Statistical Methods in Medical Research Clinical Cross-over Trials in Phase I
نویسنده
چکیده
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منابع مشابه
Characteristics of Clinical Trials in Iran: A Sample of 5000 Trials Registered in IRCT
Background and Objectives: A considerable number of clinical trials are conducted in Iran each year. Not much is known about the characteristics of them, this study aimed to investigate key characteristics of Iranian clinical trials. Methods: All clinical trial protocols registered in IRCT until November 2013 were selected. Text mining techniques were used to extract information from data t...
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BACKGROUND More than 95% of published phase I trials have used the 3 + 3 design to identify the dose to be recommended for phase II trials. However, the statistical community agrees on the limitations of the 3 + 3 design compared with model-based approaches. Moreover, the mechanisms of action of targeted agents strongly challenge the hypothesis that the maximum tolerated dose constitutes the op...
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In this paper we discuss statistical considerations regarding endpoints in preventive vaccine trials. Brief discussion is given to preclinical, Phase I, and Phase II trials, with the bulk of attention paid to endpoint choice and analysis in Phase III efficacy trials. In addition to traditional efficacy measures of vaccine effects for immunized individuals, consideration is given to waning, stra...
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Background and purpose: Uremic pruritus is a common complication in patients with chronic kidney disease, for which different treatments are applied. This study aimed to compare the effects of Zinc sulfate with Hydroxyzine in reducing pruritus in hemodialysis patients. Materials and methods: In this cross over randomized trial, 100 hemodialysis patients with uremic pruritus who met the study i...
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An early phase clinical trial is the first step in evaluating the effects in humans of a potential new anti-disease agent or combination of agents. Usually called "phase I" or "phase I/II" trials, these experiments typically have the nominal scientific goal of determining an acceptable dose, most often based on adverse event probabilities. This arose from a tradition of phase I trials to evalua...
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