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Racial/Ethnic composition of study participants in FDA-approved oncology new molecular entities, 2006-2008

Christine Merenda1

  • 1Public Health Service, US Food and Drug Administration, Silver Spring, MD 20993, USA. christine.merenda@fda.hhs.gov

Journal of the National Medical Association
|January 25, 2013
PubMed

Insights

Clinical trial diversity is crucial for equitable healthcare. This study found shifts in racial/ethnic participation in oncology trials, with increased representation for some groups but decreased participation for others.

Area of Science:

  • Clinical research
  • Oncology
  • Health equity

Background:

  • The US Food and Drug Administration (FDA) emphasizes representative clinical trial participant demographics for product safety and efficacy.
  • Observed differences in medical product responses across racial/ethnic subgroups necessitate accurate participant data.
  • Oncology trials were selected due to cancer's disparate incidence and impact on various racial/ethnic communities.

Purpose of the Study:

  • To analyze the racial/ethnic composition of participants in clinical trials for FDA-approved oncology products.
  • To compare current trial demographics with historical data.
  • To evaluate the inclusion of race-based findings in FDA-approved product labeling.

Main Methods:

  • Searched New Drug and Biologics Licensing Application databases for new molecular entity (NME) oncology approvals (2006-2008).
  • Reviewed pivotal Phase II and III trial data for NME applications.
  • Compared racial/ethnic composition of recent trials with earlier ones and assessed labeling for race-based findings.

Main Results:

  • US participants constituted an average of 20.3% of total participants across reviewed studies.
  • Participation of White and Black/African American individuals decreased, while Latino, Asian, and Native Hawaiian/Pacific Islander representation increased.
  • The proportion of US participants with undetermined race/ethnicity significantly decreased from 31% to less than 1%.
  • Six out of ten (60%) FDA-approved oncology product labels included race-based findings.

Conclusions:

  • Shifts in racial/ethnic participation in oncology clinical trials indicate evolving demographics.
  • Improved data collection and reporting have enhanced the determination of participant race/ethnicity.
  • While some progress is noted, continued efforts are needed to ensure comprehensive representation and reporting of race-based findings in oncology drug development and labeling.

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