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CATEGORIES:MRC Biostatistics Unit Seminars
SUMMARY:BSU Seminar: “Optimal design of First in Human tri
als via dynamic programming” - Dr Lizzi Pitt\, Uni
versity of Bath
DTSTART;TZID=Europe/London:20220510T140000
DTEND;TZID=Europe/London:20220510T150000
UID:TALK173987AThttp://talks.cam.ac.uk
URL:http://talks.cam.ac.uk/talk/index/173987
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 trial.\n\nFirst i
n Human trials are conducted sequentially\, alloca
ting a dose to one cohort at a time. After observi
ng results from one cohort\, trial teams must deci
de which dose to give the next cohort. We have dev
eloped a framework to make these decisions optimal
ly. The emphasis is on fully specifying the aims o
f the trial up front: if you tell us what you want
the trial to do\, we can find the optimal design
for your specific trial.\n\nWe obtain optimal desi
gns via dynamic programming. This requires a set o
f calculations to be performed for every possible
data set at each stage of the trial. Even with a s
mall sample size this state space is large\, and p
rohibitively large when it comes to considering ph
ase I trials with a safety and an efficacy endpoin
t. We consider reformulating the state space as th
e space of posterior density functions for the dos
e-response model parameter and adapting the dynami
c programming algorithm to a sample of this space.
This produces a design that is a good approximati
on to the optimal rule produced by performing dyna
mic programming on the space of all possible data
sets. We use this approximate version of the algor
ithm to find an optimal design for a First in Huma
n 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 trial aims
up front and choosing a design that meets those ai
ms. This framework enables objective comparison of
phase I trial designs to find the optimal design
for a specific trial.
LOCATION:Seminar Room 2\, School of Clinical Medicine\, Add
enbrooke's Hospital
CONTACT:Alison Quenault
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