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Abstract:
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Traditional clinical trial phases in oncology development are losing popularity to first-in-human trials expanded with appropriate patient populations. This newer paradigm may substantially cut years off the traditional clinical development time for NDA submission. Having entire drug development in a single protocol is particularly attractive for breakthrough therapies involving high unmet patient needs where shorter timelines are advantageous. However, such protocols can be highly problematic if they lack clear objectives, well-defined populations, and independent oversight. This roundtable invites your ideas, concerns, and experiences on how an expansion cohort trial can be efficiently designed to meet scientific, regulatory, and patient needs.
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