Biomarker-adaptive clinical trial designs

The Cross-Validated Adaptive Signature Design

(2010) B. Freidlin et al.   CLINICAL CANCER RESEARCH

A threshold sample-enrichment approach in a clinical trial with heterogeneous subpopulations

(2010) Aiyi Liu et al.   Clinical Trials

Predictive biomarker validation in practice: lessons from real trials

(2010) Sumithra J Mandrekar et al.   Clinical Trials

Randomized Clinical Trials With Biomarkers: Design Issues

(2010) B. Freidlin et al.   JNCI-Journal of the National Cancer Institute

A Comparison of Phase II Study Strategies

(2009) S. Hunsberger et al.   CLINICAL CANCER RESEARCH

I-SPY 2: An Adaptive Breast Cancer Trial Design in the Setting of Neoadjuvant Chemotherapy

(2009) AD Barker et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

Clinical trial designs for evaluating the medical utility of prognostic and predictive biomarkers in oncology

(2009) Richard Simon   Personalized Medicine

Multi-Arm Clinical Trials of New Agents: Some Design Considerations

(2008) B. Freidlin et al.   CLINICAL CANCER RESEARCH

Monitoring for Lack of Benefit: A Critical Component of a Randomized Clinical Trial

(2008) Boris Freidlin et al.   JOURNAL OF CLINICAL ONCOLOGY

Adaptive designs: Looking for a needle in the haystack—A new challenge in medical research

(2007) Peter Bauer   STATISTICS IN MEDICINE