Modeling the relationship between progression-free survival and overall survival: the phase II/III trial.

ABSTRACT: The standard phase II trial design has changed dramatically over the past decade. Randomized phase II studies have essentially become the standard phase II design in oncology for a variety of reasons. The use of these designs is motivated by concerns about the use of historical data to determine if a new agent or regimen shows promise of activity. However, randomized phase II designs come with the cost of increased study duration and patient resources. Progression-free survival (PFS) is an important endpoint used in many phase II designs. In many clinical settings, changes in PFS with the introduction of a new treatment may represent true benefit in terms of the gold standard outcome, overall survival (OS). The phase II/III design has been proposed as an approach to shorten the time of dis

SUBMITTER: Redman MW 

PROVIDER: S-EPMC4131693 | biostudies-literature | 2013 May

REPOSITORIES: biostudies-literature