Clinical Trial Diversity Campaign Distracting From Health Equity Problems, Califf Says
The FDA commissioner says that improving health disparities would fix the lack of diversity in clinical trials.
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Even if the agency had the legal power, it likely did not have the resources to oversee all clinical trials, rather than only those that qualified under the IND regulations, but the extra oversight could have increased coordination and ensured more data was fit for regulatory purposes.
NIH Director Nominee Monica Bertagnolli is on board with both agencies working to better determine how approved treatments work in the real-world, FDA Commissioner Robert Califf said.
The director of the US FDA’s Center for Drug Evaluation and Research acknowledged that the FDA cannot improve trial diversity alone.