In the world of clinical research, diversity, equity, and inclusion (DEI) are not just buzzwords—they are essential pillars for advancing healthcare outcomes for all populations. Historically, clinical trials have often lacked diversity, leading to data gaps that can impact the effectiveness of treatments for underrepresented communities. Increasing access to clinical research is crucial not only for scientific rigor but also for ensuring that medical advancements benefit everyone, regardless of race, ethnicity, gender, or socioeconomic status.
When Sarah Cross, Vice President and Global Head of Medical Affairs, heard about Reflections, a cross-industry consortium dedicated to improving DEI in clinical research, she agreed to join their Steering Committee without any hesitation. We sat down with Sarah and her colleague, Bea Doe-Printemps, Patient Engagement Project Specialist, to learn more about the Reflections initiative and the power of art in community engagement.
Sarah and Bea, thanks for your time today. Can you start by sharing more about Reflections and the goals/mission of the program?
Sarah: Reflections is a unique initiative within our industry. Its mission is to drive awareness, education, and access to clinical trials with a focus on expanding diversity and inclusion in medical research. It’s a landmark consortium in terms of bringing together not only the CRO industry, but importantly stakeholders across healthcare, life sciences, and community sectors, including sponsors, advocacy groups, and site networks to drive social and health equity. We’re hoping to create positive change through direct community engagement.
Bea: As Sarah said, this is a first of its kind group, bringing together cross-functional, cross-sector stakeholders. We’ve never seen that. It’s always been CRO focused on CRO objectives, or sponsor focused on sponsor objectives, but here we have everyone coming together for a common goal of enhancing DEI in clinical research. We all know patient recruitment and retention is the number one priority, and often, the number one barrier in clinical trials. I’m excited to see the needle shifting in a more positive direction.
The Reflections launch event was held on October 13, which featured a public art installation in the heart of Atlanta. Can you summarize your experiences at the event and share more about how art was used to educate attendees about medical research?
Bea: Art was used in a life-size format to truly depict clinical trials. Artists created three exhibits, but I was drawn to the walk-in pharmacy. Inside the pharmacy were empty pill bottles where attendees could make a ‘note’ on a pill about what they hoped could change for the better in medicine. Some attendees wrote things like ‘cure MS,’ others focused on ‘research for all,’ and I even saw some with a goal of ‘creating more medicines.’ It was really inspiring.
Sarah: The launch event that took place in Atlanta was really the beginning. It was day one of this collective initiative that we are growing not only through grassroots initiatives, but through digital means and other capacities as well. The goal of the event was to leverage local artists and bring a perspective of what medical research could look like through immersive art installations.
It was impactful to see the community engage. We talk a lot in terms of industry language, and I think by leveraging art, it was a way to help engage and educate the community through a common language. And it worked. We had eight patients consented for clinical trials on site during the launch event, which was very exciting to see.
From left, hand-written messages on pill bottles from ‘The Pharmacy of the Future’ installation, Sarah and Bea stand in front of the ‘Tranquiloscope’ installation
As you mentioned earlier, Reflections is focused on improving diversity and inclusion in clinical research. Where do you currently see the biggest gaps for DEI in the clinical trial space and where, perhaps, are we making some progress?
Sarah: For me, the greatest gap is having a like-minded way to talk about clinical research. Something that’s critical when we think about diversity and inclusion is how do we educate? How do we create awareness? And how do we create a common language where we all understand what we’re talking about? Only then can we help broaden access and increase the scope. I would also say that historically there’s been a lot of individual organizational advancement in DEI, whether that’s great work by advocacy groups or great work by sponsors or CROs taking a step. But the siloed approach has really been a barrier to substantial progress. This is where the Reflections initiative is so critical – coming together collectively across the industry to help bridge the gaps that still limit DEI in medical research.
Bea: Education is the first thing for me. Many people may not be aware of clinical trials or what’s available to them or even being offered by their primary care physician, so providing an avenue to raise awareness of research is key. The second is a diverse workforce. When clinical trial site staff and PIs reflect the community or target populations that they are trying to serve, it’s very powerful for the patients who are considering participating in a study. The third is meeting people where they are. Reflections got into the center of Atlanta, engaging with people in the community and hearing from them first-hand. The importance of this kind of community engagement to drive DEI forward cannot be overstated.
Earlier this year, the FDA released its draft guidance on DEI in clinical research. What steps can sponsors take to ensure compliance with this new guidance?
Bea: I think the first place to start is actually reading the guidance, not only the one from 2024, but also the one from 2022. This will be a helpful first step to understanding the differences between those. It’s important to note that this is a draft guidance which the FDA distributed for comments, so nothing is official yet. We’re hoping to see some continued refinement in the near future so there can be consistent information for all of us to work from.
Sarah: Given this is draft guidance, there’s always room for interpretation. From a sponsor perspective, this has led to lack of clarity in terms of the “what” and the “how” and even the “when.” And I think partnering with regulatory experts at a CRO can help inform on that. Something critical to point out is that the draft guidance is currently written around larger phase three pivotal trials, and it’s important to understand that earlier phase studies inform later phase drug and device development. So, creating earlier upstream plans is a critical step to ensuring that one, we’re representative of the patient population earlier in development, and two, we’re being truly inclusive as we start to expand into later phase asset development.
Lastly, having a framework or structure around DEI and bringing in the right stakeholders to support that is very important. This could be a CRO, or healthcare providers, or PIs. But really, most importantly, incorporating the voice of the target patient population of a new drug or device is how we can begin to make significant strides in improving DEI in research.
What’s next for the Reflections program? How can people get involved if they are interested?
Sarah: The fantastic thing about the Reflections launch event in Atlanta was that it was truly day one. The art installation will be taken around to different locations in the greater Atlanta community to create broader engagement and awareness. So, we’re looking forward to a journey over the next three months with the existing art exhibit. From there, we want to listen to the community to help inform what’s next. We had so many incredible attendees, whether it was influencers within the Atlanta community, site networks and individual sites, advocacy groups, stakeholders from across sponsors, CROs, etc. Now we want to hear from them what is next and how we can collectively build on this important work!
For those who may be interested, you can go to bereflected.org to learn more about Reflections and the launch event and see some of the art that was there. You can also follow along with us on social media. If you’re local to Atlanta, you can get involved by finding where the installation art exhibits are moving to next. Lastly, there’s a long roadmap currently being developed by the Reflections Steering Committee to outline how we will engage the community more broadly, not only in the Atlanta region but across the US and globally.
___
To hear more from Sarah and Bea on their perspectives of DEI in clinical research, book a meeting with them here.
Webinar 
Perspectives Blog 