A hybrid phase I‐II/III clinical trial design allowing dose re‐optimization in phase III

A Hybrid Geometric Phase II/III Clinical Trial Design based on Treatment Failure Time and Toxicity.

The problem of comparing several experimental treatments to a standard arises frequently in medical research. Various multi-stage randomized phase II/III designs have been proposed that select one or more promising experimental treatments and compare them to the standard while controlling overall Type I and Type II error rates. This paper addresses phase II/III settings where the joint goals ar...

Phase I Clinical Trial Design

Design of Phase III Clinical Trials

Run-in phase III trial design with pharmacodynamics predictive biomarkers.

BACKGROUND Developments in biotechnology have stimulated the use of predictive biomarkers to identify patients who are likely to benefit from a targeted therapy. Several randomized phase III designs have been introduced for development of a targeted therapy using a diagnostic test. Most such designs require biomarkers measured before treatment. In many cases, it has been very difficult to ident...

Design of a phase III clinical trial with prospective biomarker validation: SWOG S0819.

The role of cetuximab in the treatment of advanced non-small cell lung cancer (NSCLC) is currently unclear. The molecular target of cetuximab, epidermal growth factor receptor (EGFR), as measured by FISH, has shown potential as a predictive biomarker for cetuximab efficacy in NSCLC. SWOG S0819 is a phase III trial evaluating both the value of cetuximab in this setting and EGFR FISH as a predict...