Trials with Maya Z

  Hello and welcome to the next episode of Trials with Maya Z, brought to you by TrialHub, a data intelligence platform that helps clinical research organizations and sponsors plan clinical trials. This podcast is about how we can make clinical trials more successful and patient friendly. Friendly, I am your host, Maya Z, and in every episode, I will be interviewing a leading expert from various industries in order to discuss some of the major challenges and brainstorm how we can solve them.

Let's get started.

 Hello everyone and welcome to Trials with Maya Z. I'm very excited today even nervous. Because I've been waiting for this episode for quite some time I can tell you actually exactly how much time from the moment I met you Sam Whitaker, who actually presents himself on LinkedIn as an innovator.

He has amazing experience in clinical research, entrepreneur, doing a lot of things, today representing Mural Health, but let me give you the word, Sam, and introduce yourself.

Thanks, Maya. Thanks for having me. I really appreciate it. I guess innovator, I actually really don't like LinkedIn in general. I think that I'm starting to warm up to it more, Over the past, say, year, and I think that at some point I was trying to fine tune my profile and just, you know, update it and make it professional.

And, I didn't want to create a description. It feels like those types of summaries or introductions seem so narrow and it strikes me that people are really, Layered and deep. Instead of making an attempt to summarize who I am, I just used a word that I think is thematic across most of the things that I do for better or for worse, trying to always identify how we can do things differently or make things better.

That's an interesting way to define like innovator, but I understand what you're saying. And I realize that I am my own type of innovator. The moment that I was working for a big company, they were trying to tell me how I should be doing things, but that was always finding my own way, I guess.

And then I decided, okay, I need to do things my own way. Not that this means that it's always the better, but actually trying to find problems and Creating solutions. And Sam, I'll go to the topic of our podcast today, because it's a lot to be said there. I personally was absolutely amazed at how much I don't know on the topic.

Something that I thought I'm quite aware of. And it impacts many different other topics. So yes, just go straight to the point today, we're discussing reimbursement of patients in clinical trials, but how this also impacts diversity. And last time, Sam, you told me something that absolutely I didn't expect.

And I'm pretty sure that a lot of people out there know about it, but even more people don't know about it, especially people outside of the States. So, tell me, Sam, how come one third of Americans are excluded from being able to participate in clinical trials no matter what kind of FDA guidelines for diversity and inclusion we have.

So tell me more. Why is that?

So, yeah, and I'll admit that It wasn't my original idea or thought that, what was the origin story here? This was, brought to my attention at a high level, by sites. So feedback that we were getting from sites that we work with, and it was anecdotal, not so much related to our product, but we were just started hearing, a bunch of reports about, participants that either aren't enrolling or dropping out of studies, because they are worried about, receiving income from studies. So the financial support that sometimes is provided to participants globally, but most of what I'm going to talk about is U. S. specific. Sometimes the financial assistance comes in the form of what we generally call a stipend.

And at least in the US, although I'll assume that it's probably similar elsewhere, stipends are considered taxable income by the IRS. And so, if you participate in my study and there's a stipend of say, I don't know, I'm making it up 100 a visit. That 100 is supposed to be reported to the IRS at the end of the year, and you are supposed to pay whatever tax is applicable to you based on that.

And so income threatens a portion of our community, but actually, before I get to that, I'll back up and say that, like, if you think about the U. S. as a single community, right? There's 334 million. Americans in the U. S. And then if you think about taking that high level, group, right?

And dividing them up into quintiles by Income, household income. The top quintile, so the top 20 percent of the country average is about 270, 000 a year, in household income, which is, you know, a lot. The bottom average is 15, 000 a year. And there's, yeah, as you would imagine, it's like a hockey stick, right?

Like the top 20%, earns a whole lot more than the, 60 to 80 percent and and that type of thing. The top 20 percent have no issue financially. There's 67 million Americans in that quintile. The other 80 percent all cannot afford to participate in a trial. They don't have the disposable income that's required in order to finance their participation.

And that comes in the form of expenses to participate. And that expense is going to be unique to each and every participant based on their own individual circumstances. So if you have one child or four children or a spouse, or maybe not a spouse, or you live in an urban area or et cetera, right?

Everyone can relate to the variations from person to person. Almost the bottom 40 percent of that group. So call it the first two quintiles, but it's almost 40%. It's 33%, right? Are individuals that, make less than a certain amount of money, and they become eligible for social welfare programs.

So in the U. S., probably the most well recognized programs would be Medicaid SNAP, which used to be known as the Food Stamp Program. So this is a program that provides you essentially purchasing power to get food.

Hmm.

in the event that you make too little to have food security.

And there's a whole bunch of other programs out there. So we're talking about health care, food, housing, some pretty basic needs. One out of every three American adults requires a welfare program. And oddly, That also includes one out of every two children in the U S which, I wasn't intimately aware of these statistics before I started digging into this.

And like maybe for another podcast, it blows my mind that there are so many people in this country who suffer in this way. Right. And this may be where they call it like the national dynamics diverge when you go from the U. S. to other countries. So, that is also why we're hyper focused right now on solving this problem in the U. S. Anyway, the 110 million Americans that rely on a welfare program, qualify for those programs because they make less than the required amount of money, and the amount is variable based on the number of people in your household and things like that. So it's not a flat amount. If they receive income from other sources, they may or may not. surpass the threshold, that they need to stay under. And so effectively any income serves to potentially be a threat to their eligibility for things like healthcare, food, and housing, right? Some pretty basic, really important things. Now practically speaking, if you were on the food stamp program, SNAP, and my clinical trial wanted to give you 200 in stipend, It may not cause you to exceed the threshold that you have to stay under.

But most welfare recipients aren't going to take the risk, right? They just know that like, I can't make money or else I'm going to lose my benefits. So in any case, when a participant comes in and they want to participate in a study for whatever reason And they find out that there is a W 9 that has to get filled out, and there might be a 1099 that gets issued to them, and they're gonna receive income, or a stipend.

They do one of three things. The first is that they just decline, and they say, I can't enroll in this study because I can't risk losing my benefits. They'll participate, but then drop out before they reach 600. I'll get back to that in a second.

Oh, wow. Okay. That's interesting.

Or they will participate in the study and just abstain from receiving financial support.

And I think that's actually probably the saddest of the three, right? So the Americans that need the support the most are also the Americans that cannot receive the support because they're worried about losing the benefits that their family relies on. If I take a step back for a moment, the 600, Scenario is really important to talk through for a minute.

In the US, the rules are such that every dollar of income that you receive you're supposed to report to the IRS and then, pay your taxes on or whatever shakes out for you, your individual situation. If a payer, so if I were to pay you a hundred dollars, you're supposed to pay income on or income tax on that.

But I don't have to do anything until I get to $600. When I exceed $600. Then as the payer, I'm responsible for issuing you a 10 99, which is a tax form, and I have to send that 10 99 also to the IRS, so they know. That you made over 600. A lot of people in our country think that you are not obligated to pay tax until you get to the 600 mark.

That's not true, but, practically speaking, that is the underlying reason why some people will enroll in a study, but then drop out before they get to 600. And so effectively you have a 334 million person community. 110 million of those people, are effectively prevented from accessing trials or saying yes, or enrolling or staying in a trial.

  I hope you're enjoying this episode. If you find this topic relevant, you'll find it helpful to book a demo with our team on trialhub. com. Since 2019, we've supported more than 3, 000 clinical trials with country, site, and patient feasibility. We'd love to show you how and help you get your trial right from the start.

And now, back to my guest.

 Interestingly, and this probably won't surprise many people who are listening to this, although they probably aren't necessarily conscious of it,

So what, what I think most people don't realize, although I don't think it'll be surprising, is that inside of this 110 million what I'm calling the welfare community is That is roughly broken down, in our country, to include 40 million, wait a minute. I got that wrong, didn't I?

I get what you're trying to say. I'm not sure that I'm still following the numbers, but I get that

110 million people are excluded, which is actually the most important thing. And actually what's even more important is these are exactly the people that probably need the most access to clinical trials.

And also are the people who didn't have access in the past as well. And that's the reason we have guidelines like for diversity, inclusion of more patients, especially patients from minorities. Sometimes these people are not even, they don't even have access to health. They do have some level of access to healthcare, but not necessarily Everything that they really need.

And clinical trials may be one of the best options, but at the same time they're excluded.

yeah, I mean, I think that's right. And, there's a disproportionate amount of underrepresented populations in the welfare community. So I think 50 percent of black Americans, are members of this community. And there are a lot of complicated dynamics that exist between, the black community and clinical research or health care, or other social issues, but even if those were eliminated tomorrow, there's still a very objective financial issue that would prevent a lot of, underrepresented people from participating. So I think the other interesting, thing that goes on in the U S is that there is no requirement to make any payment to a participant in trials. And so you don't have to provide a stipend. You don't have to reimburse them for anything. I think oftentimes there is at least some form of reimbursement, partial reimbursement.

But we talked about the 110 million, right? There is another roughly 157 million. That, I've been calling recently the GoFundMe community, and they essentially represent the middle class, of the United States. These are people that make too much money to qualify for welfare, but not enough money that you are, In the top quintile or, super comfortable.

Right. And so if you were to go to GoFundMe and just search for clinical trial, you'll see there are over 500 results and you can start reading the stories. And there are common themes and this is not a one off problem. People are starting funding efforts in order to figure out how to afford the flight, the airfare for their caregiver, or for themselves. Or oftentimes the standard of care is not covered by insurance if it's in the context of a clinical trial. And so the individual has to figure out how they're going to pay for this. And a lot of the stories are about really devastating, diseases, cancer, terminal cancer, pediatric brain tumors, things where, the individuals are desperate to have a chance to get access.

And, so if you were to combine these two groups of people, right, the people that either can't afford it or, have a structural barrier preventing them from accepting, You have literally 80 percent of the U. S. And in that top quintile, the top 20 percent of the U. S. Those people can participate.

There are very few relatively relative to the whole population. Very few. Minorities or people with chronic health conditions that oftentimes disproportionately affect lower-income communities. And I don't think that this is necessarily a silver bullet, but I think that if we were to do, we as a community and clinical research were to do, I think what is the obvious and most reasonable thing.

And I'm going to say, I think we should simply create an environment where everyone who enroll in your trial should have what I've called a net neutral financial experience. So any expense that you incur, and that could be superficial from parking expense,s or gas, or you had to buy lunch all the way through to individual specific, issues like child care, elder care, pet care, or whatever your situation causes you to incur, we should be making you whole on those points, right?

And we're, and eliminating a reason why you have to say no or inversely can't say yes.

Yeah, Sam, let me stop you here because, we'll come back to this topic again because, you're currently doing something amazing and that's exactly what, now you started describing. So I'll come back to that as well. I just wanted to say that I honestly, probably I'm going to hate myself for saying that, but that's what I feel.

Because I observe the space all the time and I see that there are simple reasons causing an inclusion of patients. Clinical trials are so burdensome and taking so long. And then again, We're trying to overcomplicate things by like creating the next tech or let's say creating the next, I don't know, but what's the promise of AI and diversity, you know, what's the promise of these new solutions.

And we are a solution provider, like my company is also a solution provider and I'm just grabbing my head like right now and I'm like, Oh, my God, there is so simple solution to that. I'm not saying it's easy to get to this solution, but there are many things that are simple. Actually, I'm also hosting a webinar again on the diversity topic and a lot of the solutions we were discussing.

There are things like. Just have someone to speak the language or make sure that you have, let's say food available while you're taking six times like blood tests and so on and so forth. Like simple, simple things that if you open your eyes for these simple things. Then you can really come up with the simple solutions. I had another podcast episode, a few weeks ago, we were speaking about clinical research transparency, and that a lot of the things are not okay with how we register trials, and how much of these trials are out there and how we're sharing the trial results.

That's completely another topic. But why I'm mentioning that because, my podcast, guest, she said something very smart. She said, We're, it's almost like if we're trying to close our eyes of what's the real reality of what's really causing the problems. and therefore, we're just trying to solve it and putting more money here, changing management, optimizing structures, like, blockchain AI, all these buzzwords, but actually not going back to the basic principles and solving what we need to be solving. Speaking of that, Sam, you actually had one incredible, LinkedIn post. I think it's the last one, that I know, , you basically went out to the community and asked what are their thoughts around what's causing the patient recruitment and retention issues.

