
  Speaker 2: And I think it will become clear why that is problematic, not only for the individual or the prospective patient, but also for the industry and the issue of diversity.
• 10:15
  Speaker 2: So, going back to my example, the vast majority of patients are underwater as a function of their participation because, unless their personal circumstances are fortunate, right, the $25 in reimbursement for parking and then another $50 in stipend might cover my expenses.
• 10:40
  Speaker 2: But in today's world it is likely that it does not cover my expenses.
• 10:45
  Speaker 2: And there are plenty of examples to reference.
• 10:51
  Speaker 2: I think one of the other interesting things that I've been spending a lot of time thinking about is kind of like the economics of trial participation in the context of payments.
• 11:03
  Speaker 2: So as your diagnosis trends towards a terminal diagnosis, your demand for experimental therapies becomes inelastic, which then allows for an environment where sponsors don't have to pay a participant even though, financially, the participant may be significantly worse off, and I think that the it's interesting because I think that is effectively an exercise in leveraging desperation in order to coerce a patient to do something that is going to make them worse off financially.
• 11:50
  Speaker 2: I suspect that this is not the intention of the framework but has developed, and I think that the lack of critical analysis of the downstream impacts of how we operate in this way have just been overlooked, or nobody's spent the time to go back and take a look at this.
• 12:12
  Speaker 1: How has our current thinking about compensation for clinical trial participation evolved?
• 12:17
  Speaker 1: Where does it come from?
• 12:18
  Speaker 2: It's actually a good question.
• 12:19
  Speaker 2: I'm not sure I know the origin story of where the first payments came from.
• 12:24
  Speaker 2: I think that at some point along the line and this may have been from the very beginning there's been this hyper sensitivity around coercion, or this idea that if we pay patients that the payment, we have to make sure that the amounts are not so large that they coerce an individual to stay in a study and continue on a treatment that may be not in the best interest of their health, and I think that that is a very smart concept on paper.
• 13:01
  Speaker 2: I suspect that in current day that probably doesn't happen very often, and I think that the data that I referenced at the beginning about who is participating in trials supports that.
• 13:16
  Speaker 2: I think that the difficult thing about this concept of coercion and protecting patients is that there is no defined framework to evaluate whether or not a payment is coercive or not.
• 13:31
  Speaker 2: So an IRB will review an ICF and all of the other materials that they would typically review.
• 13:39
  Speaker 2: In the ICF there should be reference to payment or reimbursement, and then it's simply a subjective decision by the reviewer or the reviewers at the IRB.
• 13:55
  Speaker 2: There was a person that I talked to earlier this week who used to be associated with an IRB at a large research university, and she was telling me that coercion could be different depending on who the participant is and that a certain amount might not be coercive for a generally more affluent population but the same amount may be coercive for a lower income population.
• 14:26
  Speaker 2: I think that she was attempting to educate me, but I was consuming that and I was thinking to myself that this is exactly the problem that exists and we're saying $100 or $200 might be appropriate for you and I, but it wouldn't be appropriate for, let's say, a single mom on welfare.
• 14:46
  Speaker 2: Interestingly, our expenses your expense to go to the study and the single mom who's on welfare assuming that you guys live in the same city or you're the same distance is the same.
• 15:02
  Speaker 2: I think that we're essentially failing to be thoughtful about how we approach this and there is no guideline and it's completely subjective and inevitably the biases of the reviewer are at play in their assessment.
• 15:22
  Speaker 1: I want to dive more into what is the exchange that is actually happening between the trial sponsor and the trial participant.
• 15:29
  Speaker 1: What is it that the sponsor company is trying to do, and what is it that we, as sponsors, need the patient for?
• 15:34
  Speaker 1: And what does the patient need us for?
• 15:40
  Speaker 2: Right, I've also been thinking about this in the context of just general product development.
• 15:46
  Speaker 2: I think any company that produces a tangible product will generally follow this framework of design, develop or build, and then you test the product and you probably repeat that for a while until it's satisfactory and then you would go into a commercialization phase where you sell your product to people who want it or need it.
• 16:11
  Speaker 2: The pharmaceutical industry is no different.
• 16:16
  Speaker 2: They design a product, test it.
• 16:21
  Speaker 2: Sorry, they design a product, build it, test it and then they commercialize.
• 16:26
  Speaker 2: The process is regulated and the testing phase is clinical research.
• 16:32
  Speaker 2: When a sponsor gets into the testing phase, they will go through the process of going from one phase to another in clinical trials.
