JSM 2012 Home

JSM 2012 Online Program

The views expressed here are those of the individual authors and not necessarily those of the JSM sponsors, their officers, or their staff.

Online Program Home

Abstract Details

Activity Number: 231
Type: Topic Contributed
Date/Time: Monday, July 30, 2012 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #305772
Title: Applications of Adaptive Designs in Clinical Trials
Author(s): Henry S Hsu*+ and Min Annie Lin
Companies: FDA/CBER and FDA/CBER
Address: 1401 Rockville Pike, HFM-210, Rockville, MD, 20852,
Keywords: adaptive designs ; regulatory perspective ; biologics
Abstract:

Speaker: Henry S. Hsu*, Ph.D., MPH; henry.hsu@fda.hhs.gov Annie Lin, Ph.D.; min.lin@fda.hhs.gov

Title: Regulatory Perspective on Adaptive Design Clinical Trials for Biologics

Since FDA has released the draft guidance on Adaptive Design Clinical Trials for Drugs and Biologics in early 2010, there are many articles and forums that discuss the proposed procedures and related issues. FDA/CBER also received an increase in adaptive design protocols in clinical trials submitted by the sponsors. In this talk, an overview of this guidance from regulatory perspective and safety consideration on biologics will be presented to include description, motivation, and general concerns on adaptive designs. Also will be presented are those generally well-understood and less regulatory experience adaptive designs with valid approaches to implementation. Finally we will provide a brief summary of proposed adaptive designs for biologics in CBER and discuss the statistical issues raised by the regulatory reviews.


The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.

Back to the full JSM 2012 program




2012 JSM Online Program Home

For information, contact jsm@amstat.org or phone (888) 231-3473.

If you have questions about the Continuing Education program, please contact the Education Department.