FDA draft guidance outlines path to increased trial inclusivity

By Jenni Spinner

- Last updated on GMT

(Anna Semenchenko/iStock via Getty Images Plus)
(Anna Semenchenko/iStock via Getty Images Plus)

Related tags Fda Clinical trial diversity Food and drug administration Patient centricity diversity

The US agency’s latest draft document lays out guidelines to help increase involvement of underrepresented ethnic and racial populations in clinical research.

The US Food and Drug Administration (FDA) has issued a new draft guidance aimed at clinical research and drug development professionals, Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials; Draft Guidance for Industry​. The document is intended to help professionals enroll a larger number of participants from currently underrepresented US racial and ethnic groups into clinical trials.

Robert Califf, FDA commissioner, said that because the country’s population is increasingly diverse, proper representation in clinical studies is an important public health issue.

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​,” Califf said. “This guidance also further demonstrates how we support the Administration’s Cancer Moonshot goal of addressing inequities in cancer care, helping to ensure that every community in America has access to cutting-edge cancer diagnostics, therapeutics, and clinical trials.​”

While many diseases have a disproportionate burden on certain groups, such groups frequently are underrepresented in research into the conditions that heavily impact them. Therefore, the clinical research field has stepped up efforts to improve recruitment and representation, yet still struggles with achieving appropriately representative patient populations for most studies.

Robert Califf, commissioner, US Food and Drug Administration

For example, the FDA points out that genetic variations can lead to varying impact of a treatment from group to group—even leading to toxicity in certain populations. Additionally, variations also can make specific drugs (such as antidepressants and blood pressure medicines) less effective for one group than another.

In the draft guidance, the FDA recommends sponsors of medical products develop and submit a Race and Ethnicity Diversity Plan to the agency in the early stages of clinical development, based on the framework outlined in the guidance.

The guidance addresses a range of barriers to participation that racial and ethnic groups may face, including:

  • mistrust of the clinical research system due to historical abuses (such as the Tuskegee experiment, which studied syphilis in Black patients without full disclosure or proper care
  • aspects of the trial design like inadequate recruitment and retention efforts
  • frequency of study visits
  • time and resource constraints for participants
  • transportation and participation conflicting with caregiver or family responsibilities
  • language and cultural differences
  • gaps in health literacy
  • lack of awareness of what a clinical trial is and what participation entails.

The draft guidance is jointly issued by several offices, including:

  • Oncology Center of Excellence
  • Center for Drug Evaluation and Research
  • Center for Biologics Evaluation and Research
  • Center for Devices and Radiological Health
  • Office of the Commissioner, Office of Minority Health and Health Equity

In February, the Biden Administration revived the Cancer Moonshot​ initiative in order to step up the federal government’s efforts in cancer prevention, detection, research, and patient care efforts. In his role as FDA commissioner, Califf serves on the White House Cancer Cabinet, which also includes other departmental agencies and components organized to develop a unified strategy in the fight against the disease. 

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