04035nam 2200649 450 991046094180332120200520144314.00-309-36858-8(CKB)3710000000433044(EBL)3439842(SSID)ssj0001591991(PQKBManifestationID)16290757(PQKBTitleCode)TC0001591991(PQKBWorkID)14877732(PQKB)10772299(MiAaPQ)EBC3439842(Au-PeEL)EBL3439842(CaPaEBR)ebr11091751(OCoLC)923137752(EXLCZ)99371000000043304420150904h20152015 uy| 0engur|n|---|||||txtccrPolicy issues in the development and adoption of biomarkers for molecularly targeted cancer therapies workshop summary /Sharyl J. Nass, Jonathan Phillips, and Margie Patlak, rapporteurs ; National Cancer Policy Forum, Board on Health Care Services, Institute of Medicine of the National AcademiesWashington, District of Columbia :The National Academies Press,[2015]©20151 online resource (100 p.)Description based upon print version of record.0-309-36857-X Includes bibliographical references.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 TestsCompanion 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 DevelopmentThe 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 CANCERCancerTreatmentUnited StatesCongressesCancerGenetic aspectsCongressesBiochemical markersCongressesElectronic books.CancerTreatmentCancerGenetic aspectsBiochemical markers616.994075Patlak MargieNass Sharyl J.Phillips JonathanNational Cancer Policy Forum (U.S.),Institute of Medicine (U.S.).Board on Health Care Services,Policy Issues in the Development and Adoption of Molecularly Targeted Therapies for Cancer (Workshop)MiAaPQMiAaPQMiAaPQBOOK9910460941803321Policy issues in the development and adoption of biomarkers for molecularly targeted cancer therapies1983055UNINA