US FDA’s Pazdur Suggests NCI Should Help Sponsors Enroll Clinical Trials For Innovative Drugs
Oncology sponsors would handle ex-US trial enrollment, but Pazdur feels tapping into the NCI network would improve trial speed and diversity. Biggest challenge will likely be generating sponsor enthusiasm for move that would involve giving up some control of development.
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Former NCI Director Monica Bertagnolli, who now is head of the NIH, said FDA, NCI and National Clinical Trials Network officials are working on potential clinical trial system innovations.
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.