Responder Analysis to Assist Decision Making: A Case Study in Chronic Pain Trials
*David Petullo, FDA Keywords: 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.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC