Continuous toxicity monitoring in phase II trials in oncology |
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Authors: | Ivanova Anastasia Qaqish Bahjat F Schell Michael J |
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Institution: | Department of Biostatistics, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina 27599-7420, USA. aivanova@bios.unc.edu |
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Abstract: | The goal of a phase II trial in oncology is to evaluate the efficacy of a new therapy. The dose investigated in a phase II trial is usually an estimate of a maximum-tolerated dose obtained in a preceding phase I trial. Because this estimate is imprecise, stopping rules for toxicity are used in many phase II trials. We give recommendations on how to construct stopping rules to monitor toxicity continuously. A table is provided from which Pocock stopping boundaries can be easily obtained for a range of toxicity rates and sample sizes. Estimation of the probability of toxicity and response is also discussed. |
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Keywords: | Phase II trial Pocock boundary Sequential monitoring Unbiased estimate |
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