Back to Search
Start Over
Under-representation of racial minorities in prostate cancer studies submitted to the US Food and Drug Administration to support potential marketing approval, 1993-2013.
- Source :
-
Cancer [Cancer] 2014 Oct 01; Vol. 120 (19), pp. 3025-32. Date of Electronic Publication: 2014 Jun 25. - Publication Year :
- 2014
-
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.<br />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.<br />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%).<br />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.<br /> (© 2014 American Cancer Society.)
- Subjects :
- Aged
Aged, 80 and over
Australia
Canada
Ethnicity statistics & numerical data
Europe
Europe, Eastern
Humans
Male
Marketing
Racial Groups statistics & numerical data
Research Design
United Kingdom
United States
United States Food and Drug Administration
Clinical Trials as Topic methods
Clinical Trials as Topic statistics & numerical data
Drug Approval
Minority Groups statistics & numerical data
Patient Selection
Prostatic Neoplasms drug therapy
Prostatic Neoplasms ethnology
Subjects
Details
- Language :
- English
- ISSN :
- 1097-0142
- Volume :
- 120
- Issue :
- 19
- Database :
- MEDLINE
- Journal :
- Cancer
- Publication Type :
- Academic Journal
- Accession number :
- 24965506
- Full Text :
- https://doi.org/10.1002/cncr.28809