Virtual Clinical Trials : Challenges and Opportunities: Proceedings of a Workshop

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 However, the current model for clinical trials is outdated, inefficient and costly.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 ContentsFront Matter1 Introduction2 Opportunities to Improve Clinical Trials3 Exploring Virtual Clinical Trials4 Access and Equity5 Policy Considerations6 Reflections on the Workshop and Potential Future DirectionsReferencesAppendix A: Workshop AgendaAppendix B: Workshop Speaker Biographical SketchesAppendix C: Examples of Virtual Clinical Trials Included in the Workshop HandoutAppendix D: Virtual Clinical Trials Presented by Speakers at the Workshop