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Case Study: Clinical Trial Diversity for LIFE-BTK
Neighborhoods with the highest amputation rates were redlined during segregation. So that's where we went to work.
We don't see clinical trial diversity as "nice to have."
It’s a necessity.
One that our teams encounter every day.
Take peripheral artery disease (PAD), a condition in which blood vessels — particularly in the legs — narrow or become blocked and can lead to amputation. PAD disproportionately impacts African American, Hispanic and Native American patients. Yet these communities remain drastically underrepresented in clinical research, making up less than 15% of participants in cardiovascular clinical trials from 2015 to 2019.
When we were planning the LIFE-BTK clinical trial to test an investigational device that treats blocked arteries in PAD, we had to ensure our research was representative of the populations that would most benefit from this treatment
We knew that …
... all have an impact on who ends up enrolled in clinical trials.
To reach communities most impacted by PAD, we couldn't fall back on old habits; seeking out clinical investigators who conducted research at hospitals and medical centers that have the infrastructure to run trials, but who didn’t necessarily have access to the patient populations most in need of a new treatment and with the least access to care.
We intentionally pursued investigators and sites that hadn't traditionally participated in clinical studies because we knew they had access to — and, more importantly, had earned the trust of — patient populations who would benefit most from this trial.
Jennifer Jones-McMeans PhD, the divisional vice president of global clinical affairs, is one of the people spearheading the change in clinical research. She is the Abbott leader responsible for the LIFE-BTK trial and says, "If we went with the status quo and left the trial enrollment to the system itself, we would have ended up with a trial like every other trial before it, where racial and ethnic people are underrepresented and yet disproportionately affected by the disease."
We set out to find new ways to reach and recruit patients in these underserved communities. Our efforts have provided insights into how to address some of the major challenges people face when it comes to clinical trial participation, and we are working to carry this knowledge into other trials and share it with the industry through our recent white paper.
Challenge 1: Lack of Trust
Challenge 2: Lack of Understanding
Challenge 3: Lack of Access
The Way Forward
Reducing practical barriers to participation requires solutions that will vary depending on the trial. They include: