ABSTRACT
As emphasized in the draft FDA guidance on enrichment strategies for clinical trials (Food and Drug Administration, 2012), characterization of
CONTENTS
8.1 Introduction ................................................................................................ 211 8.2 Subgroup Search Methods ....................................................................... 213
8.2.1 Global Outcome Modeling ........................................................... 215 8.2.2 Global Treatment Effect Modeling .............................................. 217 8.2.3 Local Modeling .............................................................................. 219 8.2.4 Identication of the Right Treatment for a Subject ................... 220
8.3 Three SIDES Subgroup Search Procedure .............................................222 8.3.1 Subgroup Search Algorithm ........................................................223 8.3.2 Complexity Control ....................................................................... 226 8.3.3 Multiplicity Control .......................................................................229 8.3.4 Algorithm Parameters ...................................................................230
