By Alaric Debarment, MedCity News | July 7, 2019
Experts said the rise of cutting-edge new therapies highlighted disparities between clinical trial populations and the patients receiving new drugs. An FDA draft guidance earlier this month sought to address the issue.
The idea of a drug having to undergo clinical trials before becoming eligible for regulatory approval seems simple enough. But while dozens of drugs win approval every year from regulators like the Food and Drug Administration and European Medicines Agency, the studies that lead to their approval are often not demographically reflective of patients in the “real world.” And with the rise of precision medicine, targeted drugs and gene therapies, lack of diversity in clinical trials can make it more challenging to get a complete picture of a drug’s safety-efficacy profile.
On June 6, the FDA issued a draft guidance on how industry could increase diversity in clinical trial populations through trial design, adjusting eligibility criteria and improving enrollment practices. This would ensure that they better reflect the general population along racial, ethnic and gender lines. Experts are divided on how much real-world effect such guidance will have even as they laud the FDA for recognizing the importance of clinical trial diversity.
What they agree on is that the status quo cannot stand. With the lack of racial and ethnic diversity in clinical trials, drugmakers are in effect marketing to Caucasians, even is the U.S. population is becoming more diverse. And that has stark implications for drug safety and efficacy.
“When you don’t have inclusion of diverse communities, you run the risk of making assumptions about drug safety and effectiveness that may not be accurate,” said Stephanie Monroe, executive director of AfricanAmericansAgainst Alzheimer’s, in an interview at the Biotechnology Innovation Organization’s annual meeting last month. “Generalizing findings of the current majority of participants – white, European men – to African-Americans, Latinos, women and others may be embracing false assumptions about the lack of differentiation between what is fast becoming the new majority.”
Monroe took part in a June 5 panel discussion at BIO on the topic of diversity in precision medicine that included an infographic —provided by contract research organization Syneos Health — giving a snapshot of how deficient clinical trial diversity is. While racial and ethnic minorities make up 38.7 percent of the U.S. population, their rates of inclusion in trials range from a high of 16 percent to as low as 2 percent. African-American participation rates are lower than 5 percent, despite their 14 percent greater risk of dying from cancers. Latinos make up only 1 percent of clinical trial participants, but 18 percent of the population as a whole.