Challenges. I guess that everyone's asking that, and everyone has a different perspective. But then there were a lot of comments after that, and I managed to review some of them. Yeah, looking at these comments, who do you think recognizes the reimbursement, of, patients in trials as a problem already?

Who is already there and who isn't there already?

I think oftentimes when there's a discussion about reimbursement or patient payments, I think that there is, a focus on tactical execution. There's a conversation about how do we give them the money. How do we pay them? What are the benefits to the site? What are the benefits to the sponsor?

And I think that there is an absence of. Kind of basic, you know, kind of common sense, user experience, type of concepts. Right. And so most of the people that I saw on that LinkedIn post, and I'll, just generally say, I think that the sites, the site personnel seem to be most in touch with this because they're interacting with the participants on the ground floor, right?

Like they're the ones that hear from the participants that, They can't receive income or whatever the point of friction is, whether it's reimbursement or not. Right? And I think that the further away that you get from the patient or the caregiver, I think the less likely you are to be connected to, the underlying or the core importance of the reimbursement.

So, you know, generally I think it's the sites. I think that there are people in the. We'll call it the sponsor or CRO or vendor community that, also recognize this, but mostly it's, I would guess sites. That said, I think that this is not my effort to, put sites up on a pedestal. I think that there are, equally some really concerning dynamics within the site community associated with participant payments.

Okay. Interesting. What about sponsors? Actually, I saw quite a few of people representing, sponsor companies. And I did see that they were aware of the problem. Actually, some of them even, were the first ones to name the problem among, like alongside of things like lack of awareness, sites not responding and so on and so forth.

So, it sounded as if they're aware, but they're blaming the model. So if they recognize the problem, what are they doing to solve it?

That's a great question. And, I think it is important to just mention that the, reimbursements are not the only part of this problem, right? I think you just mentioned a couple of them. If you think about the participants' journey from the time that they

google clinical trial or introduced for the first time and their decision to interact with the trial. Maybe they fill out a form or go to a screening visit or whatever. I think if you start to think about what the potential places that they could, interact with. Decide no or drop out.

I think that all of those are really relevant. So awareness, trust enablement, we'll call it for reimbursement or financial barriers. And there's surely that or, we'll call it drop out from the recruitment funnel from prequalification to, scheduling, uh, when, when, if sites way too long, I actually read a post on LinkedIn this morning, and I'll say that, the graph, the data that Nelson Rutrick posted this morning, was really helpful in kind of visualizing the impact of, not following up quickly, in any event, you, I think you're right,?

It's so like, sponsors, at least some of them, some of the people in the sponsor community are aware of this, what are they doing? It's unclear to me. And I think that, before we started, we talked a little bit about, why some people are, um, empowered or privileged to take on, you know, some activities or solve some problems and other people don't have the bandwidth to do it.

So, that's probably a component of it. I think that one of the criticisms that I have in general, and this is throughout, call it 15 years, 15 plus years of being in this industry is that, I hear a lot of people. Identify a problem, or even I'll say complain about a problem. But it's very infrequent that I hear anyone follow up the identification of a problem with, an idea to solve it.

And you can see that on LinkedIn. You can see it, especially on panels and at conferences.

My favorite, but that's another topic.

Yeah, no, I know. But that's not to say though, that there aren't, I mean, there's entities or people in every ecosystem, I think in every industry that are responsible for solutions or new things.

And, there are people that sponsors, or CROs, or other big companies that are open to trying new things. I wouldn't say that they're, you know, nine out of 10, but, if you find the one and you get an opportunity and prove it out, then it'll snowball.

And I would add something to that, being an entrepreneur. I learned the hard way that the idea is worth until you actually start realizing like making something about this idea, creating it because the devil is in the details, like people say. So I think that what I learned from my, Conversations with people like you all the time is that even though we are pitching different problems, issues in the clinical research space, one of the key problems we have is this lack of collaboration, not in the sense of really uniting around these problems and solving them together.

Sometimes it's because of the lack of this leadership. Even one company going out and saying, Hey, we recognize that. And we want to change it though. I have to say that lately I seen more and more examples of this is. Somehow changing. And it's very interesting observation that I have, but usually, it depends on the ownership of the company.

Is it a privately owned company or is it a public company? If it's a privately owned company, somehow, at least that's my observation. I may be wrong here, but I have several examples where these companies really took into consideration the real business problem, and decided, okay. We need to take the extra mile.

