How to Recruit Diverse Patient Populations in Clinical Research

Dr. Fabian Sandoval of the Emerson Clinical Research Institute shares his firsthand experiences and learnings on the topic of patient diversity in clinical research, including the importance of sharing both his successes and failures and important considerations for sites that want to improve the diversity of their patient populations.



Fabian, tell us a little bit about yourself and your experience.

I’m Colombian, but I was raised in northern Virginia. I got a bilingual medical training and moved on to research after my residency. I soon realized I wasn’t keen on the monotony of regular medical practice. I ended up moving into clinical trials and research and have been in the industry ever since.


You’re a key member of the SCRS’s Diversity Awareness Program. Can you tell us about your history with the program?

SCRS started this program because there was a need and continues to be a need to not just raise awareness, but to do something about the lack of diverse populations that participate in clinical trials. When I heard about the idea for SCRS to focus on improving diversity, I knew that I had to be involved.


What are the most important lessons you’ve learned from your participation in SCRS’s Diversity Awareness Program?

When it comes to pharma sponsors of all sizes and CROs, there was a lack of awareness of the issue of diversity. Many people I spoke to did not know about the FDASIA (Safety and Innovation Act) Section 907, which states the importance of diversity in clinical research. I knew it was important to increase awareness of this policy, even among sponsors who I wasn’t working with, because I recognized its importance and potential to change clinical trials.


What can happen when sites are greedy with their information or don’t share amongst themselves the strategies they’ve utilized to improve diversity?

There’s no point in having “gold nuggets” of information if they aren’t shared. The reason we do clinical trials is to improve medicine and one day we or someone we care about may need that drug. So if we’re successful at a task, we need to share what we’ve learned so other people can take something away from our successes and our failures. Passing on those gold nuggets is critical to improving our work overall.


Can you tell us a little bit about the FDA Snapshots website?

This website tells you what drug was recently approved and breaks down the demographics of the participants. What we can take away from this information is that if the medication was not tested on a diverse population, it may not work on every single person. And if it doesn’t work, we haven’t done our due diligence or been good scientists. This is useful because it gives us an idea of which populations we need to do a better job at targeting next time around.


What can other sites do to improve the diversity of the populations they’re enrolling?

Look out the window of your office, look at people in the stores, and go and understand the community that’s around you. If you aren’t seeing a reflection of that population in your patients, then there’s a disconnect that’s fixed by getting to know your neighbors and community. Meeting church leaders and business owners is a great place to start. It’s more challenging during COVID, but as businesses open up, you can go and safely introduce yourself.


How can sites adapt during COVID-19 to ensure they’re still making their presence known in their communities?

Still having outdoor signage to let people know you’re there is important. Because we can’t go out in the community much, we’re utilizing social media like Facebook Live to talk and engage with people in the community. We don’t want to bore them, so we connect with them by providing them with useful information on top of sharing what research we’re working on. This allows us to maintain a presence so that community members know we’re still here and ready to help.


What does it really mean to have culturally competent staff at your site?

Cultural competency and being aware of the nuances of different cultures is important so you don’t offend or lose anyone. I was vision screening a Vietnamese patient who didn’t know how to pronounce certain letters of the US alphabet used in the vision chart, because those letters weren’t used in her language, and shame on me for not knowing that.

We need to understand what works or doesn’t work for each individual. This will help ensure they’re comfortable to engage in the study.


What considerations should sites keep in mind when developing an effective communications or marketing strategy to reach the patients in their communities?

It’s important to know that not everyone has insurance or legal status in some communities. If you want these patients to participate, tell them they don’t need to worry about insurance and that you’ll never share their personal information with ICE or the police. It’s critical to let them know they’re in a safe environment. Transparency on the site’s end is key, because it can help patients let their guard down and even encourage their family or other members of their communities to participate.


Tell us about your site and the successful (or unsuccessful) strategies you’ve implemented to make sure your patients are representative of your community.

My first study was a pediatric study. I took all of my advertising money and put it into a bus campaign because I assumed all kids rode the bus. The ads ran for four months and I got three calls, none of which were from actual patients. I realized I needed to do a better job of finding the right patients. So instead, I went to daycares, talked to the parents, and started to make the right connections.

If we don’t really understand our patient populations and where we can find them, it’s not going to work. It’s critical that we work on that understanding because we don’t want to waste time and efforts; we want to be good stewards of the sponsors we’re working with and be considerate of spending the marketing dollars appropriately.


Tell everybody a little bit about your advocacy for health literacy and your TV show.

I’ve always wanted to promote health literacy. The terminology and acronyms that we don’t think twice about can be confusing for people outside the industry – and not just that, but also for people from outside the country or culture.

To accomplish my goal of educating the community, we started the Emerson Diversity Health Foundation. It’s designed to provide community outreach and education awareness. We partnered with sponsors to create a TV show, “Tu Salud Tu Familia” (Your Health Your Family), that’s been on for a year and a half and is now Emmy-nominated. It airs every Saturday morning and we are joined by elected officials, thought leaders from industry organizations, and patients who help us explore a health topic in simple terms. We reach 50,000 people live, and our social media presence has helped us expand our reach all across the country even though we’re a local show.

Again, the success of this doesn’t just benefit me, it benefits everyone. An educated patient knows the value of healthcare and research and knows where to get access to these important resources.

Watch Tu Salud Tu Familia on YouTube (English subtitles are available) or follow the show on Facebook, Instagram, and Twitter.


Fabian Sandoval (00:03):

Go and understand the community that’s around you. And if you have a diverse population and you’re not seeing those patients, there is a gigantic disconnect, which easily is fixed by simply going to know your neighbors, know the community that’s around you and do something with it.

Announcer (00:24):

Welcome back to the Trial Better Podcast. Today, Fabian Sandoval, CEO and Research Director at the Emerson Clinical Research Institute, sits down with our host, Jason Eger. We’ll hear from Fabian about the importance of community engagement for clinical research sites, and he’ll share his perspective on how sites can contribute to increased patient diversity in clinical trials. Join us now as Trial Better shares this very important discussion.

Jason Eger (00:52):

Hi everybody, and welcome to the Trial Better Podcast. I’m your host, Jason Eger, ERT’s Director of Operational Readiness. Today, we’re going to expand on our last discussion on diversity in patient populations by providing some real world context. We have a really exciting guest today on our episode. It’s Fabian Sandoval, CEO and Research Director at the Emerson Clinical Research Institute. Fabian, thanks for joining us on Trial Better.

Fabian Sandoval (01:15):

Hola Jason, thanks for having me on the show today. It’s going to be a very interesting and fun discussion. I am very pleased that you guys have allowed me to be a part of it.

Jason Eger (01:26):

No doubt. Welcome. Fabian, why don’t you tell the audience a little bit about yourself and your experience?

Fabian Sandoval (01:33):

Sure. Let’s see. Who am I and where do I come from? [inaudible 00:01:36]. I’m Colombian. I was raised here in Northern Virginia. Left, went off to graduate school and decided to go off to a medical school because it was the cool thing to do [inaudible 00:01:53]. Went and got a bilingual medical training. I was in Mexico for four years. Came back, did my residencies and moved on to more research, then started to dabble in the importance of clinical trials.

Fabian Sandoval (02:06):

I really wasn’t keen in the regular medical practice. I knew that after speaking to lots of my friends and colleagues that it could become a little routine, and I knew that clinical trials was not a routine thing. And since I was looking at NIH when I was a little kid, I said, “Let’s try research. I think this is what I really want to do.” And here we are lots of years later.

Jason Eger (02:31):

That’s right. And so Fabian, you’re a key member in the Society of Clinical Research Site’s Diversity Awareness Program, SCRS, for those that don’t know. Can you tell us a little bit about your history with the program and what it means to you?

Fabian Sandoval (02:46):

Sure, Jason. SCRS started as diversity program because there was this need and there continues to be a need to provide not just awareness, but to actually do something about the lack of diverse populations that participate in clinical trials. And being a part of SCRS before the diversity program started, I realized that this is something that I had to be a part of when the idea from SCRS’s leadership came to be to say, “Let’s do diversity clinical trials.” I said, “Absolutely, and I need to be on this panel.”

