The Two Sides of Dichotomization, and Their Synthesis?
*Heng Li, FDA/CDRH Keywords: responder analyses, dichotomization, patient-reported outcomes, measurement error, stochastic ordering, non-parametric statistics An essential part of clinical trial design is the pre-specification of endpoints, or outcomes, by which to assess the safety and effectiveness of the medical product or therapy to be studied in the trial. Sometimes transformations of endpoints are considered and study hypotheses are formulated in terms of some transformed outcome measures. In this presentation we discuss the transformation to a binary variable, otherwise known as dichotomization. We try to reconcile some opposing views on this subject from more general perspectives.
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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