Summary of Responses: Blinded vs. Open Label

• Agreement that blinding all drugs is difficult

  • pill burden
  • unavailability of placebo
  • use of resistance testing to choose OBR

• Partial blinding (test/control) is sufficient

• Statistical considerations for open label studies

  • blinding reduces bias
  • patient/physician expectations when assignment is known
  • differential dropout (switches, loss to follow-up)
  • need to account for these in analysis

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