US FDA Calls For Clinical Trial Diversity Plan ‘As Soon As Practicable’ In Product Development
Draft guidance outlines Race and Diversity Plan that would reify some of FDA’s efforts to increase racial and ethnic diversity in clinical trials with a mechanism that is applicable from IND through approval.
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PhRMA is funding an initiative to establish a network of sustainable, community-based trial sites. During 18-month proof of concept phase, 10 sites will receive training, technical support and mentorship.
Project Site Selector will allow FDA Oncology Center of Excellence staff to discuss site selection process with industry and potentially help improve clinical trial diversity efforts.
Oncology Center of Excellence Director Richard Pazdur asked whether the FDA should have more conversations with sponsors about site selection and percentages of US participants.