Policy issues in the development and adoption of biomarkers for molecularly targeted cancer therapies : workshop summary /

A long-held goal in oncology has been to develop therapies that target the specific abnormalities in each patient's cancer rather than simply treating cancers based on the tissue of origin. In the past decade, advances in technology have enabled researchers to relatively quickly and inexpensive...

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Detalles Bibliográficos
Clasificación:Libro Electrónico
Autores principales: Nass, Sharyl J. (Autor), Phillips, Jonathan (Public health researcher) (Autor), Patlak, Margie (Autor)
Autor Corporativo: Policy Issues in the Development and Adoption of Molecularly Targeted Therapies for Cancer (Workshop)
Formato: Electrónico Congresos, conferencias eBook
Idioma:Inglés
Publicado: Washington, D.C. : National Academies Press, [2015]
Temas:
Cancer > Treatment > United States > Congresses.
Cancer > Genetic aspects > Congresses.
Biochemical markers > Congresses.
Neoplasms > drug therapy
Molecular Targeted Therapy
Cancer > Traitement > États-Unis > Congrès.
Cancer > Aspect génétique > Congrès.
Marqueurs biologiques > Congrès.
Biochemical markers
Cancer > Genetic aspects
Cancer > Treatment
United States
Congress
proceedings (reports)
Conference papers and proceedings
Conference papers and proceedings.
Actes de congrès.
Acceso en línea:Texto completo
Tabla de Contenidos:
  • Front Matter; Reviewers; Acknowledgments; Contents; Boxes, Figures, and Tables; Acronyms; Workshop Summary; INTRODUCTION; MOLECULAR BIOLOGY REVOLUTION IN CANCER DIAGNOSIS AND TREATMENT; Lessons Learned from Single Analyte Tests; Next-Generation Sequencing; RNA Sequencing Tests; Tests for Circulating Tumor DNA; Business Climate for Developing Diagnostic Tests; CHALLENGES IN BIOMARKER TEST DEVELOPMENT; Setting Standards; Assessing Analytical Validity, Clinical Validity, and Clinical Utility; Sharing Data; REGULATORY OVERSIGHT CHALLENGES; Evolving Regulation of Laboratory-Developed Tests
  • Companion DiagnosticsCLINICAL IMPLEMENTATION CHALLENGES; Insufficient or Inadequate Specimens; Tsunami of Information; Choosing the Best Test; Time Delays; Lack of Resources; Reporting Test Results; Incidental Findings; REIMBURSEMENT CHALLENGES; Lack of Evidence; Investigational and Off-Label Uses; Incidental Findings; Greater Expense, But Not Necessarily Greater Value; GATHERING THE EVIDENCE: INNOVATIVE CLINICAL TRIALS; Basket Trials; Lung-MAP Umbrella Trial; Challenges with Basket and Umbrella Trials; GATHERING THE EVIDENCE: COVERAGE DECISIONS; Coverage with Evidence Development
  • The MolDx Approach to Test ReimbursementGreen Park Collaborative Recommendations; GATHERING THE EVIDENCE: DATABASES AND REGISTRIES; My Cancer Genome; ClinGen; Targeted Agent and Molecular Profiling Utilization Registry; Challenges in Using Databases; EDUCATION AND CLINICAL DECISION SUPPORT NEEDS; Guidelines; Treatment Pathways; RESEARCH NEEDS; CLOSING REMARKS; REFERENCES; Appendix: Workshop Statement of Task and Agenda; POLICY ISSUES IN THE DEVELOPMENT AND ADOPTION OF MOLECULARLY TARGETED THERAPIES FOR CANCER

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