Staff Writer: Deileta Kamhunga
It’s well established that there are serious inequities in cancer care and outcomes in the U.S. and around the globe. But are pivotal clinical trials including populations representative of all patients, particularly those who experience these inequities? Researchers set out to determine if clinical trials for lymphomas reflect the populations affected by these diseases. Their research was published in the Journal of Clinical Oncology and presented at the 2022 ASCO Annual Meeting.
Lymphoma clinical trial information was collected from the Food and Drug Administration (FDA) databases, including oncology (cancer)/hematologic malignancies approval notifications and novel drug approvals between 2011 and 2021. Trials were also reviewed for demographic data on ClinicalTrials.gov (CT.gov) and in the primary literature related to drug approval. Only studies for adult patients were included. The burden of diseases based on Surveillance, Epidemiology, and End Results (SEER) data was used to compare U.S. participants.
Ultimately, it was found that of the 33 pivotal trials identified in the FDA databases, 18 had available race data on CT.gov or in the medical literature. A total of 3 trials focused on classical Hodgkin’s Lymphoma (cHL) and 15 on non-Hodgkin’s Lymphoma (NHL). The researchers found that Black patients were underrepresented, as well as Hispanics to a certain extent, in both cHL and NHL trials. Females were also underrepresented, particularly in NHL trials.
In closing, this study demonstrates that there is racial, ethnic, and sex misrepresentation within clinical trials that led to the approval of drugs for lymphomas in the U.S. between 2011 and 2021. Furthermore, there was significant underreporting of racial and ethnic subgroups in clinical trials [1].
Source:
[1] Casey, M., Odhiambo, L. A., Shoukier, M., Islam, K. M., Aggarwal, N., & Cortes, J.E. (2022, June). Are pivotal clinical trials for lymphomas that led to drug approval representative of the population affected by these diseases [Poster session]? 2022 ASCO Annual Meeting, Chicago, IL. https://meetings.asco.org/abstracts-presentations/206701
