Stopping a clinical trial very early because of toxicity: summarizing the evidence.
When a trial is stopped early because of a specific toxicity, it may be important to summarize the statistical evidence for stopping. Such a summary needs to take into account the sequential nature of the stopping rule. We address some practical issues involved in analyzing such toxicity data coming from a trial that was stopped after the fourth patient was evaluated.
Korn
E L
EL
Biometric Research Branch, National Cancer Institute, Bethesda, Maryland 20892.
Yu
K F
KF
Miller
L L
LL
D001499:Bayes Theorem; D002986:Clinical Trials as Topic / Q000009:adverse effects*; D016001:Confidence Intervals; D064420:Drug-Related Side Effects and Adverse Reactions; D016179:Granulocyte Colony-Stimulating Factor / Q000009:adverse effects; D006801:Humans; D007970:Leukopenia / Q000209:etiology
D016179:Granulocyte Colony-Stimulating Factor