CLINICAL DEVELOPMENT IN ONCOLOGY
Sponsors must take on FDA’s diversity guidance to improve community trust
With data still showing that ethnic minorities account for less than 40% of US trial populations, there is an urgent need to improve diversity in clinical research.
ABIGAIL BEANEY
The FDA has released draft guidance, outlining to sponsors precautions they can take to improve diversity in clinical research. Image credit:
PeopleImages.com - Yuri A via
Shutterstock.com.
T
he topic of improving diversity in clinical trials has been at the top of the agenda at most health conferences
over the past few years. This is something which has been heavily
acknowledged by the industry, including the US Food and Drug Administration (FDA), which has recently spoken out a lot about the lack of diversity in US-based clinical trials. On June 26, 2024, the FDA released
guidance on recommended steps for sponsors and drug developers to take to improve diversity in clinical trials. The guidance applies to both drug and device trials. Sponsors are asked to consider several
factors including site locations and community- based care as a way to make it easier and more
accessible to diverse populations to be more involved in research. Esther Krofah, executive vice president for
health at Californian-based think tank, the Milken Institute, told Clinical Trials Arena that after years of campaigning, it is good to see such cohesive and stringent guidance in this area.
Abigail Beaney: Explain what is contained in this guidance and what precautions sponsors need to take when they are setting up these Phase III and pivotal trials.
Esther Krofah: We at the Milken Institute have advocated not only for the creation of these diversity action plans but generally for the
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