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SUMMARY:Utility and pitfals of dose ranging trials with multiple study obj
 ectives: fixed or adaptive - Wang\, S-J (FDA)
DTSTART:20110816T103000Z
DTEND:20110816T110000Z
UID:TALK32376@talks.cam.ac.uk
CONTACT:Mustapha Amrani
DESCRIPTION:Multiple study objectives have been proposed in dose-ranging s
 tudies. Traditionally\, a dose-response study is pursued as a fixed design
  of equal randomization ratio to each study arm and with only single study
  objective of detecting dose-response (DR). The PhRMA adaptive dose rangin
 g working group has taken the ownership of the problem using an adaptive d
 esign or an adaptive analysis approach acknowledging the trial exploratory
 . The authors have critically pursued multiple study objectives via simula
 tion studies (JBS 2007\, SBR 2010) and concluded that achieving the first 
 goal of detecting DR is much easier than achieving the fourth goal of esti
 mating it\, or the second and third goals of identifying the target dose t
 o bring into the confirmatory phase. It is tempting to consider dose-rangi
 ng\, dose-response and sometimes exposure-response studies as pivotal evid
 ence\, especially when they are designed as a two-stage adaptive trial. De
 sign according to the study objective is vital to the success of the study
 . In this presentation\, the utility and pitfalls of a two-stage adaptive 
 dose-ranging trial will be elucidated. Challenges and reflection on some o
 f the successful and not so successful regulatory examples will be highlig
 hted. The appropriate stages distinguishing between learning stage versus 
 confirmatory stage in a drug development program will also be discussed us
 ing some typical studies.\n
LOCATION:Seminar Room 1\, Newton Institute
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