Real-world evidence generation and evaluation of therapeutics : proceedings of a workshop /

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 de...

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Bibliographic Details
Main Author: Downey, Autumn S. (rapporteur.)
Corporate Authors: National Academies of Sciences, Engineering, and Medicine (U.S.). Forum on Drug Discovery, Development, and Translation (sponsoring body.), Real-World Evidence Generation and Evaluation of Therapeutics (Workshop) :
Other Authors: Gee, Amanda Wagner (rapporteur.), Claiborne, Anne B. (rapporteur.)
Format: Conference Proceeding eBook
Published: Washington, DC : The National Academies Press, [2017]
Series:Online access: NCBI NCBI Bookshelf.
Online access: National Academy of Sciences National Academies Press.
Online Access:CONNECT
Table of 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.