D.R.I.V.E. is a strategic framework for promoting representative enrollment in clinical trials. D.R.I.V.E. addresses safety and efficacy concerns that arise when studies are conducted in populations that do not reflect the different patient groups that treatments are intended to serve. Join Maya Birhiray, medical science liaison, to learn more about this initiative and its importance in clinical trials.

HealthTree Resources:

• HealthTree CureHub and Clinical Trial Finder
• Lymphoma Clinical Trial Articles
• HealthTree Connect Groups
  • Black Health
  • Self Advocacy and Health Equity

Indy Hematology Education Resources:

• The DRIVE Initiative website can be accessed here.
• The DRIVE Score Calculator can be accessed here.

Let me know your thoughts on today's episode! Please share them in a comment or reach out anytime at hannah@healthtree.org. 

Hannah Loosle (00:12)
Hi everyone, welcome to today's episode of the HealthTree Podcast for Lymphoma, where we connect patients with lymphoma to the research and information they need to know about. If you've been with us before, welcome back. If this is your first time joining us, welcome. We're so happy to have you join our lymphoma community. My name is Hannah Loosle. I'm your host and the Lymphoma Education Manager here at Health Tree Foundation.

The goal of this podcast is to make research and new information coming out about your cancer easy to understand and easily accessible. If you've ever found yourself overwhelmed by clinicaltrial.gov or a medical abstract, we are here to change that. Stick around until the end of the episode when I'll be back to share my final thoughts on today's interview as well as some additional resources you can dive into related to today's topic.

The topic of today's podcast is the DRIVE Initiative for Clinical Trial Excellence, Pulling from the Abstract Practical Strategies for Creating Diversity, Equity, Inclusion, and Access in Cancer Clinical Research or DRIVE. We are going to be joined in just a few minutes by Maya Birhiray an author on the abstract I just mentioned. Before we bring her on, I wanted to give you all a little introduction.

Maya Birhiray holds a Bachelor of Science in Biomedical Health Sciences from Purdue University, West Lafayette, and a Master of Science in Anatomy, Cell Biology, and Physiology from the Indiana University School of Medicine. Currently serving as a medical science liaison for Indy Hematology Education, Maya collaborates with the IHE faculty and external organizations to plan and execute impactful educational events.

In addition to her liaison responsibilities, Maya is the co-author and creator of the DRIVE Initiative, which aims to promote diversity, inclusion, and equity within cancer clinical research. Through this work, she is committed to fostering a more equitable healthcare environment and enhancing educational opportunities for all. I chose Maya and the topic for today's episode because the DRIVE Initiative is an important framework for clinical trial recruitment. And now, without further ado, let's bring on Maya.

Hannah Loosle (02:09)
Welcome, Maya. Thank you so much for joining us today. I'm really excited to dig into your work. But first, before we jump into the DRIVE initiative, I like to start by setting the scene for our audience. So let's start with the why behind your research. What problem or issue did you see in the cancer space that you were hoping to fill with your research and with this initiative?

Maya Birhiray (02:29)
Hi, Hannah. Thank you so much for having me today. So that's a great question. Anyone who knows the Drive Initiative knows that it is a labor of love for me and my father. We co-created it and co-authored the original paper that talks about the Drive Initiative and our idea for it. And my engagement in the health equity space really started. During the latter half of my college career at Purdue University, I took a bioethics class as well as anthropology classes, which really got me thinking a lot more about non-physical aspects of health mixed with the COVID-19 pandemic and everything that was happening with vaccines and the death rates and how it was disproportionately affecting black and brown, people of color, I really started to kind of think a lot more about the why behind health disparities and health equity and where all of that came from. Being a black woman myself and always wanting to go into medicine, I started to kind of think about what the experiences that I experience, how they differ from the experiences that maybe someone that is white or white passing experiences.

Hannah Loosle (03:43)
Thank you so much for providing us with that context. And I'm very excited to dive into this initiative. It's such an important topic. So let's start with a high level overview of the DRIVE initiative. So can you start by just telling us what the DRIVE framework is and how it aims to improve clinical research?

