Clinical Trials Must Include Diversity Plan in FDA Applications

Many patients from rural areas and marginalized backgrounds are severely underrepresented in many clinical trials. To address this problem, the US Food and Drug Administration (FDA) has announced that in the near future, all clinical trials registered through the agency must contain a plan to ensure diversity in the participant population. The plan will take time, however, as the agency must issue a final guidance and wait for public input.

According to Max Kozlov, “When the make-up of a pool of participants doesn’t reflect the population that could benefit from a particular drug, it suggests that the clinical-research findings will not be relevant for everyone, says Marian Knight, a perinatal epidemiologist at the University of Oxford, UK. It also undermines trust in the medical establishment, she adds.”

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(Source: Nature, February 16^th, 2023)