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

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

"One of the challenges in treating cancer is the disease's complexity and variation among patients. Cancer manifests differently in each patient, so treatments that are effective in one patient may not be effective in another. As cancer care becomes more personalized, subpopulations of ind...

Full description

Bibliographic Details
Main Author: Policy Issues in the Development and Adoption of Molecularly Targeted Therapies for Cancer (Workshop) (corporate author, -)
Corporate Authors: Policy Issues in the Development and Adoption of Molecularly Targeted Therapies for Cancer (Workshop) Corporate Author (corporate author), National Cancer Policy Forum (U.S.), issuing body (issuing body), Institute of Medicine (U.S.). Board on Health Care Services, issuing body
Other Authors: Patlak, Margie, author (author), Nass, Sharyl J., author, Phillips, Jonathan, author
Format: eBook
Language:Inglés
Published: Washington, District of Columbia : The National Academies Press [2015]
Edition:1st ed
Subjects:
Cancer > Treatment > United States > Congresses.
Cancer > Genetic aspects > Congresses.
Biochemical markers > Congresses.
United States.
See on Biblioteca Universitat Ramon Llull:https://discovery.url.edu/permalink/34CSUC_URL/1im36ta/alma991009816728206719
Table of Contents:
  • 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

Similar Items