Maya Birhiray (04:02)
Yes, so DRIVE is a five-step action plan. Each part of that action plan actually spells out the word DRIVE. So the D is for DRIVE Officer for Clinical Trial Excellence. The R is for Ranking. The I is individual plan. V is Verification. And E is Elevate and Educate researchers that are going to help trials get to clinical trial excellence. So each of those five steps was built with a lot of background research on what things were working or what things we thought would work to help address health disparities and move cancer and all clinical research towards a more equitable future.

Hannah Loosle (04:50)
Thank you for that answer. And why is diversity in clinical trials so important? And how does diversity improve the quality and accuracy of cancer research?

Maya Birhiray (05:01)
So in terms of DRIVE, we really look at diversity equals representative. having research that mimics the population of cancer patients is really important because of things like historical migration patterns and different genetic differences between ethnicities. Those things will impact the way that a patient will react to treatment. Thus, they should be involved in the study of the treatment because without featuring representative populations in the research, the diverse populations of cancer patients are going to receive those treatments. And we don't really have the background knowledge to assess adverse reactions. Is this medicine really going to be efficacious for those populations of people? We're assuming and we're experiencing something called data hallucination, where we're assuming that the results and the data that we're receiving is going to be applicable for everyone when we know that that isn't necessarily the case because there are biologically based differences between different races and ethnicities.

Hannah Loosle (06:11)
Absolutely, it's so important that the population that will be receiving any sort of cancer treatment or anything like that is the same population that these drugs and treatments are being tested on to make sure it will actually work for that population. And I would love to understand some more of the barriers to diversity in clinical trials. So what are some of the challenges that exist in recruiting diverse populations for clinical research and how does the DRIVE initiative address these gaps?

Maya Birhiray (06:41)
So there are a lot of challenges when it comes to recruiting diverse populations. A lot of those come from historical mistrust. So those we would like to call patient barriers, but there are also physician barriers as well as barriers from the way that things are structured. Oneof the most significant barriers is mistrust. A lot of that mistrust comes from historical events like the Tuskegee syphilis study, the Nuremberg trials, and then the case of Henrietta Lacks And without education for patients as well as providers on how they can understand where this historical mistrust is coming from. Patients don't have that knowledge base to understand how things have changed and how there are greater precautions in place in clinical research to keep the patients safe and keep them making sure they have very clear, very deliberate informed consent. There are major safety concerns, of course, there is the risk of adverse reactions when it comes to trial, treatments and drugs and things like that. There's also a risk of adverse reactions when it comes to standard of care treatment as well. But just really making sure that patients, specifically patients of color, those that were impacted by previous transgressions have the awareness that there are safety precautions in place. So part of, Part of DRIVE is really focusing on educating not only patients, but providers, industry on some of those barriers that can prevent patients from enrolling.

Hannah Loosle (08:14)
Yeah, absolutely. And it's definitely easy to understand where so many of these patients are coming from. Like you talked about with all of these experiments in the past causing mistrust in clinical trials and research today. It's really hard to overcome those

It's great that DRIVE is focused on that and helping patients understand the positive impacts of clinical trial participation.

And now let's dive into the specifics of DRIVE a little bit more. So we'll go through each letter in the acronym. So starting with the letter D, can you explain the role of a diversity officer in clinical research and how this role can make a difference?

Maya Birhiray (08:53)
Yes, so DRIVE underwent some language changes. now our D is for the DRIVE officer for clinical trial excellence. But the idea and the concept behind the officer is the same, which is having an individual that is separate from the research team to eliminate conflicts of interest, any bias, and whose sole purpose, similar to the safety officer with DSMBs, is to provide governance over the representation of the trial to ensure that there's generalizability and transportability of the data.

Hannah Loosle (09:26)
Perfect. And then can you explain what the DRIVE ranking system is and how it encourages better representation in clinical trials?

Maya Birhiray (09:33)
Yes, so the ranking system is a standardized format for scoring that can be used by patients, providers, industry, and essentially it assesses the representation of the clinical trial research based on the epidemiology of the target disease. And it's stratified by race and ethnicity, and the scale is from zero being the worst to five being the best. And we have created a threshold for what we like to call clinical trial excellence, which is a three, which essentially means that half of the minority epidemiology of the disease is being matched in the actual trial in terms of enrollment. So one of the big reasons why we thought having a ranking or a scoring system is that once you start keeping score, people want to perform. They want to score higher, they want to do better. And the whole idea behind this is standard to reach excellence, to make it so that drug approvals, if you're not representative in the trials that are associated with drug approval, that is maybe not going to result in drug approval. So that is our ultimate goal, is that our ranking and our scoring system is used in a more proactive way to create standards.

Hannah Loosle (10:52)
I love that. And I like how you said, you know, how people want to do better when they're being ranked or when they're being scored. So that's definitely really good way to hold research teams accountable for the work that they're doing. And then what is the importance of researchers creating an individual strategy?

Maya Birhiray (11:11)
An individual strategy is arguably one of the most important parts of DRIVE because having a personal accountability is so important and personal actions and deliberate actions, that's where we're going to see the difference in results when it comes to health equity. Individual providers saying, I'm really going to make a concerted effort to focus on giving treatments and giving drugs that are representative of the patients that I'm seeing, or I'm going to make a concerted effort to use research that's hitting these thresholds. I'm going to help if they're PIs in any studies, I'm going to help these trials hit their enrollment goals. I'm going to really make a lot of effort. So it's really focusing on on the deliberate actions that each individual can take and looking inward and seeing what biases, unconscious biases that they may have and how they can educate themselves, how they can address those things and making sure that self-evaluation is always, it's continual and it's consistently occurring, making sure that they're evolving as more research comes out, as more information comes out, they're consistently evolving and wanting to learn and wanting to better themselves in whatever way they need to.

Hannah Loosle (12:33)
Thank you. And yeah, I agree that the individual strategy is so important because any sort of change that we're going to see in clinical trial research and ensuring diversity and representation starts at an individual level. So I really love that piece of it as well.

So can you explain the V of this initiative and its importance?

Maya Birhiray (12:56)
Yes, so V is for verification, like I said earlier, and it really goes hand in hand with R, which is ranking and scoring. And verification is incredibly important when it comes sure that the information that is being reported in the official capacity is accurate. So right now all of the verification of DRIVE scores that are being used in the official capacity is done by the IHE administration. And we just really want to make sure that patients, providers, they know that the DRIVE scores that are being reported are, they're not being falsified and they are being reported correctly because if that information is falsified or being incorrectly reported, it's just as helpful as not having the information at all.

So we really want to make sure that there's a lot of certainty and trust for the DRIVE metric. so patients and researchers know that there's validity. Right now, our DRIVE calculator, which does all of our scoring, is publicly available for anyone on the Indy Hematology website. So the idea is that while any scores that are used in an official capacity are going to be verified, there is still the opportunity for patients, researchers, industry to kind of check and see, I'm on this treatment regimen. Was it accurate? Was it representative of me or my friends or my family or anything like that so they can really go through and check things themselves? We wanted it to be accessible for the public to be able to kind of assess things on their own.

Hannah Loosle (14:16)
Perfect. And then finally, can you explain the E of the initiative?

Maya Birhiray (14:37)
Yes, so E is elevate and educate researchers that are going to be focused on prioritizing clinical trial excellence. So the role of IHE in that is really creating those educational materials for researchers, for providers, and making sure that they have the resources that are necessary to achieve clinical trial excellence. We've also really been focusing on getting early career investigators interested in research and and really educating them on the principles of DRIVE and the principles of clinical trial excellence and enrollment because if we are able to catch researchers early in their careers it becomes an ingrained part of their career to be looking for how representative the the research that they're participating in or conducting is and making sure that the research that they are using to inform their decisions and treatments of patients is going to be representative for the patient that's right in front of them.

Hannah Loosle (15:41)
Thank you for that overview of DRIVE. That's super helpful to understand this initiative. do you have any real world examples of seeing the DRIVE initiative in action?

Maya Birhiray (15:52)
Yes, so right now we are really focused on sharing the DRIVE initiative, making it well known, and we are hoping in the next couple of months and years to see a really big large scale implementation. Right now we've had a lot of industry and organizational stakeholders that have been really interested in the initiative and we've had a lot of meetings with them and their internal boards to share the initiative in more detail. And they have been within their organizations and implementing it at their research sites and on a smaller scale, but we're really looking to scale that up and across the board. also, this past year in July, we had our Maui Summit where what came out of that summit was the Declaration of Maui, which is a collective statement and kind of pledge to making actionable steps to achieve clinical trial excellence and to increase the representativeness of clinical research. So we have signatories from industry as well as some providers, organizational leaders, things of that nature. the full Maui Declaration is also available on our website, as well as a way to virtually sign the declaration and make that pledge. We want to see as many people as possible making that pledge, making the commitment to clinical trial excellence and dedicating themselves to this work.

Hannah Loosle (17:24)
That's amazing. And what long-term effects could widespread adoption of the DRIVE initiative have on cancer treatment outcomes for underrepresented populations?

Maya Birhiray (17:35)
long-term adopting DRIVE would be amazing. It would be just incredible for research as a whole, for understanding populations and getting a greater sense that the treatment, that are coming out of research are designed and evaluated for all patients. we want to see and we expect to see outcomes for underserved populations improve because access to clinical research is a really important part of many cancer patients' treatment. And like I said earlier, doing so will mean that we will have a greater awareness of adverse reactions, efficacy, regimens. It will just really help those outcomes for those underrepresented populations because

We believe in research. There's no question that research is incredibly important. It really does make a difference in the treatment and care of cancer patients. And so we just want to see that spread across the board and make sure that everyone is seeing those benefits.

Hannah Loosle (18:45)
Absolutely, I agree. that's why this initiative and conversations like this are so important to get the word out.

I do think that it will have really positive outcomes for underrepresented populations if more research adapts this kind of framework. And what can patients and caregivers do to advocate for more inclusive and representative research?

Maya Birhiray (19:15)
Ask questions, ask questions, ask as many questions as you need to because what we've seen historically is that many patients aren't even getting the opportunity to enroll in research because they're not being asked. There is a lot of unconscious bias from providers regarding patients and many of the patients are being kind of prematurely denied from engaging in research because their providers aren't asking them or because they assume that they either are not interested or would not be eligible. And so asking providers specifically about research, how they can be involved, if there are other issues that might ordinarily prevent a patient from engaging in research such as, know, meeting childcare, you know, loss of wages because of, you know, extra appointments, things like that. A lot of pharmaceutical companies and other study sponsors have resources that are available to help patients with those external barriers to enrollment. So asking providers, are there any resources that are available for this issue?

like does the, you know, can the study sponsor help me with this thing? I I want to engage in research and I want to do so in a way that is going to be conducive for both me and for the research. There's also been major pushes to reevaluate the inclusion and exclusion criteria that is very unilaterally used in clinical research. So having patients and caregivers ask about those eligibility criteria because

We have also seen there's a lot of opportunity for inclusion and exclusion criteria to kind of be overwritten by the study sponsor to say, you know, we do have this inclusion exclusion criteria, but it's not really based on anything that is a real concern for this patient or for this study. A lot of times inclusion exclusion criteria are, like I said, unilaterally used and kind of recycled from trial to trial. And sometimes those criteria aren't necessarily applicable for a given patient or a given study. Obviously, the inclusion and exclusion criteria are for safety. So just asking clarification questions regarding them is always important just to make sure that you know, if there is a safety concern or something like that where a provider doesn't think it's gonna be advantageous for a patient to be enrolled on trial, that is still very valid. But just asking questions to clarify and get better understanding is hands down one of the best ways.

