Lack of Diversity in Cancer Drug Clinical Trials May Exacerbate Racial Disparities in Mortality Rates.


Letter to the Editor, Cancer Epidemiology.

A study published in Cancer Epidemiology in April 2014 showed that between 1990 and 2009, the disparity in breast cancer mortality between Black and White women has widened in our country’s most populated states. Like most cancer experts, the authors (Ms. Hunt and her colleagues) conclude that although there have been advances in breast cancer screening, prevention and treatment, these advances have not been equally available to Black and White patients.[1]

In July 2014, Dr. Laurén Doamekpor and Dr. Diana Zuckerman of the National Center for Health Research published a response in the same journal, agreeing that access is a problem but pointing out that a lack of racial and ethnic diversity in clinical trials may exacerbate this disparity.[2] Scientific knowledge gained from clinical trials on prevention and treatment is important; unfortunately, patients of color continue to be underrepresented in clinical trials that are submitted to the Food and Drug Administration (FDA) when a company applies for FDA approval.[3]  Since relatively few people of color are included in studies submitted to the FDA, and even fewer studies analyze and report safety and efficacy separately by race or ethnicity, it is unlikely that scientists will discover treatments that are safe and effective for minority patients if those patients metabolize certain drugs differently or tend to have different types of cancer, such as triple negative breast cancer. This contributes to racial disparities when treatments are not adequately tested for  safety or efficacy in these populations.

  1. http://dx.doi.org/10.1016/j.canep.2013.09.009
  2. http://dx.doi.org/10.1016/j.canep.2014.06.007
  3. http://www.fda.gov/downloads/RegulatoryInformation/
    Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/
    FDASIA/UCM365544.pdf (accessed 31.03.14