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SUMMARY:Bayesian approaches to Phase I clinical trials: methodological and
  practical aspects - Neuenschwander\, B (Novartis Pharma AG)
DTSTART:20110816T140000Z
DTEND:20110816T143000Z
UID:TALK32378@talks.cam.ac.uk
CONTACT:Mustapha Amrani
DESCRIPTION:Statistics plays an important role in drug development\, in pa
 rticular in confirmatory (phase III) clinical trials\, where statistically
  convincing evidence is a requirement for the registration of a drug. Howe
 ver\, statistical contributions to phase I clinical trials are typically s
 parse. A notable exception is oncology\, where statistical methods abound.
 \n\nAfter a short review of the main approaches to phase I cancer trials\,
  we discuss a fully adaptive model-based Bayesian approach which strikes a
  reasonable balance with regard to various objectives. First\, proper quan
 tification of the risk of dose-limiting toxicities (DLT) is the key to acc
 eptable dosing recommendations during the trial\, and the declaration of t
 he maximum tolerable dose (MTD)\, a dose with an acceptable risk of DLT\, 
 at the end of the trial. In other words\, statistically driven dosing-reco
 mmendations should be clinically meaningful. Second\, the operating charac
 teristics of the design should be acceptable. That is\, the probability to
  find the correct MTD should be reasonably high. Third\, not too many pati
 ents should be exposed to overly toxic doses. And fourth\, the approach sh
 ould allow for the inclusion of relevant study-external information\, such
  as pre-clinical data or data from other human studies.\n\nThe methodologi
 cal and practical aspects of the Bayesian approach to dose finding trials 
 in Oncology phase I will be discussed\, and examples from actual trials wi
 ll be used to illustrate and highlight important issues. The presentation 
 concludes with a discussion of the main challenges for a large-scale imple
 mentation of innovative clinical trial designs in the pharmaceutical indus
 try.\n\n
LOCATION:Seminar Room 1\, Newton Institute
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