Registration is open for the:
Special Course on Predictive Models and Enrichment Study Design Strategies
October 20-22, 2014: The Carolina Inn on the Campus of the University of
North Carolina at Chapel Hill, NC (USA)
This is a 3-day advanced course designed to help scientists to develop and
use predictive models for implementing enrichment study design with
particular emphasis in CNS diseases.
Enrichment is the prospective use of any patient characteristic demographic,
pathophysiologic, historical, genetic, and others to select a study
population in which detection of a drug effect is more likely than it would
be in an unselected population.
Study enrichment is intended to increase study power by:
. Decreasing heterogeneity (noise); choosing an appropriate
population, i.e. patients who definitely have the disease or exclude
patients placebo-responders;
. Identifying a population capable (or more capable) of responding
to the treatment using a predictive enrichment approach.
The workshop includes lectures and hands-on training on concepts,
applications, and software tools. Examples will be presented and discussed
for:
Prognostic enrichment strategies: choosing patients with a greater
likelihood of having a substantial worsening in condition. Two-case-study in
Alzheimer's disease and in a Rare Diseases (Amyotrophic Lateral Sclerosis)
will be used to implement study design where patients with more rapid
progression are selected based on a disease-progression model.
Decreasing heterogeneity in the response by controlling the placebo effect:
excluding patients with improvement in clinical scores for reasons other
than a response to the test treatment due to placebo response. A case-study
in Major Depressive Disorders (MDD) where a model of placebo response will
be used for implementing a placebo-lead in enrichment design and an adaptive
enrichment approach.
A Clinical Trial Simulator developed in R will be used to simulate clinical
trials and to evaluate the benefit of implementing enrichment strategies to
decrease heterogeneity in patient population and for controlling the placebo
effect. The R scripts for the trial simulator will be distributed to the
participants.
Additional details are available at:
http://www.pharmacometricaworkshop.webs.com
www.pharmacometricaworkshop.webs.com
Roberto Gomeni, PhD, HDR, Adjunct Professor at UNC
PharmacoMetrica
Longcol, 12270 La Fouillade (France)
E-mail: <mailto:[email protected]>
[email protected]
Mobile: +33(0) 760 45 1976
http://www.pharmacometrica.com/ www.pharmacometrica.com
Next workshops on pharmacometrics: http://pharmacometricaworkshop.webs.com