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PHASE I AND PHASE I/II TRIAL DESIGN

UAB Center for Clinical and Translational Science (CCTS)

Monday, February 27, 2012 from 11:00 AM to 12:00 PM (CST)

PHASE I AND PHASE I/II TRIAL DESIGN

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PHASE I AND PHASE I/II TRIAL DESIGN
PHASE I AND PHASE I/II TRIAL DESIGN presented by Dr. John O'Quigley. Presentation in the West Pavilion Board Room. Snacks will be served.
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Event Details

The UAB Center for Clinical and Translational Science and the Department of Biostatistics present:

PHASE I AND PHASE I/II TRIAL DESIGN

presented by John O'Quigley, PhD, University of Paris VI, Paris, France


There has been extensive investigation into the design and analysis of Phase I dose finding studies during the last twenty or so years. Several reports have shown very clearly that the old 3+3 standard trial design is wholly inadequate for the task and is quite likely partly responsible for the high rate of failure of treatments at the Phase II and Phase III stage. Adoption of new methods has been unfortunately slow, often as a result of misplaced fears about their operating characteristics. As a consequence the gap between the statistical theory and the regular clinical research practice has grown and only now are we beginning to see applied examples of more carefully constructed designs which incorporate patient heterogeneity, designs which make fuller use of information on intermediary grades, designs which take account of errors in the attribution of drug related toxicities and designs that directly address the problems of combination therapies. No less important is the fact that until we clearly make a break with the old 3+3 designs it is difficult to make use of recent designs that consider the question of efficacy and tolerance simultaneously (so called Phase I/II designs). This talk will cover a number of these issues. The statistical level is elementary and accessible to clinicians without much background in statistics.

Have questions about PHASE I AND PHASE I/II TRIAL DESIGN? Contact UAB Center for Clinical and Translational Science (CCTS)

When

Monday, February 27, 2012 from 11:00 AM to 12:00 PM (CST)


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Organizer

UAB Center for Clinical and Translational Science (CCTS)

The UAB Center for Clinical and Translational Science (CCTS) accelerates research for improved human health.  Led by Robert P. Kimberly, MD, Associate Dean for Biomedical Research, CCTS funding is provided by the NIH National Center for Advancing Translational Sciences grant UL1 TR000165. 

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