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Public Engagement and Clinical Trials New Models and Disruptive Technologies: Workshop Summary (2012) / Chapter Skim
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Appendix B: The Clinical Trials Process
Pages 99-100

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From page 99...
... approval for a new drug are designed to show its safety and effi cacy over the course of a few years. These trials seek to answer narrowly defined questions related to safety and efficacy in a carefully selected group of study participants most likely to experience the intended effects 99
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From page 100...
... These trials involve subjects with the target disease and usually last months. Once preliminary evidence from phase II reveals that a treatment is effective, phase III trials are designed to fully examine the risk/benefit profile of an experimental drug or treatment and test it over a longer period of time in a broader population (1,000−3,000)
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Key Terms

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  • regulatory approval
  • trials process
  • research sponsor
  • trials help

  • narrowly defined
  • prospectively evaluates
  • five discrete
  • human capital
  • preliminary trials

  • phase iii
  • workshop examined
  • gaining regulatory
  • study protocol
  • preliminary evidence

  • provide ethical
  • broader population
  • drug candidates
  • defined questions
  • extensive blueprint

  • iii trials
  • carefully selected
  • research question
  • answer narrowly
  • discrete phases

  • questions related
  • companies rank
  • help companies
  • trials test
  • multicenter trials


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