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SUMMARY:Adaptive Dose-Ranging Designs with Two Efficacy Endpoints - Dragal
 in\, V (Aptiv Solutions\, USA)
DTSTART:20110816T083000Z
DTEND:20110816T090000Z
UID:TALK32375@talks.cam.ac.uk
CONTACT:Mustapha Amrani
DESCRIPTION:Following the introduction of the continual reassessment metho
 d by OQuigley\, Pepe and Fisher\, there has been considerable interest in 
 formal statistical procedures for phase I dose-finding studies. The great 
 majority of published accounts relate to cancer patients treated once with
  a single dose of the test drug who return a single binary observation con
 cerning the incidence of toxicity. However\, most phase I dose-finding stu
 dies are not of such a simple form. Drugs being developed for milder condi
 tions than cancer are usually first tested in healthy volunteers who parti
 cipate in multiple dosing periods\, returning a continuous pharmacokinetic
  response each time. \n\nThis talk will describe Bayesian decision procedu
 res which have been developed for such dose-finding studies in healthy vol
 unteers. The principles behind the approach will be described and an evalu
 ation of its properties presented. An account will be given of an implemen
 tation of the approach in a study conducted in Scandinavia. Generalisation
  to studies in which more than one response is used will also be discussed
 . \n\n\n
LOCATION:Seminar Room 1\, Newton Institute
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