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Review

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

National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Sciences Policy; Forum on Drug Discovery, Development, and Translation
Carolyn Shore, Eeshan Khandekar, Joe Alper
, editors.
Washington (DC): National Academies Press (US); 2019 Jul 23.
The National Academies Collection: Reports funded by National Institutes of Health.
Free Books & Documents
Review

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

National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Sciences Policy; Forum on Drug Discovery, Development, and Translation.
Free Books & Documents

Excerpt

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 However, the current model for clinical trials is outdated, inefficient and costly.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.

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Grants and funding

This activity was supported by contracts between the National Academy of Sciences and AbbVie Inc.; American Society for Microbiology; Amgen Inc. (Contract No. GHCCOPS-CSARF-126570); Association of American Medical Colleges; AstraZeneca; Burroughs Wellcome Fund (Contract No. 1019001); Critical Path Institute; Eli Lilly and Company; FasterCures; Foundation for the National Institutes of Health; Friends of Cancer Research; GlaxoSmithKline (Contract No. OTH-PPL-30507); Johnson & Johnson; Merck & Co., Inc. (Contract No. CMO-180308-002499; MRLCPO-18-2641); National Institutes of Health (Contract No. HHSN263201800029I; Task Order No. HHSN26300007): National Cancer Institute, National Center for Advancing Translational Sciences, National Institute of Allergy and Infectious Diseases, National Institute of Mental Health, National Institute of Neurological Disorders and Stroke, Office of Science Policy; New England Journal of Medicine; Pfizer Inc.; Sanofi (Contract No. 38532911); Takeda Pharmaceuticals (Contract No. 53108); and U.S. Food and Drug Administration (Grant No. 5R13FD005496-03, 5R13FD005496-04): Center for Drug Evaluation and Research, Office of the Commissioner. Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project.

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