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E-raamat: Virtual Clinical Trials: Challenges and Opportunities: Proceedings of a Workshop

  • Formaat: 126 pages
  • Ilmumisaeg: 16-Oct-2019
  • Kirjastus: National Academies Press
  • Keel: eng
  • ISBN-13: 9780309494915
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  • Formaat: 126 pages
  • Ilmumisaeg: 16-Oct-2019
  • Kirjastus: National Academies Press
  • Keel: eng
  • ISBN-13: 9780309494915
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Successful drug development relies on accurate and efficient clinical trials to deliver the best and most effective pharmaceuticals and clinical care to patients. However, the current model for clinical trials is outdated, inefficient and costly. Clinical trials are limited by small sample sizes that do not reflect variations among patients in the real world, financial burdens on participants, and slow processes, and these factors contribute to the disconnect between clinical research and clinical practice.





On November 28-29, the National Academies of Sciences, Engineering, and Medicine convened a workshop to investigate the current clinical trials system and explore the potential benefits and challenges of implementing virtual clinical trials as an enhanced alternative for the future. This publication summarizes the presentations and discussions from the workshop.

Table of Contents



Front Matter 1 Introduction 2 Opportunities to Improve Clinical Trials 3 Exploring Virtual Clinical Trials 4 Access and Equity 5 Policy Considerations 6 Reflections on the Workshop and Potential Future Directions References Appendix A: Workshop Agenda Appendix B: Workshop Speaker Biographical Sketches Appendix C: Examples of Virtual Clinical Trials Included in the Workshop Handout Appendix D: Virtual Clinical Trials Presented by Speakers at the Workshop
Acronyms And Abbreviations xvii
1 Introduction
1(6)
Denning Virtual Clinical Trials
3(2)
Organization of the Proceedings of a Workshop
5(2)
2 Opportunities To Improve Clinical Trials
7(12)
A Patient Perspective
8(2)
An Industry Perspective
10(1)
An Academic Perspective
11(5)
Discussion
16(3)
3 Exploring Virtual Clinical Trials
19(18)
Lessons Learned from Clinical Care
21(1)
Lessons Learned from Observational Studies
22(4)
Lessons Learned from Interventional Studies
26(7)
Panel Reactions
33(2)
Discussion
35(2)
4 Access And Equity
37(14)
A Patient Perspective
39(1)
Recruitment for Clinical Trials
39(2)
Underserved Community Outreach and Engagement
41(4)
Lessons Learned from Behavioral Interventions
45(3)
Discussion
48(3)
5 Policy Considerations
51(14)
A Regulatory Perspective
53(2)
Clinical Trials Transformation Initiative: Decentralized Clinical Trials Project
55(3)
Privacy Protections for Virtual Clinical Trials
58(2)
Informed Consent for Passive Data Collection
60(1)
Discussion
61(4)
6 Reflections On The Workshop And Potential Future Directions
65(14)
Session 1 Opportunities to Improve Clinical Trials
65(1)
Session 2 Exploring Clinical Trials
66(1)
Session 3 Access and Equity
66(1)
Session 4 Policy Considerations
67(1)
Next Steps
67(4)
References
71(8)
APPENDIXES
A Workshop Agenda
79(8)
B Workshop Speaker Biographical Sketches
87(12)
C Examples Of Virtual Clinical Trials Included In The Workshop Handout
99(6)
D Virtual Clinical Trials Presented By Speakers At The Workshop
105