Survival trial design and monitoring using historical controls
نویسندگان
چکیده
منابع مشابه
The Paired Availability Design for Historical Controls
BACKGROUND Although a randomized trial represents the most rigorous method of evaluating a medical intervention, some interventions would be extremely difficult to evaluate using this study design. One alternative, an observational cohort study, can give biased results if it is not possible to adjust for all relevant risk factors. METHODS A recently developed and less well-known alternative i...
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In this paper, two parametric sequential tests are proposed for historical control trial designs under the Weibull model. The proposed tests are asymptotically normal with properties of Brownian motion. The sample size formulas and information times are derived for both tests. A multi-stage sequential procedure based on sequential conditional probability ratio test methodology is proposed for m...
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Control conditions were introduced through the trial of Mesmerism in Paris. Placebo controls became codified standard in 1946. Although seemingly unchallenged, there are various problems with this received view. The notion of a placebo is only defined from the negative. A positive notion proposed that placebo effects are effects owing to the meaning an intervention has for an individual. Thus, ...
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Delivering radiation to eradicate a solid tumor while minimizing damage to nearby critical organs remains a challenge. For esophageal cancer, radiation therapy may damage the heart or lungs, and several qualitatively different, possibly recurrent toxicities associated with chemoradiation or surgery may occur, each at two or more possible grades. In this article, we describe a Bayesian group seq...
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ژورنال
عنوان ژورنال: Pharmaceutical Statistics
سال: 2016
ISSN: 1539-1604
DOI: 10.1002/pst.1756