The US Food and Drug Administration (FDA) has published draft guidance to assist drugmakers and medical device makers when submitting Diversity Action Plans to improve enrolment in clinical studies.
The new guidance will help to improve the racial, ethnic and other diversity within clinical trials by increasing clinical study enrolment among participants from underrepresented populations to enhance the understanding of a disease or medical product being studied.
The Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies was developed by the Oncology Center of Excellence Project Equity, the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health, the Office of Women’s Health and the Office of Minority Health and Health Equity.
The guidance outlines the FDA’s recommended steps to enhance diversity within clinical trials and provides suggestions for companies and researchers conducting them, including ways to set goals for study enrolment “separated by the age group, ethnicity, sex and race of clinically relevant study populations,” said the US regulator.
New provisions of the Federal Food, Drug and Cosmetic Act added by the Food and Drug Omnibus Reform Act outline requirements for sponsors to submit Diversity Action Plans and apply to phase 3 clinical studies as well as others of a drug or biological product and certain clinical studies of devices.
It states that Diversity Action Plans should specify the sponsor’s rationale and goals for clinical study enrolment and must describe how the sponsor intends to meet them, while also urging sponsors and investigators to consider factors of clinical trial diversity beyond age, ethnicity, sex and race to represent patients who will be treated if the product is approved.
The requirement to submit a Diversity Action Plan applies to clinical studies, for which enrolment begins 180 days after publication of the final guidance.
Richard Pazdur, director, FDA Oncology Center of Excellence and acting director, Office of Oncologic Diseases, FDA Center for Drug Evaluation and Research, said: “These plans may help ensure that sponsors are thinking critically and intentionally about the many characteristics of the patient population they aim to treat when designing their clinical study.”