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Clinical Trial Diversity Requires Sponsors Work With An Assortment Of Patient Advocates, Community Organizations

 
• By Sue Sutter

US FDA oncology officials are concerned that the entities sponsors are consulting in developing and implementing clinical trial diversity plans are not sufficiently diverse themselves and do not represent patients in underserved communities.

Casting net
Sponsors need to cast a wider net when consulting patient advocacy and community-based organizations for help on clinical trial diversity plans. • Source: Shutterstock

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

  • 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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