Analysis of racial distribution amongst patients in phase III cancer clinical trials.

Abstract

6588 Background: Minority races are often under-represented in cancer clinical trials as enrollment often occurs in large centers. Racial diversity may vary by geographical location and socio-economically backward areas may have a very different racial mix. This study explores the representation of different races in phase 3 clinical trials conducted in the past 10 years. Methods: Details about adult patients involved in phase 3 trials was extracted from the clinical trials.gov for 3 common solid organs and 3 hematological malignancies [breast, colon, lung, diffuse large B-cell lymphoma (DLBCL), acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL)]. The racial distribution of the patient population in these trials was analyzed. Results: African American and Asian patients are under-represented in all phase 3 cancer clinical trials. The table shows the average racial distribution in clinical trials for each organ specific malignancy. Conclusions: Most phase 3 clinical trials except for lung cancer, predominantly consisted of Caucasian patients. Applying the results of these trails to patients of other races should be done with caution. This study highlights the disparity of race in patients enrolled in clinical trials when compared to diverse and different populations that are encountered in practice. [Table: see text]