Hannah Loosle (22:18)
Absolutely, I love that answer of just being sure to ask questions in every step of your treatment journey and to be able to be involved in clinical research and things like that. So thank you for that answer. And what are the next steps for the DRIVE initiative and how will its continued development impact inclusion in cancer research?

Maya Birhiray (22:41)
Yes, I'm very, excited about our next steps for DRIVE. So right now we are working one of our most immediate upcoming changes is to our calculator. We are working with the University of Kentucky. They have a program called Cancer in Focus, which looks at the epidemiology data of the comprehensive cancer centers that are the NCI cancer centers, and we're doing a geographic expansion of our calculator. So now when you go to the calculator, you'll be able to select your catchment area, and then you will be able to select your disease state, and you can get now DRIVE scores that are even more accurate to where you are conducting your research, where your patients are at, things of that nature, because we recognize that the population of patients that live in New York City is going to be different from the population of patients that live in Indiana. So making sure that if a trial is more local or more focused on a certain group of patients that they're not being negatively impacted by the scoring mechanism, which uses national data from the SEER database. So we're really excited about that expansion, we are also looking to expand beyond just cancer. There's a lot of utility for DRIVE and for the calculator outside of just cancer. And we want to apply it to other disease states. And those are some of the things that we're working on in regards to our calculator. We're continuing, like I said, to work with major stakeholders and industry, organizational leaders to bring our DRIVE initiative to more patients, more providers, more researchers, as well as getting, creating some of those standards and really looking at the impact of outcomes for patients. We believe very wholeheartedly in the initiative, but we wanna see some hard results and hard data points to show that outcomes are improved for patients that are able to be treated with or engage with research that is going to be more representative for them.

Hannah Loosle (24:51)
That's great. It sounds like you have a lot of amazing things in the works for this initiative. So I'm very excited to hear about that adjustments to the calculator. I think that will be great to be able to differentiate, like you said, between urban areas and rural areas and all that kind of stuff. And yeah, this altogether is just an amazing initiative. So I'm very excited. For my last question, I just wanted to see if you had any final thoughts about DRIVE that you think would be important for patients to know or understand.

Maya Birhiray (25:27)
I definitely want to say to patients that DRIVE was designed for them. It was designed with them in mind, every patient. One of the other things that we're looking at doing in the future is expanding the calculator outside of just race and ethnicity, looking at social economic status, like you said, versus urban populations. Because there are more things that have an impact on health disparities, health equity, and patient outcomes than just race and ethnicity. We know that when patients are further away from these academic centers where a lot of major research is being held, they aren't getting access to cutting edge treatments, CAR T cells, bispecific antibody therapy, things like that, because a lot of patients wanna go to their community oncologists. They want to stay in the community. They don't wanna go super far from home and making sure that those patients are being represented as well, because their experience and what they're going through is also so valid and they are also being seen. So we are just wanting DRIVE to really be all about representation on all fronts. For all patients, that is our guiding principle because we want to see health equity across the board. We want to see better patient outcomes. We want to see cancer go down. That's what we want. It's all about the patients. It always will be all about the patients, and they are the guiding principle.

Hannah Loosle (27:09)
Thank you for that answer and thank you so much for joining us today and sharing about the incredible work you're doing. This whole interview has been so informative so I just want to thank you on behalf of Health Tree and our lymphoma community for sharing this with us today.

Maya Birhiray (27:24)
Thank you.

Hannah Loosle (27:26)
I loved this interview with Maya. It was great to hear about all the work going into the DRIVE initiative to ensure representation in clinical research. I'm also really excited to see the changes that we discussed with the calculator and how that can improve patient outcomes. I really appreciated hearing about how this work is being done for patients and to improve patient outcomes, since that is the reason we are in the field and sharing information like this with patients like you.

If you want to keep learning, I will link the DRIVE initiative website in the description as well as some HealthTree resources about clinical trials. Thank you for joining us today on the health tree podcast for lymphoma. I hope you learned something new. I would love to hear your thoughts on today's episode. Share them with me in a comment or send them to me in an email. You can find my email in the episode description. Join us again next time to learn more about lymphoma research and what it means for you.