Racial/Ethnic Composition of Study Participants in FDA-Approved Oncology New Molecular Entities, 2006-2008

Abstract

The US Food and Drug Administration (FDA) has an ongoing interest in identifying the race/ethnicity of clinical trial participants to ensure they are representative of the people who will use the products once they are approved, and differences in response to medical products have already been observed in racial/ethnic subgroups of the US population. As a result, we reviewed the racial/ethnic composition of study participants in clinical trials of FDA-approved oncology products. Oncology products were chosen because of the disparate incidence and impact of cancer in racial/ethnic communities. New Drug and Biologics Licensing Application databases were searched for new molecular entity (NME) approvals for oncologic treatment from January 1, 2006, through December 31, 2008. We then reviewed NME applications for the pivotal Phase II and III trials used for approval decisions. We then compared the racial/ethnic composition results from the recent trials with those conducted earlier. We also assessed FDA-approved labeling to determine the extent to which race-based findings were included. US participants averaged 20.3% (range, 11%-97%) of the total participants in the studies reviewed. A comparison of the racial/ ethnic composition showed the participation of whites and blacks or African Americans have decreased, while that of Latinos, Asians, and Native Hawaiians/Pacific Islanders has increased. The results suggest better attention to compliance with collection and reporting, as the percentage of US study participants whose race and/or ethnicity could not be determined decreased from 31% to < 1%. With respect to product labeling, the current study found 6 (60%) included race-based findings.