| Time | Session \n \; | \;Speaker | \;Abstract | Slides \; |
| \;8:50 | \;Registration &\; Coffee
\; | &nb sp\; | \; | \; |
| \;9:1 0 | \;Welcome &am
p\; Introduction \; | \; | \ ; | \; |
| \;9:15 | \; | Benoit Beck (Axiosis) \; \n \; | TBC
\n \; | Please click here to view the slid
e deck |
| \;Best practice in modelling and si
mulation: initiatives from PSI and EFPIA | \;Michael O&rsquo\;Kelly (Quint
iles) |
\;At \;an EMA-IFPIA workshop on modelling and simulation in 2011\, reg
ulators called for a Best Practice document for projects involving modelli
ng and simulation. Finally\, in the last few months\, two different workin
g groups have come up with two tools aimed at helping statisticians and th
eir colleagues to promote and use best practice. The European Federation o
f Pharmaceutical Industries &\; Associations (EFPIA) working group on M
odel Informed Drug Discovery and Development (MID3) has just published a w
ide-ranging 90-page paper on the whys and hows of Best Practice. The paper
includes as a supplement a table of 103 examples of the use of modelling
and simulation in pharmaceutical science. At the same time\, the Board of
PSI in December adopted a Best Practice document proposed by the PSI Model
ling and Simulation Special Interest Group (SIG). The two initiatives are
consistent in their recommendations\, with the SIG providing a template th
at could be used to put the recommendations for best practice into action.
This presentation will identify the elements necessary for best practice
in simulation of clinical trials\, and survey current practice in this are
a. | Please click here to view the slide deck | |
| \;10:45 | \;Tea &\; Coffee \; | \; | \; | \; |
| \;11:15 | \;Writing Clinical Trial \;Simulators: there&r
squo\;s more to it than the stats analysis. | \;Tom Parke (Berry Consultan
ts) | When wr
iting ones first trial simulator it&rsquo\;s inevitable that one&rsquo\;s
focus (as a \;stats programmer) is on the novel aspect of the trial de
sign that has required writing a simulator in the first place. However the
re are other aspects of trial simulation that will end up as being every b
it as important. By understanding these other aspects in advance you&rsquo
\;ll be able to better plan to accommodate them and do a better job of wri
ting and using a trial simulator. | \;Please click h
ere to view the slide deck |
| \;12:00 | \;Assessment of
various continual reassessment method models for dose-escalation phase 1 o
ncology clinical trials: Clinical trial data and simulation studies | \;Ga
reth James (Phastar) | \;\n Background: The continu al reassessment method (CRM) is considered more efficient and ethical than standard methods for dose-escalation trials in oncology\, but requires an underlying estimate of the dose-toxicity relationship (&ldquo\;prior skel eton&rdquo\;) and there is limited guidance of what this should be when li ttle is known about this association. Aim: \; To compare the CRM with different prior skeleton approaches and the 3+3 metho d in their ability to determine the true maximum tolerated dose (MTD) of v arious &ldquo\;true&rdquo\; dose-toxicity relationships. | \; |
| \ ;12:45 | \;Lunch<
/strong> | \; | \; | \; |
| \;13:45 | Simulating Dose Finding Designs using Bayesian D
ecisions\, with examples for Severe Asthma\, Ulcerative Colitis and Alzhei
mer&rsquo\;s Disease. | \;Alun Bedding (AZ) < /td> | \;Choosing the correct
dose for Phase III is a pivotal part of drug development. \; Model ba
sed approaches are the most appropriate way of doing this and Bayesian dec
isions are more informative. Simulation is needed in order to understand t
he operating characteristics of designs given different assumptions. \
; Examples\, including those for severe asthma\, ulcerative colitis and Al
zheimer&rsquo\;s disease will be used for illustration. | \;Please click here to view the slide deck |
| \;14:30 | \;Use of simulations to aid decision making | \;Jane
Temple (GSK) | \; \;In clinical trial design we often use simulations to illu
strate operational characteristics where analytical solutions are intracta
ble. \; In this talk we will look at some case studies where these sim
ulations have aided decision making and so increased understanding within
the project team. \; We will look at an example of complex go/no go cr
iteria and how these criteria were refined based on the results of the sim
ulation. \; We will look at an example of how simulations were used to
explore the impact of partial data on the operational characteristics of
a futility analysis. | \;Please click here
to view the slide deck |
| \;15:15 | \;Tea &\; Coffe
e | &n
bsp\; | ||
| &nb sp\;15:45 | \;Sim
ulating a sequences of clinical trials - a whole drug development program\
, in order to optimize the design\, planning and resource allocation | \;T
om Parke (Berry Consultants) | \;It&rsquo\;s hard to judge how big a phase 2 shoul
d be\, what the trade off in power and type error should be\, and what the
significance of other post phase 2 errors (such dose selection\, populati
on selection\, estimate of effect size) might be\, without considering the
whole picture of time to registration\, overall probability of technical
success and overall value / clinical usefulness should the treatment be su
ccessfully registered. | \;Please cli
ck here to view the slide deck |
| \;14 :30 | \;Close | \; | < td class="PSI-default-tableTableLastCol"> \;\; |
| Registration Costs | \; |
| \;Registration on or before 4th
April | \; |
| \;PSI Member | £\;120 (plus VAT) \; | \;Non-Member | £\;160 (plus VAT) |
| \;Academic | £\;60 \; (plus VAT) |
| \;Registration after 4th April | &nb sp\; |
| \;PSI Member | £\;160 (plus VAT) |
| &nb
sp\;Non-Member | &poun d\;220 (plus VAT) \; |
| \;Academic | £\;90 \; (plus VAT)< /td> |
| \;Fee includes lunch &\; refreshments | \; |