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Real-world evidence generation and evaluation of therapeutics : proceedings of a workshop / Autumn Downey, Amanda Wagner Gee, and Anne B. Claiborne, rapporteurs ; Forum on Drug Discovery, Development, and Translation, Board on Health Sciences Policy, Health and Medicine Division, the National Academies of Sciences, Engineering, Medicine.

Author/creator Downey, Autumn S. rapporteur.
Format Electronic and Book
Publication Info Washington, DC : The National Academies Press, [2017]
Description1 online resource (1 PDF file (xvi, 85 pages)) : illustrations
Supplemental Content Direct link to resource
Other author/creatorGee, Amanda Wagner, rapporteur.
Other author/creatorClaiborne, Anne B., rapporteur.
Other author/creatorNational Academies of Sciences, Engineering, and Medicine (U.S.). Forum on Drug Discovery, Development, and Translation, sponsoring body.
Other author/creatorReal-World Evidence Generation and Evaluation of Therapeutics (Workshop) : (2016 : Washington, D.C.)
Contents Introducation -- Improving evidence generation for decision making on approval and use of new treatments: some stakeholder priorities -- Opportunities for real-world data -- Generating and incorporating real-world evidence into medical product development and evaluation: building from successful case studies -- Potential strategies for a way forward -- Appendix A: Bibliography -- Appendix B: Workshop agenda -- Appendix C: Participant biographies -- Appendix D: Discussion paper: real-world evidence to guide the approval and use of new treatments.
Summary The volume and complexity of information about individual patients is greatly increasing with use of electronic records and personal devices. Potential effects on medical product development in the context of this wealth of real-world data could be numerous and varied, ranging from the ability to determine both large-scale and patient-specific effects of treatments to the ability to assess how therapeutics affect patients' lives through measurement of lifestyle changes. In October 2016, the National Academies of Sciences, Engineering, and Medicine held a workshop to facilitate dialogue among stakeholders about the opportunities and challenges for incorporating real-world evidence into all stages in the process for the generation and evaluation of therapeutics. Participants explored unmet stakeholder needs and opportunities to generate new kinds of evidence that meet those needs. This publication summarizes the presentations and discussions from the workshop.
Bibliography noteIncludes bibliographical references.
Funding informationThis activity was supported by AbbVie Inc.; American Diabetes Association; American Society of Microbiology; Amgen Inc. (Contract No. GHCCOPS-CSARF-85167); Association of American Medical Colleges; AstraZeneca; Baxalta; Burroughs Wellcome Fund (Contract No. 1016598); Critical Path Institute; Eli Lilly & Co.; FasterCures; Friends of Cancer Research; GlaxoSmithKline (Contract No. 016084); Johnson & Johnson; Merck & Co., Inc. (Contract No. CMO-16208-001245); National Institutes of Health (NIH) (Contract No. HHSN263201200074I, Task Order HHSN26300093): 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; New England Journal of Medicine; Pfizer Inc.; Sanofi; Takeda Pharmaceuticals (Contract No. 53108); and U.S. Food and Drug Administration (Contract No. 1R13FD005496-01). 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.
Source of descriptionOnline resource; title from PDF title page (viewed August 26, 2017).
Issued in other formPrint version: Downey, Autumn S. Real-world evidence generation and evaluation of therapeutics. Washington, DC : National Academies Press, [2017] 0309455626

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