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SUMMARY:Phase II Clinical Trial Designs: Then and Now - Michael Grayling (
 MRC-BSU)
DTSTART:20140223T160000Z
DTEND:20140223T163000Z
UID:TALK50872@talks.cam.ac.uk
CONTACT:Mary Fortune
DESCRIPTION:Over the past few decades\, clinicians have been forced to dea
 l with a revolution in the proposed procedures for the progression of a dr
 ug through phase II trials. Historically\, a single-arm phase II design\, 
 in which all patients receive the experimental treatment\, was employed as
  the principal way to determine whether to proceed to a randomised control
 led phase III trial. However\, single-arm trials are commonly associated w
 ith high type-I error rates\, as well as biased estimated treatment effect
 s. As a result\, it has become increasingly clear that this classical phas
 e II design performs poorly in predicting the likelihood of phase III succ
 ess. Consequently\, there has been much interest recently in the use of ra
 ndomised phase II designs\, and a more commonly accepted phase II developm
 ent plan today has become to utilize a single-arm designed trial\, followe
 d by a pilot randomised study if the null hypothesis is rejected at the si
 ngle-arm stage. In my talk\, I will detail how the most common single-arm 
 and randomised two-arm trials are optimally designed and the roles each pl
 ay today\, before discussing a simple way in which the expected sample siz
 e of the single-arm followed by randomised two-arm development plan may be
  reduced over current practice. 
LOCATION:Winstanley Lecture Theatre\, Trinity College
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