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Real-World Evidence Generation and Evaluation of Therapeutics Proceedings of a Workshop (2017) / Chapter Skim
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1 Introduction
Pages 1-6

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From page 1...
... These sources may include large simple trials, or pragmatic clinical trials, prospective observational or registry studies, retrospective database studies, case reports, administrative and health care claims, electronic health records, data obtained as part of a public health investigation or routine public health surveillance, and registries (e.g., device, procedural, or disease registries)
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From page 2...
... Food and Drug Administration (FDA) has characterized as health care information aggregated from sources outside traditional clinical research settings (Sherman et al., 2016)
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From page 3...
... in the context of different clinical/­ cientific s questions; and o  Strengths and limitations of different data sources at different stages of treatment development and licensing process. • Methodologies and best practices for high-quality real-world evidence generation and application, including o  Innovations in clinical trial design to maximize value of information for the full range of stakeholders; o onsiderations of how evidence generation from existing studies C could potentially inform the design of future clinical trials and amplify understanding of product efficacy; o iscussion of how shared goals of payers and regulators can better D align evidence generation processes used for regulatory evaluation and decisions on use by payers; and o e-evaluation of traditional distinctions between goals and methods R of preapproval and postapproval research.
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From page 4...
... 3  Publications from previous National Academies workshops with particular relevance to the topic of real-world evidence include • Large Simple Trials and Knowledge Generation in a Learning Health System: Workshop Summary (IOM, 2013b) , which focused on opportunities to advance a learning health system and improve the efficiency of drug development by integrating research at the point of care through large simple trials; • Sharing Clinical Research Data: Workshop Summary (IOM, 2013c)
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From page 5...
... The workshop was webcast live and online participants were able to contribute to the discussions through the hashtag #RealWorldEvidence. The slide presentations and videos are archived on the Forum website.4 The proceedings is organized as follows: • Chapter 2 introduces the topic of real-world evidence in greater detail by describing some priorities for improving evidence gen eration to support decision making on approval and use of ther apeutics as proposed by several diverse stakeholders, including regulators, patients, health care providers, payers, and industry.
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Key Terms

  • electronic health
  • evidence generation
  • safety surveillance
  • traditional clinical
  • pragmatic clinical

  • learning health
  • clinical trial
  • health records
  • medical product
  • comparative effectiveness

  • simple trials
  • workshop summary
  • drug development
  • sources outside
  • opinions expressed

  • regulatory science
  • health data
  • efficacy clinical
  • controlled data
  • health devices

  • electronic medical
  • sharing clinical
  • linking data
  • evidence include
  • health surveillance

  • care data
  • patient care
  • health record
  • medical devices
  • health investigation


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