The US Food and Drug Administration (FDA) now requires a diversity action plan to be submitted as part of the study protocols. The American Association for Cancer Research (AACR) has published an article to guide trial sponsors through this process.

The requirement of a diversity action plan is part of the US FDA’s 2022 draft guidance to boost ethnic and racial diversity in the clinical trials conducted in the country.

Diversity in clinical trials is an ongoing issue, with the British Medical Journal (BMJ) publishing a study evaluating diversity in the clinical trials for US FDA-approved cancer drugs.

The article was authored by experts from the Oncology Centre of Excellence (OCE), a part of the US FDA, the AACR, and the pharmaceutical industry (Janssen, AstraZeneca, Roche, Moderna, and Bayer). It was published on 28 June in the Clinical Cancer Research journal, a part of AACR.

It builds on AACR meetings that discussed various aspects of diversity inclusion in clinical trials, including the current practices, key challenges, and potential solutions.

Multiple areas were explored to ensure diversity, equity, and inclusion (DEI) in cancer drug development. These were company-wide directives such as dedicated funding and staff, creating a specialised DEI strategy for clinical development, and setting DEI goals for each trial.

Some community-based solutions include engaging with community and patient organisations and supporting access to clinical trials in clinics that have not previously conducted research.

AACR CEO Margaret Foti stated: “[DEI] issue is a priority for AACR and is one that aligns with President Biden’s Cancer Moonshot goal of eliminating inequities in cancer care.”

Recent efforts to increase diversity in clinical trials include Abbot’s Diversity in clinical trials initiative and Mirati’s collaboration with Sarah Cannon Research Institute.