Application and Impact of Run-In Studies

Fralick M, Avorn J, Franklin JM, Abdurrob A, Kesselheim AS - Journal of General Internal Medicine

  • Price, Value, and Access
  • Regulation and Clinical Evidence

Summary:

This meta-analysis of 106 randomized controlled trials for four DPP4 inhibitor medications found that trials with run-in phases and without run-in phases produced similar estimates of efficacy (hemoglobin A1C reduction) and safety (serious adverse events). Given the comparable outcomes and the substantial costs and time required for run-in phases, their use should be reconsidered in clinical trials of short duration.

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