Developing biomarker-based tools for cancer screening, diagnosis, and treatment : the state of the science, evaluation, implementation, and economics : workshop summary / Margie Patlak and Sharyl Nass, rapporteurs ; National Cancer Policy Forum.

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Bibliographic Details
Main Author: Patlak, Margie
Corporate Authors: National Cancer Policy Forum (U.S.), United States. Department of Health and Human Services
Other Authors: Nass, Sharyl J.
Format: eBook
Language:English
Published: Washington, D.C. : National Academies Press, ©2006.
Subjects:
Online Access:Click for online access
Table of Contents:
  • Cover
  • Reviewers
  • Contents
  • Introduction
  • Overview of Technologies Used to Discover Cancer Biomarkers
  • Genomics, Proteomics, and Metabolomics
  • Molecular Imaging
  • Meeting the Technical Challenges of Biomarker Validation and Qualification
  • Coordinating the Development of Biomarkers and Targeted Therapies
  • Therapeutics Industry Perspective
  • Diagnostics Industry Perspective
  • NCI Perspective
  • Clinical Investigator Perspective
  • Biomarker Development and Regulatory Oversight
  • FDA Critical Path Initiative
  • Oversight of Diagnostic Tests
  • Designing Clinical Studies of Biomarkers
  • Assessment and Adoption of Biomarker-Based Technologies
  • Federal Programs for Technology Assessment
  • Insurance Coverage Decisions and Practice Guidelines
  • CMS Coverage of Biomarkers
  • Economic Impact of Biomarkers
  • Cost-Effectiveness Analysis
  • The Value of Information and Research
  • Technology Assessment in the Private Sector
  • Clinical Development Strategies for Biomarker Utilization Discussion
  • Strategies for Implementing Standardized Biorepositories Discussion
  • Strategies for Determining Analytic Validity and Clinical Utility of Biomarkers Discussion
  • Strategies to Develop Biomarkers for Early Detection Discussion
  • Mechanisms for Developing an Evidence Base Discussion
  • Evaluation of Evidence in Decision Making Discussion
  • Incorporating Biomarker Evidence Into Clinical Practice Discussion
  • Acronyms
  • Glossary
  • References
  • Appendixes
  • Appendix A Workshop Agenda
  • Appendix B Workshop Speakers, Moderators, Invited Discussants, and Participants
  • Last Page.