By Nanette K. Wenger, MD, MACC, MACP, FAHA
The lack of demographic representation in clinical trials is long-felt and well-known challenge for the research community. Regulatory bodies such as the U.S. Food and Drug Administration (FDA) are putting pressure on the industry to make trials more representative of the real world population. While this is helpful, the FDA’s recent guidance for industry on the topic remains just that – guidance. This means that researchers can still choose not to follow these guidelines with little to no consequence.
In the United States many communities of patients are under-represented. For some examples, whites make up roughly two-thirds (67%) of the overall U.S. population, but account for 83% of research study participants. Compare that to African Americans who make up 13.4% of the U.S. population and 5% of study participants and Hispanic populations who comprise 18.1% of U.S. residents yet make up less than 1% of clinical trial participants. Women are nearly twice as likely as men to experience adverse drug effects, a problem linked to the fact that not enough women are participating in clinical trials, leading to a lack of insights into how therapies will uniquely affect women.