Authored by Dr. Brian Koffman
Bottom Line:
Minority patients are underrepresented in hematology clinical trials, but this is improved by using nontraditional trial sites in other counties with greater racial diversity. This is critical as the FDA is doing the right thing by mandating that for their approval, new therapies must be tested in a population that is similar to the population where they will ultimately be used. This applies to drugs for diseases including chronic lymphocytic leukemia (CLL).
Who Performed the Research and Where Was it Presented:
Dr. Brittaney-Belle Gordon led a multi-center group of researchers to present this research at the European Hematology Association (EHA) Annual Congress in Madrid in 2024.
Background:
Despite FDA mandates reflecting the importance of clinical trial populations reflecting the real-world community that will use the therapy being studied, recruiting minorities to trials has proven difficult in CLL and across all blood malignancies. There are many reasons for this challenge, but one possibility is that most clinical trials are happening at tertiary academic centers where there may be fewer minority patients. This study is designed to assess that possibility.
Methods and Participants:
Two lists of trial sites were created. Both had had front-line experience with acalabrutinib.
The traditional (Trad) list was chosen from the top 25 of 3030 American clinical trial sites based on historical performance with clinical trial enrollment and proven access to CLL patients.
On the novel (Nov) list, multi-practice sites were prioritized that were found in communities with a diverse population as measured in county census data.
Traditional and novel sites were then compared based on demographics, trial experience, and diversity, including social determinants of health metrics.
Results:
- Nov sites had a mean lifetime experience of 7.33 CLL clinical trials vs. 120.80 (p<0.05) of the Trad sites.
- In the Nov site patient population, 18% were older, defined as 60 and above (vs. 13%) compared to Trad sites.
- Gender and marriage status were similar in the Trad and Nov sites.
- In Nov sites, 63% were from minority populations compared to only 53% in Trad sites, with 25% African American (vs. 18%), 20% Hispanic (vs. 17%), 7% Asian (vs 9%) and identical 1% of patients being American Indian and Alaskan Native in both.
- Nov site patients were also less likely to attain education beyond high school.
- They had less median household income ($69,000 vs. $81,000) and a slightly higher percentage living below the poverty line (17% vs. 15%)
- Employment and homeownership rates were similar.
- Nov site populations were twice as socially vulnerable as their traditional site counterparts (0.29 vs. 0.15).
- Nov sites also had higher minority population density than Trad sites.
Summary and Conclusion:
This research confirms the need for a path forward to ensure that future trials are more inclusive and serve a more diverse population. It makes sense that using sites in communities with a more diverse population would increase the likelihood of recruiting more minority patients. That may mean relying less heavily on tertiary academic centers in the future.
Links and Resources:
Listen to Dr. Koffman’s monologue below.
Access the original EHA abstract at METHOD OF CLINICAL TRIAL SITE SELECTION TO IMPROVE CLINICAL TRIAL DIVERSITY
