A 25-year review of sequential methodology in clinical studies.
This paper explores the theoretical developments and subsequent uptake of sequential methodology in clinical studies in the 25 years since Statistics in Medicine was launched. The review examines the contributions which have been made to all four phases into which clinical trials are traditionally classified and highlights major statistical advancements, together with assessing application of the techniques. The vast majority of work has been in the setting of phase III clinical trials and so emphasis will be placed here. Finally, comments are given indicating how the subject area may develop in the future.
Todd
Susan
S
Medical and Pharmaceutical Statistics Research Unit, The University of Reading, PO Box 240, Earley Gate, Reading RG6 6FN, UK. s.c.todd@reading.ac.uk
D002986:Clinical Trials as Topic / Q000379:methods*; D017321:Clinical Trials, Phase I as Topic / Q000379:methods; D017322:Clinical Trials, Phase II as Topic / Q000379:methods; D017326:Clinical Trials, Phase III as Topic / Q000379:methods; D017327:Clinical Trials, Phase IV as Topic / Q000379:methods; D003627:Data Interpretation, Statistical; D006801:Humans; D012107:Research Design