Statistical Issues in Medical Device Trials: A Panel Discussion

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Statistical Issues in Medical Device Trials A
Panel Discussion

• Medical Device versus Drug Similarities and
  Differences, David Breiter and Jeng Mah (Guidant)
• Drugs Versus Devices, Gosford Sawyerr (Medtronic)
• Non-Randomized Studies Studies with Historical
  Controls and Operating Performance Criteria
  (OPCs), Jeff Cerkvenik (Medtronic)
• Challenges of Drug Eluting Stents, Peter Lam
  (Boston Scientific)
• Other Issues for Statisticians in Medical
  Devices, Greg Campbell (FDA)

FDA-Industry Workshop,Washington DC, Friday,
September 16, 2005, 230-350 p.m., Delaware Room
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