US FDA’s Project Site Selector Kicks Off With A Look At Why Cancer Trials Go Overseas
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.
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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.
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.
FDA’s top cancer drug regulator is urging industry to increase diversity in trial populations in the name of re-establishing trust in medicine. A webcast to discuss the topic also showcased a bit of industry trust-building in action.