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Do Clinical Trials Match the Demographic and Geographic Diversity of Populations With Blood Cancers?

By: Vanessa A. Carter, BS
Posted: Friday, August 26, 2022

Jorge E. Cortes, MD, of Georgia Cancer Center at Augusta University, and colleagues created a novel geospatial map that shows the locations of clinical trial participation sites along with disease-specific mortality to demonstrate probable disparities in treatment among patients with leukemias or multiple myeloma. Published in the Journal of Clinical Oncology, the results of this trial outlined significant underrepresentation and inequality affecting minority populations in clinical trials that led to drug approvals.

“Trials should represent the population with the disease and should be within reach of patients in areas of need,” highlighted the study authors. “These disparities within cancer research need to be addressed to make results applicable to all populations.”

The U.S. Food and Drug Administration databases were queried for clinical trials leading to drug approval for treatment of leukemias or multiple myeloma. Geographic and demographic data, such as region and state, race, ethnicity, sex, and malignancy subtypes, were collected from primary manuscripts and ClinicalTrials.gov.

The investigators identified 41 trials leading to drug approval that recorded data regarding race and 20 that recorded ethnicity. In total, these trials consisted of 13,731 patients, with 81.6% identifying as White. Multiple myeloma was represented in 16 trials reporting on race, which included 7,287 participants; most patients were White (80.3%), followed by Black (10.7%) and Asian-Pacific Islander (4.7%). Hispanic patients made up 3.8% of the population, although ethnicity data were available only for half of these trials.

Of note, all malignancies except multiple myeloma demonstrated poor regional and state participation in clinical trials compared with mortality. However, White patients were significantly overrepresented in multiple myeloma trials compared with minority patients (P < .0001). In contrast, Black, Hispanic, and Native American patients were consistently underrepresented in clinical trials when compared with the general population.

Disclosure: For full disclosures of the study authors, visit ascopubs.org.


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