BIO recommends improvements to FDA’s clinical trial diversity guidance

On April 13, the U.S. Food and Drug Administration (FDA) released new draft guidance for industry on “creating strategies to recruit additional participants from underrepresented racial and ethnic communities in clinical trials in the United States.”

“The U.S. population has become increasingly diverse, and ensuring meaningful representation of racial and ethnic minorities in clinical trials for regulated medical products is fundamental to public health,” said FDA Commissioner Robert M. Califf, M.D.

Despite bearing a disproportionate burden for some diseases, racial and ethnic minorities are commonly underrepresented in biomedical studies, Bio.News wrote recently.

“Clinical trials provide an important foundation of information for determining whether a medical product is safe and effective; hence, enrollment in clinical trials should reflect the variety of the community that may eventually utilize the treatment,” said FDA.

In comments filed earlier this month, the Biotechnology Innovation Organization (BIO) made two overarching suggestions for strengthening the guidance:

1. Patient and community engagement/building trust: “BIO proposes that the Agency ensures that they have the necessary expertise to be able to address concerns related to enrolling and retaining diverse patients (i.e., site operations, community engagement strategies and reducing burdens to trial/study design and conduct).”
2. FDA-sponsored communication and engagement: “Specifically, it would be helpful to provide more clarity on the timing and operational aspects of FDA’s expected review of the Diversity Plan,” building from provisions described in the PDUFA VII commitment letter.

BIO also discussed the significance of collecting and analyzing data by “self-assigned” or “self-reported” race and ethnicity to address socio-cultural concerns that contribute to underrepresentation, as well as how data collected internationally may be used.