Title: Design of a phase III clinical trial with prospective biomarker validation: SWOG S0819 Authors and Affiliations:
نویسندگان
چکیده
Running Title: On the design of SWOG S0819
منابع مشابه
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...
متن کاملModeling the relationship between progression-free survival and overall survival: the phase II/III trial.
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 ...
متن کاملRandomized phase II trial designs with biomarkers.
Efficient development of targeted therapies that may only benefit a fraction of patients requires clinical trial designs that use biomarkers to identify sensitive subpopulations. Various randomized phase III trial designs have been proposed for definitive evaluation of new targeted treatments and their associated biomarkers (eg, enrichment designs and biomarker-stratified designs). Before proce...
متن کاملDesign of clinical trials for biomarker research in oncology.
The developmental pathway from discovery to clinical practice for biomarkers and biomarker-directed therapies is complex. While several issues need careful consideration, two critical issues that surround the validation of biomarkers are the choice of clinical trial design (which is based on the strength of the preliminary evidence and marker prevalence) and the biomarker assay related issues s...
متن کاملBiomarker-adaptive threshold design: a procedure for evaluating treatment with possible biomarker-defined subset effect.
BACKGROUND Many molecularly targeted anticancer agents entering the definitive stage of clinical development benefit only a subset of treated patients. This may lead to missing effective agents by the traditional broad-eligibility randomized trials due to the dilution of the overall treatment effect. We propose a statistically rigorous biomarker-adaptive threshold phase III design for settings ...
متن کامل