Representation of Minorities and Women in Oncology Clinical Trials From 2003 to 2016

Key Points

  • A study finds that African American and Hispanic patients were underrepresented in clinical trials.
  • Older patients and women were less likely to be enrolled in clinical trials.

In a study reported in the Journal of Oncology Practice, Duma et al found that African American, Hispanic, older, and female patients were underrepresented in oncology clinical trials during the period of 2003 to 2016.

Study Details

The study involved analysis of enrollment data from all cancer therapeutic trials reported as completed in ClinicalTrials.gov from 2003 to 2016. Enrollment fractions for the groups of interest were calculated by dividing the number of enrollees in the trials by cancer prevalence in the 2013 Surveillance, Epidemiology, and End Results database.

Trends in Enrollment

Of 1,012 clinical trials identified, 310 (31%) reported ethnicity, representing a total of 55,689 enrollees. White patients were more likely to be enrolled in clinical trials (enrollment fraction = 1.2%) compared with African American patients (enrollment fraction = 0.7%; P <.001 vs white patients) and Hispanic patients (enrollment fraction = 0.4%; P < .001 vs white patients). Compared with historical data from 1996 to 2002, clinical trial participation decreased from 9.2% to 6.0% for African American patients and from 3.1% to 2.6% for Hispanic patients. Patients aged < 65years were more likely to be enrolled than older patients (64% vs 36%, P < .001). Female patients accounted for 35% of patient enrollment for trials in melanoma, 39% for lung cancer, and 40% for pancreatic cancer.

The investigators concluded: “We observed a decrease in recruitment of minorities over the past 14 years compared with historical data. African Americans, Hispanics, and women were less likely to be enrolled in cancer clinical trials. Future trials should take extra measures to recruit participants that adequately represent the U.S. cancer population.”

Narjust Duma, MD, of Mayo Clinic, Rochester, is the corresponding author of the Journal of Oncology Practice article.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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