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El. knyga: Multi-Center Phase III Clinical Trials and NCI Cooperative Groups: Workshop Summary

  • Formatas: 134 pages
  • Išleidimo metai: 30-Jan-2009
  • Leidėjas: National Academies Press
  • Kalba: eng
  • ISBN-13: 9780309177474
Kitos knygos pagal šią temą:
  • Formatas: 134 pages
  • Išleidimo metai: 30-Jan-2009
  • Leidėjas: National Academies Press
  • Kalba: eng
  • ISBN-13: 9780309177474
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The NCI-sponsored cooperative groups have made important contributions to improving treatment for many types of cancer, including breast, ovarian, colorectal, and childhood cancers. Cooperative group research has been instrumental in establishing innovative treatments that improve outcomes and quality of life. Despite these successes, the Cooperative Group Program has faced a number of challenges that threaten its effectiveness.



To address this problem, the National Cancer Policy Forum (NCPF) convened a workshop titled "Multi-Center Phase III Clinical Trials and NCI Cooperative Groups" in Washington, DC, on July 1-2, 2008. The purpose of the workshop was to outline the challenges that the public clinical cancer research enterprise faces, and to identify possible solutions to these challenges.

Table of Contents



Front Matter 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
Introduction 1(2)
Adapting the Cooperative Groups in a Changing Clinical Environment
3(2)
Organization of the NCI Clinical Trials System
5(22)
The NCI's Clinical Trials System
5(7)
Mayo Clinic and North Central Cancer Treatment Group
12(2)
Radiation Therapy Oncology Group
14(3)
Improving Clinical Trial Start-Up Times
17(8)
IRB Issues
25(2)
Lessons from Non-Cooperative Group Multi-Center Clinical Trials
27(14)
Organization of Multi-Center Clinical Trials
27(4)
Industry-Sponsored Multi-Center Clinical Trials
31(4)
Private Physician Perspective on Multi-Center Clinical Trials
35(6)
Barriers to Patient Recruitment and Physician Participation
41(24)
Academic Challenges
43(4)
Insurance Barriers
47(3)
Academic Recognition for Clinical Trialists
50(4)
CCOP Perspective on Patient Accrual
54(5)
Perspective from a National Health Care System
59(2)
Patient Perspective
61(4)
Data Collection Standards and Monitoring
65(10)
The NCI Perspective
65(2)
Industry Perspective
67(3)
Cooperative Groups Perspective
70(1)
FDA Perspective
71(4)
Costs of Cooperative Group Clinical Trials
75(16)
Cooperative Groups Cost Analysis
75(2)
Clinical Trial Cost Management
77(5)
Regulatory Costs
82(2)
CMS Perspective
84(2)
Private Health Insurer Perspective
86(5)
Summary and Wrap-Up
91(6)
Possible Paths Forward
93(4)
References
97(6)
Abbreviations and Acronyms
103(2)
Glossary
105
Appendixes
A Workshop Agenda
111
B Workshop Speakers
117
C Letter from John Niederhuber, Director of the National Cancer Institute, to Members of the National Cancer Policy Forum
119