Statistical consideration of adaptive methods in clinical development

J Biopharm Stat. 2005;15(4):575-91. doi: 10.1081/BIP-200062277.

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.

MeSH terms

  • Algorithms
  • Clinical Trials as Topic*
  • Data Interpretation, Statistical*
  • Dose-Response Relationship, Drug
  • Population
  • Research Design*
  • United States
  • United States Food and Drug Administration