Racial and ethnic minorities are among the fastest growing of all communities in the United States, making up nearly 40% of the population. Yet studies show poorer health outcomes among minorities across a wide spectrum of diseases. This past year, we’ve seen that many people from minority groups are also at increased risk of getting sick and dying from COVID-19.
National Minority Health Month in April highlights efforts to improve the health of people in racial and ethnic minority groups. One piece of this puzzle is aimed at increasing minority participation in clinical trials -- a priority for guest, Manmeet Ahluwalia, M.D., deputy director, chief scientific officer and chief of solid tumor medical oncology at Baptist Health’s Miami Cancer Institute.
Racial and ethnic minorities are among the fastest growing of all communities in the United States, making up nearly 40% of the population. Yet studies show poorer health outcomes among minorities across a wide spectrum of diseases. This past year, we’ve seen that many people from minority groups are also at increased risk of getting sick and dying from COVID-19.
National Minority Health Month in April highlights efforts to improve the health of people in racial and ethnic minority groups. One piece of this puzzle is aimed at increasing minority participation in clinical trials -- a priority for guest, Manmeet Ahluwalia, M.D., deputy director, chief scientific officer and chief of solid tumor medical oncology at Baptist Health’s Miami Cancer Institute.
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Dr. Jonathan Fialkow:
Welcome Baptist Health Talk Podcast listeners. I'm your host, Dr. Jonathan Fialkow. I'm a preventative cardiologist and lipidologist at Baptist Health's Miami Cardiac and Vascular Institute, where I'm also chief of cardiology at Baptist Hospital and chief population health officer at Baptist Health. Racial and ethnic minorities are among the fastest growing of all communities in United States, making up nearly 40% of our population. Yet studies show poor health outcomes among minorities across a wide spectrum of diseases. This past year, we've seen that many people from minority groups are also at increased risk of getting sick and dying from COVID-19. National Minority Health Month in April highlights efforts to improve the health of people in the racial and ethnic minority groups. One piece of this puzzle is aimed at increasing minority participation in clinical trials. That's a priority for our guest today, Dr. Manmeet Ahluwalia, deputy director, chief scientific officer, and chief of solid tumor medical oncology at Baptist Health's Miami Cancer Institute. Welcome to the podcast, Manmeet.
Dr. Manmeet Ahluwalia:
Thank you, Jonathan. It's such a pleasure and privilege to be here today.
Dr. Jonathan Fialkow:
So I know your expertise and your passion is in this area and there's some stuff to unpack for our listeners. Let's start with a basic premise before we start talking about the importance of minority and more diverse participation in clinical trials. What are clinical trials? We know, especially over the last few decades, these clinical trials have been part and parcel of the way we as physicians learn what works, what doesn't work, how to manage populations, how to manage disease states. Speak a little bit about just how clinical trials work and where they are in our healthcare continuum.
Dr. Manmeet Ahluwalia:
Yeah, so very eloquently put Jonathan. So let's start with the basic question. What's a clinical trial? A clinical trial is a kind of a clinical research designed to evaluate, examine, and test new medications and interventions to help get our patients the best standard of care. So before anything becomes standard of care, those drugs or interventions are tested in a clinical trial to see what's the benefit and what are the side effects of such an approach.
Dr. Jonathan Fialkow:
And isn't it fair to say, because I think the population sometimes hears about studies say and studies say, that there's a lot of bad research out there and not well baked research, but a well-run clinical trial, well-designed, well-managed really does give a lot of information towards us. Can you speak a little bit about how clinical trials are designed to make sure that they're more accurate and validated in terms of their information?
Dr. Manmeet Ahluwalia:
Absolutely. I mean, as you know very well yourself being in clinical research, clinical trials take a lot of effort, a lot of time, a lot of thinking. So for any person to go on a clinical trial, a researcher like you or me will ask an important question that needs to be answered under the purview of clinical trial. Then we have a very well-designed protocol which details how such kind of research will be carried through. That then go through a lot of times when you're looking at new drugs, through an FDA purview, whether such drug or intervention makes sense in patients. It goes to a scientific review committee, as well as IRB. So because you not only want to give patients the best modalities, but we also want to safeguard their interest in terms of side effects. So a lot of different people work together for such an approach.
Dr. Jonathan Fialkow:
I so much appreciate that comment. And again, we know that going back decades, medications were recommended and approved, things we did as doctors were not done through clinical trials and could have been wrong. How many times do we say, "Oh, I was told that 20 years ago, and look at what's wrong." But in this day and age, a true clinical trial process, it's for safety, and you mentioned that several times. It's to make sure that the trial participant, but then the basis of the trial, is a safe thing to do for the people who may benefit from the trial. So I do want to emphasize the safety of both the trials and what we learn from the trials.
Dr. Jonathan Fialkow:
So now let's talk a little bit more about the diversity and the minority aspect. I, even going back into cardiology, the old Framingham heart study, which was from the 50s and 60s, which was the progenitor of a lot of our cardiac risk factors, was basically done in Framingham, Massachusetts, and it was a bunch of middle-aged white men of European descent. Didn't really reflect our current populations and some of the assumptions there. So what's our present state regarding minority participation in clinical trials in the country?
Dr. Manmeet Ahluwalia:
So Jonathan, as you highlighted, being a cardiac investigator about the studies and the Farmington heart study. I'm a cancer doctor, so before we delve into the minority participation, I just want to highlight also since we are in the National Minority Health Month, there is cancer disparities. They exist. And that's very critically important to recognize. So we do know that African Americans have a higher death rates than other racial ethnic groups for many, although not all cancer types. We do know that there is higher incidence of Hispanic and Latino or African American women, who have a higher rate of cervical cancer compared to the white women. And we also do know that when minorities get cancer, the incidence of death is higher than the white Caucasian population.
Dr. Manmeet Ahluwalia:
So we definitely have our work cut out in front of us. So there is a cancer disparity that exists, which leads into your next question, which was what is the current state of minority participation in clinical trials? So let me just share some stats with you which will help put this in perspective. In 2019, 11 new drugs were approved by the FDA for cancer. And to accomplish this, close to 3,600 patients participated in clinical trials of which, 73% were white Caucasian, 4% were African American or blacks, 5% were Hispanic. So why is this important? When you look at 2019 census report, almost 18 to 19% of our American population is Hispanic or Latino. Almost 14% of our patient population is African American. So you can see a very wide dichotomy here that the patients who are participating in trials from these two ethnic groups are less than 10% on clinical trials, but the makeup, as you stated, around 35% of our patient population. So there is a big disparity that exists here.
Dr. Jonathan Fialkow:
Take that one level higher. So why is it important? For example, why is it important for our clinical trial database to represent our demographics? I mean, are there differences in how African Americans respond than Hispanics and Caucasians? Are the differences between men and women? Are there differences in older and younger person? If everyone responded the same, then it wouldn't matter, but speak a little bit why it's important to have a more representative demographic in our clinical trials.
Dr. Manmeet Ahluwalia:
Yeah, you make an amazingly eloquent and important point here, Jonathan. That's the difference. So we do know that there are genetic differences, how pathways get activated or deactivated in patients. So I just shared with you in a very glaring, but an important fact. Until recently, the NCI, the National Cancer Institute has been supporting these various cancers where they've been banking tissue looking into... Investigators and physician scientists use those resources to do their studies to find what are the disparities and alterations in different outcomes.
Dr. Manmeet Ahluwalia:
When they were looking at the TCGA, they looked at the minorities, there were not enough even bank samples in the bio-repository of NCI to really look at what would be a difference between an African American pathways compared to white. So we do very good with the Caucasian because 90 plus percent of those patients are the ones which are in clinical trials, so all the bank specimens we have is in them. So when you look for new pathways for drug discovery, pharmaceutical companies rely on these pathways. So we don't even know what other pathways which are activated in African American or Hispanic compared to white Caucasian. So how will you design a trial when you don't even know what's the differences?
Dr. Jonathan Fialkow:
What are we doing about that? I mean, we'll talk a little bit about why that might be the case, of what limits minorities in clinical trials, having recognized what those limitations are. Is there anything that Miami Cancer Institute is doing specifically for engaging and enrolling minority populations? What actions can we take?
Dr. Manmeet Ahluwalia:
So as you know we are very privileged because we... So if you look at Miami-Dade County, almost 71, 72% of our patient population is Hispanic or Latino. At Miami Cancer Institute, almost 80% of patients that we serve are of Hispanic or Latino type. So one of the critical things in that aspect that we have done is we have a very robust bio-repository. We are banking on specimens of our patients who come through. So this is one of the most ethnically diverse population in the continental United States, predominantly of Hispanic ancestry. So we will be have those tissue, and we've worked with our collaborators at Florida International University or other collaborators around the country, we can actually investigate what are the different genetic factors which drive cancer in this patient population.
