title: Statistical consideration of adaptive methods in clinical development.
abstract: In recent years, the use of adaptive methods in clinical development based on accrued data has become very popular due to its flexibility in modifying trial procedures and/or statistical procedures of on-going clinical trials. However, it is a concern that the actual patient population after the modifications could deviate from the originally targeted patient population. Major modifications of trial procedures and/or statistical procedures of on-going trials may result in a totally different trial, which is unable to address the scientific/medical questions that the trial intends to answer.
authors: Division of Biostatistics and Bioinformatics, National Health Research Institutes, Taipei, Taiwan. schow@nhri.org.tw
authors: Shein-Chung
authors: SC
authors: Chow
authors: Mark
authors: M
authors: Chang
authors: Annpey
authors: A
authors: Pong
mesh_terms: D000465:Algorithms; D002986:Clinical Trials as Topic; D003627:Data Interpretation, Statistical; D004305:Dose-Response Relationship, Drug; D011153:Population; D012107:Research Design; D014481:United States; D014486:United States Food and Drug Administration