We need to really invest time and money into solving this in a better way because we will be doing. Things the same way, like everyone else, and we'll be getting the same result. Another thing that I see as a problem that everyone doing the same thing and like expecting different results, but yeah, Sam, you also mentioned, that you are already working.

Like you decided not to wait, not to observe, and this, your exercise with GoFundMe profiles, something that I actually encourage everyone to do. I actually did it after you mentioned that. And, interestingly enough, I realized that we can even encourage people who go through our platform for patients.

We have a platform for patients that we help them for free to identify clinical trials. Exactly trying somehow to minimize the lack of awareness among, clinical trials and we navigate these patients, but very often patients don't even know that these platforms exist, go fund me, not just go fund me in the States, but there are others in other countries. So I actually saw that this is an opportunity for us to raise awareness. Hey, you know what? That's 1 opportunity where you can find some funding for your treatment, no matter whether that's a clinical trial or not. But yes, you were inspired by that. Great example, and you decided to act upon that.

So can you tell us a little bit more, what are you doing today to actually find a solution on this problem? That we're all stuck?

So we're doing two things. I'll start with the first because I can give more detail about it. And a lot of people are already aware of it. So a little bit less than a year ago, Emma Aikerman, who's one of the product people at Mural Health, was here.

Kind of raised this issue to my attention after talking with sites, right? And so I asked her to find out is anybody working on eliminating the tax barrier for the welfare community and she went out and found a couple of groups that were aware of the issue and had formed Working groups that are meant to help to figure out how to solve the problem.

And we said, okay, great. Can we help, can we get involved? And, we ended up finding out, especially the first group that we talked to said that we could help. But in order to help, we had to become a member of their association. And I said, okay, cool. How much, or like, what do I have to do? And they said, you just have to pay a 35, 000 fee.

It became crystal clear to me, like immediately that they weren't actually serious about the problem. And so I told Emma, I said, let's just go out and hire a lobbyist and, change the law, right? So this is a legislative solution. There's also another solution to this problem, but in August of last year, we hired a lobbying firm.

I wrote a paper that it's really a letter, but it felt like a paper. I felt like I was in college. You can find that at diversity. muralhealth. com if you want to read it. And then when that was finished, our lobbyists did what they, are great at, and they got us access to politicians, representatives in Congress, and we started to pitch the bill and the concept, and we ended up finding two representatives, in the House of Representatives to sponsor the bill.

We wrote the bill, negotiated it, and then in January of this year the bill was introduced into Congress. We've collected one more co sponsor, it is a bipartisan bill, so both Republicans and Democrats are supportive of it, and now we're going through the process. If anyone's interested, you can Google the bill, you can Google the Harley Jacobson Clinical Trial Income Exemption Act, Harley Jacobson was a friend of mine who died of ALS,

Or you can Google HR 7418, which is the identifier of the bill and read about it.

So this is like a journey, right? And so we've started to try to collect support in the Senate. And, only 5 percent of bills that are introduced or ever made law. I think we have a, I like to think we have a better chance than 5%, but it's definitely not 95%. So we'll see how this goes.

In the process of going through this deep dive into all of the laws and dynamics, I started, I think in December, I was one week and I thought to myself, Oh man, what if Congress doesn't do what I want them to do? Which is a funny, kind of late for that thought, right? And I tried to start thinking about is there a way for me to eliminate the tax barrier

Hmm

in the context of the existing rules, and we ended up figuring out that there is a way to do this, it requires a specific corporate structure and it requires me or Mural Health to take responsibility for the payment and being the payer, which a lot of companies don't want to do. Because then it also makes them responsible for tax compliance and any sort of fines or consequences if you fail to comply. And, there's a whole bunch of like tax related financial and legal liability associated with it.

In any event, that is like a work in progress. But, what we're calling it is, a centralized reimbursement model. And the reason why we want to take responsibility as the payer is so that we can control the labeling. Of the payment, and our goal is to really only utilize stipends.

When it's appropriate, and in my view, I think that stipends are really only appropriate in situations where you're actually trying to incentivize behavior, incentive. Incentives are like a bad word, but they are okay. According to the FDA. But my goal is to ultimately get as much value to the participant in the form of reimbursement as possible.

If I do that, reimbursements are not taxable. If it's all reimbursement, I don't have to collect W nine information. And so as an industry, if I could snap my fingers and everyone just to stop paying stipends, the issue is solved. No more issue, right? That's probably not going to happen because the industry is so fragmented and there's a lot of different personalities and tolerances for risk.

So instead of relying on grassroots effort to change every one's mind, we are developing a centralized way of essentially funneling the distribution so that we can control it and provide the benefit.

Yeah. I see that you're thinking of like, this is the ideal world, but if the ideal world doesn't happen, this is another way we can go about this ideal world to actually make things better, for participants. I was thinking, how can the industry support you to reach to this ideal world?

Is there anything? Like we all can do to support what you're trying to achieve, because it's obvious that this ideal world has benefits for all of us as patients, as sites, as sponsors, CROs vendors, everyone. So is there anything we can do now in a few months?

Well, yeah, I mean, there's actually a handful of things that you could do right now. I think that the 1 is to, reach out to your representative or senator and make them aware of the bill and tell them that you're supportive. That's 1 thing you

Oh, wow. Great.

The other thing, if you are an entity or a business entity or somebody that has influence over an entity, you can sign on to the letter that we, are sending to the House Ways and Means and Senate Finance Committee, there's a handful of big pharma, small sites, midsize tech companies that are signed on.

You can see

I'll get the link to this letter and I'll make sure that we share that. And yeah. Okay. That's the second thing.

The other thing, yeah, the other thing that you could do, if you are a study team or a clin ops person is, attempt to make a policy inside of your organization that, reimbursement is, standard. I don't know if you saw it, but a while back I posted a LinkedIn post about an interaction that I had with a clinops person at oncology focused sponsor.

And, I asked her about payments to participants in the U S and she said, we don't pay anything. And I said, why not? Like the participants have expenses. And she said, no, all of our participants have cancer. And,

and it's not ethical and right, it's not, and she's literally said, we don't have to pay them.

They'll they'll do whatever we want.

Oh, yeah, that's the other thing Which is very sad.

So I think that's part of it, right? And then I think that, if you're an IRB, if you are a member of an IRB, and you're listening to this, I think that IRBs are also in part responsible for this issue, right? And so in the context of an IRB, payments are always scrutinized in the context of are we paying too much and are we being coercive or, you know, is there an undue influence being put on the individual?

Fine. That's not what I'm talking about. I want the IRB to approach, the analysis of participant payments the other way around and think, is this enough? Is this enough to make the participant payment? Net neutral on expense. And if the answer is no, kick it back and say, you have to, we have to look out for the participant.

You have to change the approach here.

Yeah, I think that there is a lot of work that we need to be doing around the ethic committees from the people that are a part of the ethic committee, from the way they're making decisions, what's ethical and what's not ethical. As a matter of fact, I had another podcast episode a month or two ago. It was about immigrants, very similar situation.

Like these immigrants, I'm not speaking about immigrants that don't speak the language and they just arrived in the country and so on and so forth. I was thinking about these people who still don't have the, let's say, the official approval to be in the country, for example. Let's say they have this special status, but at the same time, It's not that they have access to health care, like proper health care.

Clinical trials may be their best option, like really best option. But because they're vulnerable, ethical committees won't allow them to be part of clinical trials. And then it's like, okay, you don't allow them, they don't have health care. You don't allow them to be a clinic in a clinical trial.

So what is actually ethical? I understand they're like vulnerable, but same case here. So You don't want to pay someone to incentivize them to be part of the trial because of the payment. At the same time, the person cannot participate because they can't afford it. So, is that ethical at the end of the day?

Anyway, I'm very passionate about this topic.

No, I mean, even in the context of reimbursement, I hear cleanups people ask about, coercion and, um,

Mmm.

And like, to be clear and if anybody's interested, reach out to me and I'll send you a link to the HHS guidance, reimbursement can never be considered undue influence.

It's a reimbursement, right? Like, you know, you've paid

something there, you're not profiting. There's no upside here. That's not what that reimbursement is about.

Yeah, exactly. Sam, I have one more question. What is the role of the FDA? Because I'm pretty sure that, actually, no, I'm assuming here, that the FDA knows about this, like, problem. These are Probably not the same people behind the diversity guidelines, but again, maybe people who work together.

