Talk of the Towne Episode 05: Diversity in research with Allison Kalloo
Antidote’s podcast, Talk of the Towne, focuses on the ultimate sweet spot: that special place where science and patients converge. Our host, Dr. Rich Towne, was trained in pharmacy and currently works in Clinical Informatics at Antidote. In each episode, Rich welcomes a new guest from an Antidote partner organization, and takes an in-depth look at a particular area of interest, zeroing in on the story that Antidote's data is telling about how best to connect patients and research.
For our fifth episode, Rich and Antidote’s Clinical Content Associate Toore Adebjao, MPH, sat down with Allison Kalloo, MPH, a founding partner and communication lead of Clinical Ambassador and iParticipate, both of which help to address clinical trial participation disparities.
Their discussion covered the state of diversity in clinical research, why it’s so important that clinical trials reflect real-world populations, and what work those in the industry can do to create more inclusive opportunities. Click the button to listen to the podcast, or read the transcription below!
Talk of the Towne Podcast:
Allison Kalloo on Diversity, Equity, and Inclusion in Clinical Research
Richard: Hi everyone, Welcome to Talk of the Towne. This is a podcast hosted by Antidote, and what we like to focus on here is that very special spot where science and patients converge, going beyond just medical jargon and really getting into the purpose of clinical research: How we can improve it for patients, how we can improve it for sponsors, just really bringing clinical trials to a better place.
Today, I'm very lucky that we have three people on the call, and I'll give some quick introductions. I'm Rich Towne, I'm a PharmD graduate from the University of Buffalo School of Pharmacy. I've worked in a bunch of different areas including primary care, managed care, pediatric care, and community pharmacy. My main role is that I lead the team at Antidote that is responsible for turning clinical trials into a more friendly patient flow, and that's also known as Antidote Match, and it's featured on many of our partner websites.
With me, I've got Toore Adebajo who's got her Masters of Public Health from the University of Pennsylvania, was most recently a planning coordinator in the division of COVID-19 containment at PDPH, or the Philadelphia Department of Public Health, and currently, she's also heavily involved in creating those annotation journeys which help to make clinical trials more patient friendly.
And then our very special guest is Allison Kalloo who holds her Masters of Public Health from Yale, has been a patient recruitment specialist for more than 20 years, is the founding partner and communication lead of Clinical Ambassador and iParticipate, both of which help to address clinical trial participation disparities, fronting access and equity on behalf of industry and patient stakeholders respectively. So as a consultant, she delivered patient perspective, including being a participant in more than 20 clinical studies. And really excited to dig into this later, but her passion for making science matter was ignited by her mother who broke racial barriers as a virologist and was also a participant in research.
So with just some background, we know that there's a lot of ways that an individual can react to a certain drug, medical device, or treatment plan. It's not as simple as every patient reacting the same way. There is age, biological sex, disabilities, chronic comorbidities, geographical location, gender identity, race, and ethnic background. And that's just a couple of things. As we continue to do research, we're learning a lot more, and a lot of these things need to be considered in a decision-making process.
With all these factors, when a new medication is tested in a clinical trial, it's crucial that these populations are reflective of the real-world populations that they've been tested in. Unfortunately, people of color have historically been underrepresented in research studies, which means that medications have not been tested in a way that reflects the needs of diverse patient groups.
A few statistics are that racial and ethnic minorities comprise 39% of the United States population but only 2 to 16% of clinical trial participants. And another deep dive means that while about 14% of Americans are Black, they count for less than 5% of trial participants. Latinos who make up about 18% of the US population only represent about 1% of clinical trial participants. So pharmaceutical companies are developing more specific and sophisticated drugs acting on things like different biomarkers, different mutations, different disease states.
But without diversity in clinical trials, it's going to be impossible to clear picture of the drug safety and efficacy in a various population. Like I mentioned earlier, we get a very clean, perfect sample by these overly curated populations. But after a drug has been on market for a while, it ends up showing that maybe there were a lot of things that were missed in the clinical trials due to those skewed populations. So are we actually seeing improvement in clinical trials? How did we get here? And what can all of us do in this space to support diversity efforts? And Toore and I are thrilled to speak with Allison about this today. Welcome to Talk of the Towne, Allison.
Allison Thank you so much, Rich and Toore, and a big thank you to Antidote for having me. I appreciate being here with you guys and being able to vent.
Richard: Yeah. There's a lot to vent about. So jump right into it. I touched on it briefly in the intro. There's been a lot of historic underrepresentation and research for communities of color and obviously, there's a lot of reasons for this. I think that understanding that context is so critical to driving improvements.
Richard: Can you kind of share some background of this underrepresentation and ways that there's been need for improvement?
Allison: More than happy to. While underrepresentation of communities of color can find some of its origins in past exploitation and past medical apartheid that has victimized minorities, that's really not all there is to it. There is no doubt that prior policies and practices of government agencies, of Big Pharma, and of unscrupulous individuals have earned our distrust of them. This still does not tell the whole story. We have to be careful that we are not failing to acknowledge how much change has actually taken place to protect patient rights, that we are not mindlessly feeding this echo chamber, and that we are not manufacturing barriers that don't really exist.
The past has undoubtedly played a significant role in our hesitancy. But the distrust is not only about what happened with science. That would be an oversimplification of American history, wouldn't it? A mere skimming of the surface. It's bigger than that and also has a lot to do with past violence, discrimination, racism directed against people of color that had nothing to do with finding cures for disease, frankly, it must also be said that unwillingness to participate in clinical research is not universal because people of color are not monoliths, and unwillingness to participate is also not unique to minorities. So painting that conclusion with a broad brush is very problematic to me. It only feeds the cyclical obstacle. Presuming unwillingness as a foregone conclusion also absolves you from having to try, doesn't it? I've made it my career to address these sometimes blatant and often nuanced issues.
iParticipate, as you mentioned in my intro, is the community-facing and patient-centric nonprofit organization I founded, which emphasizes turning education into empowerment and awareness into accountability. We use creative means for constructive ins. iParticipate acknowledges that underrepresentation that we encounter today is much more about current affairs and implicit bias, access to healthcare, practice of medicine, and less about historical issues. The powers that be might do well to focus their attention on earning trustworthiness now rather than harping on the past and making that an excuse for not investing in what needs to take place today.
Toore: Thank you for that, Allison. I know in a previous interview you broke down the challenge of representation in research. You've broken it down to functional barriers to access as well as lack of exposure to research options in particular in a healthcare setting. Can you talk a little bit more about this?
Allison: Absolutely. Let's start with the fact that it is rare that a provider will actually discuss clinical trials at all. And when they do, it's almost always when their patient has exhausted all other options and they are in a terminal situation that needs to stop. Clinical trials are still seen as a last-ditch effort in the eyes of too many physicians. And in my personal experience, the only time the topic of participation has ever been broached with me was when I brought it up. And even then he or she did not have much to offer by way of guidance, recommendations, opinion, or even a robust perspective to offer as a recruitment specialist. Regretfully, the healthcare setting has been a source of deep disappointment because it represents what I would consider the most profound opportunity to partner and to create broader allies. But it's lost when healthcare providers and professionals don't saddle up to be proponents and advocates and the optimal stewards of evidence-based medicine.
As patient advocates, connecting the dots between clinical trials and clinical practice is the least we can do.
Richard: When I think of providers, I know that there is historically just a complete lack of wanting to participate necessarily. And I always really chalked up to lack of awareness, but it's also really interesting that there's this concern for a financial reason or even maybe just a reputation reason, that concern that they might lose patients.
Richard: And something I'm really interested in personally is, do you think that the way that we select study investigators and study sites has kind of put us in the situation where they feel like they could lose patients?
Allison: I do think that that is a point of pain for the entire process. I think there needs to be more attention paid to how that selection takes place, what the criteria are for selecting, not just investigators, but the sites, the site staff. There needs to be more attention to soft skills and the way that the message is delivered such that it's less medical jargon, more lay language, it's presented as a care option because that's what clinical trials are. They should be considered a care option, and it should also be brought to the attention of providers everywhere that clinical trials are an adjuvant if you will, an adjunct, an addition, a compliment to what they're doing. It doesn't take away from them. It only reinforces how dedicated and unbiased, if you will, they are with regard to the health and well-being of their own patients.
Toore: Do you have any suggestions to improve maybe the buy-in or participation of physicians from early on? Because I know with clinical trials, recruitment is often done external to physicians, and it's left between the sponsors, the clinical trial recruitment team and the patient themselves, often missing that middleman that's the physician.
Allison: Correct. So true, So true. Well, what we've done on this end is to actually develop a series of materials, of educational interventional print pieces that are also digitally available to kind of massage, if you will, that relationship and that understanding. And to also give providers an easy means of access to the information that they can share with patients
So we've seen some success with that. We'd like to get those pieces out more broadly speaking and make it a universal kind of point of access and outreach so that this community, the community of providers is not overlooked If we could gain more access, I think we could move the needle on this.
Toore: That sounds very promising. So moving on to study design and diversity and recruitment issues. We've seen instances where those in the industry say that they have the best intentions in terms of appropriate diversity in their trial, but they design the study without regard for social determinants of health. What would you say are the biggest mistakes you see made in study design? And those mistakes, can those be solved for during the recruitment process?
Allison: As you know, that's a loaded question. The results of homogeneity in study sample population are the equivalent of expecting everyone to wear the same size shoes and the same shoes in general. While that analogy isn't oversimplification, expecting the data retrieved from white participants only to apply to people of color is just as absurd. Abundant scientific literature bears this out. Pharmacokinetics reveals differences that can be significant, and we don't know what we don't know. And when researchers and industries settle for lack of diversity in their patient participant pool, for me, it's shorthand for saying, well, we really don't care enough to make this happen, and we have no intention of designing interventions sophisticated enough to actually control for these preexisting conditions that accommodate these comorbidities or that actually reflect people's lived realities.
And people of color do often have more complex medical histories and or risk factors. Social determinants of health and disease are embedded with multi-generational variables that impact our personal health journeys. That's the reason that even people of color with means and access to significant resources continue to suffer disproportionate disease and shorten lifespans.
It just underscores how pervasive disparities are, even when income and education and other social markers are controlled for. Disparities persist. And again, we are not monoliths, and the efforts to recruit people of color cannot presume that all of us simply need a ride to the study site to bridge that disconnect. Logistical challenges written into these protocols can actually be mitigated with community intel that we provide via the iParticipate focus groups and our boots on the ground. So we let you know with specificity what people will respond to and what makes sense in a protocol and what doesn't. But the interventions to make protocols more realistic needs to start as soon as possible in the study development phase. Prioritized if you will. Not as an afterthought.
Richard: One of the things that I'm really interested in is how you just said things that aren't specifically written in the protocol. Obviously, we can look at comorbidities and especially previous guests of this podcast have been talking about lupus patients. He brought up that common comorbidities are excluded for lupus patients are kidney disease due to lupus and brain and mental health disorders due to lupus. However, those affect a significant amount of patients, and when the drug is approved, it's not contraindicated in those patients. And there was a very interesting stat that only 10% of all patients are eligible beyond all the disparities for a clinical trial, but about 90% of the patients are going to end up receiving the drug.
Richard: So totally agree that we definitely need to see a major change. But I did really want to dive in on how there are things not written in the protocol, there are logistics that beyond just the inclusion/exclusion criteria, study commitments, I need to stay in the study, the hours the site might be open. Do you have any additional thoughts on that and you know how that could potentially be improved? Or maybe you don't see it as a problem?
Allison: Well, it is a problem. It's more often a problem than not. Part of that problem is that those issues are not fleshed out and readily obvious when you're interacting, when you are in the process of providing informed consent. A lot of those things are just buried in the various sections of the informed consent. And my proposal is that there be a study summary that flushes out those things, bullet points getting right to...let's get to the meat of the matter. How much time is involved? How many procedures? Do I need to come fasting? All of those things. How long is it going to take? How much am I getting paid for this visit? All of those things need to be right up front, and we shouldn't have to fish for those things within the informed consent. It should also be discussed face-to-face with the study coordinator or whoever is presenting the informed consent.
