title: An overview of statistical approaches for adaptive designs and design modifications.
abstract: With adaptive design methods for clinical trials, design elements such as sample size or further interim sample sizes may be changed during the course of the trial depending on all previously collected data. The focus of the overview is on group sequential approaches where the types of adaptations need not be specified in advance. An overview of the different statistical approaches for adaptive design methods proposed in the literature is given, relations between these methods are described and some perspectives of application and for future research are discussed.
authors.affiliation: Institute of Medical Biometry and Epidemiology, Philipps-University of Marburg, Bunsenstrasse 3, D-35037 Marburg, Germany. hsimbe@med.uni-marburg.de
authors.forename: Helmut
authors.initials: H
authors.lastname: Schäfer
authors.forename: Nina
authors.initials: N
authors.lastname: Timmesfeld
authors.forename: Hans-Helge
authors.initials: HH
authors.lastname: Müller
mesh_terms: D002986:Clinical Trials as Topic / Q000706:statistics & numerical data; D003627:Data Interpretation, Statistical; D015233:Models, Statistical; D011336:Probability; D012107:Research Design; D018401:Sample Size