The ConcertAI Podcast | Trial Diversity feat. Warren Whyte

Jeff Elton (00:01):

Hi, this is Jeff Elton, CEO of ConcertAI and welcome to the ConcertAI podcast series. Today, I have the pleasure of being joined by Dr. Warren Whyte. Dr. Whyte heads up ConcertAI’s Health Equity and Trial Diversity Initiatives, and is a leader in this field working with multiple biopharma sponsors. His work and the work of his team has influenced all of what ConcertAI brings to clients, customers, and biopharma partners, including the integration of social determinants of health with all of our data sets, a first in class for anybody in the RWD industry, also integrating health equity and trial diversity considerations into all of our technology solutions. I’m really looking forward to the conversation today. There couldn’t be a more important topic with a more influential individual in the field.

Welcome to the ConcertAI podcast room. I’m here today with one of my really long-term colleagues, Warren Whyte, and it really is a particular pleasure because Warren and I’ve been able to have our careers intertwine a bit and it’s in a topic that both he and I have a lot of passion for and he’s exemplified just extraordinary leadership on. But before we get into that, Warren, I’d love for you to do a bit of an introduction to yourself. You’ve got a nice far-ranging career and wonderful scientific credentials but guided yourself where your passion and responsibilities took you. Give us a little bit of your own background.

Warren Whyte (01:35):

Well, thank you for having me, Jeff. It’s just great to see close hand, just a lot of the work that ConcertAI is doing and for me to be a part of it. This podcast is just a great opportunity for people to talk about their journeys, talk about the work that they’re doing and how they’re making a contribution to the healthcare industry. I feel blessed to be here today.

My journey was, and still is, an interesting one. I don’t consider myself to be someone that follows the straight and narrow. I tend to follow my passions and my passions lead me to interesting places. When I grew up, I wanted to be a professor, and I started my academic career going down that path. It was not until I got my PhD at MIT when I realized I don’t think I want to be a professor.

I want to find a way to infuse my scientific expertise with my business acumen and strategic expertise that I picked up while being a member of the consulting club at MIT. So when I graduated, I was fortunate to land a job at a boutique life science consulting firm, and I did that for a couple of years. That gave me the opportunity to see close hand the challenges that healthcare companies and organizations face. It’s one thing to have a really keen knowledge of the research and the development and pre-discovery phases of a therapeutic, but when you get to the medical affairs, the commercialization and the marketing of it, there’s a whole host of other challenges, so that consulting work really gave me that opportunity to do that. But I wanted to do more with data and tech. Being at MIT, I felt like there was tremendous opportunity to leverage big data and digital technologies to advance healthcare efforts.

I was fortunate. I remember where I was the day that I got a call from Accenture and they looked at my background and they thought that, “I think you’ll be a good fit to work alongside this tremendous individual.” His name is Dr. Jeff Elton. And I was like, “Okay, I will take that shot.” I’m really glad I did it because since then you and I have been working on how we could leverage data and technology to advance healthcare efforts. I did that at Accenture and then left Accenture came here to ConcertAI, which I’m still doing that, but now it’s with a deeper focus on health equity. I’ll leave it at that.

Jeff Elton (04:15):

Yeah. Well, I’m super pleased you did, and I think you did bring your professorial instincts here. I know I learned a few things from you as well as we were going through that process. Staying on that education theme here for a second, I want you to maybe help explain a few concepts and terms here, because I think sometimes the terms have different meanings and the work we would do to advance things may be a little bit different.

There’s health disparities, there’s the concept of health equity, which sounds almost more like a goal to a degree. More recently, coming from FDA imperatives and this idea to make sure that the ultimate trial population seems to be more likely treated, there’s this concept of trial diversity. Can you take us through a little bit of, for you, and as you think about operationalizing those and bringing those concepts to life, how would you give them some definition and maybe also align, what’s their importance?

Warren Whyte (05:17):

Yeah. So I’ll take each one individually. Health disparities, they’ve been longstanding. They’ve been an unfortunate feature of our healthcare system for several decades. However, 2020, COVID-19, really shone a light on health disparities, particularly among the black and Latino communities that have been negatively and disproportionately impacted by that virus. Health disparity is where you have a meaningful and negative difference in a healthcare characteristic between two groups of people.

