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SUMMARY:A conservative approach to leveraging external evidence for effect
 ive clinical trial design  - Fabio Rigat\, AstraZeneca Ltd)
DTSTART:20241008T181500Z
DTEND:20241008T203000Z
UID:TALK206875@talks.cam.ac.uk
CONTACT:Peter Watson
DESCRIPTION:Prior probabilities of clinical hypotheses are not systematica
 lly used for clinical trial design yet\, due to a concern that poor priors
  may lead to poor decisions. To address this concern\, a conservative appr
 oach to Bayesian trial design is illustrated here\, requiring that the ope
 rational characteristics of the primary trial outcome are stronger than th
 e prior. This approach is complementary to current Bayesian design methods
 \, in that it insures against prior-data conflict by defining a sample siz
 e commensurate to a discrete design prior. This approach is ethical\, in t
 hat it requires designs appropriate to achieving pre-specified levels of c
 linical equipoise imbalance. Practical examples are discussed\, illustrati
 ng design of trials with binary or time to event endpoints. Moderate incre
 ases in phase II study sample size are shown to deliver strong levels of o
 verall evidence for go/no-go clinical development decisions. Levels of neg
 ative evidence provided by group sequential confirmatory designs are found
  negligible\, highlighting the importance of complementing efficacy bounda
 ries with non-binding futility criteria. 
LOCATION:MRC Cognition and Brain Sciences Unit\, Chaucer Road\, Cambridge
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