RL29 Issues on Statistical Assessment of Abuse Potential of a New Drug (Human Studies)
*Ling Chen, U.S. Food and Drug Administration Keywords: In a randomized double-blind, double-dummy, placebo-, positive-controlled, and crossover designed drug abuse potential study, there are at least 5 treatments in the study, which includes placebo, several doses of a test drug, and several doses of a positive control drug. Study subjects are volunteers with histories of drug abuse. Because placebo responses are used to compare with responses from the positive control group for validating the study, and also used to compare with responses from the test drug for assessing abuse potential, for a successful drug abuse potential study, it is important to accurately assess placebo effect for each endpoint of interest. In this roundtable discussion, we will focus on evaluation of placebo effect and comparisons with placebo arm in drug abuse potential studies.
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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