When we talk about health equity, that is sort of the north star, if you will. That’s the goal that we want to achieve. And that’s when there are no differences, i.e., parity, across all key indicators of healthcare for any group of individual. We oftentimes think about patient outcomes being the same regardless of race, ethnicity, background, gender, age. That’s how we in the industry define health equity as we think about it in the terms of outcomes.

Lately though, I would say in the last year and a half, there’s been increased scrutiny and focus around what you just mentioned, around trial diversity. Clinical trials, they’re the mainstay of our healthcare. It’s how we are advancing novel therapeutics, it’s how patients are getting access to the latest and greatest that our partners have created and developed. But it’s unfortunate that certain groups are not reflected or properly represented in clinical trials. What that means is, and gets to the definition of trial diversity, we aspire to have clinical trial participants and participation be reflective of the national average, the US population. What that means is, for example, African Americans make up 12% to 16% of the US population. So what we hope to see is that within clinical trials, you’ll be able to have the same proportion of these racial and ethnic groups. Unfortunately, we do not, so there’s been increased scrutiny and, as a result, efforts by regulators like the Food and Drug Administration to ensure proper representation of certain racial and ethnic groups in clinical trials, i.e., diversity.

Jeff Elton (07:45):

I think you gave such an important definition around trial diversity. I want to stay close to that theme here for a minute. I know you personally, and you’ve done some work professionally in the context of some of what you’re doing at ConcertAI around study designs themselves. This notion of even, how do I define what might be the goals of diversity for a very specific study design where it’s the therapeutic entity, the disease state, and then how do I maybe take now where I can understand what the characteristics are and make sure that the design of the study itself now embodies those people that were disproportionately negatively affected? But then also translate that into how do I make sure that the trial itself can actually accrue patients so that the net ultimate results of the trial is actually a diverse population participating? Can you take us through a little bit? Because I know you’ve been spending time yourself personally, even on underlying methodologies, tools, and approaches for doing this.

Warren Whyte (08:45):

Yeah. If I could take clinical trials and break it up into just three basic stages. You have the basic research question, then you have the clinical trial design, and then, ultimately, you have the execution of the clinical trial. Let’s focus on these three broad areas.

When we’re talking about the research question, we want to make sure that the question that we’re asking will afford benefits for all patients that you’re trying to help. Sometimes, if we’re not careful, we could introduce a certain bias in how we framed a question that could ultimately lead to a certain group being disadvantaged or marginalized, and you don’t even know it. So it first requires us to reevaluate our research questions, making sure that we’re asking questions in a way that, ultimately, we are able to achieve equitable outcomes for everyone and not just a specific group.

The next phase, clinical trial design. This is an important one because I would say, historically, we’ve been, as an industry, collectively, following a set of rules and guidelines, standard protocols for how to conduct a clinical trial. And I think we need to take a step back and reevaluate that because within these standardized protocols, there are inherent biases that are negatively impacting certain groups from being ultimately able to participate. What we should be desiring to do is redesigning these studies so that they’re more reflective of the standard of care that’s being provided today as opposed to the historical procedures and protocols that have been longstanding.

We can do that by evaluating things like eligibility criteria and ensuring that we are not summarily excluding anyone based on certain criteria that have no meaning or benefits to the performance of a drug. But because it’s an artifact of a protocol that’s been leveraged hundreds of times, it continues to persist.

We could finally get to the trial execution and reexamine where we’re conducting clinical trials. It’s not enough to continue executing trials at these large academic medical centers. We’re seeing a shift in cancer care such that they’re now being provided out of community clinics. And we want to make sure that the trials that we’re executing are occurring where the disparities are existing, where underrepresented groups are residing, such that there isn’t a heavy patient and trial burden placed on them to participate. Because it’s one thing to get these patients ultimately to enroll, but if you’re not careful, they would withdraw from these clinical trials because of the burdens that are placed on them to try and participate.

To recap, just those three phases, reevaluating research questions, taking a closer look at the study protocols that a clinical trial is based off of, and then finally execution of those trials, making them in sites, in regions and areas where disparities are known to exist.

