Could The US FDA Set Clinical Trial Diversity Minimums?
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.
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The director of the US FDA’s Center for Drug Evaluation and Research acknowledged that the FDA cannot improve trial diversity alone.
No negative actions have been taken in the US FDA’s oncology review divisions, but vague diversity guidance continues to raise concerns.
Speed, logistics and global regulatory demands are all reasons why sponsors increasingly look outside the US to enroll cancer trials, industry reps say during the inaugural event for the Oncology Center of Excellence's new initiative; OCE director Pazdur says multiregional trials can help provide patients access to important new drugs quickly in the US or worldwide.