A multi-stage drop-the-losers design for multi-arm clinical trials
نویسندگان
چکیده
منابع مشابه
A multi-stage drop-the-losers design for multi-arm clinical trials
Multi-arm multi-stage trials can improve the efficiency of the drug development process when multiple new treatments are available for testing. A group-sequential approach can be used in order to design multi-arm multi-stage trials, using an extension to Dunnett's multiple-testing procedure. The actual sample size used in such a trial is a random variable that has high variability. This can cau...
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In early stages of drug development there is often uncertainty about the most promising among a set of different treatments. In order to ensure the best use of resources it is important to decide which, if any, of the treatments should be taken forward for further testing. Multi-arm multi-stage (MAMS) trials provide gains in efficiency over separate randomised trials of each treatment. They all...
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Adaptive designs that are based on group-sequential approaches have the benefit of being efficient as stopping boundaries can be found that lead to good operating characteristics with test decisions based solely on sufficient statistics. The drawback of these so called “pre-planned adaptive” designs is that unexpected design changes are not possible without impacting the error rates. “Flexible ...
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Multi-arm multi-stage designs can improve the efficiency of the drug-development process by evaluating multiple experimental arms against a common control within one trial. This reduces the number of patients required compared to a series of trials testing each experimental arm separately against control. By allowing for multiple stages experimental treatments can be eliminated early from the s...
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Multi-arm clinical trials that compare several active treatments to a common control have been proposed as an efficient means of making an informed decision about which of several treatments should be evaluated further in a confirmatory study. Additional efficiency is gained by incorporating interim analyses and, in particular, seamless Phase II/III designs have been the focus of recent researc...
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ژورنال
عنوان ژورنال: Statistical Methods in Medical Research
سال: 2016
ISSN: 0962-2802,1477-0334
DOI: 10.1177/0962280214550759