FDA Draft Guide Recommends Seamless Trials For Drugs That Fulfill Unmet Clinical Need, Treat Pediatric Cancers

August 10, 2018
FDA issued draft guidance Friday (Aug. 10) intended to help streamline the drug development process for cancer drugs and biological products by providing sponsors with advice on how they can design and conduct seamless clinical trials, which allow drug developers to conduct one continuous trial and avoid the stops and starts associated with traditional three-phase trials. While seamless trials pose risks, the agency says sponsors can mitigate those risks by monitoring and assessing data in real-time; quickly responding to and...

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