Predictive Models and Enrichment Study Design Strategies Workshop

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