Pressure Grows for More Inclusive Clinical Trials

Despite guidances and rules advising sponsors to include all demographic groups in clinical trials, many subgroups remain underrepresented.
Applied Clinical Trials Online: Apr 1, 2014

Health policymakers, academic researchers, and regulators are clamoring for biomedical studies to fully examine how new drugs and medical products affect a broad spectrum of patient populations, including women, minorities, children, and older individuals with chronic diseases. Despite multiple FDA guidances and rules over the years advising sponsors to include all demographic groups in clinical trials, many subgroups remain underrepresented. A 2011 report from FDA found that African-Americans constitute 12% of the U.S. population, but make up only 5% of clinical trial participants; the disparity is even greater for Hispanics, which account for 16% of Americans, but only 1% of research subjects. Read More