Responder Analysis to Assist Decision Making: A Case Study in Chronic Pain Trials
*David Petullo, FDA 


In chronic pain trials, a responder is often defined as a patient having at least a 30% improvement in their baseline pain score. However, information is lost when a continuous outcome (i.e. pain score) is reduced to a binary outcome. In this presentation, I will describe a responder analysis that considers every possible definition of response (i.e. from no response to complete response). This approach allows better interpretability of the response profile and further assist in the decision making process.