The Resource 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

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

Label
Real-world evidence generation and evaluation of therapeutics : proceedings of a workshop
Title
Real-world evidence generation and evaluation of therapeutics
Title remainder
proceedings of a workshop
Statement of responsibility
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
Creator
Contributor
Sponsoring body
Subject
Genre
Language
eng
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
Cataloging source
NLM
Dewey number
615
Funding information
This 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
Illustrations
illustrations
Index
no index present
LC call number
R723.7
Literary form
non fiction
Nature of contents
  • dictionaries
  • bibliography
http://bibfra.me/vocab/relation/rapporteur
  • DjJWlE-vN_o
  • EEmUXLUVgRc
  • jJyRsQ8Lx0g
Label
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
Publication
Bibliography note
Includes bibliographical references
http://library.link/vocab/branchCode
  • net
Carrier category
online resource
Carrier category code
cr
Carrier MARC source
rdacarrier
Color
multicolored
Content category
text
Content type code
txt
Content type MARC source
rdacontent
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
Control code
ocn993587827
Dimensions
unknown
Extent
1 online resource (1 PDF file (xvi, 85 pages))
Form of item
online
Isbn
9780309455633
Media category
computer
Media MARC source
rdamedia
Media type code
c
Other physical details
illustrations
http://library.link/vocab/recordID
.b37396808
Specific material designation
remote
System control number
  • (OCoLC)993587827
  • pebc0309455634

Library Locations

    • Deakin University Library - Geelong Waurn Ponds CampusBorrow it
      75 Pigdons Road, Waurn Ponds, Victoria, 3216, AU
      -38.195656 144.304955
Processing Feedback ...