Online Program Home
  My Program

All Times EDT

Abstract Details

Activity Number: 410 - Benefit-Risk Methods for Medical Devices and Diagnostics
Type: Topic Contributed
Date/Time: Wednesday, August 5, 2020 : 1:00 PM to 2:50 PM
Sponsor: Section on Medical Devices and Diagnostics
Abstract #309642
Title: Using Outcomes to Analyze Patients Rather Than Patients to Analyze Outcomes
Author(s): Scott Evans*
Keywords: DOOR; partial credit; pramatic trial; benefit:risk

Typical analyses of clinical trials involve intervention comparisons for each efficacy and safety outcome. Outcome-specific effects are tabulated and potentially combined in benefit:risk analyses with the belief that such analyses inform the totality of effects on patients. However such approaches do not incorporate associations between outcomes of interest, suffer from competing risk challenges, and since efficacy and safety analyses are conducted on different analysis populations, the population to which these benefit:risk analyses apply, is unclear.

This deficit can be remedied with more thoughtful benefit:risk evaluation with a pragmatic focus. Critical components of this vision include: (i) using outcomes to analyze patients rather than patients to analyze outcomes, (ii) incorporating patient values, and (iii) evaluating personalized effects. Crucial to this approach entails improved understanding of how to analyze one patient before analyzing many. Newly developed approaches to the design and analyses of trials such as partial credit and the desirability of outcome ranking (DOOR), are being implemented to more optimally inform patient treatment.

Authors who are presenting talks have a * after their name.

Back to the full JSM 2020 program