Enrollment and Stopping Rules for Managing Toxicity in Phase II Oncology Trials with Delayed Outcome

Enrollment and Stopping Rules for Managing Toxicity in Phase II Oncology Trials with Delayed Outcome Public Deposited

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Creator

Song, Guochen
- Affiliation: Gillings School of Global Public Health, Department of Biostatistics

Abstract

Stopping rules for toxicity are routinely used in phase II oncology trials. If the follow-up for toxicity is long, it is desirable to have a stopping rule that uses all toxicity information available, not only information from patients with full follow-up. Further, to prevent excessive toxicity in such trials, an enrollment rule is needed. The enrollment rule informs an investigator about the maximum number of patients that can be enrolled depending on the current enrollment and all available information about toxicity. We give recommendations on how to construct Bayesian and frequentist.

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