Sample Size Planning for Psychiatric Clinical Trials
*Anastasia Ivanova, University of North Carolina at Chapel Hill Keywords: SPCD, Phase 2, Dose-finding The sequential parallel comparison design (SPCD) is a two-stage design recommended for trials with possibly high placebo response. Drug-placebo comparison is followed by placebo non-responders being re-randomized between drug and placebo. Such two-stage strategy might be beneficial when combined with dose selection in a Phase 2 trial. Data obtained in such a study can guide the sponsor as to what study design to use in a pivotal trial, parallel design, placebo lead-in or a two-stage approach such as the SPCD. We give recommendations on how to design such a study, analyze the data and compute required sample size.
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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