Global Trial Diversity: Navigating the Path to Action

After moderating ACRP's webinar, Liz Beatty, shares how to turn the discussion into action with three key takeaways to guide the industry forward.


In the U.S., diversity is a topic that permeates many areas of our lives. We have data on the ethnic and racial demographics that make up the country, research digging into existing disparities, and advocates for representation across varied backgrounds like disability status or the LGBTQ+ community. However, the conversations we have about diversity are unique to our country and the people that make it up. Meanwhile, other countries look at diversity through different lenses, some placing more emphasis on urban versus rural living, socio-economic status, or literacy status. The very concept and definition of diversity at a global scale is, in itself diverse. This can make addressing globally representative clinical research intimidating. However, representative trials mean good science and good science results in safer, more effective treatments for all people. It’s time for us, as an industry, to place our focus on identifying where we can collaborate, listen to each other, and embrace the unique nuances that belong to communities across the globe.

As a first step and a way to amplify the voices looking to lead the discussion on global diversity, I recently moderated a webinar, Broadening Your Approach to Trial Diversity on a Global Scale in collaboration with ACRP. I was joined by panelists Dr. Ade Lawrence, founder and Principal Investigator at BioLuminux Research in Milton Keyes, England, Lloryn Hubbard, Director of Patient Diversity at PPD, a part of Thermo Fisher, and Sarah Bridges, research coordinator at Maritime SPOR SUPPORT Unit in New Brunswick, Canada. Together, we dove into what will really make an impact in diversifying clinical research across the globe. 

Our conversation spanned a number of topics, all tied together by the underlying importance of empowering communities to drive diversity. Now, coming away from the webinar and eager to turn the discussion into action, here are three key takeaways to guide our future. 

 

Make global collaboration a guiding light 

Despite each panelist having a different perspective and representing a different country, their thoughts were unanimously punctuated by a call for collaboration. Finding a global definition of diversity will be impossible, so instead our intent should be to look for more opportunities to strategically unite stakeholders across the industry.

Prioritizing collaboration will be especially key as the FDA’s required action plans go into effect. As the DEPICT Act, passed by the U.S. Congress a year ago, states: sponsors must submit action plans outlining their enrollment goals, rationale, and plan for achieving them. Once these plans have been created, they can’t be executed without the support of sites and key partners, including CROs. Early collaboration between stakeholders will be essential to making this possible. If sponsors work with sites in the initial stages of developing plans and protocols, they can listen to them and hear what is realistic and evade the often perpetuating issue of missing out on opportunities due to budget and protocol constraints. As Lloryn Hubbard explained during the webinar, “We need to have more community-focused research centers incorporated into these plans because they are the ones that are actually seeing the patients that we want to see.” 

Listening to and including the individuals who work with patients every day will have an immeasurable impact on ensuring diversity action plans are executed. Sarah Bridges put it best: “It can’t just be the site leads or PI’s thinking about diversity. We really need to make sure that everybody in that research team is inspired to learn and to make those changes.”

 

Embrace the power that already exists in the community

During the webinar, Dr. Lawrence broke down his view of diversity, defining a representative population as one that encompasses more than characteristics or genetic composition and includes the lived experiences that have shaped patients, their ability to access care, and geographic factors. 

His perspective on what diversity means speaks to how ingrained P.I.s are in their communities and how well they know the people they serve. Cultural sensitivity and a deep understanding of local populations is what truly drives representative trial enrollment across the world and community researchers will be the central resource to making that a reality. 

Sponsors should view global diversity initiatives through the lens of collaborative partnerships with communities, acknowledging that what works in one country may not in another. Because of this, community sites must be used to bridge the relationship between underrepresented patients and trials. The key is not to reinvent the wheel, but to embrace the uniqueness each community brings and trust the sites there to leverage their existing resources and strategies to reliably enroll patients. 

 

Let sites know you’re listening

Sites are already doing incredible things to connect with their communities. During the webinar, Bridges shared one of the programs her site has held: a Cafe Scientifique at a local community center, inviting individuals who had arrived in Canada within the past five years to share their perspectives on clinical research and learn about participating in Canada. To fully trust that sites have relationships with diverse populations, sponsors need to know these initiatives, but in order to know them, sites must be encouraged to tell them. 

Dr. Lawrence made a great point, sharing that oftentimes sites are under pressure to hit deadlines and tick boxes in trials. Today’s current feasibility has no way of showcasing the breadth of a site’s community initiatives, meaning those that are taking that extra time to support their community have few opportunities to stand out. So many sites work tirelessly to support their communities and build the relationships that enable reliable enrollment and sponsors genuinely value the impact these initiatives have on trials and want to support them. Sponsors should be transparent in communicating their motivations for enrolling representative trials and open the line of communication with sites to hear about their efforts and let them know they have the resources to fund and support efforts that enable more enrollment. Because the current feasibility model doesn’t offer many ways for sites to communicate their initiatives or sponsors to review it, creating this type of change will require sponsors to innovate their approach to feasibility, seeking out new ways to unlock the full picture.  

 

What’s next?

In order to see progress in global diversity, we must continue these conversations. At Inato, how to approach global diversity has been an ongoing conversation between our team members based in North America and Europe as we’ve shared different perspectives on what representative trials mean. Thanks to these discussions, our first product updates to accommodate global perspectives of diversity are underway. This year we brought on project manager, Karen Mok, dedicated to spearheading our diversity features and leading the charge in understanding how our marketplace can meet the needs of patients across the globe. Her work has allowed us to expand how our sites can showcase their diversity efforts, now helping sites better share their community engagement activities and accessible facilities as well as allowing sites to add information for demographics like age, gender identity, sexual orientation, and disability status to their Enrollment Plans. The release of these new features will have a huge impact in how trials on Inato support diversity and how we’re able to include sites across over 70 countries in conversations around representation. It’s just a step, but it’s the start of a bold path forward as we continue to invest in global diversity across the industry.

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