title: Under-representation of racial minorities in prostate cancer studies submitted to the US Food and Drug Administration to support potential marketing approval, 1993-2013.
abstract: 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 clinical studies. The enrollment of racial minorities was compared in key clinical studies submitted to the FDA in the last 10 years in support of potential marketing approval for prostate cancer (PCa) prevention or treatment.
  
  
  METHODS
  Patient demographic data were obtained from archival data sets of large registration trials submitted to the FDA to support proposed PCa indications. Six countries/regions were analyzed: the United States, Canada, Australia, Europe, the United Kingdom, and Eastern Europe. Background racial demographics were collected from national census data.
  
  
  RESULTS
  Seventeen key PCa clinical trials were analyzed. These trials were conducted in the past 20 years, comprising 39,574 patients with known racial information. Most patients were enrolled in the United States, but there appeared to be a trend toward increased non-US enrollment over time. In all countries, racial minorities were generally under-represented. There was no significant improvement in racial minority enrollment over time. The United States enrolled the largest nonwhite population (7.1%).
  
  
  CONCLUSIONS
  Over the past 20 years, racial minorities were consistently under-represented in key PCa trials. There is a need for effective measures that will improve enrollment of racial minorities. With increased global enrollment, drug developers should aim to recruit a patient population that resembles the racial demographics of the patient population to which drug use will be generalized upon approval.
authors: Office of Hematology and Oncology Products, Office of New Drugs, Center for Drug Evaluation Research, US Food and Drug Administration, Silver Spring, Maryland.
authors: Michel D
authors: MD
authors: Wissing
authors: Paul G
authors: PG
authors: Kluetz
authors: Yang-Min
authors: YM
authors: Ning
authors: Jonca
authors: J
authors: Bull
authors: Christine
authors: C
authors: Merenda
authors: Anthony J
authors: AJ
authors: Murgo
authors: Richard
authors: R
authors: Pazdur
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001315:Australia; D002170:Canada; D002986:Clinical Trials as Topic / Q000379:methods / Q000706:statistics & numerical data; D017277:Drug Approval; D005006:Ethnicity / Q000706:statistics & numerical data; D005060:Europe; D005061:Europe, Eastern; D006801:Humans; D008297:Male; D040541:Marketing; D008913:Minority Groups / Q000706:statistics & numerical data*; D018579:Patient Selection; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000208:ethnology*; D044469:Racial Groups / Q000706:statistics & numerical data; D012107:Research Design; D006113:United Kingdom; D014481:United States; D014486:United States Food and Drug Administration
keywords: US Food and Drug Administration; clinical trial; phase 3; prostate cancer; race relations