• 16:43
  Speaker 2: I think unique dynamic that exists in the pharma space compared to other spaces that produce products that are high risk, like the auto industry or you can think of bullet proof vests, for example.
• 16:57
  Speaker 2: The thing that's unique is that the unproven product has to be tested in humans.
• 17:10
  Speaker 2: Through that process, the sponsor collects data in order to find out if the product is safe and or effective, in order to make sure that the product is safe or effective for the consumer.
• 17:26
  Speaker 2: The FDA, who's essentially the third party regulator oversees this process and makes the final determination.
• 17:34
  Speaker 2: Ultimately, the sponsor is after data from the participant.
• 17:39
  Speaker 2: The data that the participant generates or provides is the value that is being sought after by the sponsor so that they can navigate the testing process, get their product to market and generate sales.
• 17:54
  Speaker 1: So if we think about the exchange that happens here, the sponsor does get a lot of value for having the patient participate in the trial.
• 18:03
  Speaker 1: The way that we think about compensating patients is more specific towards the site visits that they have to go to and not so much in the broader context of what is the value that is actually being exchanged.
• 18:19
  Speaker 2: That's right, I think.
• 18:20
  Speaker 2: To get back, I forgot to mention the second point.
• 18:24
  Speaker 2: What's in it for the patient?
• 18:25
  Speaker 2: Why would a participant enroll in a study?
• 18:26
  Speaker 2: It's typically not a function of profits or generating profits.
• 18:33
  Speaker 2: I think that in most cases there is some sort of medical issue that the participant needs help solving, Whether it's a friend's father, who's generally healthy, enrolled in some sort of cardiology study and it wasn't because he was bored and he also wasn't terminal.
• 18:56
  Speaker 2: He just has a heart issue and his doctor referred him to a study where there was an investigational drug that could help him.
• 19:05
  Speaker 2: So he did.
• 19:05
  Speaker 2: I think there's a spectrum of severity.
• 19:10
  Speaker 2: We can go from a teenager who's got really bad acne that is looking for a solution to acne.
• 19:18
  Speaker 2: I don't mean to minimize that scenario, but I think relative on the spectrum where on the opposite end we have, let's say, an ALS patient or a terminal brain tumor patient where there's no standard of care.
• 19:36
  Speaker 1: I'm curious to go back to the topic we started before about the IRB, evaluating the payments that will be provided to the study participants.
• 19:45
  Speaker 1: Also, is it part of the role to ensure access to trials or what is their mandate?
• 19:55
  Speaker 2: So the IRB is responsible for essentially looking after the human participants and essentially preventing them from being harmed in the process of human research.
• 20:12
  Speaker 2: Unless I have missed something, they are not responsible for ensuring access.
• 20:19
  Speaker 2: I think that at a high level and I read this directly off of the HHS website the other day, but I'm forgetting it word for word but essentially they are responsible for making sure that the patient's safe or their well-being I think that was specifically the word that was used on the government's website is that they were, among other things, responsible for the well-being of the participant.
• 20:51
  Speaker 1: But currently they're the only organ that tries to evaluate you can say well the well-being of the patients in a trial.
• 21:01
  Speaker 1: There is no other body evaluating the payment that we provide to patients.
• 21:08
  Speaker 2: Is that correctly understood?
• 21:09
  Speaker 2: Yeah, I think so.
• 21:10
  Speaker 2: With regard to an IRB, I think they're in place to make sure that one or more research sites are compliant with regulation and that there's nothing essentially funky going on that would put the human participants at risk.
• 21:24
  Speaker 2: And I think that, in the context of evaluating payments, I suspect that there's very little time or effort that is spent contemplating payments in the context of a patient population.
• 21:36
  Speaker 2: I think it's simply a matter of subjectively doing a review and thinking is this coercive?
• 21:43
  Speaker 2: And if the answer is no, they move on to the other components of the proposed research.
• 21:49
  Speaker 2: I think that what they are failing to consider is not so much I think that they do a good job of answering the question is this amount too much for this patient population?
• 22:03
  Speaker 2: But they I've never heard once an IRB come back to a sponsor or a CRO and say hold on, this isn't enough for this patient population.
• 22:17
  Speaker 2: You're not providing any compensation for this cancer participant.
• 22:24
  Speaker 2: You only have two sites.
• 22:25
  Speaker 2: They might be coming from a long way.
• 22:27
  Speaker 2: That is, it's not appropriate.
• 22:29
  Speaker 2: They're going to exclude a large number of participants and the ones that are going to be able to participate may end up being essentially harmed financially, which I don't think is like a matter of like.
