Online Program Home
  My Program

Abstract Details

Activity Number: 651 - Perception and Use of Adaptive Designs in Industry and Academia: Comparison of the Four DIA Adaptive Design Scientific Working Group Surveys Conducted from 2000 Through 2015
Type: Topic Contributed
Date/Time: Thursday, August 3, 2017 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #323925 View Presentation
Title: Perception and Use of Adaptive Designs in Industry and Academia - Findings of a Review of Registries
Author(s): Lingyun Liu*
Companies: Cytel, Inc
Keywords: Adaptive Design
Abstract:

Adaptive designs have gained in popularity since the first seminal paper by Bauer and Kohne 1994. Compared to the conventional designs, adaptive designs save patients and costs in exchange of the operational complexities. Statistical methodologies for performing appropriate final analysis in face of various adaptations including sample size re-esitmation, adaptive treatment selection and population enrichment has been addressed in the literature. Regulatory agencies in the United States and Europe have issued guidance documents for use of adaptive design in clinical trials.Two surveys have been conducted by the DIA Adaptive Design Working Group (Quinlan et al, 2010; Morgan et al,2014) to capture what is happening in reality. With the continuous efforts, this survey is to identify the improvements and consistent barriers with adaptive designs since the last survey.This survey consists of three parts:survey of use of adaptive design in real world, literature review and registry review.This presentation will touch upon the approach to the registry review,the main results of the registry review and the general trend over the four periods 2000-2003, 2004-2007, 2008-2011, and 2012-2015.


Authors who are presenting talks have a * after their name.

Back to the full JSM 2017 program

 
 
Copyright © American Statistical Association