Committees Announcement Important Dates Featured Speakers Hotel

An adaptive trial is one in which interim data from the trial itself is used to modify and improve the study design, without undermining its validity or integrity. Trial sponsors and regulators have expressed a great deal of interest in designing such trials because of their potential benefit for Phase II and Phase III programs. In the Phase II setting an adaptive trial can assign a larger proportion of the enrolled subjects to the treatment arms that are performing well, drop arms that are performing poorly, and investigate a wider range of doses so as to better identify the nature of the dose-response relationship and select doses that are most likely to succeed at Phase III. When the trial proceeds to Phase III an adaptive design can facilitate early identification of efficacious treatments, determine if the trial could be terminated for futility, and make sample size adjustments at interim looks so as to ensure that the trial is adequately powered. In some cases it might even be possible to enrich the patient population by altering the eligibility criteria at an interim look. Thus, adaptive trials have the potential to translate into more ethical treatment of patients within trials, more efficient drug development, and better focusing of available resources. On the other hand, such trials require tremendous up-front planning and simulation to verify their operating characteristics, precisely because they are so flexible. In this seminar we give an overview of adaptive clinical trials, pointing out their advantages as well as their limitations. Many different types of adaptive trials will be discussed including Phase II response adaptive dose ranging trials, seamless phase II/III trials, Phase III group sequential trials and Phase III trials with sample size re-estimation. The presentation will be conceptual rather than technical and will be illustrated by several examples of actual trials, some of them drawn from our own consulting experience. Logistical and regulatory issues will be discussed.

	First International Workshop in Sequential Methodologies

	Contributing to theoretical and applied aspects of sequential methodologies in all areas of statistical science and applications. Hosted at Auburn University, July 22-25, 2007
Committees/Organizers Plenary Speakers Sponsors Important Dates Registration Abstract Submission Program/Schedule Special Attractions Conference Proceedings Hotel/Transport Auburn Tourism Contact Information Main Page	Tutorial on the Flexible Adaptive Trial Design: Improving the Return on Clinical Trials 1:30-3:00pm, July 23, 2007 AUHCC (room TBA) Cyrus R. Mehta, Ph.D. President, Cytel Inc. 675 Massachusetts Avenue Cambridge, MA 02139 Registration for Tutorial: Registration for Tutorial on the "Flexible Adaptive Trial Design: Improving the Return on Clinical Trials" by Dr. Cyrus Mehta, Cytel Inc. If you are not planning on attending the workshop as a whole, but wish to attend the Tutorial by Dr. Mehta, you may register and pay for this tutorial only. You will not be entitled to participate in any other workshop activities unless the full registration is paid. The fee for the Tutorial ONLY is $100 before June 30, 2007 and $150 there after. The tutorial registration form can be found in pdf here and in MS Word format here. See tutorial description here. Full workshop registrants/participants may attend the tutorial free-of-charge. Description: An adaptive trial is one in which interim data from the trial itself is used to modify and improve the study design, without undermining its validity or integrity. Trial sponsors and regulators have expressed a great deal of interest in designing such trials because of their potential benefit for Phase II and Phase III programs. In the Phase II setting an adaptive trial can assign a larger proportion of the enrolled subjects to the treatment arms that are performing well, drop arms that are performing poorly, and investigate a wider range of doses so as to better identify the nature of the dose-response relationship and select doses that are most likely to succeed at Phase III. When the trial proceeds to Phase III an adaptive design can facilitate early identification of efficacious treatments, determine if the trial could be terminated for futility, and make sample size adjustments at interim looks so as to ensure that the trial is adequately powered. In some cases it might even be possible to enrich the patient population by altering the eligibility criteria at an interim look. Thus, adaptive trials have the potential to translate into more ethical treatment of patients within trials, more efficient drug development, and better focusing of available resources. On the other hand, such trials require tremendous up-front planning and simulation to verify their operating characteristics, precisely because they are so flexible. In this seminar we give an overview of adaptive clinical trials, pointing out their advantages as well as their limitations. Many different types of adaptive trials will be discussed including Phase II response adaptive dose ranging trials, seamless phase II/III trials, Phase III group sequential trials and Phase III trials with sample size re-estimation. The presentation will be conceptual rather than technical and will be illustrated by several examples of actual trials, some of them drawn from our own consulting experience. Logistical and regulatory issues will be discussed.
	Auburn University	Sequential Analysis
	University of Connecticut	Taylor & Francis Group