Developing Biomarker-based Tools for Cancer Screening, Diagnosis, and Treatment: The State of the Science, Evaluation, Implementation, and Economics Workshop Summary

Front Matter
......Page 2
Contents
......Page 10
Introduction
......Page 12
Genomics, Proteomics, and Metabolomics......Page 14
Molecular Imaging......Page 20
Meeting the Technical Challenges of Biomarker Validation and Qualification......Page 22
Coordinating the Development of Biomarkers and Targeted Therapies......Page 31
Therapeutics Industry Perspective......Page 32
Diagnostics Industry Perspective......Page 35
NCI Perspective......Page 37
Clinical Investigator Perspective......Page 39
Biomarker Development and Regulatory Oversight......Page 40
FDA Critical Path Initiative......Page 41
Oversight of Diagnostic Tests......Page 43
Designing Clinical Studies of Biomarkers......Page 47
Assessment and Adoption of Biomarker-Based Technologies......Page 50
Federal Programs for Technology Assessment......Page 51
Insurance Coverage Decisions and Practice Guidelines......Page 54
CMS Coverage of Biomarkers......Page 57
Cost-Effectiveness Analysis......Page 59
Technology Assessment in the Private Sector......Page 64
Clinical Development Strategies for Biomarker Utilization Discussion......Page 68
Strategies for Implementing Standardized Biorepositories Discussion......Page 72
Strategies for Determining Analytic Validity and Clinical Utility of Biomarkers Discussion......Page 77
Strategies to Develop Biomarkers for Early Detection Discussion......Page 80
Mechanisms for Developing an Evidence Base Discussion......Page 84
Evaluation of Evidence in Decision Making Discussion......Page 87
Incorporating Biomarker Evidence into Clinical Practice Discussion......Page 91
Acronyms......Page 96
Glossary......Page 97
References......Page 103
Workshop Agenda......Page 104
Workshop Speakers, Moderators, Invited Discussants, and Participants......Page 110