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The Role of Operating Characteristic in Assessing Bayesian Designs in Pharmaceutical Drug Development

Monday 15th August 2011 - 09:45 to 10:30
INI Seminar Room 1
Session Title: 
Opening session
Session Chair: 
Stefanie Biedermann
The guidelines that are available covering the reporting of Bayesian clinical trials cover many important aspects including the choice of prior, issues surrounding computation such as the convergence of MCMC approaches and the appropriate statistics for summarising posterior distributions. Noteworthy is the total absence of any discussion of operating characteristics of Bayesian designs. This may be because these guidelines are largely written by academic and/or autonomous government groups and not by those involved in pharmaceutical drug development, for example sponsor associations or regulatory agencies. However operating characteristics are becoming of increasing importance in drug development as is witnessed by the EMA and FDA guidances on adaptive designs and the FDA guidance on Bayesian methodology in device trials. In this talk I investigate issues in determining operating characteristics of clinical trial designs with a particular emphasis on Bayesian designs but will also cover more general issues such as the design of simulation experiments and simulation evidence for strong control of type I error.
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Presentation Material: 
University of Cambridge Research Councils UK
    Clay Mathematics Institute London Mathematical Society NM Rothschild and Sons