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Adaptive Design for Clinical Trials
Wednesday, November 14
8:30 am – 11:00 am
Wednesday Morning Symposia are Funded by a Grant from
Symposium
ACPE #073-999-07-534-l04
Earlier this year the FDA Deputy Commissioner for Medical and Scientific Affairs, Scott Gottlieb, announced the Agency’s new push for adaptive trials during the 2006 conference on Adaptive Trial Design. To this end, the FDA is working on a series of guidance documents that will articulate the pathway for developing adaptive approaches to clinical trials. Adaptive design is a trial design that allows modifications to some aspects of the trial after its initiation using interim analysis without undermining the validity and integrity of the trial. Adaptive procedures can offer significant ethical and cost advantages over standard fixed procedures. Examples of modifications to a trial include sample size re-estimation, adaptive randomization, early stopping due to efficacy or futility, dropping inferior treatment groups. These new approaches to clinical trials can result in trial designs that tell us more about safety and benefits of drugs, in potentially shorter time frames, exposing fewer people to experimental treatments, and resulting in clinical trials that may not only be more efficient but are more attractive to patients and their physicians to enroll in. However adaptive procedures are more complicated to design and to analyze, and in some settings are more difficult to implement. The symposium will feature speakers that will address basic concepts in adaptive trial design, and discuss the advantages and challenges of implementing this approach.
Moderator
Deepa S. Deshpande, Ph.D.
Acologix, Inc.
Presentation Title to be Announced
Jerald S. Schindler, Ph.D.
Cytel, Inc.
Speech Titles and Speakers to be Announced
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