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

  • Formāts: 112 pages
  • Izdošanas datums: 18-Oct-2006
  • Izdevniecība: National Academies Press
  • Valoda: eng
  • ISBN-13: 9780309658140
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  • Formāts: 112 pages
  • Izdošanas datums: 18-Oct-2006
  • Izdevniecība: National Academies Press
  • Valoda: eng
  • ISBN-13: 9780309658140
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Research has long sought to identify biomarkers that could detect cancer at an early stage, or predict the optimal cancer therapy for specific patients. Fueling interest in this research are recent technological advances in genomics, proteomics, and metabolomics that can enable researchers to capture the molecular fingerprints of specific cancers and fine-tune their classification according to the molecular defects they harbor. The discovery and development of new markers of cancer could potentially improve cancer screening, diagnosis, and treatment. Given the potential impact cancer biomarkers could have on the cost effectiveness of cancer detection and treatment, they could profoundly alter the economic burden of cancer as well. Despite the promise of cancer biomarkers, few biomarker-based cancer tests have entered the market, and the translation of research findings on cancer biomarkers into clinically useful tests seems to be lagging. This is perhaps not surprising given the technical, financial, regulatory, and social challenges linked to the discovery, development, validation, and incorporation of biomarker tests into clinical practice. To explore those challenges and ways to overcome them, the National Cancer Policy Forum held the conference "Developing Biomarker-Based Tools for Cancer Screening, Diagnosis and Treatment: The State of the Science, Evaluation, Implementation, and Economics" in Washington, D.C., from March 20 to 22, 2006. At this conference, experts gave presentations in one of six sessions. In addition, seven small group discussions explored the policy implications surrounding biomarker development and adoption into clinical practice. Developing Biomarker-based Tools for Developing Cancer Screening, Diagnosis, and Treatment: The State of the Science, Evaluation, Implementation, and Economics-Workshop Summary presents the conference proceedings and will be used by an Institute of Medicine (IOM) committee to develop consensus-based recommendations for moving the field of cancer biomarkers forward.
Developing Biomarker-Based Tools for Cancer Screening, Diagnosis, and Treatment: The State of the Science, Evaluation, Implementation, and Economics
Introduction
1(2)
Overview of Technologies Used to Discover Cancer Biomarkers
3(8)
Genomics, Proteomics, and Metabolomics
3(6)
Molecular Imaging
9(2)
Meeting the Technical Challenges of Biomarker Validation and Qualification
11(9)
Coordinating the Development of Biomarkers and Targeted Therapies
20(9)
Therapeutics Industry Perspective
21(3)
Diagnostics Industry Perspective
24(2)
NCI Perspective
26(2)
Clinical Investigator Perspective
28(1)
Biomarker Development and Regulatory Oversight
29(10)
FDA Critical Path Initiative
30(2)
Oversight of Diagnostic Tests
32(4)
Designing Clinical Studies of Biomarkers
36(3)
Assessment and Adoption of Biomarker-Based Technologies
39(9)
Federal Programs for Technology Assessment
40(3)
Insurance Coverage Decisions and Practice Guidelines
43(3)
CMS Coverage of Biomarkers
46(2)
Economic Impact of Biomarkers
48(9)
Cost-Effectiveness Analysis
48(5)
The Value of Information and Research
53(1)
Technology Assessment in the Private Sector
53(4)
Clinical Development Strategies for Biomarker Utilization Discussion
57(4)
Strategies for Implementing Standardized Biorepositories Discussion
61(5)
Strategies for Determining Analytic Validity and Clinical Utility of Biomarkers Discussion
66(3)
Strategies to Develop Biomarkers for Early Detection Discussion
69(4)
Mechanisms for Developing an Evidence Base Discussion
73(3)
Evaluation of Evidence in Decision Making Discussion
76(4)
Incorporating Biomarker Evidence into Clinical Practice Discussion
80(5)
Acronyms
85(1)
Glossary
86(6)
References
92
APPENDIXES
Workshop Agenda
93(6)
Workshop Speakers, Moderators, Invited Discussants, and Participants
99
Margie Patlak and Sharyl Nass, Rapporteurs