US FDA Project Protect Oncology Safety Program In Broad Use After Quiet Launch
Project Protect is the Oncology Center of Excellence’s latest program to support cancer drug development; the safety signal tool has been used to support 44 drug applications.
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OCE Director Richard Pazdur says idea for the latest initiative stemmed from a clinical trial in lung cancer that he thought only needed to measure the impact on overall survival.
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.
Rapid, uncoordinated growth has turned the PD-1/L1 inhibitor pipeline into a global stampede, FDA’s Pazdur and Beaver say. Solutions like a unified submission pathway and coordinated trial design pose challenges requiring international cooperation among governments and industry alike.