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Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products Workshop Summary (2014) / Chapter Skim
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Appendix C: Bibliography
Pages 105-112

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From page 105...
... 2012. Meta-analysis of clinical trial safety data in a drug development program: Answers to frequently asked questions.
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From page 106...
... New England Journal of Medicine 364:852-860. Workshop presentation by Michaela Kiernan: Identifying and Retaining Subgroups in Clinical Trials in the Context of Uncertainty About the External Validity of Clinical Trials Goldberg, J
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From page 107...
... 2012. Influence of reported study design characteristics on intervention effect estimates from randomized controlled trials.
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From page 108...
... Cambridge, United Kingdom, and New York: Cambridge University Press. Wallsten, T
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From page 109...
... Cambridge, MA: Harvard University Press. NRC (National Research Council)
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From page 110...
... Oxford, United Kingdom: Oxford University Press.
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From page 111...
... New York: Cambridge University Press. NRC (National Research Council)
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Key Terms

  • clinical trials
  • british medical
  • accessed august
  • medical journal
  • drug safety

  • pharmaceutical products
  • uncertainty workshop
  • controlled trials
  • clinical trial
  • randomized controlled

  • earthscan risk
  • drug development
  • drug regulatory
  • draft pdufa
  • structured approach

  • bayesian approaches
  • safety monitoring
  • regulatory decision
  • treatment effects
  • implementation plan

  • communicating uncertainty
  • external validity
  • harvard business
  • retaining subgroups
  • saster risks

  • drug risk
  • prospective drug
  • trials goldberg
  • drug discovery
  • business school


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