title: Methodological developments vs. regulatory requirements.
abstract: This is a discussion of the following three papers appearing in this special issue on adaptive designs: 'FDA's critical path initiative: A perspective on contributions of biostatistics' by Robert T. O'Neill, 'A regulatory view on adaptive/flexible clinical trial design' by H. M. James Hung, Robert T. O'Neill, Sue-Jane Wang and John Lawrence; and 'Confirmatory clinical trials with an adaptive design' by Armin Koch.
authors.affiliation: Core Unit for Medical Statistics and Informatics, Section of Medical Statistics, Medical University of Vienna, Spitalgasse 23, 1090 Vienna, Austria. peter.bauer@meduniwien.ac.at
authors.forename: Peter
authors.initials: P
authors.lastname: Bauer
mesh_terms: D001699:Biometry; D002986:Clinical Trials as Topic / Q000706:statistics & numerical data*; D003627:Data Interpretation, Statistical; D012107:Research Design / Q000706:statistics & numerical data; D018401:Sample Size