FDA Introduces New Program To Promote Greater Diversity in Cancer Clinical Trials

Agency hopes the program will result in cancer treatment clinical trials that represent all patient demographics.

Federal health officials have launched a new program designed to improve access to cancer clinical trials for historically underrepresented groups, with the goal of expanding access to emerging treatments and medical devices.

The U.S. Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE) announced the OCE Equity program on May 20. The program focuses on access to oncology clinical research for racial and ethnic minorities, as well as other groups that have experienced barriers to healthcare.

Clinical trials test a drug, medical device, or other medical intervention on willing participants in the hope the trial can provide a new treatment for the disease or condition. However, historically, clinical trials have overwhelmingly involved white men, underrepresenting women and minority groups.

Researchers previously excluded women, racial and ethnic minorities to ensure the data was consistent and reliable. It wasn’t until 1993 that congress passed a law requiring the inclusion of women and minority groups in clinical trials, but many researchers still fail to adequately test their products and devices on groups that represent the wider population.

This practice has resulted in several health concerns specific to underrepresented groups not being detected until drugs or medical devices were already widely in use. For example, concerns about the safety and accuracy of pulse oximeters for people with darker skin were long raised by the medical community, as far back as the 1980s, but were ignored by federal regulators.

Additionally, the FDA often approves pediatric heart devices without clinical trials involving children. Instead, manufacturers use data from adults to determine the safety of devices on children. Children face unique physiological and drug dosing requirements.

The OCE Equity Program is an expansion of the FDA’s Project Equity, which was established in 2021 to ensure that cancer treatment clinical trial data submitted to the FDA includes representation of all patient demographics, especially those for whom the medical products were intended.

The expansion is an effort to increase access to cancer clinical trials for racial and ethnic minorities, patients living in rural areas, sexual and gender minorities, and patients with economic, language, or cultural barriers to healthcare services. These groups can include patients with various types of cancer who need new or different treatments but may live hundreds of miles from clinical trial centers, transgendered patients who face unique treatment difficulties, low-income patients who have trouble accessing care, and patients whose first language is not English.

The FDA hopes the program will result in:

• Developing policies to help enroll underrepresented groups and vulnerable subgroups into oncology clinical trials and move beyond barriers to access.
• Collaboration on research, policy, and educational initiatives to promote access to clinical trials.
• Presenting analyses of data from diverse clinical trials to promote the development of research that benefits all patients.

Those with questions about the program can contact the FDA at OCE-Equity@fda.hhs.gov.