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 | ||
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Lo trovi qui: Univ. Federico II | ||
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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 | ||
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Lo trovi qui: Univ. Federico II | ||
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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
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Washington, DC, : National Academies Press, 2011 | ||
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Lo trovi qui: Univ. Federico II | ||
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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
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Washington, DC, : National Academies Press, 2011 | ||
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Lo trovi qui: Univ. Federico II | ||
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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
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||
Washington, DC, : National Academies Press, 2011 | ||
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Lo trovi qui: Univ. Federico II | ||
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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] | ||
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Lo trovi qui: Univ. Federico II | ||
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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] | ||
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Lo trovi qui: Univ. Federico II | ||
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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] | ||
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Lo trovi qui: Univ. Federico II | ||
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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 | ||
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Lo trovi qui: Univ. Federico II | ||
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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 | ||
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Lo trovi qui: Univ. Federico II | ||
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