Biomarker Qualification: Toward a Multiple Stakeholder Framework for Biomarker Development, Regulatory Acceptance, and Utilization

Catalyzing the critical path initiative: FDA's progress in drug development activities

(2015) A Parekh et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS

VALIDATION OF SURROGATE ENDPOINTS IN ADVANCED SOLID TUMORS: SYSTEMATIC REVIEW OF STATISTICAL METHODS, RESULTS, AND IMPLICATIONS FOR POLICY MAKERS

(2014) Oriana Ciani et al.   INTERNATIONAL JOURNAL OF TECHNOLOGY ASSESSMENT IN HEALTH CARE

Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012

(2014) Nicholas S. Downing et al.   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Biomarkers: refining diagnosis and expediting drug development - reality, aspiration and the role of open innovation

(2014) H. Salter et al.   JOURNAL OF INTERNAL MEDICINE

Policy: NIH plans to enhance reproducibility

(2014) Francis S. Collins et al.   NATURE

The Predictive Safety Testing Consortium and the Coalition Against Major Diseases

(2014) Diane Stephenson et al.   NATURE REVIEWS DRUG DISCOVERY

The Biomarkers Consortium

(2014) David Wholley   NATURE REVIEWS DRUG DISCOVERY

Power failure: why small sample size undermines the reliability of neuroscience

(2013) Katherine S. Button et al.   NATURE REVIEWS NEUROSCIENCE

Biomarkers in drug development and regulation: a paradigm for clinical implementation of personalized medicine

(2011) Issam Zineh et al.   Biomarkers in Medicine

Believe it or not: how much can we rely on published data on potential drug targets?

(2011) Florian Prinz et al.   NATURE REVIEWS DRUG DISCOVERY

Regulatory Issues in use of Biomarkers in Oncology Trials

(2011) Aloka G. Chakravarty et al.   Statistics in Biopharmaceutical Research

Acceptance of Biomarker-Based Tests for Application in Clinical Practice: Criteria and Obstacles

(2010) M Pirmohamed   CLINICAL PHARMACOLOGY & THERAPEUTICS

A Bayesian Approach to Surrogacy Assessment Using Principal Stratification in Clinical Trials

(2009) Yun Li et al.   BIOMETRICS

The Value, Qualification, and Regulatory Use of Surrogate End Points in Drug Development

(2009) CD Lathia et al.   CLINICAL PHARMACOLOGY & THERAPEUTICS