IngentaConnect Stopping rules for phase II studies

Authors: Stallard, Nigel¹; Whitehead, John¹; Todd, Susan¹; Whitehead, Anne¹

Source: British Journal of Clinical Pharmacology, Volume 51, Number 6, June 2001 , pp. 523-529(7)

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.

Keywords: clinical trial design; early stopping; group sequential designs

Document Type: Research article

DOI: 10.1046/j.0306-5251.2001.01381.x

Affiliations: 1: Medical and Pharmaceutical Statistics Research Unit, The University of Reading, PO Box 240, Earley Gate, Reading, Berkshire, RG6 6FN

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