Adaptive designs in clinical drug development: opportunities, challenges, and scope reflections following PhRMA's November 2006 workshop

J Biopharm Stat. 2007;17(6):957-64. doi: 10.1080/10543400701643764.

Abstract

This paper provides reflections on the opportunities, scope and challenges of adaptive design as discussed at PhRMA's workshop held in November 2006. We also provide a status report of workstreams within PhRMA's working group on adaptive designs, which were triggered by the November workshop. Rather than providing a comprehensive review of the presentations given, we limit ourselves to a selection of key statements. The authors reflect the position of PhRMA's working group on adaptive designs.

MeSH terms

  • Clinical Trials Data Monitoring Committees
  • Clinical Trials as Topic / methods*
  • Clinical Trials as Topic / statistics & numerical data
  • Data Interpretation, Statistical
  • Drug Industry*
  • Humans
  • Research Design*
  • United States
  • United States Food and Drug Administration