Still some places available for the Special Course on Predictive Models and
Enrichment Study Design Strategies
April 23-25, 2014: Château de Longcol, La Fouillade (France :
www.chateaudelongcol.com)
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. The workshop includes lectures and hands-on training
on concepts, applications, and software tools. Examples will be presented and
discussed for:
Decreasing heterogeneity in the response – excluding patients with improvement
in clinical scores for reasons other than a response to the test treatment
(spontaneous improvement, or 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.
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.
A Clinical Trial Simulator developed in R will be used to simulate clinical
trials and to evaluate the benefit of implementing enrichment strategies. 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
http://pharmacometricaworkshop.webs.com