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
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
Bibliography
Includes bibliographical references (page 92)
Notes
Study supported by contracts between the National Academy of Sciences and the Dept. of Health and Human Services HHSH25056133 HHSN261200611002C 200-2005-13434 HHSM-500-2005-00179P HHSP23320042509XI 223-01-2460
