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Updated: Jun 17, 2026

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
Optimal designs for two-arm, phase II clinical trial design with multiple constraints
Matthew S Mayo1, Jonathan D Mahnken, Seng-Jaw Soong
1Department of Biostatistics, University of Kansas Medical Center, Kansas City, Kansas 66160, USA. mmayo@kumc.edu
Abstract:
Multi-stage Phase II trials are often employed in practice but may not be the best approach when the endpoint of interest is not obtained soon after enrollment and/or when a control arm is desired. We present a new design in which sample size determination includes a control arm and allows for the estimation of response for each treatment as well as estimation of the difference in the response rates. We evaluate this design under varying allocation schemes to treatment arms and response rates for each treatment.
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