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Tutorial #2: Bayesian Methods for Drug Safety Evaluation and Signal Detection

Apr 6 2014 9:00AM - Apr 6 2014 12:00PM | Bethesda North Marriott Hotel and Conference Center 5701 Marinelli Road, North Bethesda, MD 20852 USA

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Overview 

As the era of "big data" arrives in full force for health care and pharmaceutical development, researchers in these areas must turn to increasingly sophisticated statistical tools for their proper analysis. Bayesian statistical methods, while dating in principle to the publication of Bayes' Rule in 1763, have only recently begun to see widespread practical application due to advances in computation and software. This tutorial, sponsored by the DIA Bayesian Scientific Working Group, will provide an overview of Bayesian statistical methods and computation, and then explore their use in meta-analysis and hierarchical modeling especially with regard to drug safety. We will demonstrate methods via case examples and discuss the impact of utilizing these approaches throughout pharmaceutical development.


At the conclusion of this tutorial, participants should be able to:

  • Describe the key concepts of Bayesian statistical methods, hierarchical modeling, computation, and software.
  • Provide a review of meta-analysis and Bayesian meta-analysis
  • Discuss how these methods may be used in conjunction with adaptive clinical trial designs that continuously monitor an adverse event of interest.
  • Explain how the basic ideas of Bayesian meta-analysis can be extended to network meta-analysis and provide an example in the context of safety.
  • Examine techniques for safety signal detection in clinical trial AE data that utilize Bayesian hierarchical modeling
  • Discuss Bayesian hierarchical modeling of lab measurements as a possible technique that can be used to incorporate historical control information for early signal detection.

Instructor(s) 

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Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

Participants with Disabilities:
Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs.

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