SILVER
SPRING, Md., June 26,
2024 /PRNewswire/ -- Today, the U.S. Food and
Drug Administration issued a draft guidance, "Diversity Action
Plans to Improve Enrollment of Participants from Underrepresented
Populations in Clinical Studies," to assist medical product
sponsors in submitting Diversity Action Plans to support certain
clinical studies. Diversity Action Plans are intended to increase
clinical study enrollment of participants of historically
underrepresented populations to help improve the data the agency
receives about the patients who may potentially use the medical
product.
Enhancing diversity within clinical studies not only facilitates
broader applicability of results across a broad spectrum of patient
populations, but also enhances understanding of the disease or
medical product under study, thus providing valuable insights to
inform the safe and effective use of the medical product among
patients.
"Participants in clinical trials should be representative of
the patients who will use the medical products," said FDA
Commissioner Robert M. Califf, M.D.
"The agency's draft guidance is an important step—and one of many
ongoing efforts—to address the participation of underrepresented
populations in clinical trials to help improve the data we
have about patients who will use the medical products if
approved."
This draft guidance describes the format and content of
Diversity Action Plans, the medical products and clinical studies
for which a Diversity Action Plan is required, as well as the
timing and process for submitting Diversity Action Plans to the
FDA. The draft guidance also outlines the criteria and process the
agency will use to evaluate a sponsor's request not to submit a
required Diversity Action Plan, also known as a waiver.
Diversity Action Plans must specify the sponsor's rationale and
goals for clinical study enrollment (separated by the age group,
ethnicity, sex and race of clinically relevant study populations)
and describe how the sponsor intends to meet those goals. The
guidance also urges sponsors and investigators to consider the many
dimensions of clinical trial diversity, even those that extend
beyond age, ethnicity, sex, and race to enroll populations that
represent the patients who will be treated if the product is
approved.
The requirement for sponsors to submit Diversity Action Plans
comes from new provisions of the Federal Food, Drug and Cosmetic
Act added by the Food and Drug Omnibus Reform Act (FDORA). These
plans apply to phase 3 clinical studies or, as appropriate, other
pivotal clinical studies of a drug or biological product, as well
as for certain clinical studies of devices, including those
intended to serve as the primary basis for the FDA's evaluation of
the safety and effectiveness and benefit-risk determination of the
device. The requirement to submit a Diversity Action Plan applies
to clinical studies for which enrollment begins 180 days after
publication of the final guidance.
"Generating data for a broader and more representative
population early in the clinical development program is among the
FDA's priorities to bring innovative medical products to the
public. With FDORA, there is now a requirement for sponsors to
submit diversity action plans. 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," said Richard Pazdur, M.D., director of the FDA's
Oncology Center of Excellence and acting director of the Office of
Oncologic Diseases in the FDA's Center for Drug Evaluation and
Research."
The draft guidance was developed by the Oncology Center of
Excellence Project Equity in collaboration with 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.
Comments on the draft guidance should be submitted within 90
days after publication in the Federal Register to Regulations.gov.
All written comments should be identified with the docket number
and with the title of the guidance document.
Additional Resources:
- Diversity Action Plans to Improve Enrollment of Participants
from Underrepresented Populations in Clinical Studies
Media Contact: Lauren-Jei
McCarthy, 240-702-3940
Consumer Inquiries: 888-INFO-FDA
The FDA, an agency within the U.S. Department
of Health and Human Services, protects the public health by
assuring the safety, effectiveness, and security of human and
veterinary drugs, vaccines and other biological products for human
use, and medical devices. The agency also is responsible for the
safety and security of our nation's food supply, cosmetics, dietary
supplements, radiation-emitting electronic products, and for
regulating tobacco products.
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SOURCE U.S. Food and Drug Administration