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SUMMARY:BSU Seminar: “Optimal design of First in Human trials via dynami
 c programming” - Dr Lizzi Pitt\, University of Bath
DTSTART:20220510T130000Z
DTEND:20220510T140000Z
UID:TALK173987@talks.cam.ac.uk
CONTACT:Alison Quenault
DESCRIPTION:What is the best design for a First in Human trial? The answer
  to this question depends on the aims and constraints of an individual tri
 al.\n\nFirst in Human trials are conducted sequentially\, allocating a dos
 e to one cohort at a time. After observing results from one cohort\, trial
  teams must decide which dose to give the next cohort. We have developed a
  framework to make these decisions optimally. The emphasis is on fully spe
 cifying the aims of the trial up front: if you tell us what you want the t
 rial to do\, we can find the optimal design for your specific trial.\n\nWe
  obtain optimal designs via dynamic programming. This requires a set of ca
 lculations to be performed for every possible data set at each stage of th
 e trial. Even with a small sample size this state space is large\, and pro
 hibitively large when it comes to considering phase I trials with a safety
  and an efficacy endpoint. We consider reformulating the state space as th
 e space of posterior density functions for the dose-response model paramet
 er and adapting the dynamic programming algorithm to a sample of this spac
 e. This produces a design that is a good approximation to the optimal rule
  produced by performing dynamic programming on the space of all possible d
 ata sets. We use this approximate version of the algorithm to find an opti
 mal design for a First in Human trial with both a binary efficacy endpoint
  and a binary safety endpoint.\n\nDifferent sets of aims lead to different
  optimal rules. This highlights the importance of clearly defining the tri
 al aims up front and choosing a design that meets those aims. This framewo
 rk enables objective comparison of phase I trial designs to find the optim
 al design for a specific trial.
LOCATION:Seminar Room 2\, School of Clinical Medicine\, Addenbrooke's Hosp
 ital
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