2009 Autumn Conference, San Diego, California USA
Poster Awardees: (View poster by clicking on title) |
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| K. Fox: “Test-Retest Characteristics of the MATRICS Consensus Cognitive Battery in a 29-Site Schizophrenia Clinical Trial of Lurasidone Versus Risperidone" | |
| E. Vieta: “Differential Response to Treatment Across Countries in a Randomized Clinical Trial of Ziprasidone and Haloperidol in Patients With Bipolar Mania" (All poster abstracts are available for public viewing. Link found at end of Day 1) |
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Related Publications: |
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Y Ando, A Hirakawa, Y Uyama V Dragalin T Park S Wang, J Wang, R O'Neill |
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Presentations and Videos
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| SESSION 1: Adaptive Design for CNS Trials | Chairs: A Leon D Berry |
| President’s WELCOME Overview, Rationale and Objectives of Session 1 |
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| An Introduction to Adaptive Design and Adaptation | |
| Adaptive Design Approaches in CNS Clinical Trials – A US Regulatory/Scientific Perspective | HM Hung SJ Wang  video |
| Bayesian Adaptive Trials and How Such Designs Can Best Be Used in CNS Trials | |
| Challenges and Solutions for Implementing Adaptive Design | |
| Practical Considerations in Designing and Executing Early Phase Adaptive Trials: An Industry Perspective | |
| Session Discussion - Q&A | |
| Update on FDA Guidance for Adaptive Design* | SJ Wang |
| Update on EU Guidance for Adaptive Design | |
| Regulatory Issues Related to Use of Adaptive Design in Japan | |
| Discussion Panel |
A Leon |
| Case Study 1 Facilitators: V Dragalin, T Parke, C Mallinckrodt  slides |
D Berry R Lenz |
| Case Study 2 Facilitators: P Lim, V Sutton, Y Ando, G Sachs |
W Olson slides |
| Poster Session | View All Poster Abstracts |
Day 2 (6 October 2009) |
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| SESSION 2: Workshops |
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| Introduction | |
| Sources And Management of Placebo Effects in CNS Clinical Trials Plenary Session SUMMARY |
Chairs: A Kalali C Bowden slides slides |
| Assessing and Methodologies for Treating Suicidality in Trials with CNS Drugs Plenary Session |
Chairs: W Goodman L Greenhill slides video |
| Methodological Issues for Studying Negative Symptoms of Schizophrenia Plenary Session |
Chairs: S Marder D Daniel video |
| Challenges in Conducting Multi-Center Academic Trials Plenary Session |
Chairs: N Schooler J Severe slides video |
| SESSION 3: Preparing for Medicine of the Future: Personalized Medicine: Its Opportunities/Challenges and How to Meet Them |
Chairs: L Alphs G Garibaldi |
| Introduction | G. Garibaldi slides video |
| Personalized Medicine in the Age of Genomics | S Potkin slides video |
| Optimizing the Approach to Personalized Medication: Selection of Indications, Study Populations and Endpoints | D Feltner slides video |
| Design and Statistical Challenges for Personalized Medicine and How to Meet Them | |
| Identifying and Meeting Regulatory Challenges for Indications in Personalized Medicine (Materials submitted, but not presented) |
K Broich slides |
| Session Summary | |
| Adjourn | |
| * Presentation materials have not as yet been released for publication in this forum. | |
European Neuropsychopharmacology: February 2011 (Volume 21, Issue 2)