title: Stopping a clinical trial very early because of toxicity: summarizing the evidence.
abstract: 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.
authors.affiliation: Biometric Research Branch, National Cancer Institute, Bethesda, Maryland 20892.
authors.forename: E L
authors.initials: EL
authors.lastname: Korn
authors.forename: K F
authors.initials: KF
authors.lastname: Yu
authors.forename: L L
authors.initials: LL
authors.lastname: Miller
mesh_terms: 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
chemical_list: D016179:Granulocyte Colony-Stimulating Factor