13 Apr FDA recommends sponsors plan to include race, ethnicity in clinical trial design

By Ferdous Al-Faruque, Regulatory Affairs Professionals Society (RAPS)

The US Food and Drug Administration (FDA) is recommending sponsors include a plan to increase diversity when proposing clinical trial designs for investigational products to agency reviewers. The move is part of the Biden administration’s focus on addressing racial and ethnic disparities in health care.

On 13 April, the FDA published a draft guidance titled, Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials. In it the agency recommends sponsors submit a “Race and Ethnicity Diversity Plan” whenever submitting an application for an investigational new drug (IND), biologics license application (BLA) or an investigational device exemption (IDE). Regulators note they will consider the plan “an important part” of the product’s development program.

“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 Califf. “Going forward, achieving greater diversity will be a key focus throughout the FDA to facilitate the development of better treatments and better ways to fight diseases that often disproportionately impact diverse communities.”

The commissioner also noted that the guidance is meant to support the Biden administration’s Cancer Moonshot project, part of which aims to address inequities in cancer care, as well as bring new cancer diagnostics and treatments to market faster. Read more …