Developing Multimodal Therapies for Brain Disorders

Multimodal therapy approaches that combine interventions aimed at different aspects of disease are emerging as potential-and perhaps essential-ways 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