Statistical consideration of adaptive methods in clinical development.
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.
Chow
Shein-Chung
SC
Division of Biostatistics and Bioinformatics, National Health Research Institutes, Taipei, Taiwan. schow@nhri.org.tw
Chang
Mark
M
Pong
Annpey
A
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