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This is the preliminary program for the 2007 Joint Statistical
Meetings in Salt Lake City, Utah.
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The views expressed here are those of the individual authors and not necessarily those of the ASA or its board, officers, or staff. Back to main JSM 2007 Program page |
= Applied Session,
= Theme Session,
= Presenter| CE_14C | Sun, 7/29/07, 1:00 PM - 5:00 PM | CC-155 A |
| Adaptive Dose-Response Studies - Continuing Education - Course | ||
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ASA |
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| Instructor(s): Christopher S. Coffey, The University of Alabama at Birmingham, Brenda Gaydos, Eli Lilly and Company, Jose Pinheiro, Novartis Pharmaceuticals | ||
| Insufficient understanding of the dose response profile of a compound is a shortcoming of clinical drug development, often leading to incorrect dose selection for the confirmatory phase. Indeed, failure to characterize adequate dosing early is often cited as a key contributor to the high late-stage attrition rate currently faced by the pharmaceutical industry. Adaptive dose-response trials allow more efficient learning about the dose response, for both efficacy and safety, earlier in development, which should ultimately reduce overall costs/timelines and provide better dosing information. Such designs may be thought of as a subset of adaptive designs in general. The rapid proliferation of adaptive designs, and inconsistent use of terminology, has created confusion about the similarities and, more importantly, the differences among the techniques. This half-day course will clarify the differences between adaptive dose-response trials and other types of adaptive designs, review traditional fixed designs and adaptive dose-response designs, and provide information on developing a Bayesian adaptive dose-response trial. Real and simulated data examples will be used to illustrate the various methods discussed in the course. The course is intended for anyone with a basic understanding of statistical methods (at approximately the 2nd year of a graduate program), basic knowledge of Bayesian methods, and some exposure to drug development concepts. | ||
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JSM 2007
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. |