Dr Abby Statler Discusses Restrictive Criteria Excluding Minority Patients From AML Trials

January 3, 2020

SAP Partners | <b>Cleveland Clinic</b>

In research presented at the 61st American Society of Hematology Annual Meeting and Exposition, Abby Statler, PhD, MPH, MA, research associate, Cleveland Clinic, and her colleagues found that African Americans with acute myeloid leukemia (AML) may be excluded from clinical trials due to renal dysfunction, despite it having no impact on AML outcomes.

In research presented at the 61st American Society of Hematology Annual Meeting and Exposition, Abby Statler, PhD, MPH, MA, research associate, Cleveland Clinic, and her colleagues found that African Americans with acute myeloid leukemia (AML) may be excluded from clinical trials due to renal dysfunction, despite it having no impact on AML outcomes.

Transcript

How are restrictive eligibility criteria contributing to keeping minority patients out of clinical trials?

So, we found within our cohort that African Americans were more likely to have kidney dysfunction compared with the white population. So, this means that clinical trials that include eligibility criteria that exclude patients with renal dysfunction may be disproportionately excluding patients with kidney disease, such as the African American patient population.

From a more broad perspective, this means that eligibility criteria may be systematically excluding African Americans from clinical trials because they have higher rates of renal dysfunction compared to the white patient population.

Are these restrictive eligibility criteria necessary or is there an argument to be made that these criteria should be relaxed?

So, for specific clinical trials it may still be appropriate to include restrictive eligibility criteria. So, I’ll give you an example. For clinical trials including interventions that are metabolized through the liver or excreted through the kidneys, it may be appropriate to still exclude patients who have minor liver or renal dysfunction.

However, for other clinical trials, our outcomes suggest that it may be appropriate to relax those eligibility criteria, and include patients who have minor renal or liver dysfunction as their outcomes are not significantly different than those patients who don’t have such abnormalities prior to the initiation of therapy.