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SUMMARY:Hypothesis testing and estimation in a group sequential phase II/I
 II clinical trial - Nigel Stallard\, University of Warwick
DTSTART:20090310T143000Z
DTEND:20090310T153000Z
UID:TALK16128@talks.cam.ac.uk
CONTACT:Michael Sweeting
DESCRIPTION:Most statistical methodology for phase III clinical trials foc
 uses on the comparison of a single experimental treatment with a control t
 reatment\, with selection of the treatment made in a phase II trial.  Rece
 ntly\, however\, there has been increasing interest in methods for phase I
 I/III trials that combine the treatment selection element of a phase II cl
 inical trial with the definitive analysis associated with phase III clinic
 al trials.\n\n\n\nThis talk will describe a method for combining phases II
  and III in a single phase II/III clinical trial that proceeds in a number
  of stages.  The first stage is rather like the usual phase II trial\, wit
 h patients randomised between a control treatment and a number of experime
 ntal treatments.  At the end of this stage\, the best experimental treatme
 nt is selected.  If this is clearly superior or clearly inferior to the co
 ntrol treatment\, the trial might be stopped at this point either for effi
 cacy or for futility respectively.  If the trial is not stopped\, it conti
 nues to the second stage\, which is more like the usual phase III trial\, 
 with recruitment to the control arm and the selected experimental treatmen
 t arm alone.  The second stage may itself include interim analyses compari
 ng the two treatments.  An extension of the group-sequential approach will
  be used to ensure that the overall type I error rate is controlled at the
  specified level.\n\n\n\nThe talk will conclude with a discussion of the p
 roblem of estimation of treatment effects after a trial in which treatment
  selection has taken place.\n\n
LOCATION:Large Seminar Room\, 1st Floor\, Institute of Public Health\, Uni
 versity Forvie Site\, Robinson Way\, Cambridge
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