Jason Eger (03:29):

And so with that, I would love for you to tell our audience a little bit more about … You participated in SCRS’s diversity program. What are the most important lessons that you’ve learned as you’ve gone through this?

Fabian Sandoval (03:42):

I think the lessons that I see, if we think about pharma, big pharma and pharma sponsors overall and CROs is that there was a lack of awareness from these organizations to the importance of clinical trials when we first started to do this at least six years ago [inaudible 00:04:03] but this topic’s been going on for years and years before I even came to think about this, right?

Fabian Sandoval (04:11):

But the fact that companies did not know what FDASIA 907 was, right, so the Food and Drug Administration, right, so the FDA’s Safety and Innovation Act 907, because that’s the section, 907, says the importance of having diversity in clinical trials, it’s important to have this in place. And when I would talk to them and say, “Hey, do you guys know what FDASIA 907 is, and you guys are aware of the importance of having diverse [inaudible 00:04:40]?”, the answer 90% of the time was, “No, we didn’t. Tell me about that.”

Fabian Sandoval (04:45):

I ended up having to give them a little flyer. We put a little flyer together to say, “Here, this is why it’s important. We may not be working together, but you need to be aware of this because it’s going to make a difference in the amount of work that we’re doing together in the development of new medications and in the approval process.”

Jason Eger (05:07):

One of the reasons that we’re glad that you joined us is because you’ve been so successful in expanding that diversity awareness program. Tell us a little bit about … We’ve had discussion offline for folks, as far as what happens when sites are greedy with their information or don’t share amongst each other? Are there additional benefits that people can gain by sharing this information?

Fabian Sandoval (05:33):

Absolutely, Jason. There’s no point in having a golden nugget of information if it’s not shared. The reason why we do what we do in clinical trials is to improve medicine. It’s to improve trials activity, because one day we may need that medication ourselves or one of our family members, right? If we are successful in a particular task, we have to share it because other people need to learn from our successes and our failures. That is why I believe it’s so important for all of us to share in those golden nuggets of information and pass them on so that we all can improve our work.

Jason Eger (06:14):

And one of the things that you taught me, Fabian, was about the FDA Snapshots website. Can you explain to people what that is, because I thought [crosstalk 00:06:27].

Fabian Sandoval (06:29):

The FDA Snapshots website, and it’s easy to find, is going to tell you what drug was recently approved and not just that, it’s going to break down for you how many males, females, race, and then based on that, you will see where your organization, where the drug that was just approved, where does it fall? And it’s not a good thing. It’s not a bad thing. It’s just reality. But what’s important about this reality is that it shows you that if the medication was not tested on a true diverse population, that medication may not work on every single person. That is very dangerous, because if it doesn’t work, we haven’t done our due diligence. We haven’t been good scientists and made sure that we are making a true difference in the development of a drug. The FDA Snapshots website will show you how many people, the ages, the race and it will say to you, “We need to do a better job at increasing these types of populations in our next go around.”

Jason Eger (07:40):

Fabian, tell us, and help out some other sites … You said no one wants to be greedy, but what can other sites do to really improve the diversity of the patient populations that they’re enrolling?

Fabian Sandoval (07:55):

Jason, it’s really simple. Honestly, just look out your window of your office. Look at the stores. Go and understand the community that’s around you. And if you have a diverse population and you’re not seeing those patients, there is a gigantic disconnect, which easily is fixed by simply going to know your neighbors, know the community that’s around you and do something with it. That is probably the biggest disconnect and the areas that sites need to know and recognize and easily fix.

Fabian Sandoval (08:33):

How are we going to fix this? We’re going to fix this by meeting with church leaders. Unfortunately right now because of COVID, that becomes a little bit more challenging, but as the businesses open back up, go and make your introductions. Let people know that you’re there, and then have culturally competent staff available.

Jason Eger (08:53):

You mentioned it because of COVID. Are you doing anything differently now that … I mean, obviously you can’t have the health fairs that you mentioned. What are you doing now to really engage the community then?

Fabian Sandoval (09:10):

We still have signs outside the building letting people know what we’re doing, but since we can’t go out, we have a pretty robust social media following. We’re going to start doing Facebook Live, and in the Facebook Live shows, it’s not going to be long, right? And they’ll air and they’ll stay there for a while. But it’s talk about, don’t just bore people with, “Please, if you have a UTI, come to our office because we have a UTI treatment. Goodbye.”

Fabian Sandoval (09:42):

No, it has to be more. Give me a little bit of a nugget of information that says, “By the way, this is the new conditions of COVID. Did you know that now children have these rashes on their soles of their feet? Those can also be associated with COVID, so please keep those in mind. And while we have you here, let’s talk about one of the researches that we’re doing that’s got noting to do with COVID, but if you have XYZ, we are here to help. And now let me tell you the benefits of this study and some of the side effects that you might see and how you can participate.”

Fabian Sandoval (10:14):

And that’s it. 15 minutes. Our span of concentration and focus on stuff is not very long, but if you can do five or 15 minutes on a Facebook Live activity, it’s great. Now, I know that there are differences in Facebook Live versus just doing a regular shoot. If you just want to record something in five minutes, that works, but with Facebook Live, you have to stay on a little bit longer so that you can get some of that engagement with people. But it’s what we’re going to have to start to do so that people know that we’re still here and we’re still ready to help.

Jason Eger (10:49):

And I think another point that you made that was so important was really making sure that you have as a site culturally competent staff. Can you tell everybody what that really means?

Fabian Sandoval (10:58):

Right. Cultural competency is so important. And what I refer to that is there is no course or class on being culturally competent. I would also refer to it as being kind of culturally sensitive, right? And each culture has its own nuances that are important. And if you’re not careful, you can insult someone and you can lose someone from being in this study, right?

Fabian Sandoval (11:26):

I love my analogy of my ophthalmology study. I’ve been giving this same analogy a few years now. I had a patient and I screened her and I did a Snellen chart to see what her vision was like, and she was [inaudible 00:11:39]. And so her son stopped me and said, “Fabian, we’re Vietnamese. In my Vietnamese culture, there is no F and there isn’t a Z in our vocabulary, so my mom doesn’t know how to pronounce those.” Shame on me for not knowing that, right? Shame.

Fabian Sandoval (11:58):

Know your cultures around you, so make sure that doesn’t happen again. Understand what works, what doesn’t work for each individual. And then if you can speak to them in their language, even better. If you’re sick and you can’t speak English properly, or you understand but you’re okay … My parents speak English pretty well. But if they had someone to talk to them in Spanish and you’re sick, way better.

Fabian Sandoval (12:23):

And I say same thing to the patients to my staff. If you’re calling someone and you’re calling someone in English, please make sure you use eloquent, appropriate vocabulary, because if you don’t, they’re sick, they’re not going to understand you, they’re just going to hang up and you’re going to lose that patient. It goes both ways. We need to be able to speak to people in a language that they understand and that they’re comfortable engaging into a study.

Jason Eger (12:49):

I think really important points that many probably take for granted until you shared it with us, so thank you. Before you get them in the office in the site, what considerations should other sites make in developing an effective communication or marketing strategy to get these patients in their communities? How do they best reach them?

Fabian Sandoval (13:12):

I think as they put this together, it’s important to know that if you are going to work with the Hispanic community, the reality is not everyone has insurance and not everyone has legal status. If you want to help out and you want to bring these patients on, you need to tell them, “Hi, first thing I want you to do is not to worry about your legal status or your insurance status, because in this study, we don’t need your insurance, right? We’re never going to share your personal information with ICE or the police” … Say it that way, right … “Because we are a safe environment to be in.” And you let them know that they’re safe and that they’re not in any of these issues, they’re going to come to you.

Fabian Sandoval (14:01):

There was a study that just got approved, and it’s an NIH-sponsored study, and it’s done through NIH Science. If NIH does not clearly let people know, “We may be the government, but we’re here to help,” it’s going to be a challenge if they’re trying to get some of these other patients involved, right? NIH is right down the street from me, so I worry about that. Are they getting enough diverse patients or as many as they could be getting? I’m sure they’re getting some, but they could be getting a lot more if they were a little bit more transparent. Sites need to be aware of that and be able to speak to them about it. And I promise you patients are going to let their guard down. They’re going to bring their whole families in and it’s going to be a beautiful experience.

Jason Eger (14:53):

Fabian, that’s great. I mean, in the spirit and the mantra that we’re sharing today, really, and just sharing with everyone, will you tell us a little bit about some of the lessons learned you’ve had over the years? What are some successful strategies or even unsuccessful strategies that you implemented to make sure that you’re representative of the patients in your community?

Fabian Sandoval (15:15):

The first study I did when I first opened the doors was a pediatric constipation study, [inaudible 00:15:20] buses. Everyone rides the bus. I’m going to take all the money that was just given from my sponsor and I’m going to put it on this bus campaign. Jason, I received three calls and these bus ads ran for four months. The two people that call me were two women that were constipated and I referred them to a primary care physician that could help them. And the third one was a guy looking for work, doing maintenance work. That’s it. That taught me that I need to do a better job to look to where these types of patients were.

Fabian Sandoval (15:56):

Then I went to daycares and I talked to parents there, and that’s where it’s hard to find these patients. It’s a simple example. I mean, there’s more complicated examples that we could look at, right? That does not work. When we’re doing ophthalmology work, don’t do print ads, right? We need to do something different. Do the radio ads. Do some of that stuff. That’s what’s going to work. I think if we don’t really understand our population, it’s not going to work.

Fabian Sandoval (16:24):

Hispanics love to use their smartphone. We all have smartphones. Hispanics have smartphones. They don’t have laptops. They don’t have a Mac computer, but they’ll have a smartphone. That’s where we’re going to find them. We don’t use Twitter very much. It doesn’t work for us. It’s too newsy. Instagram is for the younger population of the Hispanic communities. But those Hispanic young patients have parents. They will be able to talk to their parents about it. We all have to take care of our parents and that works, so you have to know your patient population so that you don’t waste your time and efforts.

Fabian Sandoval (17:05):

And we need to be, Jason, good stewards of our sponsor’s funds. I hate trying to gouge a sponsor for more money, because I think if I’m charging them more for this study, if I’m talking to them more, that means when I need the medication, my insurance copay’s going to be way higher if I ever need this pill. Let’s try to be good humans and just ask for the funds that are needed, and spend the marketing appropriately, which we try to do.

Jason Eger (17:36):

Fabian, I mean, you’re so conscious. One of the things that I don’t know that people know about you is that you’re an advocate for health literacy. Why don’t you tell everybody about the television show that you’ve got?

Fabian Sandoval (17:47):

Sure, Jason. That was a great thing that we were able to do. I’ve always wanted to promote health literacy. I’d say terminology that is simple to you and me who are in the area of healthcare, we understand these terms. We know what these acronyms mean, but someone who is not health literate is clueless, is clueless as something as simple as acronyms for a UTI, right? Urinary tract infection, right? We all know that, but other people may not. There’s different words, even different cultures within different countries. In Central and South America, there’s three or four different ways of calling something a UTI.

Fabian Sandoval (18:28):

My goal was to make sure I educate our communities. I begged and pleaded to say, “How are we going to do this?” We started a foundation. The Emerson Diversity Health Foundation is designed to provide community outreach and education awareness. I was able to grab some sponsors along. Thanks to Genentech, that was our first visionary company that said, “Yes, we see the value in this,” and then to Medidata to also see some of the value that we’re doing, we were able to start our TV show. It’s been on air for a year and a half and I’m proud to say that we’re an Emmy-nominated TV show.

Fabian Sandoval (19:04):

And our TV show airs every Saturday morning and we pick a health topic and we tear it apart. We have community discussions. We talk about clinical trials. We have elected leaders. We have FDA, CDC, NIH thought leaders on these topics. And we talk about it and we interview patients on their conditions and we just use simple terms to tell people what the condition is and if there’s access to a clinical trial, we will help them. I don’t care if it’s [inaudible 00:19:36] or not. Our show is local, 50,000 people that watch us every Saturday morning, just live. Plus all our social media that we do, that it has expanded our reach.

Fabian Sandoval (19:47):

People ask us from across the country for advice, and we tell them where they can go get some research opportunities. My goal, Jason, is not to keep this … Once again, like I said, it’s not for me. This is for everybody. Everyone needs to benefit from this. The sponsors, the patients all need to be aware of what we’re doing in our TV show so that we can educate, because an educated patient really knows what the value is and knows where to get healthcare access. And I’m so proud of the show. It’s on a shoestring budget literally, and we’re making something happen.

Jason Eger (20:23):

First of all, congratulations to you on the Emmy nomination.

Fabian Sandoval (20:26):

It’s great.

Jason Eger (20:26):

Yeah, I mean, very impressive. And secondly, what’s the name of your show so we can have the audience tune in?

Fabian Sandoval (20:32):

Yeah, so the TV show, in Spanish, it’s called [foreign language 00:20:39] Your Health, Your Family, and Facebook, Instagram, Twitter, of course, we have to do all those things. And if you go to YouTube, you can watch them. If you can pull them from our website, you can watch them. And there’s actually a little widget wheel at the bottom and you could change the language so you actually have the language subtitled in English. The show’s in Spanish, but you can actually change the subtitles to English.

Fabian Sandoval (21:01):

Mindful that when you do change it over, it does change some of the terminology, like I said in one show, “Now Dr. Audrey in her segment [inaudible 00:21:09] health of the community,” and when it read the translation, it’s “ow Dr. Audrey, who’s sitting at the bar.” The AI of this is still not perfect, but she wasn’t at the bar. She was actually in studio, but everything else comes out pretty well. I encourage you guys to watch it. It’s very good. And sponsors can just pull information from it. And you just call us and ask us if you can [inaudible 00:21:33] take some of the information and share it with other people. That’s the whole point of the show. [Foreign language 00:21:39], Your Health, Your Family, is here for everybody.

Jason Eger (21:44):

Fabian, thank you so much for joining us on Trial Better, and thank you for what you’re doing. In today’s world, I think sharing is what we’re all teaching all of our kids. Thank you for being here and the work that you’re doing with the Diversity Awareness Program. Thanks for joining us today, Fabian.

Fabian Sandoval (22:00):

Hey Jason, thank you so much.

Jason Eger (22:03):

As always, thanks to our audience for tuning in to the trial better podcast. Please remember to comment, rate or review Trial Better on Apple Podcast or your favorite podcast channel. You could also reach out to us at [email protected] with any questions or suggestions that you might have. We’ll see you next time on the Trial Better Podcast.

Announcer (22:22):

That’s a wrap on this episode of Trial Better. Thanks to Fabian Sandoval for stopping by to share his invaluable, real-world perspective on the steps sites can take to contribute to diversifying the patient populations of clinical trials. Please remember to comment, rate or review Trial Better on Apple Podcast or your favorite podcast channel. You can also reach us at [email protected]. Thanks for listening.


Fabian Sandoval, MD

Dr. Fabian Sandoval, CEO & Research Director, has over 25 years of bench to bedside research experience. His diversified research career has been in academia, healthcare systems and the public sector. He received his Bachelors of Science in molecular and cellular biology from Marymount University, and his Doctorate of Medicine from the Autonomous University of Guadalajara, School of Medicine.

Before opening the doors to Emerson Clinical Research Institute (ECRI), Dr. Sandoval’s research activities have included bench research at the National Institutes of Neurological Disorders and Stroke (NINDS) where he focused his work on Early Onset Alzheimer’s Disease, and Cretzfelt-Jakob Disease. At the NIHs’ Clinical Center conducting research in the outpatient Oncology unit, followed by his successful support of an NIH RO1 grant on preventing epilepsy in post-traumatic brain injury patients in adults and children, simultaneously run at the Washington Hospital Center, and Children’s National Medical Center.


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