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Multi-center phase III clinical trials and NCI cooperative groups [[electronic resource] ] : workshop summary / / Margie Patlak, Sharyl Nass, and Christine Micheel, rapporteurs ; National Cancer Policy Forum, Institute of Medicine of the National Academies
Multi-center phase III clinical trials and NCI cooperative groups [[electronic resource] ] : workshop summary / / Margie Patlak, Sharyl Nass, and Christine Micheel, rapporteurs ; National Cancer Policy Forum, Institute of Medicine of the National Academies
Pubbl/distr/stampa Washington, D.C., : National Academies Press, 2009
Descrizione fisica 1 online resource (135 p.)
Disciplina 610.724
Altri autori (Persone) PatlakMargie
NassSharyl J
MicheelChristine
Soggetto topico Cancer - Treatment - United States
Clinical trials
ISBN 0-309-17747-2
1-282-00804-8
9786612008047
0-309-12868-4
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto ""Reviewers""; ""Contents""; ""Introduction""; ""Session 1A: Organization of the NCI Clinical Trials System""; ""Session 1B: Lessons from Non-Cooperative Group Multi-Center Clinical Trials""; ""Session 2: Barriers to Patient Recruitment and Physician Participation""; ""Session 3: Data Collection Standards and Monitoring""; ""Session 4: Costs of Cooperative Group Clinical Trials""; ""Summary and Wrap-Up""; ""References""; ""Abbreviations and Acronyms""; ""Glossary""; ""Appendix A: Workshop Agenda""; ""Appendix B: Workshop Speakers""
""Appendix C: Letter from John Niederhuber, Director of the National Cancer Institute, to Members of the National Cancer Policy Forum""
Record Nr. UNINA-9910777709403321
Washington, D.C., : National Academies Press, 2009
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Multi-center phase III clinical trials and NCI cooperative groups : workshop summary / / Margie Patlak, Sharyl Nass, and Christine Micheel, rapporteurs ; National Cancer Policy Forum, Institute of Medicine of the National Academies
Multi-center phase III clinical trials and NCI cooperative groups : workshop summary / / Margie Patlak, Sharyl Nass, and Christine Micheel, rapporteurs ; National Cancer Policy Forum, Institute of Medicine of the National Academies
Edizione [1st ed.]
Pubbl/distr/stampa Washington, D.C., : National Academies Press, 2009
Descrizione fisica 1 online resource (135 p.)
Disciplina 610.724
Altri autori (Persone) PatlakMargie
NassSharyl J
MicheelChristine
Soggetto topico Cancer - Treatment - United States
Clinical trials
ISBN 0-309-17747-2
1-282-00804-8
9786612008047
0-309-12868-4
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto ""Reviewers""; ""Contents""; ""Introduction""; ""Session 1A: Organization of the NCI Clinical Trials System""; ""Session 1B: Lessons from Non-Cooperative Group Multi-Center Clinical Trials""; ""Session 2: Barriers to Patient Recruitment and Physician Participation""; ""Session 3: Data Collection Standards and Monitoring""; ""Session 4: Costs of Cooperative Group Clinical Trials""; ""Summary and Wrap-Up""; ""References""; ""Abbreviations and Acronyms""; ""Glossary""; ""Appendix A: Workshop Agenda""; ""Appendix B: Workshop Speakers""
""Appendix C: Letter from John Niederhuber, Director of the National Cancer Institute, to Members of the National Cancer Policy Forum""
Record Nr. UNINA-9910816136503321
Washington, D.C., : National Academies Press, 2009
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
National cancer policy summit [[electronic resource] ] : opportunities and challenges in cancer research and care / / meeting summary by Margie Patlak, Sharyl J. Nass and Erin Balogh
National cancer policy summit [[electronic resource] ] : opportunities and challenges in cancer research and care / / meeting summary by Margie Patlak, Sharyl J. Nass and Erin Balogh
Autore Patlak Margie
Pubbl/distr/stampa Washington, DC, : National Academies Press, 2011
Descrizione fisica 1 online resource (60 p.)
Disciplina 616.99405
Altri autori (Persone) NassSharyl J
BaloghErin
Soggetto topico Cancer - Research
Cancer - Treatment - United States
Soggetto genere / forma Electronic books.
ISBN 1-283-13507-8
9786613135070
0-309-18740-0
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto ""Front Matter""; ""Reviewers""; ""Acknowledgments""; ""Contents""; ""The National Cancer Policy Summit: Opportunities and Challenges in Cancer Research and Care""; ""Appendix: Summit Agenda""
Record Nr. UNINA-9910456521703321
Patlak Margie  
Washington, DC, : National Academies Press, 2011
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
National cancer policy summit [[electronic resource] ] : opportunities and challenges in cancer research and care / / meeting summary by Margie Patlak, Sharyl J. Nass and Erin Balogh
National cancer policy summit [[electronic resource] ] : opportunities and challenges in cancer research and care / / meeting summary by Margie Patlak, Sharyl J. Nass and Erin Balogh
Autore Patlak Margie
Pubbl/distr/stampa Washington, DC, : National Academies Press, 2011
Descrizione fisica 1 online resource (60 p.)
