Seamless Designs: Current Practice and Considerations for Early-Phase Drug Development in Oncology.

Volume: 111, Issue: 2, Pages: 118 - 128
Published: Feb 1, 2019
Abstract
Traditionally, drug development has evaluated dose, safety, activity, and comparative benefit in a sequence of phases using trial designs and endpoints specifically devised for each phase. Innovations in drug development seek to consolidate the phases and rapidly expand accrual with null trial designs. Although consolidation and rapid accrual may yield efficiencies, widespread use of seamless first-in-human (FiH) trials without careful...
Paper Details
Title
Seamless Designs: Current Practice and Considerations for Early-Phase Drug Development in Oncology.
Published Date
Feb 1, 2019
Volume
111
Issue
2
Pages
118 - 128
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