Jeff Elton (11:48):

We think of ourselves as being scientific, but I’m hearing you say that even unconsciously, unwittingly, just by virtue of using past work and past artifacts to plan the future, we may be sustaining some of those particular biases. Not that it was the intent of the researcher, but it’s just in that particular methodology and people do take [inaudible 00:12:11]. I’m hearing you say I almost have to be even more vigilant or maybe even establish new standards, and I may have to question those areas and at least analyze and assess those areas to make sure that they have no bias that actually would run counter to the diversity goals I’m trying to get.

That’s an analytic problem, but it also sounds like it’s a cultural problem of the organization and the team and the research community as part of that. Are you starting to see more vigilance around that and appropriate consciousness around that?

Warren Whyte (12:44):

I am seeing a lot of increased attention and therefore devotion to ensuring that we are achieving equitable outcomes. For me, what that looks like is keeping the patient at the forefront of every single thing that I do from the moment I wake up and read an email to the moment I am creating a presentation to send to you or another of my colleagues, the time I go to bed, every action I am taking is, in my eyes, thinking, how is this bettering a patient? And when I have that lens on it makes me want to work with alacrity and with speed.

Jeff Elton (13:26):

Well, I want to give you an opportunity to talk about how you actually are doing that. I appreciate your words, but you are an individual that is actually doing this. You helped organize and lead an initiative inside ConcertAI that bears the name ERACE, which has an intended multiple meetings to the name. As part of that, not only have you initiated research activities, but you’ve also initiated external partnerships that are, what I’d almost call, on-the-ground level where healthcare is taking place.

Warren Whyte (14:02):


Jeff Elton (14:02):

But bringing to it activities to clinical settings and areas and peoples that really haven’t actually been part of these things in the past. So maybe you could tell us a little bit more about ERACE, what its intent is, but also the NCI,, National Cancer Institute, InCorp and the Louisiana program that you really catalyze as well.

Warren Whyte (14:23):

I’m really proud of the work we’re doing under ERACE or Engaging Research To Achieve Cancer Care Equity. It’s three years old, started at the height of the pandemic and it was our collective response to some of the inequities and injustices that we were seeing unfold throughout the country. And because ConcertAI has such a large and meaningful footprint in cancer care, it just made sense that ERACE’s sole mission would be to tackle cancer care inequities and research disparities. So it was me and two other colleagues, Onisia Nisbit and Maxine Fisher that was responsible for the name and its intention with regards to leveraging data and digital technologies to address health disparities and other inequities.

But as large as ConcertAI is and as powerful as it is in terms of its data, its breadth and its depth of its coverage, we realized that we couldn’t do this alone. We need to work with our industry partners in order to really make sustained change happen. I’m proud that under ERACE, we’ve set up a number of partnerships and collaborations across various sub industries within healthcare to make a difference in health inequity. That includes academic partners, but also regulators like you just mentioned, the NCI, NCOR, National Community Oncology Research Program.

I’m really excited about that partnership in particular because it’s not only part of the NIH and it’s not only aligned with the NIH’s mission for health equity, but in terms of the number of resources that they could bring to bear, coupled with our data and clinical development technologies behind it, we have an opportunity within the next five years, and I’m being very serious here, we have an opportunity within the next five years to radically rethink how participants are being enrolled in clinical trials.

We have an opportunity to have the diversity of these clinical trials be truly reflective of the country as a whole. I believe our mission in the next three years across the 100 hospitals that we’re going to be ultimately working in, get to a point where you have roughly 40% to 50% of the clinical trial participants be minorities. If you think about that for a second, that is an amazing feat to accomplish, given where we are today, where minorities will make up roughly 20% of clinical trial participation.

So 50%. How can we get there? And I’m just fortunate that we have some really smart people at the NIH that we’re working with that have a really good grasp on some of the barriers and challenges that patients are facing, whether they be structural, clinical, physician or otherwise. And what they needed was evidence and insights, which our data can bring to bear, coupled with some of the automated technologies and tools that remove some of the manual labor that is embedded within clinical trial infrastructure.

