Representative trials don’t look the same across the world, so how can sites, sponsors, and CROs take action to ensure that diversity is a priority, especially when so much is still unclear? ACRP recently hosted the Broadening Your Approach to Trial Diversity on a Global Scale webinar, bringing together unique perspectives to dive deeply into this topic and explore opportunities for inspiring action.
Our own Co-founder and Chief Strategy Officer Liz Beatty moderated the discussion with Dr. Ade Lawrence, founder and Principal Investigator at BioLuminux Research in Milton Keyes, England, Lloryn Hubbard, Director of Patient Diversity at PPD, and Sarah Bridges, research coordinator at Maritime SPOR SUPPORT Unit in New Brunswick, Canada. The group took on the largely undefined topic of globally representative research, exploring the directions we can go as an industry to see a real impact. To kick off the webinar, the panelists broke down where their country stands in terms of regulatory guidance on trial diversity.
United Kingdom
Dr. Lawrence explained that the COVID-19 pandemic was a catalyst for change in the United Kingdom when it became clear how little representation ethnically diverse communities had in research. While The Medicines and Healthcare Products Regulatory Agency is still in the process of putting together official guidance, steps have been taken by the MHRA to consult experienced stakeholders to identify a strategic approach toward creating guidelines that have the ability to promote real change.
Canada
Canada’s regulations are in a similar stage as the United Kingdom. As Bridges explained, their efforts are focused on analyzing data to determine where disparities exist between different demographics. Bridges said that in her team’s experience, these endeavors are already igniting conversations between sites and sponsors to collaborate on improving trial diversity.
United States
For the U.S., not only has the FDA put out new guidelines, but Congress recently passed the DEPICT Act, meaning diversity action plans are required by law, calling on pharma sponsors to create thorough plans that outline which demographics they aim to recruit, why, and how. With Congress now involved, Hubbard explained that the pressure is on the FDA now to show them what these plans will achieve. This will be significant for ensuring real progress is made, “The regulation has definitely pushed this conversation forward and made it a priority for the industry. It's in the law now.”
What does this really mean for the industry?
Webinar poll results: just 5% of the audience strongly agreed that, as an industry, we are making progress in diversity
As Beatty put it, “The regulations and the guidance will open the conversation, but we'll need to do a lot more as an industry to really move the needle.”
Hubbard explained that we need better strategies to ensure the diversity plans’ intent trickles all the way down to the study level. Many of the tactics needed to help the diversity plans succeed aren't being discussed with people who are actually on the study team level or at the site level to ensure that it's feasible within the constructs of the study as planned. Bridges echoed this, saying “We really need to make sure that everybody in that research team is inspired to [think about diversity], to learn, and to make those changes.”
Global Collaboration
In order for the diversity action plans to be effective, there must also be a thorough understanding not only of the demographics that truly represent the global population but how to reach them. Without a strategy to reach certain populations, no amount of desire for change can bridge the gap to underrepresented patients. Bridges and Lawrence expressed concern for the patients they see at their sites who may be at a greater disadvantage in accessing trials. Whether financial barriers or lacking a stable address are preventing participation, a plan for ensuring those people can be a part of clinical research will be a crucial step. It falls into the broader goal of ensuring all stakeholders are well versed in how to productively promote inclusion.
Where do we start?
Hubbard and Lawrence both shared that there must be a commitment to truly understanding other countries in order to collaborate internationally. “We’re missing a landscape of what we can and cannot collect in other countries,” Hubbard explained. They explored several areas we, as an industry, should invest in to successfully navigate global diversity:
- Understanding what diversity means in other countries
- Thinking globally about community engagement and how that might look across the world
- Cultural sensitivity around perceptions of clinical research and collecting diversity data
- Prioritizing patient comfort and recruitment strategies for community-based sites
Ultimately, much of this information will come from listening to researchers in the community who speak patients’ language, and live and work in their neighborhoods.
Community Commitments
Webinar poll results: 99% of sites in the audience said they feel showcasing their diversity helps them in getting selected for trials.
Bridges shared how her site is taking action at a grassroots level to reach more patients. They hosted a “Cafe Scientifique,” inviting individuals who had arrived in Canada within the last five years to a local community center where they held open conversations to learn about perceptions of clinical research in other countries while teaching them about the industry in Canada. The most important part of this event? Building trust and relationships with these community members.
“[Community engagement] doesn't even always have to be about trials. It's about getting your face known.” – Sarah Bridges
Reiterating his earlier call for collaboration, Dr. Lawrence said that, while emphasizing how crucial grassroot efforts are for enabling diversity and understanding your patient population, these valuable programs can be challenging for sites. In the current trial landscape, timelines are tight and sites are focused on hitting goals and ticking boxes, not leaving much room for concerted community engagement efforts and rich relationship building. “It’s very difficult to do alone,” he said. The support of sponsors and CROs would change that.
Next Up: Inspiring action
Webinar poll results: 61% of sponsors in the audience reported that diversity plays a significant role in site selection
Hubbard shared how sites can make that happen: “We need to hear those stories, share them with your CRO, share them with the sponsor, share them in a way that shows value.”
It can require additional effort, but investing in a document that outlines community engagement programs and shows how crucial they are to accessing underrepresented patients is the best way to gain support. “Sponsors are valuing this. They are valuing sites that are putting this effort in. They want to see more of these sites.”
Across the board, sites, CROs, and sponsors alike value the importance of globally representative trials. The next steps? Based on the insights from these panelists, collaboration between stakeholders is imperative, and a prioritization to support communities will be the key to seeing change.