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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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Levy Dental Medicine Library - Stacks RC270.3.T84 P38 2006
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Format:
Book
Author/Creator:
Patlak, Margie.
Contributor:
Nass, Sharyl J.
National Cancer Policy Forum (U.S.)
United States. Department of Health and Human Services.
Language:
English
Subjects (All):
Tumor markers--Congresses.
Tumor markers.
Neoplasms--prevention & control.
Mass Screening--methods.
Biomarkers, Tumor--analysis.
Medical Subjects:
Neoplasms--prevention & control.
Mass Screening--methods.
Biomarkers, Tumor--analysis.
Genre:
Conference papers and proceedings.
Physical Description:
x, 102 pages : illustrations ; 23 cm
Place of Publication:
Washington, D.C. : National Academies Press, [2006]
Contents:
Overview of Technologies Used to Discover Cancer Biomarkers 3
Genomics, Proteomics, and Metabolomics 3
Molecular Imaging 9
Meeting the Technical Challenges of Biomarker Validation and Qualification 11
Coordinating the Development of Biomarkers and Targeted Therapies 20
Therapeutics Industry Perspective 21
Diagnostics Industry Perspective 24
NCI Perspective 26
Clinical Investigator Perspective 28
Biomarker Development and Regulatory Oversight 29
FDA Critical Path Initiative 30
Oversight of Diagnostic Tests 32
Designing Clinical Studies of Biomarkers 36
Assessment and Adoption of Biomarker-Based Technologies 39
Federal Programs for Technology Assessment 40
Insurance Coverage Decisions and Practice Guidelines 43
CMS Coverage of Biomarkers 46
Economic Impact of Biomarkers 48
Cost-Effectiveness Analysis 48
The Value of Information and Research 53
Technology Assessment in the Private Sector 53
Clinical Development Strategies for Biomarker Utilization Discussion 57
Strategies for Implementing Standardized Biorepositories Discussion 61
Strategies for Determining Analytic Validity and Clinical Utility of Biomarkers Discussion 66
Strategies to Develop Biomarkers for Early Detection Discussion 69
Mechanisms for Developing an Evidence Base Discussion 73
Evaluation of Evidence in Decision Making Discussion 76
Incorporating Biomarker Evidence into Clinical Practice Discussion 80
A Workshop Agenda 93
B Workshop Speakers, Moderators, Invited Discussants, and Participants 99.
Notes:
Includes bibliographical references (page 92).
ISBN:
0309101344
9780309101349
OCLC:
70874173

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