Live Webcast CoursePlanned for Spring 2013 February 2013-June 2013 (Specific Dates TBD)
Course Description: MI260 provides an introduction to meta analysis concepts and methods, with a strong focus on model-based meta-analysis of summary data or a combination of summary and individual data from clinical trials to support decision-making in clinical drug development. Upon completion of the course, participants will be able to write a meta-analysis plan, design a model-based meta-analysis of clinical trial data to address strategic decisions in a clinical drug development program, and implement it using a Bayesian approach executed with WinBUGS and R. Participants will also be able to construct a model for the relationship between an efficacy- or safety-related clinical outcome and independent variables such as dose, time and patient characteristics by analysis of summary data from multiple studies, e.g., treatment means and standard deviations, and construct such a model by analysis of a combination of summary and individual data, as well as execute and interpret population simulations to support decision-making in clinical drug development. Participants may apply the 3 credit hours from this course to the Metrum Institute Certificate Program in Pharmacometrics.
Prerequisites: Experience with PK-PD modeling and some familiarity and hands-on experience with nonlinear regression, mixed-effects modeling, Bayesian modeling using WinBUGS, and use of R (or S-Plus). Applicable MI courses include: MI200, MI205 and MI250, or
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Computer Hardware/Software: This course requires a Windows computer with an available USB 2.0 port. All required software used for hands-on examples will be freeware/open-source software and simple instructions will be provided for users to configure their computers before the course.