Application of Propensity Score Quintile Matching for Baseline Parameters in a Medical Device Trial Design

• Activity Number: 38 - Study Design: Historical Controls, Endpoint Timing, and Regulatory Considerations
• Type: Contributed
• Date/Time: Sunday, July 29, 2018 : 2:00 PM to 3:50 PM
• Sponsor: Section on Medical Devices and Diagnostics
• Author(s): Hong Wang* and Songtao Jiang and Peter Lam
• Companies: Boston Scientific Corporation and Boston Scientific and Boston Scientific
• Keywords: Propensity Score; Logistic Regression; Trial Design; Historical Data

Abstract

Propensity score method is widely used in the medical device trial design utilizing historical controls as the least burden approach when abundant historical data are available. In this real world data application, the propensity score quintile approach is utilized to assess the balance of the pre-specified baseline parameters in a stent trial to evaluate the Dual Anti-Platelet Therapy (DAPT) duration effect on clinical outcomes. The trial design will be presented and adjusted baseline variables will be compared between the test and historical control groups, specifically, the subject demographics, clinical history, risk factor, and pre-procedure lesion characteristics will be assessed before and after the propensity score adjustment without assessing the outcome data.