Screening designs for drug development.
نویسندگان
چکیده
We propose drug screening designs based on a Bayesian decision-theoretic approach. The discussion is motivated by screening designs for phase II studies. The proposed screening designs allow consideration of multiple treatments simultaneously. In each period, new treatments can arise and currently considered treatments can be dropped. Once a treatment is removed from the phase II screening trial, a terminal decision is made about abandoning the treatment or recommending it for a future confirmatory phase III study. The decision about dropping treatments from the active set is a sequential stopping decision. We propose a solution based on decision boundaries in the space of marginal posterior moments for the unknown parameter of interest that relates to each treatment. We present a Monte Carlo simulation algorithm to implement the proposed approach. We provide an implementation of the proposed method as an easy to use R library available for public domain download (http://www.stat.rice.edu/~rusi/ or http://odin.mdacc.tmc.edu/~pm/).
منابع مشابه
***Removed from the Issue*** Application of Cell-Based Assay Systems for the Early Screening of Human Drug Hepatotoxicity in the Discovery Phase of Drug Development
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Withdrawing of Article ''Application of Cell-Based Assay Systems for the Early Screening of Human Drug Hepatotoxicity in the Discovery Phase of Drug Development''
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Withdrawing of Article ''Application of Cell-Based Assay Systems for the Early Screening of Human Drug Hepatotoxicity in the Discovery Phase of Drug Development''
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***Removed from the Issue*** Application of Cell-Based Assay Systems for the Early Screening of Human Drug Hepatotoxicity in the Discovery Phase of Drug Development
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Planning multi-arm screening studies within the context of a drug development program
Screening trials are small trials used to decide whether an intervention is sufficiently promising to warrant a large confirmatory trial. Previous literature examined the situation where treatments are tested sequentially until one is considered sufficiently promising to take forward to a confirmatory trial. An important consideration for sponsors of clinical trials is how screening trials shou...
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ورودعنوان ژورنال:
- Biostatistics
دوره 8 3 شماره
صفحات -
تاریخ انتشار 2007