Dr Matthew Maurer: LEO Cohort Shows Effects of DLBCL Trial Inclusion Criteria on Participant Diversity

Building equitable clinical trials means being thoughtful about trial design and criteria, said Matthew J. Maurer, DSc, statistician at Mayo Clinic, director of the statistics and informatics core of the Lymphoma Epidemiology of Outcomes (LEO) cohort.

Matthew J. Maurer, DSc, statistician at Mayo Clinic, director of the statistics and informatics core of the Lymphoma Epidemiology of Outcomes (LEO) cohort, discusses the cohort's findings and implications, including that up to a quarter of patients are excluded from frontline clinical trials of diffuse large B-cell lymphoma (DLBCL) based on 5 organ function lab values.


What 5 lab values were included in the LEO cohort, and what differences did you find based on race or ethnicity?

The 5 lab values that we looked at related to organ function were hemoglobin, neutrophil count, creatinine clearance, bilirubin, and platelets.

We did see very significant differences in some of these lab values by race and ethnicity. For example, Black patients had significantly lower hemoglobin than White patients in the LEO cohort. In addition, Black patients also had significantly higher creatinine levels compared to White and other minority patients in the study. Depending on what the criteria that were applied in terms of the cut offs on the trials, these criteria may have excluded patients differently based on race and ethnicity.

What other differences by race and ethnicity did you find in patients with DLBCL?

Strikingly, Black patients were much younger than White patients with DLBCL who enrolled in the LEO cohort. Median age for Black patients with DLBCL in our cohort was 51 years compared to 65 in White patients. So, despite the fact that Black patients were significantly younger, had better kidney function than White patients on trials, Black patients were excluded from trials based on these organ function labs at a much higher rate.

Were some trials you looked at more restrictive than others?

It's interesting that these clinical trials can have a fair amount of variation in how these criteria are set, so that's why we looked at a number of recent phase 3 clinical trials in frontline DLBCL. For example, for hemoglobin, some studies used a cutoff of 9 grams per deciliter, some used 10, some didn't have a hemoglobin cutoff at all, it was not part of the exclusion criteria. So I think we need to be really thoughtful about where these values come from and how we build the eligibility criteria on our trials because, as we showed in our study here within the LEO cohort, these choices have a huge impact on the patients that can go on the trials. And we're seeing quite a bit of inequity in how these are set in terms of, they have differential impact across racial and ethnic groups. To build equitable trials moving forward, we need to be really thoughtful about how we're designing studies and what these criteria are.

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