Toore: Okay. So Allison, earlier this year, we at Antidote, we began collecting race and ethnicity data when people searched for trials using our technology. Our results, interestingly enough, they were fairly close to the 2020 census. However, even though we had read it as an interest, that there is an interest in taking part from these populations, we saw that the largest trend and the data as it pertains to that, the numbers weren't exactly where they needed to be. How do you think we could harness the interest that we see in this data and then turn it into participation?
Allison: Excellent question, Toore. So glad you asked. So in my humble opinion, harnessing interest and transforming it into actual participation requires intentionality and planning, no doubt. Allowing people to see participation as a benefit and as an advantage to them in their health and their lives, it requires making not only the mechanics understandable but making the process manageable. The decision calculus meaningful, the opportunity relatable. Oh, and the study contacts actually contactable. iParticipate makes the endeavor of study participation something people can actually embrace. We don't talk about it from a theoretical point of view. We speak from a participants' perspective because we do take part in studies. I call it iParticipate on purpose. To my surprise still, many of those who work in this space don't actively participate themselves, as I've mentioned before. So how do you even attempt to convince someone to do something you're not doing yourself cannot speak to with your own experience and expect people to be receptive to it.
People see through that. They see through a facade, and they will call you on it. Authenticity is a theme of gravitas with a lot of people. And for instance, I was recently at my own study visit wrapping up my Novavax COVID vaccine study, and I happened to ask the study coordinator, who was someone who was new to me, whether she'd ever participated in any study. And she was a woman of color. And she was very matter-of-fact about saying no. I was a little taken aback, but people have a right to their own opinion. She didn't voice the opinion, but she made no bones about the fact that she had not ever been a participant. And clearly from her reaction wasn't planning to. So how can you speak with reassurance and credibility without the perspective of those you seek to enroll? The narrative about participating needs to be more than one-dimensional, and it needs to come to life in living color.
Again, this is our sweet spot. We emphasize relatability and multidimensionality because people are multi-dimensional. We encounter interest in taking part because we've laid it out with texture, with transparency. And so doing so means not presuming that we have all the answers, but that our enthusiasm is informed by facts. And then we infuse our communication with flavor, if you will.
Richard: There's been research by Deloitte that found that about 70% of people, even if they're interested, are going to live more than two hours away from the nearest study center. And we already talked about where we select sites. One of the biggest trends lately has been that rise of decentralized trials.
Richard: And I was really curious for your thoughts on decentralized trials and if you think that's a really valuable tool for improving representation in clinical trials.
Allison: Yes and no. So glad you brought that up, Rich, especially since, as you mentioned, decentralized trials seem to have now taken center stage in this industry. Certain aspects of DCTs do have their place, of course. Convenience has its usefulness. However, caveat, too often the push to make everything virtual seems to overlook the fact that reaching people and convincing them to participate remains a deeply human endeavor, a deeply personal endeavor. Trust is not captured through an algorithm. Participants are not entrusting your technology, they're ultimately entrusting other people. So promoting digital, virtual, e-based solutions as the holy grail, which resolve recruitment and retention for a study's patient demographic and in particular minorities, in my opinion, is a fool's errand, plain and simple. Convenience is great, but it presumes that we have already made the case, already made the connections, we've had the conversations, we've established the trust and rapport, and that we have provided a support system for when that technology becomes glitchy, that you've already got the people part and cultural competence part handled, if you will.
: And as a patient myself, my decision to participate or not always boils down to the people I have access to, to their soft skills, to knowing that I can actually interact with someone real. It's much less, for me, about the convenience factor. Participants, in my opinion, are much more cooperative, and I think in this industry we refer to it as the compliance vector, when the process is in fact pleasant, when they have locked into, shall we say, solid reasons, rationale to do it, to participate, and that the whole endeavor has been made meaningful for them. And then it becomes something that they actually want to do, and watch how their behavior follows in kind. People will do what they want to do. They will find a way. I hope that answers your question.
Richard: Yeah, it does. And something you brought up a couple times now is soft skills are a requirement. I was really curious if there was any way...let's say an investigator or someone who's training investigators for a study happens to be listening to this podcast, what kind of soft skills do you think are really important for them to develop?
Allison: Some of these skills are difficult to train people to have. You either have it or you don't, in my opinion — the listening factor, the eye contact factor, the ability to repeat back to someone what you think they said to make sure that you in fact did hear them correctly. Of course, empathy goes a long way, but it's hard to be empathetic in a process that you have not taken part in.
When you haven't sat on the other side of the table, you have not been a participant yourself, the empathy factor is a reach. So I would definitely encourage, emphatically encourage all those who have any influence over this process, who work in this industry at any level at all to take part in a clinical trial. At least you'll have some inkling as to what it's like, and you can speak to that with some authority, with some believability, with some credibility when the soft skills need to kick in to high gear.
Allison: And you know what? Not for nothing. There needs to be a mechanism in place that lets people know how they're doing. How effective was this team in being relatable and humanizing the process? And I've noticed this across all that I've ever participated in, none of them have actually circled back around and said, Oh by the way, how'd we do? How did we do? So there needs to be checks and balances there. I mean a simple Yelp process. I would give you five stars. Nope, I think I'd give you two, and here's why. Something that captures the patient perspective and reinforces the fact that our opinions matter, that you're actually listening and you're repeating back to us what we've told you and this is how you're committed to addressing those things. I think that would be enormously helpful, impactful,
Richard: Talking about all these improvements that we can make and looking at ways that could be supported or even mandated comes from the top, and I think that really starts with the FDA. And the FDA stated that...they've said exactly what we do, people in clinical trials, populations in clinical trials, that needs to mirror the real world population. But it still seems that drugs are getting approved without enough data. The FDA hasn't made a formal stance yet. I was just curious, why do you think this is continuing to happen? And do you see in the future the FDA making a hard and fast rule that without this data, a drug doesn't get approved?
Allison: Okay, Rich, I'm going to admit something to you. You're poking the bear right now with that question.
Richard: I figured I was, but I wanted to hear what you had to say.
Allison: How very intuitive of you. Well, I have long been of the opinion that FDA guidances are simply not enough. They have been and remain mere suggestions. There are no regulations in place with any teeth. No mandates, if you will, with enforcement. And that is why at last review of the FDA drug trial snapshot, roughly 75% of the drugs approved had not had any statistically significant data on people of color, to your point. Sponsors are not being held responsible for or accountable for what data they don't provide about their compounds and biologics actually working safely and effectively across all the populations that will ultimately use them.
And that barely scratches the surface of the discussion that needs to take place about patients who are disproportionately affected by a condition but who are not represented in the studies that actually bring a therapeutic to market. It's a practical issue. It's a scientific integrity issue. It's a healthcare economics issue. And it's a social justice issue for crying out loud. And fewer black box warnings would be necessary once there were more data on communities of color. It continues to happen because Congress has not made it their business to develop the legislation that can move this mountain. The FDA can and should do more to make equitable representation mandatory, full stop.
Richard: So something else that's happening legally that I think is very interesting that might actually start leading to this change that we're talking about is that as of January 2022, Clinical Trial Treatment Act went into effect which required coverage of those routine clinical trial costs for Medicaid patients. And there's a lot of opinion pieces going around that say this law could improve racial diversity, age inclusion, disability representation. Do you think that this law is actually going to lead to that outcome? And do you think that this might actually have even more impact in the future? Or do we require something else beyond just the Clinical Trial Treatment Act?
