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

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 "seamless" trial designs. Although consolidation and rapid accrual may yield efficiencies, widespread use of seamless first-in-human (FiH) trials without careful consideration of objectives, statistical analysis plans, or trial oversight raises concerns. A working group formed by the National Cancer Institute convened to consider and discuss opportunities and challenges for such trials as well as encourage responsible use of these designs. We reviewed all abstracts presented at American Society of Clinical Onco

SUBMITTER: Hobbs BP 

PROVIDER: S-EPMC6376915 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature