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
