Risk–benefit trade-offs and precision utilities in phase I-II clinical trials
Pavlos Msaouel,
Juhee Lee,
Peter F Thall
Abstract:Background: Identifying optimal doses in early-phase clinical trials is critically important. Therapies administered at doses that are either unsafe or biologically ineffective are unlikely to be successful in subsequent clinical trials or to obtain regulatory approval. Identifying appropriate doses for new agents is a complex process that involves balancing the risks and benefits of outcomes such as biological efficacy, toxicity, and patient quality of life. Purpose: While conventional phase I trials rely sol… Show more
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