So I’m really excited about this mission and this collaboration with NIH, and if you’ll have me on this podcast in a couple of years, I’ll be really excited to report some of those findings and our results and getting towards really true, meaningful minority participation in clinical trials.

Jeff Elton (18:01):

I think one, it’s your passion and commitment here is just super clear. As you and I have learned on a lot of issues, there’s intellectual and then there’s force of will to get the issue to move forward. When you’re changing embedded beliefs and you’re trying to catalyze something where nothing exists, there’s just the passion and the force of will combined with logic and operational excellence, et cetera, it is all required. So I appreciate your bringing the passion and the force of will to bear here. By the way, I think we’ll probably do this annually, not just every two years, because I think we want to actually make sure that we’re working our way across.

I also want to tell you, as I listened to you and thinking about that number of 50%, I was out west last week and I was with a community oncology group, 60 different group practices, which you and I will spend some more time on, and they indicated that 69% of their physician population were racial and ethnic minority, and that their patient population mirrored that. One of the things that I found personally so exciting was that mirroring between the physician composition and the patient composition, and I recall in some of your own work, the aspects of trust between the patient and the physician in the community would also be a catalyst to participate in more clinical research. I’m curious, what’s your perspective on that?

Warren Whyte (19:31):

I hesitate. I have a few thoughts and I’ll try and be as succinct as possible about this topic. The physician-patient interaction and the dynamic is an important one when we talk about clinical trials, but more generally when we’re talking about healthcare, access to affordable care services. That interaction between the physician and the patient is crucial. It’s vital. So therefore, there has to be a certain level of trust and more than trust, I think, it’s empathy on the part of the physician towards the patient that that physician is treating.

I’ve heard, and to an extent, I do believe, that when you have a physician that is of a similar background, whether it be race, ethnicity, nationality, as the patient that he’s treating, there is a certain level of comfort and trust that comes with that. It’s almost like there’s a feeling or belief that, “Okay, the physician gets me, the physician can walk in my shoes, knows what my life is like and what my ordeal is like.”

But the reason why I hesitate is because I feel like that’s too easy. It’s easy to think, “Okay, well then let’s have more black and brown individuals be physicians treating black and brown patients, and therefore, automatically, trust will come.” No. I think what is more important is going back to the empathy and the compassion that an individual has towards another. I see too often physicians being condescending, feeling like they know it all and taking a lot of the power out of the hands of the patient and making them feel like they don’t know how best to take care of their health. That’s why they’re in the doctor’s office, right?

But it doesn’t matter the color of the person’s skin or their background when it comes to, “Can you treat me like a human being? Do you see me?” That goes farther in the conversation between a physician and patient than do you and I share a same background.

Jeff Elton (21:42):

Articulately framed. When you think about it, there’s an optimism even to that point, because empathy can be selected for, empathy can be brought into who goes to medical school. Empathy can be part of the culture of a clinical organization in terms of how it practices medicine. That actually feels quite actionable, and that may be more democratizing in unifying.

These are complex topics, and I’m going to actually give you an equally complex topic there, which is that sometimes equitable research may come from an equitable culture of the organization that actually is sponsoring that research. At least there’s some view that the culture of the organization is in itself helps guide the nature of its questions, what it prioritizes, et cetera. Do you see the life sciences, research-centric organizations emphasizing and building the nature of that culture?

Warren Whyte (22:53):

Yes, I do. We’re seeing it now with increased chief equity roles at organizations. We’re seeing greater emphasis on workforce diversity and creating a more diverse, inclusive, and equitable culture in organizations. That is necessary. It’s like a breeding ground that will therefore foster actions and activities centered around achieving equitable outcomes.

A really good example of that is the place right work at ConcertAI where we, by we I mean our tremendous leader here in you, Jeff, saying, “You know what? We are going to embed health equity work into every project and sale that we do with our customers. It’s important to us, so therefore it should be important to our partners.” That comes from culture. When you have that mindset, it’s like a mind shift now. In everything that we do, in our products and our services, there will be a health equity component around it in which we are addressing some research disparity. That level of commitment comes from the culture and the people that are deciding, “No, this is important to me, therefore it’s going to be important to us as an organization, and therefore it’s going to be important to our customers as well.”

