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• W641998032 abstract "The randomized placebo-phase design, also known as the randomized delayed-start design, has been proposed as an approach to circumvent the reluctance of patients and physicians to participate in trials with a placebo control. Although there is some practical appeal to the design and it has been used in an increasing number of active and ongoing trials, there are often overlooked issues relative to statistical power, estimating sample size and determining plans for interim analysis that may limit its usefulness. We developed a general model for describing the pattern of treatment response and based on the specified parameters of this model, derive and compare different strategies for interim monitoring. In addition to statistical power considerations, we also provide results from extensive simulations investigating the robustness of the proposed procedures since the efficiency of the randomized placebo-phase design is highly dependent on the assumptions made about the form of the alternative hypotheses. Public Health Relevance: The randomized clinical trial is the gold standard for evaluating new medical treatments/public health interventions. Indiscriminate use of the RPPD may result in failure to identify important new treatment/interventions because of low statistical power." @default.
• W641998032 created "2016-06-24" @default.
• W641998032 creator A5018354390 @default.
• W641998032 date "2010-09-29" @default.
• W641998032 modified "2023-09-27" @default.
• W641998032 title "THE RANDOMIZED PLACEBO-PHASE DESIGN: EVALUATION, INTERIM MONITORING AND ANALYSIS" @default.
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