4.2 Review

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

Related references

Note: Only part of the references are listed.
Article Pharmacology & Pharmacy

Clinical Trial Designs for Predictive Biomarker Validation: One Size Does Not Fit All

Sumithra J. Mandrekar et al.

JOURNAL OF BIOPHARMACEUTICAL STATISTICS (2009)

Editorial Material Oncology

Use of Archived Specimens in Evaluation of Prognostic and Predictive Biomarkers

Richard M. Simon et al.

JOURNAL OF THE NATIONAL CANCER INSTITUTE (2009)

Article Oncology

The Use of Genomics in Clinical Trial Design

Richard Simon

CLINICAL CANCER RESEARCH (2008)

Article Oncology

Validation of Analytic Methods for Biomarkers Used in Drug Development

Cindy H. Chau et al.

CLINICAL CANCER RESEARCH (2008)

Article Oncology

Randomized phase III clinical trial designs for targeted agents

Antje Hoering et al.

CLINICAL CANCER RESEARCH (2008)

Review Oncology

Development of the 21-gene assay and its application in clinical practice and clinical trials

Joseph A. Sparano et al.

JOURNAL OF CLINICAL ONCOLOGY (2008)

Article Oncology

HER2 status and efficacy of adjuvant anthracyclines in early breast cancer:: A pooled analysis of randomized trials

Alessandra Gennari et al.

JNCI-JOURNAL OF THE NATIONAL CANCER INSTITUTE (2008)

Review Multidisciplinary Sciences

The cancer biomarker problem

Charles L. Sawyers

NATURE (2008)

Article Medicine, General & Internal

K-ras mutations and benefit from cetuximab in advanced colorectal cancer

Christos S. Karapetis et al.

NEW ENGLAND JOURNAL OF MEDICINE (2008)

Article Medicine, General & Internal

HER2 and response to paclitaxel in node-positive breast cancer

Daniel F. Hayes et al.

NEW ENGLAND JOURNAL OF MEDICINE (2007)

Article Mathematical & Computational Biology

A method for testing a prespecified subgroup in clinical trials

Yang Song et al.

STATISTICS IN MEDICINE (2007)

Article Pharmacology & Pharmacy

Approaches to evaluation of treatment effect in randomized clinical trials with genomic subset

Sue-Jane Wang et al.

PHARMACEUTICAL STATISTICS (2007)

Review Oncology

Gene signature evaluation as a prognostic tool: challenges in the design of the MINDACT trial

Jan Bogaerts et al.

NATURE CLINICAL PRACTICE ONCOLOGY (2006)

Article Genetics & Heredity

Use of genomic signatures in therapeutics development in oncology and other diseases

R. Simon et al.

PHARMACOGENOMICS JOURNAL (2006)

Article Biochemical Research Methods

Prediction error estimation: a comparison of resampling methods

AM Molinaro et al.

BIOINFORMATICS (2005)

Article Mathematical & Computational Biology

On the efficiency of targeted clinical trials

A Maitournam et al.

STATISTICS IN MEDICINE (2005)

Article Genetics & Heredity

Clinical trial designs for prospective validation of biomarkers

SJ Mandrekar et al.

AMERICAN JOURNAL OF PHARMACOGENOMICS (2005)

Article Medicine, General & Internal

A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer

S Paik et al.

NEW ENGLAND JOURNAL OF MEDICINE (2004)

Article Oncology

Evaluating the efficiency of targeted designs for randomized clinical trials

R Simon et al.

CLINICAL CANCER RESEARCH (2004)

Article Public, Environmental & Occupational Health

Limitations of the odds ratio in gauging the performance of a diagnostic, prognostic, or screening marker

MS Pepe et al.

AMERICAN JOURNAL OF EPIDEMIOLOGY (2004)