Dr. Manmeet Ahluwalia:
Also a big emphasis of Miami Cancer Institute as we serve our patients and our community is to have a clinical trial for everyone who walks through the doors. And since 80% of our patient population is minority, a big emphasis of that is to improve minority participation in clinical trials, which will be important for patients that we serve directly, but also will play a very large role at a national level because we will be able to increase the Hispanic patient population participation in clinical trials even nationally.
Dr. Jonathan Fialkow:
So that's well said as well. When we perform clinical trials at Baptist Health and in the Miami Cancer Institute as an example, that data gets aggregated nationally. So it's not just our trial. We are participating in these national and sometimes international trials. So we are fulfilling a demographic for those populations that can be replicated across the country and across the world, which is very inspiring and wonderful. And when you say there's a clinical trial for everyone, you mean we have such broad based clinical research going on that there's no one who wouldn't benefit from having their particular condition helping us learn more. But it's fair to say clinical trial participation is not obligatory for a person, so we don't want people to think they need to do this. It's just helping our academic pursuit with medical conditions and treatments for those conditions.
Dr. Manmeet Ahluwalia:
No, absolutely. I mean, our job is to be able to have more options for our patients. One of the key things there are a lot of... There are a lot of misconceptions about clinical trials. One of them we addressed before. Am I going to be a guinea pig? And we know that clinical trials go through a very large process of being vetted before they reach a patient. But I also tell patients, it is another option for you in your armamentarium as you want to be cared for. And as you know, in challenging diseases, it's always better to have more options than not.
Dr. Jonathan Fialkow:
Sure. So take a different direction, when we're actually performing clinical trials and we don't need to get into depth for that in this conversation, but perhaps we'll go through maybe a follow-up podcast on what clinical trials look like. I think there's a misconception out there as well. But how has telemedicine and other things that COVID brought to us, has that impacted clinical trial participation? I mean, it used to be thought that I have to go to a doctor's office every week for three years, or what have you. Have we been able to make the clinical trial process a little bit more patient centric, so to speak?
Dr. Manmeet Ahluwalia:
Yeah, absolutely. As a physician leader you saw this, you lived on the front lines. So I tell people if there was one silver lining to the pandemic, it was that it helped focus awareness on the role of telemedicine can play not only for clinical trials, but in delivery of healthcare overall. So to answer your question more specifically, absolutely. We probably in one year made more progress than we would have made in a decade. We realize that the clinical research does not need to be the cumbersome process it is in the United States. If you even take a look at the vaccine approvals, we've worked at record pace collaborating.
Dr. Manmeet Ahluwalia:
So one of the things we did when the pandemic hit us was to look back at our clinical trials and make it as easy for patients to participate in it. So some of the visits, we did not involve a blood draw for which the patient needed to come in, or they required a drug that had to be given through a intravenous infusion, we made that visit telemedicine based. So patients did not need to unnecessarily come to the cancer center or the healthcare facility because obviously a lot of cancer patients are immunocompromised and we wanted to protect them through the COVID pandemic. So I think we work together. We made our informed consent process, that's where patients signed whether they will go on a clinical trial, much easier, and we made them electronic as well. So patients didn't need to see you in person. We could talk over the phone, discuss the pros and cons and answer any questions that patients had.
Dr. Jonathan Fialkow:
Again, very exciting and very inspiring. I'm going to switch gears to my last two questions, maybe put you at a disadvantage, Manmeet, but I want to take advantage of your expertise and your experience. You've been in south Florida a little bit now. What are you seeing regarding what are called healthcare disparities that might exist between populations and how can you see us as practitioners, as providers, as those accountable towards the medical care in our communities improve that? First describe, if you could, what are healthcare disparities and maybe a little bit about where we can work towards improving that.
Dr. Manmeet Ahluwalia:
So as I stress, I'll take an example to answer this very broad topic. The cancer disparities exist very broadly in our country, but as I shared with you there, the incidence of cervical cancer for example, is greater in the Hispanic, Latino, American patient population and African American compared to the white women. And to me, that's an opportunity for us to work. To me, no one should have cervical cancer. If we think we are a developed country and we are leading the [inaudible 00:14:51] for whole world, cervical cancer is a preventable cancer. So we have our work cut out for us in terms of addressing such disparities.
