Development of Interactive Software for Bayesian Optimal Phase 1 Clinical Trial Design*

We describe an interactive Web-based software, developed by an interdisciplinary team, to sequentially assign dose levels to patients in a Phase 1 clinical trial. The methodology is based on state-of-the-art Bayesian optimal design theory, and has been described in the biostatistics literature. We describe the methodology and the development of the software, and give examples using the Web-based program. We describe subtleties, such as the elicitation of priors, numerical integration, and overdosing constraints.

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