Dr Mazyar Shadman Highlights the Challenges of Subgroup Analysis When Trials Lack Diversity

Increased diversity in clinical trials remains an unmet need, and in the new SEQUOIA trial, the majority of patients being White males meant researchers could not do a subgroup analysis looking at outcomes for specific races, age groups or genders, said Mazyar Shadman, MD, MPH, associate professor of medical oncology at Fred Hutchinson Cancer Research Center, and assistant professor of medicine at University of Washington.

Shadman recently co-authored a study presented at the 2022 European Hematology Association (EHA) Congress, titled, "Patient-reported outcomes from a phase 3 randomized study of zanubrutinib versus bendamustine plus rituximab in patients with treatment-naive CLL/SLL."

Transcript

Can you speak on patient enrollment of the SEQUOIA trial by race, demographics, and other factors?

Majority of patients in this study were Caucasian male population, and that is something that we see across the border for all clinical trials. This is an unmet need in clinical trial design, and as a community of clinical investigators, we need to do a better job in increasing the diversity of our population.

Unfortunately, because of the fact that the majority of patients were White male, we were not able to do a subgroup analysis, for example, looking at specific races, age groups, or genders in terms of whether or not these improvements are seen in each subgroup, just simply because of small numbers. But really in the future there should be a focus on trying to get these studies more diverse so we can answer many more questions that are relevant to patients who come from different backgrounds in terms of any type of variable that you consider as a minority.

Are there any plans to investigate health-related quality of life in the other patient cohort arms of the SEQUOIA trial?

There's definitely data collected for all cohorts of the SEQUOIA study. So, this is something that should definitely be considered, specifically looking at 17p deleted patients because those patients only received zanubrutinib so [they] would be a subgroup of patients with more high-risk disease from the biological standpoint. So, definitely something to look at.