Oncology Clinical Trial Eligibility Expansion A Focus For US FDA; Sponsors Overcoming Initial Hesitation
US FDA plans to release a second set of guidances to industry; sponsors caution that tradeoffs need to be clear from onset.
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Oncology Center of Excellence director said clinical trial participation may increase if the research questions are ‘significant to answer.’
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.
NCI networks had vast under accrual in the past year, but Sharpless says industry has been affected to a greater degree. He says the institute also has been better at accruing minority patients.