Statistical rules for safety monitoring in clinical trials

CONCLUSIONS: Because the goal is to minimize the number of patients exposed to and experiencing toxicities from an unsafe therapy, we recommend using the Pocock or Beta-Binomial, weak prior methods for constructing safety stopping rules. At the design stage, the operating characteristics of candidate rules should be evaluated under various possible toxicity rates in order to guide the choice of rule(s) for a given trial; our R package facilitates this evaluation.PMID:37877375 | DOI:10.1177/17407745231203391

Source: Clinical Trials - October 25, 2023 Category: Research Authors: Michael J Martens Brent R Logan Source Type: research