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General Departmental Seminar Series


Adaptive model-based designs in clinical drug development

Vlad Dragalin, Wyeth Research

Friday, October 19, 2007
12:00 pm
5275 MSC



The objective of a clinical trial may be either to target the maximum tolerated dose or minimum effective dose,
or to find the therapeutic range, or to determine the optimal safe dose to be recommended for confirmation,
or to confirm efficacy over control in a Phase III clinical trial. This clinical goal is usually determined by the clinicians
from the pharmaceutical industry, practicing physicians, key opinion leaders in the field, and the regulatory agency.
Once agreement has been reached on the objective, it is the statistician's responsibility to provide the appropriate
design and statistical inferential structure required to achieve that goal. There is a plenty of available designs on
statistician's shelf. The greatest challenge is their implementation. I exemplify this in three case studies.

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