Dr. Manmeet Ahluwalia:
But I am very excited because I think south Florida, we are just having an inflection of people coming here. There are stats like every day 1000 to 2000 patients people are moving into Florida. So I think we have an opportunity here to serve a greater patient population, but also there are a lot of healthcare companies which are moving into Florida utilizing the lack of state tax here. So it'll give us an opportunity for people like you and me to work more closely with some of these biotech industries to bring innovations to patients at home faster rather than waiting, because a lot of innovation used to happen in Boston, New York. But I think now we can have innovation happening right at home here in south Florida.
Dr. Jonathan Fialkow:
And I look forward to continuing to drive that along with you. So it's recognizing where those healthcare needs are and what communities are at higher risk, and then identifying those patients and giving their providers and the patients resources like Miami Cancer Institute and clinical trials and whatnot. The other question is, again, broad based and then we'll wrap up, is similarly we want, and it makes sense to have a more diverse physician population with minority representation and whatnot. Have you seen movements in that area in the United States in your time here?
Dr. Manmeet Ahluwalia:
No, absolutely. I think what is happening is with the current administration, they are recognizing that there are, as we stressed before, disparities in care, depending on ethnicities, and it starts with self-identification. Sometimes people feel more comfortable with physicians of their own race or color to talk about issues. So one of the big things that we are working both at the state level and at a national level in oncological societies is how can we increase the minority enrollment in medical school? How can we help train those people in clinical research? People like you and me who are leaders in the field have this duty or responsibility to train the next generation of leaders. And with a particular emphasis on people or physicians of color or race to be the leaders for their field. So I think there is a lot of recognition of this.
Dr. Manmeet Ahluwalia:
Even pharmaceutical companies now, and I'll take one example, this is just an example, the number of pharmaceutical companies doing this, Bristol Myers Squibb, for example, has grants out there where physicians of diversity are going to be given grants to develop their careers in research. So I think there are numerous opportunities for us to give back to the field by training those people. So serve the community at large. And we know African American and Hispanic patients or population in this country is the fastest growing segment. And another thing we did not cover today is the elderly. We need to make sure that even in the trials there's a greater representation of our patient population who are more than 65, 70 years of age. And as we are growing, our definition of elderly keeps changing too. So I think there are numerous fronts where we can work together.
Dr. Jonathan Fialkow:
Very exciting. Again, as always appreciate your insight, your passion, your experience, your knowledge, all the benefits you bring to Baptist Health and the Miami Cancer Institute. Great points being made to our listeners. Again, clinical research trials are really how we learn and how we advance medical care in a safe way to provide safe treatments for patients. Don't be afraid of them. We want broad representation across different genders, ages, races, as Manmeet mentioned, and that we can then apply that information towards those in need. And there's still a ways to go, and certainly in south Florida regarding how we identify those populations at risk for certain conditions and what resources we provide. But certainly I think Dr. Ahluwalia and I are very much engaged and excited about the direction that we're going. So my Manmeet Ahluwalia, I really appreciate your time. Any final comment you'd like to make before we wrap up or anything we missed?
Dr. Manmeet Ahluwalia:
I think I would just say, adding to this excellent summary that you gave, I'm very excited about the future. I think there is an immense opportunity for us to work together, to serve patient populations, those that we directly serve here in south Florida, but all over the globe, because if we can increase the clinical trial participation, we will have better ideas of what these drugs will do, because we treat a lot of these patients in the clinic every day, you and me, people like us. And sometimes there's not enough information because the clinical trial participation did not involve these patients. So we don't know how these drugs will be effective in that patient population or what unique side effects they can have based on their ethnicity or their color. So I think I'm excited. We can all work together and serve the communities.
Dr. Jonathan Fialkow:
Well said. Before we sign off, listeners, we could really use your help and feedback. Please take a moment and give this podcast a five star review on whichever platform you listen to us on. If you have comments or suggestions for future topics, we'd love to hear from you. Email us baptisthealthtalk@baptisthealth.net. That's baptisthealthtalk@baptisthealth.net. Thanks for listening, and until next time, stay safe and mask up.
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