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SUMMARY:The Role of Operating Characteristic in Assessing Bayesian Designs
  in Pharmaceutical Drug Development - Grieve\, A (ClinResearch)
DTSTART:20110815T084500Z
DTEND:20110815T093000Z
UID:TALK32355@talks.cam.ac.uk
CONTACT:Mustapha Amrani
DESCRIPTION:The guidelines that are available covering the reporting of Ba
 yesian clinical trials cover many important aspects including the choice o
 f prior\, issues surrounding computation such as the convergence of MCMC a
 pproaches and the appropriate statistics for summarising posterior distrib
 utions. Noteworthy is the total absence of any discussion of operating cha
 racteristics of Bayesian designs. This may be because these guidelines are
  largely written by academic and/or autonomous government groups and not b
 y 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 Baye
 sian methodology in device trials. In this talk I investigate issues in de
 termining operating characteristics of clinical trial designs with a parti
 cular 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. \n\n\n
LOCATION:Seminar Room 1\, Newton Institute
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