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E-raamat: Neuroscience Trials of the Future: Proceedings of a Workshop

  • Formaat: 110 pages
  • Ilmumisaeg: 07-Nov-2016
  • Kirjastus: National Academies Press
  • Keel: eng
  • ISBN-13: 9780309442565
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  • Formaat: 110 pages
  • Ilmumisaeg: 07-Nov-2016
  • Kirjastus: National Academies Press
  • Keel: eng
  • ISBN-13: 9780309442565
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On March 3-4, 2016, the National Academies of Sciences, Engineering, and Medicine's Forum on Neuroscience and Nervous System Disorders held a workshop in Washington, DC, bringing together key stakeholders to discuss opportunities for improving the integrity, efficiency, and validity of clinical trials for nervous system disorders. Participants in the workshop represented a range of diverse perspectives, including individuals not normally associated with traditional clinical trials. The purpose of this workshop was to generate discussion about not only what is feasible now, but what may be possible with the implementation of cutting-edge technologies in the future.

Table of Contents



Front Matter 1 Introduction 2 Neuroscience Clinical Trials: An Overview of Challenges and Potential Opportunities 3 Clinical Trial Design 4 Transforming Clinical Trials with Technology 5 The Regulatory Landscape: International Opportunities and Challenges 6 Ethical Considerations 7 Improving the Evidence Base for Real-World Use Appendix A: References Appendix B: Workshop Agenda Appendix C: Registered Attendees
1 Introduction
1(4)
Workshop Objectives
3(1)
Organization of Proceedings
3(2)
2 Neuroscience Clinical Trials: An Overview of Challenges and Potential Opportunities
5(10)
Challenges and Barriers to Neuroscience Clinical Trials
6(2)
Opportunities to Improve Neuroscience Clinical Trials
8(7)
3 Clinical Trial Design
15(22)
Alternatives to the DSM
16(4)
Better Disease Models
20(2)
Biomarkers
22(5)
Clinically Meaningful Outcomes
27(1)
Novel Clinical Trial Designs
28(4)
Lessons Learned from Other Therapeutic Areas
32(2)
Developing More Effective Therapeutics Through Precision Medicine: Implications for Clinical Trials
34(3)
4 Transforming Clinical Trials with Technology
37(6)
Patient Recruitment and Retention in Clinical Trials
38(2)
Novel Assessment Tools
40(3)
5 The Regulatory Landscape: International Opportunities and Challenges
43(10)
Regulatory Perspectives from the United States
44(2)
Regulatory Perspectives from Italy
46(2)
Potential Regulatory Implications for Clinical Research Innovations
48(5)
6 Ethical Considerations
53(6)
Data Protection
54(2)
Human Subjects Protection
56(3)
7 Improving the Evidence Base for Real-World Use
59(10)
Perspectives from Payers
60(1)
Perspectives from the Pharmaceutical Industry
61(1)
Methodology for Observational Studies
62(1)
Methodology for Pragmatic Trials
62(2)
Data Sources for Real-World Trials
64(2)
Final Remarks
66(3)
APPENDIXES
A References
69(10)
B Workshop Agenda
79(12)
C Registered Attendees
91