Multi-Arm Clinical Trials of New Agents: Some Design Considerations: Table 1.
نویسندگان
چکیده
منابع مشابه
Multi-arm clinical trials of new agents: some design considerations.
A major challenge in the development of anticancer therapies is the considerable time and resources needed for conducting randomized clinical trials (RCT). There is a need for more efficient RCT designs that accelerate development, minimize costs, and make trials more appealing to patients. We review the statistical and logistical characteristics of multi-arm designs that compare several experi...
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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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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 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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ژورنال
عنوان ژورنال: Clinical Cancer Research
سال: 2008
ISSN: 1078-0432,1557-3265
DOI: 10.1158/1078-0432.ccr-08-0325