So how come we end up having a diversity guideline, but not actually first solving the reimbursement issue? Like, I just wonder, to me, it doesn't make any sense.

So I assume actually that the FDA is not aware of this, conflict, the conflict between the tax code and their effort to diversify trials. It's one of the things that we will bring to their attention as a result of our work in Washington. I also think that this will be interesting and relevant to the White House Office of Science and Technology, which is one of the groups that are working on the cancer moonshot.

So I don't think that the FDA is probably aware is my hope. I think that there is a role though that the FDA could play, that would be really, powerful. A few minutes ago I said something about IRBs, holding essentially their customers accountable.

If you're familiar with, The mortgage crisis that happened in 2008, or if you've ever seen the movie, I think it's the big short, and if you haven't, you should watch it. It's interesting, but also relevant, because In my view, and this won't probably be popular, I think that the IRBs in our country are similar to the credit rating agencies of the mortgage crisis.

So these are groups that, in one way or another benefit economically. From reviewing and approving protocols. And if you don't cooperate, right there, your customer is going to go somewhere else. and so that's fine, right? And that, dynamics fine. But I think that in that case, you need to have some oversight.

That oversight is provided by, the OHRP, which is the office for human research protection, which is part of. HHS, FDA, the FDA is also part of HHS. So the FDA and, OHRP are, you know, think of them maybe as like brother and sister or something, with HHS as their parent, the OHRP, for one reason or another, and I haven't dug into why, performs very few audits of IRBs.

And so, on the surface, it doesn't seem like OHRP is doing a great job of Holding IRB is accountable to a standard. And I think that, you know, the FDA and HHS could have, an influence on this now that said, I don't know why that is maybe the HRP doesn't have funding or who knows, like there could be very like,

maybe there is a clear reason after it, like behind that, but you're raising a fair point. Yeah, makes sense. Before I ask you my last question that I asked everyone that joins me in my podcast, I just want to go back to my audience and I know you're gonna blush now, but, basically we were having this conversation before we started, the episode, Sam, it's essential everyone that we don't only have our like these problems in our heads, and we don't only communicate these problems and just come up with ideas, but every one of us is a leader on its own, on his own, on her own, these solutions depend on every one of us, one way or another.

By raising the problems, by pushing others, by following others, like Sam. I encourage everyone to read more about the topic to find different ways to support Sam and his efforts. Because like I said, if Sam is successful with what he's trying to achieve, every one of us will be also more successful.

And what's most important is that we'll have innovative treatments on the market, the number one. Bits and like sentence every single company has on their websites. So if we want to make this reality now, there is a good time. And I'm pretty sure that, you know, about other issues, probably not as big, but it doesn't matter.

Don't quit. Go big. Dream big. And just start by acting. Start speaking, finding the other people, and doing something about it. Sam, last question. If there is one thing like you said, many things, but still, if there is one thing that you think will make clinical trials more patient-friendly and successful, what would that be?

So, when you mentioned that to me earlier too, I think, to put in the back of my head, um, You said in an ideal world, right? And, of course, there's a bunch of things that I talked about that I'd love to see change, but I'll go outside of financial support. And I'd say that if I could pick anything, I think I would eliminate the need for a requirement to include placebo groups in studies that involve terminal participants. That would be what I would change. I think it would have a tremendous impact on the world and the participants. But I think that I know only a little bit about this issue, but I think that it would also increase timelines and costs, which is likely the reason why this doesn't happen now.

But, like I said, I'm a freshman on this topic, but that's what I would change.

Which allows us to dream the ideal world, right? Thank you so much, Sam. It was a pleasure to have you on my podcast. Thank you so much for sharing that with me, with everyone else. And yes, keep this amazing work that you're doing. Let us know how we can support you. I'll make sure that, all the links and everything that you posted will be communicated afterwards as well, but don't stop.

We believe in that as well. And thank you for doing that for every one of us.

Thanks, Maya. Thanks for having me.

  Hope you enjoyed listening to Trials with Maya Z. If you're interested to hear more about how clinical trials can serve patients globally, subscribe to the podcast on Spotify, Apple Podcasts, and Google Podcasts. Have a great day.