A two-way enriched clinical trial design merging placebo lead-in and randomized withdrawal
View Presentation Anastasia Ivanova, University of North Carolina - Chapel Hill *Roy Tamura , University of South Florida Keywords: enriched trial, score tests, sample size A new clinical trial design, designated the two-way enriched design (TED), which augments the standard randomized placebo controlled trial with second stage enrichment designs in placebo non-responders and drug responders is described. The trial is run in two stages. In the first stage patients are randomized between drug and placebo. In the second stage placebo non-responders are re-randomized between drug and placebo and drug responders are re-randomized between drug and placebo. All first stage data, and second stage data from first stage placebo non-responders and first stage drug responders, are utilized in the efficacy analysis. We define 1, 2, and 3 df score tests for the TED. The TED is compared to the standard parallel trial, placebo lead-in and randomized withdrawal trials in terms of sample size (entered and randomized) for a Phase 2 trial in generalized anxiety disorder.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
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August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
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August 26, 2013
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September 9, 2013
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September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC