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Developing Multimodal Therapies for Brain Disorders: Proceedings of a Workshop [Pehme köide]

  • Formaat: Paperback / softback, 96 pages, kõrgus x laius: 229x152 mm
  • Ilmumisaeg: 13-Mar-2017
  • Kirjastus: National Academies Press
  • ISBN-10: 0309450268
  • ISBN-13: 9780309450263
Teised raamatud teemal:
  • Formaat: Paperback / softback, 96 pages, kõrgus x laius: 229x152 mm
  • Ilmumisaeg: 13-Mar-2017
  • Kirjastus: National Academies Press
  • ISBN-10: 0309450268
  • ISBN-13: 9780309450263
Teised raamatud teemal:
Multimodal therapy approaches that combine interventions aimed at different aspects of disease are emerging as potentialand perhaps essentialways to enhance clinical outcomes for patients with psychiatric and neurological disorders. In order to examine the general principles underlying multimodal therapies and to explore challenges, potential barriers, and opportunities for their development, the National Academies of Sciences, Engineering, and Medicine convened a workshop in June 2016. Participants explored scientific, clinical, regulatory, and reimbursement issues related to multimodal approaches and potential opportunities to enhance clinical outcomes for individuals with nervous system disorders. This publication summarizes the presentations and discussions from the workshop.

Table of Contents



Front Matter 1 Introduction 2 Multimodal Therapy: Overview of Principles, Barriers, and Opportunities 3 Exploring the State of the Science 4 Regulatory and Reimbursement Considerations 5 Trial Designs to Establish Efficacy and Safety in Multimodal Therapies 6 Developing Multimodal Therapies: Practical Considerations Relating to Industry 7 Role of Research Funders in Multimodal Therapy Development Appendix A: References Appendix B: Workshop Agenda Appendix C: Registered Participants
1 Introduction
1(4)
Workshop Objectives
1(2)
Organization of the Proceedings
3(2)
2 Multimodal Therapy: Overview of Principles, Barriers, and Opportunities
5(14)
Defining Multimodal Therapy
5(3)
Rationale for Multimodal Therapies in Brain Disorders
8(2)
Challenges and Barriers
10(4)
Potential Opportunities to Advance Multimodal Therapy Development
14(5)
3 Exploring the State of the Science
19(10)
Co-Delivery of Pharmacological Interventions for Alzheimer's Disease
20(2)
Concomitant Delivery of Two Interventions with Different Modalities
22(3)
Simultaneous Use of Two Modalities in a Single Procedure
25(4)
4 Regulatory and Reimbursement Considerations
29(8)
Regulatory Pathways for Drugs, Biologics, Devices, and Combination Products
31(2)
Payer Perspectives on Multimodal Therapies
33(3)
Harmonizing Evidence for Payers and Regulators
36(1)
5 Trial Designs to Establish Efficacy and Safety in Multimodal Therapies
37(10)
Platform Trials and Adaptive Trials
38(4)
Quantifying Dose with Non-Pharmacologic Interventions
42(2)
Assessing Response to Interventions
44(3)
6 Developing Multimodal Therapies: Practical Considerations Relating to Industry
47(6)
Integrating Therapeutic Devices into Psychiatry
48(1)
Targeted Drug Delivery: Intrathecal Infusion Therapy for Chronic Pain
49(1)
A Multinational Collaboration to Develop a Multimodal Therapy
50(3)
7 Role of Research Funders in Multimodal Therapy Development
53(8)
Role of Research Agencies in De-Risking Multimodal Therapy Development
54(3)
Role of Disease-Specific Funding in Multimodal Therapy Development
57(4)
APPENDIXES
A References
61(6)
B Workshop Agenda
67(12)
C Registered Participants
79