The US Food and Drug Administration wants to see more diversity in the patient advocacy groups and community organizations with which biopharma sponsors engage as they develop and implement clinical trial diversity plans.
Key Takeaways
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Sponsors are urged to consult with patient advocacy organizations and community-based groups in the development and implementation of clinical trial diversity plans.
With almost two years of reviewing diversity plans under its belt, the FDA’s oncology review staff is concerned that sponsors...
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