39: Methods to Predict and Control Confounding Placebo Effect: Case Studies

Music City Center 

In randomized clinical trials (RCTs) with subjective outcomes, the placebo effect is one of the major challenges in evaluating possible mechanisms related to the true therapeutic effect and is highly associated with the failure of many RCTs for many clinical trials. To address the issue, we have taken initiatives to evaluate the impact of placebo effect on RCTs, by implementing innovative statistical methods to predict and control it using baseline predictors. In this presentation, these methods have been evaluated by comprehensive simulation. In addition, case studies using these methods will be presented.

prediction

placebo effect

prognostic score

weighted MMRM