Clinical trials : journal of the Society for Clinical Trials
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There is a little empirical evidence to determine which, if any, monitoring practices best achieve the goals of trial monitoring set forth in ICH E6 under the variable circumstances of different clinical trial settings. ⋯ These findings underscore the necessity of research to provide an evidence base for monitoring practice.
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There is a debate among cancer researchers about the use of single-arm or randomized phase II clinical trial designs; however, there is limited published objective evaluation of this issue. ⋯ Both single-arm and randomized phase II trials appear warranted in certain situations. Investigators should increase consideration of the potential impact on phase III trials to optimally select the proper trial design prior to phase II study implementation.
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The number of published Phase I trials for determining a maximum tolerated combination of two agents is increasing, with a majority of those trials suffering from poor study design. A recent editorial proposed a 3+3+3 design, which takes the traditional 3+3 design used for one-agent dose-finding and adds an additional possible cohort of three patients. ⋯ Algorithmic A+B+C designs are potentially useful in the design of Phase I trials of combinations of two agents. However, a head-to-head comparison to model-based designs is needed to warrant their general use.