Disciplina 616.99405
Altri autori (Persone) NassSharyl J
BaloghErin
Soggetto topico Cancer - Research
Cancer - Treatment - United States
ISBN 0-309-21593-5
1-283-13507-8
9786613135070
0-309-18740-0
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto ""Front Matter""; ""Reviewers""; ""Acknowledgments""; ""Contents""; ""The National Cancer Policy Summit: Opportunities and Challenges in Cancer Research and Care""; ""Appendix: Summit Agenda""
Record Nr. UNINA-9910781327803321
Patlak Margie  
Washington, DC, : National Academies Press, 2011
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
National cancer policy summit : opportunities and challenges in cancer research and care / / meeting summary by Margie Patlak, Sharyl J. Nass and Erin Balogh
National cancer policy summit : opportunities and challenges in cancer research and care / / meeting summary by Margie Patlak, Sharyl J. Nass and Erin Balogh
Autore Patlak Margie
Edizione [1st ed.]
Pubbl/distr/stampa Washington, DC, : National Academies Press, 2011
Descrizione fisica 1 online resource (60 p.)
Disciplina 616.99405
Altri autori (Persone) NassSharyl J
BaloghErin
Soggetto topico Cancer - Research
Cancer - Treatment - United States
ISBN 0-309-21593-5
1-283-13507-8
9786613135070
0-309-18740-0
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto ""Front Matter""; ""Reviewers""; ""Acknowledgments""; ""Contents""; ""The National Cancer Policy Summit: Opportunities and Challenges in Cancer Research and Care""; ""Appendix: Summit Agenda""
Record Nr. UNINA-9910818716803321
Patlak Margie  
Washington, DC, : National Academies Press, 2011
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Policy 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 Academies
Policy 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 Academies
Pubbl/distr/stampa Washington, District of Columbia : , : The National Academies Press, , [2015]
Descrizione fisica 1 online resource (100 p.)
Disciplina 616.994075
Soggetto topico Cancer - Treatment - United States
Cancer - Genetic aspects
Biochemical markers
Soggetto genere / forma Electronic books.
ISBN 0-309-36858-8
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto 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
Record Nr. UNINA-9910460941803321
Washington, District of Columbia : , : The National Academies Press, , [2015]
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Policy 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 Academies
Policy 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 Academies
Pubbl/distr/stampa Washington, District of Columbia : , : The National Academies Press, , [2015]
Descrizione fisica 1 online resource (100 p.)
Disciplina 616.994075
Soggetto topico Cancer - Treatment - United States
Cancer - Genetic aspects
Biochemical markers
ISBN 0-309-36860-X
0-309-36858-8
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto 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
Record Nr. UNINA-9910797236603321
Washington, District of Columbia : , : The National Academies Press, , [2015]
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Policy 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 Academies
Policy 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 Academies
Pubbl/distr/stampa Washington, District of Columbia : , : The National Academies Press, , [2015]
Descrizione fisica 1 online resource (100 p.)
Disciplina 616.994075
Soggetto topico Cancer - Treatment - United States
Cancer - Genetic aspects
Biochemical markers
ISBN 0-309-36860-X
0-309-36858-8
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto 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
Record Nr. UNINA-9910812458303321
Washington, District of Columbia : , : The National Academies Press, , [2015]
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Policy issues in the development of personalized medicine in oncology [[electronic resource] ] : workshop summary / / Margie Patlak and Laura Levit, rapporteurs ; National Cancer Policy Forum, Board on Health Care Services, Institute of Medicine of the National Academies
Policy issues in the development of personalized medicine in oncology [[electronic resource] ] : workshop summary / / Margie Patlak and Laura Levit, rapporteurs ; National Cancer Policy Forum, Board on Health Care Services, Institute of Medicine of the National Academies
Pubbl/distr/stampa Washington, D.C., : National Academies Press, c2010
Descrizione fisica 1 online resource (95 p.)
Disciplina 616.994
Altri autori (Persone) LevitLaura A
PatlakMargie
Soggetto topico Cancer - Treatment - United States
Medical care - United States
Medical policy - United States
Soggetto genere / forma Electronic books.
ISBN 1-282-50135-6
9786612501357
0-309-14576-7
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto ""Front Matter""; ""Reviewers""; ""Contents""; ""Introduction""; ""Personalized Cancer Medicine Technology""; ""Regulation of Predictive Tests""; ""Reimbursement""; ""Summary""; ""References""; ""Acronyms""; ""Glossary""; ""Appendix A: Workshop Agenda""; ""Appendix B: Workshop Speakers and Moderators""
Record Nr. UNINA-9910456577603321
Washington, D.C., : National Academies Press, c2010
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Policy issues in the development of personalized medicine in oncology [[electronic resource] ] : workshop summary / / Margie Patlak and Laura Levit, rapporteurs ; National Cancer Policy Forum, Board on Health Care Services, Institute of Medicine of the National Academies
Policy issues in the development of personalized medicine in oncology [[electronic resource] ] : workshop summary / / Margie Patlak and Laura Levit, rapporteurs ; National Cancer Policy Forum, Board on Health Care Services, Institute of Medicine of the National Academies
Pubbl/distr/stampa Washington, D.C., : National Academies Press, c2010
Descrizione fisica 1 online resource (95 p.)
Disciplina 616.994
Altri autori (Persone) LevitLaura A
PatlakMargie
Soggetto topico Cancer - Treatment - United States
Medical care - United States
Medical policy - United States
ISBN 0-309-15135-X
1-282-50135-6
9786612501357
0-309-14576-7
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto ""Front Matter""; ""Reviewers""; ""Contents""; ""Introduction""; ""Personalized Cancer Medicine Technology""; ""Regulation of Predictive Tests""; ""Reimbursement""; ""Summary""; ""References""; ""Acronyms""; ""Glossary""; ""Appendix A: Workshop Agenda""; ""Appendix B: Workshop Speakers and Moderators""
Record Nr. UNINA-9910781188403321
Washington, D.C., : National Academies Press, c2010
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui