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Activity Number:
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233
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Type:
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Contributed
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Date/Time:
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Monday, August 3, 2009 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #304706 |
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Title:
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Evaluation of the Randomized Placebo-Phase Design for Clinical Trials
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Author(s):
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Stephanie L. Shook*+ and Howard Rockette
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Companies:
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University of Pittsburgh and University of Pittsburgh
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Address:
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445 Grace Street, Mount Washington, PA, 15211,
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Keywords:
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randomized placebo-phase design ; delayed treatment ; statistical power ; clinical trials
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Abstract:
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The randomized placebo-phase design has been proposed as an approach to circumvent the reluctance of patients and physicians to participate in trials with a placebo control. The design utilizes active drug in both arms but in one arm, treatment is delayed a specified period of time. The time to event is then compared in the two groups. Although there is some practical appeal to the design, there are often overlooked issues relative to statistical power that may limit its usefulness. We propose a general model for this type of design and evaluate the statistical power for various alternatives of the pattern and magnitude of the treatment effect. A simulation study is conducted and guidelines are given as to when the use of such a design is justified.
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