title: Stopping rules for phase II studies.
abstract: This paper, the second in a series of three papers concerned with the statistical aspects of interim analyses in clinical trials, is concerned with stopping rules in phase II clinical trials. Phase II trials are generally small-scale studies, and may include one or more experimental treatments with or without a control. A common feature is that the results primarily determine the course of further clinical evaluation of a treatment rather than providing definitive evidence of treatment efficacy. This means that there is more flexibility available in the design and analysis of such studies than in phase III trials. This has led to a range of different approaches being taken to the statistical design of stopping rules for such trials. This paper briefly describes and compares the different approaches. In most cases the stopping rules can be described and implemented easily without knowledge of the detailed statistical and computational methods used to obtain the rules.
authors: Medical and Pharmaceutical Statistics Research Unit, The University of Reading, PO Box 240, Earley Gate, Reading, Berkshire, RG6 6FN, UK. n.stallard@reading.ac.uk
authors: N
authors: N
authors: Stallard
authors: J
authors: J
authors: Whitehead
authors: S
authors: S
authors: Todd
authors: A
authors: A
authors: Whitehead
mesh_terms: D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001499:Bayes Theorem; D015982:Bias; D017322:Clinical Trials, Phase II as Topic / Q000379:methods* / Q000706:statistics & numerical data; D003627:Data Interpretation, Statistical; D003662:Decision Theory; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy*; D012107:Research Design / Q000592:standards*; D018401:Sample Size; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents