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Treatment Comparison for a Single Arm Study Utilizing External Control: Performing Inference when Imputing Potential

Wei-Chen Chen1, Nelson Lu2, Chenguang Wang3

  • 1Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA.

Therapeutic Innovation & Regulatory Science
|July 22, 2025
PubMed

Keywords:
External controlPotential outcomePotential outcome model (POM)Single-arm studyTreatment comparison

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