4.6 Review

Study Designs and Statistical Analyses for Biomarker Research

Related references

Note: Only part of the references are listed.
Review Pathology

Integrating biomarkers in clinical trials

Marc Buyse et al.

EXPERT REVIEW OF MOLECULAR DIAGNOSTICS (2011)

Review Medicine, General & Internal

Comparison of Effect Sizes Associated With Biomarkers Reported in Highly Cited Individual Articles and in Subsequent Meta-analyses

John P. A. Ioannidis et al.

JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION (2011)

Article Pharmacology & Pharmacy

A statistician's perspective on biomarkers in drug development

Martin Jenkins et al.

PHARMACEUTICAL STATISTICS (2011)

Article Mathematical & Computational Biology

Regulatory Issues in use of Biomarkers in Oncology Trials

Aloka G. Chakravarty et al.

STATISTICS IN BIOPHARMACEUTICAL RESEARCH (2011)

Article Oncology

The Cross-Validated Adaptive Signature Design

Boris Freidlin et al.

CLINICAL CANCER RESEARCH (2010)

Article Medicine, Research & Experimental

The efficiency of clinical trial designs for predictive biomarker validation

K. Y. Young et al.

CLINICAL TRIALS (2010)

Article Medicine, Research & Experimental

Bayesian adaptive randomization designs for targeted agent development

J. Jack Lee et al.

CLINICAL TRIALS (2010)

Editorial Material Oncology

Randomized Clinical Trials With Biomarkers: Design Issues

Boris Freidlin et al.

JOURNAL OF THE NATIONAL CANCER INSTITUTE (2010)

Article Oncology

The False Discovery Rate: A Key Concept in Large-Scale Genetic Studies

James J. Chen et al.

CANCER CONTROL (2010)

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)

Article Medicine, General & Internal

Cytochrome P-450 Polymorphisms and Response to Clopidogrel.

Jessica L. Mega et al.

NEW ENGLAND JOURNAL OF MEDICINE (2009)

Article Oncology

The Use of Genomics in Clinical Trial Design

Richard Simon

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 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

Biomarkers in cancer staging, prognosis and treatment selection

JA Ludwig et al.

NATURE REVIEWS CANCER (2005)

Article Medicine, General & Internal

Trastuzumab after adjuvant chemotherapy in HER2-positive breast cancer

MJ Piccart-Gebhart et al.

NEW ENGLAND JOURNAL OF MEDICINE (2005)

Review Oncology

Clinical trial designs for predictive marker validation in cancer treatment trials

DJ Sargent et al.

JOURNAL OF CLINICAL ONCOLOGY (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)

Review Biotechnology & Applied Microbiology

Clinical biomarkers in drug discovery and development

R Frank et al.

NATURE REVIEWS DRUG DISCOVERY (2003)

Article Cardiac & Cardiovascular Systems

B-type natriuretic peptide predicts sudden death in patients with chronic heart failure

R Berger et al.

CIRCULATION (2002)

Article Medicine, General & Internal

Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2.

DJ Slamon et al.

NEW ENGLAND JOURNAL OF MEDICINE (2001)

Article Medicine, General & Internal

Subgroup analysis and other (mis)uses of baseline data in clinical trials

SF Assmann et al.

LANCET (2000)