title: Strategies for including patients recruited during interim analysis of clinical trials.
abstract: In clinical trials a periodical check of safety and efficacy data is often needed. For organizational reasons it is rarely desirable to stop a trial during such an interim analysis. Therefore, new study patients are included in the trial while the interim analysis is ongoing. Disregarding the additional information provided by these interim patients would be unsatisfactory, especially for an office of regulatory affairs. Consequently, the rules for group sequential or adaptive decisions must be adjusted to the recruitment of interim patients. In this paper, two strategies for modifying study designs to consider the analysis of interim patients are proposed.
authors.affiliation: Institute of Medical Biostatistics, Epidemiology and Informatics, University of Mainz, Germany. faldum@imbei.uni-mainz.de
authors.forename: Andreas
authors.initials: A
authors.lastname: Faldum
authors.forename: Gerhard
authors.initials: G
authors.lastname: Hommel
mesh_terms: D002986:Clinical Trials as Topic / Q000379:methods* / Q000706:statistics & numerical data*; D006801:Humans; D012107:Research Design; D018401:Sample Size