Increasing Patient Diversity in Clinical Trials

 

Host Jason Eger, ERT’s Director of Operational Readiness, is joined by Dr. Diana Foster, Vice President of Strategy and Special Projects at the Society for Clinical Research Sites, to discuss how clinical research sites can help the industry improve patient diversity in clinical research.

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episode notes:

 

Diana, tell us a little about yourself and your experience.

I began my career in clinical research over three decades ago. In that time, I’ve had a variety of different experiences, but much of it has focused on working closely and directly with clinical research sites. I owned a clinical research site early in her career and went on to have involvement in a site management organization and a global patient recruitment firm. I’ve also worked on the CRO side of clinical research. Later in my career, I was approached by the founder of the Society of Clinical Research Sites (SCRS), Christine Pierre. It was a natural progression to become a part of SCRS’s strategy, development, and special projects. Recently, I’ve spent more time focused on our Diversity Awareness Program, where my firsthand understanding of the site element of clinical research and its importance to the delivery of quality clinical trials is extremely valuable.

What is SCRS and its mission?

The SCRS was founded by Christine Pierre, who passed away two years ago. However, SCRS’s drive and motivation is based on Christine’s vision of what’s missing in the clinical research space. She believed that sites should have a seat at the table in the clinical research community. In the past, sites were seen as somewhat of a silent partner. The SCRS was developed to raise the voice of sites, and we’ve done that – we now represent over 10,000 sites in more than 50 countries across the world.

Can you tell us a little bit about SCRS’s Diversity Awareness Program?

The opportunity to be involved in diversity came to SCRS 2016 when we were invited to participate in an FDA effort to focus on diversity in clinical trials. Following this, we were approached by Merck about developing a special emphasis on how clinical research sites fit into the conversation about improving diversity within studies, and what tools they need to deliver on recruiting diverse populations. Since then, the SCRS has established a working group of 30 different organizations that generate an annual plan of work to support sites in the recruitment of diverse patient populations.

Why should sponsors and sites be investing in and focusing on diversity in clinical research?

It’s imperative to have a patient population that is representative across a disease entity, so we can accurately measure the impact of a compound for all patients, not just a small subgroup of them. Diversity has been a long-standing challenge in clinical research, but over the last three to five years we have seen more of a focus and ability to create awareness of the importance of diverse representation. This emphasis isn’t just coming from organizations like the SCRS but also from the sponsors and providers. The industry is realizing that diversity is no longer an option; it’s essential.

What have you learned since being a part of SCRS’s Diversity Awareness Program that surprised you?

The most surprising thing has been some of the things we’ve learned and validated are very simple, but they haven’t been implemented on a wide scale. For example, sites tend to be somewhat insulated and don’t think about the broader communities around them. Expanding their reach within their own neighborhoods can have a positive impact on how diverse their patient populations are. To solve problems like these, the SCRS has created a scientifically based assessment tool. This tool can help sites measure their awareness and understanding of diverse population recruitment, so they can address areas where they aren’t as strong. Now, the SCRS is looking ahead to see how we can support sites and provide them with resources to make positive changes based on this data.

Where can people find more information about this tool and SCRS in general?

Visit myscrs.org for more information.

What’s next in advancing efforts to diversify patient populations in clinical studies?

We’re facing new challenges in clinical research with COVID-19 and the virtualization of trials. We’ll be required to lean more on technology and new ways to conduct trials. This will play very directly into the emphasis of diversity in the new trials that will be conducted, particularly for COVID-19 but also in general.

Any final thoughts?

The SCRS has begun to assess different populations in different regions and countries to gather a global perspective on this topic. There’s a lot of exciting and important work ahead, and we welcome and need more support and help within the working group.


Transcript:

Diana (00:04):

This diversity has long been a challenging area in clinical research. This is nothing new, just in terms of the importance. But the ability to better focus and create awareness of the importance of diverse representative populations. The understanding that’s no longer an option to recruit diverse populations, it is essential.

Announcer (00:27):

Welcome back to the Trial Better Podcast. In this episode, we’ll focus on diversity in clinical trials and how the lack of diversity can jeopardize the quality of trial data. To help us explore this topic, our host Jason Eger, is joined by Diana Foster, Vice President of Strategy and Special Projects at SCRS, the Society of Clinical Research Sites.

Announcer (00:49):

Today, they’ll discuss the SCRS Diversity Awareness Program and why sponsors should focus more on diversity in clinical research. So let’s not waste time and jump into this edition of the Trial Better Podcast.

