LEADER 04035nam 2200649 450 001 9910460941803321 005 20200520144314.0 010 $a0-309-36858-8 035 $a(CKB)3710000000433044 035 $a(EBL)3439842 035 $a(SSID)ssj0001591991 035 $a(PQKBManifestationID)16290757 035 $a(PQKBTitleCode)TC0001591991 035 $a(PQKBWorkID)14877732 035 $a(PQKB)10772299 035 $a(MiAaPQ)EBC3439842 035 $a(Au-PeEL)EBL3439842 035 $a(CaPaEBR)ebr11091751 035 $a(OCoLC)923137752 035 $a(EXLCZ)993710000000433044 100 $a20150904h20152015 uy| 0 101 0 $aeng 135 $aur|n|---||||| 181 $ctxt 182 $cc 183 $acr 200 10$aPolicy issues in the development and adoption of biomarkers for molecularly targeted cancer therapies $eworkshop summary /$fSharyl J. Nass, Jonathan Phillips, and Margie Patlak, rapporteurs ; National Cancer Policy Forum, Board on Health Care Services, Institute of Medicine of the National Academies 210 1$aWashington, District of Columbia :$cThe National Academies Press,$d[2015] 210 4$dİ2015 215 $a1 online resource (100 p.) 300 $aDescription based upon print version of record. 311 $a0-309-36857-X 320 $aIncludes bibliographical references. 327 $aFront 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 327 $aCompanion 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 327 $aThe 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 606 $aCancer$xTreatment$zUnited States$vCongresses 606 $aCancer$xGenetic aspects$vCongresses 606 $aBiochemical markers$vCongresses 608 $aElectronic books. 615 0$aCancer$xTreatment 615 0$aCancer$xGenetic aspects 615 0$aBiochemical markers 676 $a616.994075 702 $aPatlak$b Margie 702 $aNass$b Sharyl J. 702 $aPhillips$b Jonathan 712 02$aNational Cancer Policy Forum (U.S.), 712 02$aInstitute of Medicine (U.S.).$bBoard on Health Care Services, 712 12$aPolicy Issues in the Development and Adoption of Molecularly Targeted Therapies for Cancer (Workshop) 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910460941803321 996 $aPolicy issues in the development and adoption of biomarkers for molecularly targeted cancer therapies$91983055 997 $aUNINA