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Abstract:
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This course will cover dose-finding methodology for Phase I clinical trials in oncology, with a primary focus on model-based designs. The topic is receiving increased attention in the statistical literature and, as a result, several new designs are available that can be used in different situations. Illustrations on how to use model-based methods-such as the continual reassessment method (CRM)-to design, implement, and carry out a Phase I trial in practice will be provided based on real oncology trials. These applications are meant to initiate discussion about issues that may arise during the conduct of the study, while offering potential solutions and lessons learned from the case studies. Appropriate design specifications and components of protocol development will be discussed. Recent methodological developments for more advanced topics such as studies involving drug combinations and multiple treatment schedules will also be addressed. Model-based extensions for these clinical settings will be illustrated through currently ongoing trials. For both the simple and more complex settings, computational considerations and available software will be reviewed.
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