Under-representation of racial minorities in prostate cancer studies submitted to the US Food and Drug Administration to support potential marketing approval, 1993-2013.

摘要: BACKGROUND US Food and Drug Administration (FDA) approval of new drugs depends on results from clinical trials that must be generalized to the US population. However, racial minorities are frequently under-represented in studies. The enrollment was compared key studies submitted FDA last 10 years support potential marketing for prostate cancer (PCa) prevention or treatment. METHODS Patient demographic data were obtained archival sets large registration proposed PCa indications. Six countries/regions analyzed: United States, Canada, Australia, Europe, Kingdom, Eastern Europe. Background demographics collected national census data. RESULTS Seventeen analyzed. These conducted past 20 years, comprising 39,574 patients with known information. Most enrolled but there appeared a trend toward increased non-US over time. In all countries, generally under-represented. There no significant improvement minority States largest nonwhite population (7.1%). CONCLUSIONS Over consistently trials. is need effective measures will improve minorities. With global enrollment, drug developers should aim recruit patient resembles which use upon approval. Cancer 2014;120:3025–3032. © 2014 American Society.