• 22:45
  Speaker 2: Well, they're not going to have as much money at retirement.
• 22:49
  Speaker 2: I think that there's lots of examples of families who participate in trials can't afford it, but the people, like friends and family or communities, will raise money and help them, to help to financially support them.
• 23:02
  Speaker 2: The failure of the IRBs to protect participants in this way may not have an obvious relationship to diversity and I think that diversity is a complicated issue but the thoughtless nature of the evaluation of payments in clinical trials I think has a direct impact on this Outside of not paying enough.
• 23:33
  Speaker 2: So I think there's like two primary issues that exist.
• 23:38
  Speaker 2: So I think that there's no requirement to make a payment to a participant at all, not even to reimburse them, and certainly not to pay them like a minimum wage or something like that, despite the value transfer.
• 23:52
  Speaker 2: There's also no consideration for the way that payment is being delivered, and I don't mean that like tactically, like a check or something else, I mean structurally.
• 24:05
  Speaker 2: So if a sponsor is willing to pay $100, it wouldn't be uncommon for the sponsor to pay $50 in reimbursement and $50 in stipend, which is like a relatively arbitrary division or structure.
• 24:23
  Speaker 2: So there's like two.
• 24:25
  Speaker 2: The two issues are is $100 enough per visit?
• 24:28
  Speaker 2: It might be for some people, it might not be for others, although nobody is asking that question.
• 24:34
  Speaker 2: The second is how does that structure impact the participants or prospective participants?
• 24:41
  Speaker 2: And so every dollar that's delivered in the form of stipend is taxable, whether or not you are profiting or losing money.
• 24:51
  Speaker 2: So you may lose $19,000 or $17,000 in a trial and you may have received $1,200 in stipend.
• 25:04
  Speaker 2: You're still going to have to pay tax on that stipend, which is not the intention of like the tax code, because a stipend is considered taxable income by the IRS.
• 25:18
  Speaker 2: It threatens about 110 million Americans.
• 25:25
  Speaker 2: So how does it do that?
• 25:27
  Speaker 2: So there's about 110 million Americans that are enrolled in a social welfare program, so you can think Medicaid food stamps is, I think, the next largest single program, and then there's others as well, I think about a dozen other programs.
• 25:44
  Speaker 2: Each of those individuals qualifies for their welfare program because they make less than a certain amount of money, and so naturally, they make a small amount of money and the government is assisting them, and so any dollar of income that they receive from an outside source could threaten their eligibility.
• 26:08
  Speaker 2: And so I think that, practically speaking, most people that are on welfare have a pretty simple analysis in their mind and they think I have to stay away from taxable income because it might put my Medicaid or my food stamps at risk.
• 26:25
  Speaker 2: The reality is that if you are low enough income, you probably can participate in the study, generate some income and not be at risk.
• 26:34
  Speaker 2: But, like if we're talking about what actually happens in the real world, when a welfare recipient enters into a research site because they have acne or they are terminally ill, they oftentimes will not enroll because it puts the welfare that they rely on at risk, or they will drop out mid-study before $600 is paid to them, because it's also a common perception that you don't have to pay taxes until you reach $600, which also isn't true, but practically speaking, that is common.
• 27:12
  Speaker 2: Or, worst of all, the third option is that they would participate in the study and just refuse to receive any sort of payment, which then puts them in an even worse position than they otherwise would be.
• 27:27
  Speaker 1: So it sounds like people may be hit twice.
• 27:31
  Speaker 1: That lower income people may lose out on their opportunity for treatment and or lose out on their opportunity for getting reimbursed or receive payment for participating in a clinical trial.
• 27:44
  Speaker 2: Yeah, I mean there's a couple of fallouts.
• 27:47
  Speaker 2: You may lose money participating in a trial.
• 27:53
  Speaker 2: You may not be able to participate because you might not be able to afford it.
• 27:57
  Speaker 2: Or, in the case of a welfare recipient, you may not be able to participate either because you can't afford it or because, if you do, you are going to lose your public housing or your food stamps or some other benefit.
• 28:15
  Speaker 2: And so then I think that when we zoom out and reflect on why is it that 80% of clinical trial participants are white, mostly male, and earn over $50,000.
• 28:31
  Speaker 2: I think that there's probably many variables that contribute to the current state.
• 28:37
  Speaker 2: But it also seems obvious to me that, like simply stated, it's easier to participate in a trial if you've got a bunch of money, and if you have not so much money, or a very small amount of money or no income, it's really difficult, if not impossible, to participate.
• 28:58
  Speaker 2: And I think, aligned with the mission of the work that I'm doing, this seems like a big barrier.
• 29:04
  Speaker 2: I don't necessarily think that if we eliminate this barrier, that suddenly trials are going to be flooded with diverse participants, but it allows for the other work to include those participants to happen.
• 29:23
  Speaker 1: That makes sense, and I also know that you are working on several ways of addressing this problem.
• 29:28
  Speaker 1: Can you tell us more about those?
• 29:32
  Speaker 2: Yeah, I mean the thing, the one we are working on a couple of different ways to eliminate the barrier of taxation for participants.
• 29:41
  Speaker 2: The first, and I think personally maybe the most interesting thing that we're doing, is back in late summer I engaged a lobbying firm and we drafted a legislation that will exclude all payments to clinical trial participants from tax.
• 30:02
  Speaker 2: So any amount that you receive as a function of your participation will be exempt from taxation and effectively eliminate the threat to your welfare program.
• 30:13
  Speaker 2: And if you're not in a welfare program, it also, you know, I think, is reasonable to exclude taxes because of the reality that the vast majority of participants are operating out of net loss as a function of their participation.
• 30:30
  Speaker 2: That's been a really interesting process.
• 30:37
  Speaker 2: In late October we kind of publicly released the letter that I wrote and then started talking with the staffers of senators and representatives in the House of Representatives.
• 30:54
  Speaker 2: I didn't get any sort of objection really.
• 30:59
  Speaker 2: I mean, there were some staffers that didn't understand clinical research, but nobody was opposed.
• 31:06
  Speaker 2: Eventually we did find some sponsors for this legislation and we drafted and finalized the legislation and, funny enough, I think, the legislation is expected to be introduced to Congress this afternoon.
• 31:24
  Speaker 1: It's sponsored by oh my goodness.
• 31:25
  Speaker 2: Yeah, I mean, there's no guarantee that it'll happen today, but last I heard it's supposed to be introduced today, sponsored by a Republican representative, mike Kelly, and a Democratic representative, chrissy Hulahan, both coincidentally from Pennsylvania, and so that is.
• 31:49
  Speaker 1: That's also an achievement, having, like both parties, support the same bill.
• 31:54
  Speaker 2: No, I know, and I think that that was our goal when we started this was to make this a clear cut benefit for everyone, regardless of your politics, and I think that we have had support so far from both parties, which has been, to be honest, refreshing for me.
• 32:17
  Speaker 2: Like this is like a firsthand example of I don't know the system working so far.
• 32:24
  Speaker 2: I think that we have a long way to go before this is actual law, but it feels like we are making progress and there are at least a handful of people in DC that understand and care about this issue.
• 32:39
  Speaker 1: That's amazing and super interesting to follow whether this happens today and what the outcome is going to be.
• 32:45
  Speaker 1: I am also interested to learn more about, maybe on a more general level, we have two authorities that are impacting each other here.
• 32:57
  Speaker 1: On the one hand side, the FDA does want to encourage more diversity in clinical research for many reasons, and at the same time, we have the US tax code, which is, in this situation, actually removing the incentives for more diversity in clinical trials.
• 33:15
  Speaker 1: How can we resolve the differences between the two?
• 33:23
  Speaker 2: Yeah, I mean, it's just an interesting, unintentional conflict of interests.
• 33:29
  Speaker 2: So the way that I've been visualizing this in my mind is that if you think of the federal government as a large corporation made up of functional areas like you've got your I don't know, I call it like your revenue department, and they've got certain rules the IRS and then you have the FDA right, an agency that's responsible for health in your large corporation.
• 33:58
  Speaker 2: They both have mandates, they both have initiatives that they're working on, but it just so happens that one prevents the other and it's entirely unintentional but it exists, and I think that one of the thing and this is one of the reasons why this legislation is, I think, making kind of natural sense to a lot of the politicians that we've managed to put it in front of I suspect that the IRS hasn't considered this and I also suspect that the FDA isn't all that aware of it either.
• 34:37
  Speaker 2: I spend a ton of time thinking about payments to clinical trial participants and the implications of payments, but I don't think that there's probably large numbers of people like me that think about this very niche, niche, nerdy part of the world, that there's a lot of other problems to think about.
• 35:03
  Speaker 2: So my hope is that maybe somebody at the FDA either sees this podcast, hears about the legislation, reads my letter, or I think that eventually the lobbyists that we're working with will approach the FDA and will be able to hopefully get their support pretty easily, I would imagine.
• 35:25
  Speaker 2: The truth is that the amount of tax revenue that's generated from stipend payments to participants in trials is effectively zero.