Allison: No, no, and yes, we do need more. I'm happy to see more regulations simply suggest the import that clinical trials play in our collective ability to pursue better health outcomes. However, Rich, this legislation is narrow, it's limited. As you mentioned, Medicaid recipients are those impacted by this legislation. If we get into the weeds, however, we have to also address the fact that making Medicaid synonymous with people of color is problematic. And even those this act can help should never in the first place be expected to pay out of pocket to participate anyway. Nobody should. The idea that anyone who volunteers to help advance science should have to pay for any component of their participation is preposterous. And finally, I'll add that focusing on Medicaid recipients over emphasizes that participants of color that should take part in studies are those of lesser financial means anyway. That smacks of the potential to exploit this demographic, and we are still dealing with the ramifications of historical exploitation. People from all walks of life should be participating and all should be compensated to do so, with no responsibility for insurance or any other coverage.
Richard For one of my last big questions, DEI in research, right now, we talk about this, there's so much that needs to happen. And to be frank, and you've talked about this before, it's lip service, it's just a mere guidance, sponsors are speaking up to this as something that we should do or something that we should step towards. Do you think that this is going to end up leading to real change? Or what else do you think is completely required to bring this for the future?
Allison: Okay. In as diplomatic a way as possible, I will say that, well, hot topics tend to be fed by the fickle interests of trends, which by definition do not last. My hope however, is that we are reaching a new zone and new rules of engagement and a new normal where diversity is not the exception, but embedded and the default of all clinical trial operations, from study design to budgeting prioritization to the assignment of roles within the organizations to strategic partnerships, vendors, consultants, all those selected outside the realm of internal. The orientation toward DEI is too critically important to only last a moment. It should be considered an obligation and a commitment by any entity in this space, to make DEI central to every aspect of their operations. The pledge and the actions that come from that pledge need to be perpetual and proactive, frankly. My hope is that I would like to know that my labor is not in vain.
Richard: So as a closing thought, before we wrap up, I just want to say this was a really powerful conversation, and I think there are just so many nuggets that hopefully we have sponsors, investigators learning, taking notes, and just for the work you've done, super grateful for everything that you've done to this point.
Allison: Thank you.
Richard: So one of our questions that we like to wrap up a podcast with is, let's say you can wave a magic wand and you can change one thing that sponsors do or give them one piece of advice. Or it doesn't even need to be the sponsor. It can be investigators, it can be study sites, it can be any facet of the healthcare population in regards to how you want to change DEI in clinical trials. What would be your one change or suggestion if you could implement it?
Allison: One hugely actionable thing that can happen today is not barring diversity, equity, and inclusion at the point of professional meetings, for example, when we can actually interact with those entities that are outside of Big Pharma and outside of CROs and outside of those larger support organizations. When my company, for example, and I'll make it very personal because it is, when we see the costs of these meetings in the thousands of dollars, it's not practicable for us to attend. And yet, these entities proclaim they want diversity. Well, diversity needs to be more broad, more comprehensive, and people need to stop assuming that there's equity with regard to these professional meetings and who we can get in front of and have conversations with.
Richard: I think that's hugely impactful and hopefully... Obviously, these meetings, like you said, can be a ridiculous cost, and honestly, it'd be just such a huge barrier from any organization participating and just limiting it to a very select echo chamber few.
Allison: Bingo. It's very elitist. Not equitable. It's the antithesis of equitable.
Richard: So to wrap up this conversation for sure, obviously, we talked about how you participate with Clinical Ambassador and iParticipate. Do you want to give any more information for listeners of this podcast on those two organizations?
Allison: I would be happy to. So Clinical Ambassador is our industry-facing organization which helps industry players across all facets to better communicate what it is they do and why and helps bridge the gap to the communities they seek to engage, to serve, to ultimately impact. iParticipate is the non-profit partner which is community-facing and patient-centric and is where the rubber meets the road and how we develop and implement our messages of impact and instill meaning and relevance to those who really need to know more about this process and who can be impacted the most by it. Feel free to visit both sites. Reach out to me either way. It's i-participate.org for iParticipate, and Clinical Ambassador is simply clinicalambassador.com. Thank you so much for the opportunity again. This has been phenomenal.
Richard: Of course. This has been a really powerful conversation. Thank you so much for joining Toore and I on Talk of the Towne.
Allison: I could not be happier, could not be more pleased and flattered. Thank you so much.
Toore: Thank you.
Richard: Thank you.