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SUMMARY:Phase II/III clinical trials: Recent developments in methodology f
 or trial design and analysis - Sue Todd\,  University of Reading
DTSTART:20130618T133000Z
DTEND:20130618T143000Z
UID:TALK44519@talks.cam.ac.uk
CONTACT:Dr Jack Bowden
DESCRIPTION:There has been much recent interest in the development of clin
 ical trial methods that enable adaptation of the study design during the c
 ourse of the trial whilst maintaining statistical and scientific integrity
  through the control of type I error rate.  One such adaptation of interes
 t is the ability to select from multiple treatments during a trial.  The s
 implest form of design is conducted in two stages.  In the first stage\, p
 atients are randomised between a placebo and a number of experimental trea
 tments.  At the end of this stage\, an interim analysis of the data observ
 ed so far\, possibly on a short-term or surrogate endpoint\, will be condu
 cted.  As a result of this\, the trial could be stopped early\, or one or 
 more of the experimental treatments may be dropped from the trial. The tri
 al then continues with further patients randomised between the placebo and
  the remaining experimental treatments. At the end of the trial\, these ex
 perimental treatments are then compared with the placebo using the data fr
 om all patients randomised.  The final statistical inference is conducted 
 so as to maintain the overall type I error rate allowing for the treatment
  selection and interim analyses.\nThis talk will describe the methodology 
 which has been developed for these types of trials\, exploring the differe
 nt approaches which are documented in the literature.  In addition\, recen
 t work in the areas of design and analysis is highlighted.\n
LOCATION:Large  Seminar Room\, 1st Floor\, Institute of Public Health\, Un
 iversity Forvie Site\, Robinson Way\, Cambridge
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