• 35:38
  Speaker 2: It's not actually zero, but relative to the government of the US or the budget.
• 35:47
  Speaker 2: Relative to the budget of the US government, it's essentially a rounding error.
• 35:57
  Speaker 1: That's some rounding error, Sam.
• 36:00
  Speaker 1: How did you arrive to be interested in this space in the first place?
• 36:03
  Speaker 1: What was your journey?
• 36:09
  Speaker 2: Originally, when I went to college, I wanted to go to medical school.
• 36:11
  Speaker 2: In an effort to get to medical school, I did a bunch of work, study jobs at the hospital.
• 36:20
  Speaker 2: I went to University of Pennsylvania and I kind of went like each year, sometimes I worked in labs, other times I worked essentially as an intern for a site coordinator who was executing trials.
• 36:34
  Speaker 2: This was how I was initially exposed to clinical research.
• 36:39
  Speaker 2: I didn't end up going to medical school, I ended up entering into I don't know call it the business world.
• 36:47
  Speaker 2: Out of college.
• 36:50
  Speaker 2: I worked in investment banking and then kind of investments and then, through my own personal journey through my 20s, I realized that I wasn't gonna be successful working in like a traditional corporate structure and found myself working at a startup that was developing payment technology.
• 37:11
  Speaker 2: Ultimately I wanted to start my own tech company and I knew a little bit about payments and I knew a little bit about clinical trials and I had an idea to develop a product that eliminated the six week process of a university cutting a check for a participant.
• 37:31
  Speaker 2: So I quit my job, started a company called Greenfire with my best friend from first grade and my wife and we built a prepaid debit card product called the ClinCard, which is, I think, today essentially the market leading, you know, prepaid debit card solution that is used by a lot of, or maybe most, studies.
• 37:56
  Speaker 2: So I think, ultimately to answer your question, like the last 15 years I've spent thinking about patient payments, how to make them, what are the shortfalls of debit cards?
• 38:10
  Speaker 2: If you were to evolve them or innovate them, what would you do?
• 38:15
  Speaker 2: I just accidentally found myself 15 years later, having spent all this time critically analyzing the situation.
• 38:29
  Speaker 1: Well, I'm very happy that you have.
• 38:31
  Speaker 1: This is definitely an area where we can improve, both in the US, but I think also we're taking a worldwide perspective.
• 38:38
  Speaker 1: Well, we are going to start rounding off and I'm going to ask you the question that we always ask our guests in the end, and that is, if I gave you the transformation trials magic wand that can transform one thing in the life sciences industry, what would you wish to change?
• 38:57
  Speaker 2: If I could, if I could have one wish, I would wish that all trials would be accessible to all individuals and so, ultimately, that everyone who could benefit or wants to participate in a trial would one know that the trial exists and then to be able to participate in that trial, or at least assess it and decide for themselves whether or not it's appropriate for them.
• 39:36
  Speaker 1: That's a wonderful wish, and then it would change the dynamics of clinical trials and the participants that we have and probably the data and the results that we would get.
• 39:45
  Speaker 2: Yeah, I agree with you.
• 39:48
  Speaker 1: Sam, if our listeners want to learn more about you or reach out with further questions, where can they find you?
• 39:55
  Speaker 2: You can find me on LinkedIn.
• 39:56
  Speaker 2: I think it's linkedincom slash Sam Whitaker.
• 39:58
  Speaker 2: Mural Health is the name of the company that I'm building now.
• 40:03
  Speaker 2: You can certainly go to muralhealthcom If you wanted to learn more about the legislation.
• 40:09
  Speaker 2: You can navigate to diversitymuralhealthcom.
• 40:13
  Speaker 2: We didn't talk about it, but we're also running a project called the Portrait Project, which is inspired by Humans of New York.
• 40:21
  Speaker 2: Think of it like the Humans of New York for clinical research.
• 40:26
  Speaker 1: That's awesome.
• 40:27
  Speaker 2: Yeah, no, it's great.
• 40:29
  Speaker 2: The stories are really interesting, the real stories of real individuals that this really talented person on our team, emily, goes out into the world and finds them similar to Brandon from Humans of New York.
• 40:42
  Speaker 2: Anyway, that is at portraitprojectmuralhealthcom.
• 40:49
  Speaker 1: I will look that up, Sam.
• 40:53
  Speaker 1: It was a pleasure talking to you.
• 40:54
  Speaker 1: Thank you so much for coming on the show.
• 40:56
  Speaker 2: Same Thanks for having me.
• 41:28
  Speaker 1: Thank you.