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

By Beth Wang / August 10, 2018 at 5:43 PM
FDA issued draft guidance Friday (Aug. 10) intended to help streamline the drug development process for cancer drugs and biological products by providing sponsors with advice on how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...

Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.