Jason (01:03):

Hi everybody, and welcome to another edition of the Trial Better Podcast. I’m your host, Jason Eger, ERT’s Director of Operational Readiness. Today, we’re really excited to welcome Diana Foster. She’s the Vice President of Strategy and Special Projects at the Society of Clinical Research Sites. I’m looking forward to a great discussion with Diana on a longstanding issue in clinical research, diversity in patient populations. Diana, thanks for joining us, and welcome to Trial Better.

Diana (01:26):

Thank you, Jason. It’s my pleasure to be here with you today.

Jason (01:32):

It’s great to have you here. Why don’t you tell the audience a little bit about yourself and your experience?

Diana (01:37):

I’d be happy to, thank you. My career in clinical research dates back now over three decades. A variety of different experiences during that time. And much of that experience has actually been focused on working very closely and very directly with the clinical research sites. So in my early career, I actually did own a clinical research site that’s still actually active today that’s performed over a thousand clinical trials to date in the field of Rheumatology and Immunology.

Diana (02:11):

Through that exposure, I went on to an entrepreneur perspective, having involvement with a site management organization, a global patient recruitment firm. And I’ve also worked to a certain degree on the CRO side. So when Christine Pierre, the founder of SCRS approached me when she started SCRS, it was really a very natural progression for me to become involved in a role where I have been working with the strategy and development, special projects and our corporate relationships within SCRS. And several years ago, we’ll talk more in a moment about the involvement in the focus on diversity that we have found ourselves working on. More recently I spent more of my time within SCRS in that capacity.

Jason (03:01):

Well, it sounds like you’re the perfect fit for SCRS. Why don’t want to tell for the folks that don’t know what exactly is SCRS? What do you do? And what’s the mission?

Diana (03:11):

SCRS was founded again, by as I mentioned earlier, our founder Christine Pierre. Our drive, our motivation our inspiration comes from Christine’s vision of why and SCRS should be formed and what was important and missing and the clinical research perspective as it was related to the site. She strongly believed that the site should have a seat at the table, and there should be an opportunity for sites to be dedicated, to having representation of the interests of the clinical research site community specifically. Much work and much focus has been done, had been done at a higher level within industry. And to a certain degree, the site was almost seen as somewhat of a silent partner. I would say that since the formation of SCRS with the mission to elevate the voice of the clinical research side in industry, that has changed dramatically. And today SCRS represents over 10,000 sites and well over now almost 50 countries across the world.

Jason (04:24):

You’re right what an important voice in the trial sites are. And now you’re speaking even louder for the focus of our podcast, that the patients. So as we talk about patient diversity in clinical research, it’s been a challenge as we all know over the years. You’re really a part of SCRS Diversity Awareness Program. Can you tell us a little bit about that program and how it was founded and why it was founded?

Diana (04:51):

I can. Interestingly enough, I think actually the opportunity to be involved in diversity somewhat came to us in the form of… Christine and I actually were both invited to be part of back in 2016 when Rob Califf, who was the FDA commissioner at the time of FDA, he had announced that 2016 would become the year of an emphasis on diversity in clinical trials. And Christine and I were invited to attend a very prestigious group in Washington DC, a discussion around the idea of the importance of elevating diversity in clinical trials at every level across the industry.

Diana (05:37):

There were some 45 different groups represented that full day that we met together for this brainstorming session. And based on the input that we were able to include in the feedback, we were able to give on behalf of the clinical research side in that meeting, we were directly approached after the meeting by Merck. Merck came forward and said… Merck had actually put this meeting together in an effort to begin to focus on the goals that Commissioner Califf had set forward for industry and ask us if we would be interested for the first time in really developing a special emphasis on how does the clinical research site fit into the perspective of diversity in clinical trials. Beyond the patient perspective, what was important to help support and develop a better understanding of what’s the sites need to deliver on recruiting diverse populations.

Diana (06:39):

So essentially that is how we started the group brought together our own working group of some 30 different organizations, advocacy groups, industry, patient recruitment firms, suppliers, special interest groups such as the Association of Black Cardiologists, the research site you’re going to hear from, one of my colleagues, Fabian Sandoval, who has a special expertise in interesting interest in recruiting diverse populations, particularly within the Hispanic community. So we brought together all of these different entities and voices and then formed a plan for a group, a working group that has continued to this day to generate annually a plan of work and activity that we’ll discuss more in a few minutes in regards to this special focus on how we can support the clinical research site in diverse population recruitment.

Jason (07:45):

Thank goodness it sounds like such an important pivotal moment that we got this program up and running. Why should sponsors and sites… Why should they be investing in this? Why should they be focusing on diversity in the clinical research?

Diana (07:59):

They’re so many reasons for that including the science, the importance of patient participation is representative across a disease entity and how it affects different populations, for example. So it’s very important that drug new compounds are tested in the appropriate population. A compound may affect someone with Asian background, Hispanic culture African-American differently, genetically and scientifically as it relates to their diverse, cultural and ethnic backgrounds. So, that’s number one importance. So, that representation has been smaller than it should be over the years. Diversity is long been a challenging area in clinical research. This is nothing new, just in terms of the importance of the ability to better focus and create awareness of the importance of diverse representative populations is something that’s newer in the last three to five years, being more an emphasis, not only organizations like us SCRS representing sites, but certainly from the sponsor and provider perspective, the understanding that it’s no longer an option to the diverse populations. It is essential.

Jason (09:28):

Thank goodness it is essential. And you’ve seen the growth of the program over time. Is there anything that has really surprised you since you discovered the program or anything, any experiences that have really popped up that stand out to you since the founding of the Diversity Awareness Program?

Diana (09:44):

I think it’s surprising to a certain degree. Let me just speak a bit about some of our work in regard to that question. I think it’s a bit surprising that it seems so obvious. Some of the things that we’ve learned that’s been validated, that’s been validated by the research we’ve done, that as simple as a site for example, not having a broad knowledge or an understanding of it might for example, be situated in a major city in a very high profile area with not so much a diverse population in their exact location, yet a few miles for them could be a community with many diverse… A very diverse population that it’s not even occurred to them, that they have that reach within their community to give the perspective to other populations that might be interested in clinical trials.

Diana (10:42):

It seems sort of basic doesn’t it that we would be thinking about our surrounding area in our community, but to a certain degree we’ve learned through our research that sites are somewhat insulated in that regard and need to be thinking about the broader community. So that brings to bear where we’ve been going over the last three years of the existence of the Diversity Awareness Program within SCRS. We’ve spent quite a lot of resource and development on the creation of an instrument, a tool to help look at and measure the sites basic perspective, awareness, and understanding of diverse population recruitment.

Diana (11:27):

We were now getting ready to publish our fourth paper on this topic. And we have created through our funding sponsorship and our aggressive working group, a body of work that’s been published now three papers, the fourth paper which will establish what is called reliability and validity of this tool to be used by industry across the board to help assess where site is coming into this perspective on diversity and awareness and recruitment and how we can help them now as next steps to validate what they… For a lack of a better description I guess what they know and what they don’t know, and then what they may need to know, and to follow that with resources.

Diana (12:19):

So we have managed to develop a very scientifically based instrument through the funding our sponsors within our organization, our sponsorship within the SCRS, of course our funds within our organization itself. But I’d like to at least call out that we have been sponsored by Merck, Janssen, the organization Pharma, the Metadata organization, Genentech, GSK, Acurian and Virtrial are the sponsoring group that have supported this work now over four years. So it’s been quite an accomplishment for a group of mostly volunteers. So we’re excited to launch that diversity site assessment tool here in the near future within the next few months to come. It will be launched actually at our annual summit meeting. That is our largest annual meeting that will be held October, where we have somewhere near 1500 sites and others interested in sites sustainability and development attending our annual US-based meeting. We do have meetings across the globe as well annually.

Jason (13:38):

Great. Diana, just as we’re talking about it, how would people find out more information about the resources you’re offering about the tool, about possibly sponsoring you all? Is there a website they could go to?

Diana (13:49):

Yes, they can certainly go to the SCRS website, the SCRS, myscrs.org, our website, which is quite comprehensive and quite expansive in terms of helping you to understand the variety of resources and programs and opportunities throughout SCRS. There is an area within the site where our papers on diversity are available, the instrument as it stands today, and a number of different historical pieces of information on the work to date for the organization as a whole, as well as diversity.

Jason (14:33):

Great. So for folks that aren’t already involved, maybe they will get involved as it’s such an important issue as we expand clinical trials. Diana, what do you think is next in advancing the efforts to really diversify the patient population in clinical studies?

Diana (14:49):

I think there’s a number of things that we’re certainly recognizing, and of course with our environment today and the new challenges that we’re facing with, as we’re all quite aware that the change in our world that change in clinical research with our situation with COVID, that we certainly know that not only just as a whole will we be required to lean more on technology and virtual opportunities and new ways to conduct our trials, but certainly that plays into very directly what another emphasis on, again even further emphasis on the importance of diversity in the trials and trials that will be conducted in COVID particularly, and the large volume of patients and diverse patients that will be required to screen and participate and be aware of these trials.

Jason (15:46):

So Diana, you talked about Dr. Sandoval and the importance of the work that he’s doing at his site. Can you tell us about the work that you’ve done with Dr. Sandoval?

Diana (15:55):

Yeah, certainly. Dr. Sandoval has been an active member of our working groups since we assembled the Diversity Awareness Program. It’s interesting to have actually almost what one would consider an exemplary model and perspective on how one would in many cases best recruit diverse populations. This has been an emphasis of his within the Hispanic community as we mentioned earlier for some time. So he brings to us that expertise that we can share with the sites through different forums and venues that we’ve had an opportunity to participate and can all help model and educate those that we’re trying to heighten their awareness on what they can do within their given diverse community.

Diana (16:45):

So we have worked with him closely throughout our different opportunities throughout the world, whether it’s presentations, programs such as today in our podcast, turning to him for expertise and advising us in the working group. So, very much looking forward to connecting the dots with our podcasts, when now Dr. Sandoval will be able to explain in reality, in practice how some of the strategy in recruiting diverse populations can come into play in a way that is doable and applicable directly to the sites and to really industry as a whole.

Jason (17:32):

And speaking of education, it’s hard to believe that our time’s almost up here Diana, but it’s clear that you’ve educated us on the importance of the work that you all are doing. Do you have any final thoughts for the audience on the Diversity Awareness Program or SCRS in general?

Diana (17:48):

My final thoughts, my closing thoughts would be just to reach out to those listening who may have a special interest in this particular area. We’re looking for ongoing sponsorship of our work, and we have a very robust working plan for 2020 to continue into 2021. We need more involvement. We would like to continue to have more representation within our working group to supplement the industry regulatory FDA sites that we currently… Advocacy groups that we currently have within the group. And always looking to expand that effort. If you have such an interest go in to our website, as we also talked about a great deal of information on the program, the direct lead in contact now for the Diversity Awareness Program is Dan Mylar and his contact information is posted there. And he would be a direct line to talking about opportunities and working with us more on this program. So we hope that this will generate that type of interest.

Jason (18:57):

Diana, thank you so much for joining us on Trial Better. You’ve really educated us today on the work that SCRS is doing in Diversity Awareness Program. And just so you know, Dr. Sandoval has agreed to participate in the next Trial Better podcast for us. So we’re excited to have him on and continue this education. So thank you again for joining us Diana.

Diana (19:17):

My pleasure. Thank you.

Jason (19:19):

And as always everyone, thanks for tuning in to Trial Better podcast. Please remember to comment, rate or review Trial Better on Apple podcasts and any of your favorite podcast channels. You can also reach us at trialbetter@ert.com with any comments or suggestions. We’ll see you all next time on Trial Better podcast.

Announcer (19:39):

That’s a wrap. Special thanks to Diana Foster for joining us in this conversation. We all look forward to the research to come from the SCRS diversity awareness program and its impact on the clinical trial industry. Be sure to join us next time as we take a deeper dive into this topic with Dr. Fabian Sandoval of the Emerson Clinical Research Institute. Dr. Sandoval will walk us through his experience with patient recruitment in multicultural communities and the tactics to consider when recruiting diverse populations. Finally, please remember to comment rate or review Trial Better on Apple podcasts or your favorite podcast channel. You can also reach us at trialbetter@ert.com. Thanks for listening and stay safe everyone.


FEATURED GUEST:


Diana Foster, PhD

Diana Foster, PhD, is the Vice President of Strategy and Development for the Society for Clinical Research Sites and is responsible for building relationships with industry that help amplify the voice of the clinical research site. She is a recognized expert in the intricacies of site management and an innovator in the use of strategic marketing tactics. Diana has designed and facilitated site management and patient recruitment trainings across the globe.


ADDITIONAL RESOURCES:


Visit Society for Clinical Research Sites

Review SCRS Site Assessment Checklist

For questions about SCRS or the Diversity Awareness Program? Contact Dan Milam, Vice President, Global Engagement: dan.milam@myscrs.org

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