Jeff Elton (24:19):

So Warren, more than most, how difficult it was to actually get together and get data and information on social determinants of health and other characteristics.

Warren Whyte (24:27):

No, that was easy.

Jeff Elton (24:28):

As you noted, we started this journey three years ago, but I actually think you can take good personal pride with your colleagues that have been working this area. All of our data products, as we think about Patient360, a hundred percent of that in 2023 will now include, not as an option, not on a research-project-specific basis, full social determinants of health and integration of some comparable elements from medical claims and an area you work in.

You’ve been doing a lot of work in trial design and things of that nature. At the end of this month, getting integrated into the clinical trial optimization solution and all the health equity considerations is now, as you well know, part of that software layer and the staff solution layer. So this has been a journey, but I think you and I committed a long time ago that this notion that data itself shouldn’t arrive with its own bias, also perpetuating some of this. It’s a difficult challenge. You actually have to understand where you are and you have to understand what you’re not seeing.

Warren Whyte (25:28):

Yeah. It’s a delicate balance, the power of data. It’s why some people are not quick to embrace it because of these challenges and biases associated with data analysis and interpretation and quality and this and that, but at the same time, the responsible and ethical thing to do here is to embrace these novel tools and technologies and use them, leverage them, in a responsible manner in order to make necessary progress and change. Social determinants is a key aspect of that, where in order to truly understand the health of an individual, you need more than just clinical or medical information. You need to really understand the socioeconomic and demographics around this particular individual to fully understand or better understand some of the issues and challenges associated with the health that’s being provided to that patient.

Jeff Elton (26:23):

Big area of debate in our advisory board as well, which has helped inform some of our approaches. I want to give you really one of the final words here. As you think about your own work, as you think about what’s progressing, if you look out, sort of 12 months from now, what do you have the most optimism about? What are you taking and looking and saying, “That seems to be moving the right direction, having the right pace and the right commitment,” such that in January of ’24, we’ll look back and say, “Yes, we actually made some progress.”

Warren Whyte (26:58):

I’m going to take your question and slightly modify it. To answer your question directly, in the next 12 months, something that I do anticipate seeing are policy changes, things will now become mandatory. Right now, we’re getting a lot of guidance and recommendations. However, I think there will come a time it will be mandated how care is being afforded to individuals. Obviously, I’m thinking about clinical trial diversity probably being the leading proponent of where I see these changes and mandatory changes being implemented.

At the same time though, in the next 12 months, an area that I think is underappreciated and needs greater attention in scrutiny is the way in which we engage with our communities. Data is great, Jeff, in the sense that it gives us knowledge of the patients that reside underneath that data, but we don’t truly understand them. The only way to do that is to be out there in the fields, in the communities and working with community-based organizations, advocacy groups, patients themselves, to truly understand the nature of the health that they’re providing, because data can only go so far before you have to incorporate the patient’s voice. When we’re talking about healthcare, that is critical, so I’m hoping, I don’t think it will happen, but I’m hoping in the next 12 months we’ll see more of our strategic partners working hand in hand with patients with community organizations to design, ultimately, the trials and the care that’s being provided to patients.

Jeff Elton (28:32):

I feel like I shouldn’t add or elaborate on that response at all. So Warren, as always, really appreciate all your perspectives. Thanks for being in Cambridge, Mass.

Warren Whyte (28:43):

Thanks for having me.

Jeff Elton (28:44):

Close to your MIT homelands here, down the street on Mass Ave. Thanks again, very much. Pleasure to have you here today.

In the field of health equity and trial diversity, it’s clear progress is being made. Data sets are now available that provide insights into who is disproportionately negatively affected by a disease. We can think about designing clinical trials differently, taking almost a zero-based approach. We can think about where we deploy trials differently, moving them closer to where patients live, and where patients really receive their care so that they’re truly representative of everybody in the country. These are super important messages and entirely actionable, and ones that we do need to take collective responsibility for.

If you’d like more information about ConcertAI’s ERACE program and trial diversity initiatives, please visit at Thank you again for everybody listening, wherever you are. So good morning, good afternoon, and good night.