4th Annual Scientific Meeting
25 – 27 February, 2008 // Washington DC, USA
Day 1 (25 February 2008) |
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| Welcome | G Gharabawi slides video |
| SESSION I: Addressing Controversies Surrounding Antidepressant Black Box Warnings | Co-chairs: AC Leon RJ Baldessarini |
| Identifying the Issues and Case Study | AC Leon slides video |
| Overview of Clinical Perspectives | RJ Baldessarini slides video |
| Statistical Issues: Meta-Analytic Approaches to Safety Data | S-L Normand slides video |
| Panel Discussion video |
AC Leon R Baldessarini SL Normand |
| Consumer Perspective on Black Boxes | J McNulty slides video |
| Legal Implications of a Black Box Warning | N Chayet video |
| Audience Q&A video |
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| The Regulatory Basis for a Black Box Warning | T Laughren slides video |
| Panel Discussion video |
|
| Summary of Session | R Baldessarini |
| Dinner Debate: Views on the Evolving Relationship Between Journal Editors and Authors: Is a Two-Tiered Approach for Industry and Academic Authors Beneficial? | Chair: R Keefe |
| Summary of Dinner Debate | A Breier slides J Kane W Carpenter |
Day 2 (26 February 2008) |
|
| SESSION II: Patient Reported Outcomes: New Approaches Using Item Banks and Computerized Adaptive Assessments | Co-chairs: G Awad slides videoN Schooler video |
| Objectives and Introduction | N Schooler G Awad |
| Overview of the NIH PROMIS Roadmap Initiative | W Riley slides video |
| Patient Reported Outcomes: Use in Psychiatry and Neurology: Experience with PROMIS and Neuro-QOL | D Victorson slides video |
| Patient Reported Outcomes in the Experiences of Participating in Clinical Trials Study (EPICS) | J Weissman slides video |
| Application Of New Patient Reported Outcome Measures and Methods in Psychiatry and Neurology Clinical Trials | D Revicki slides video |
| FDA Perspective: Regulatory Perspective on New Approaches to Endpoint Measurement | L Burke slides video |
| Industry Perspective: Item Banks and Computerized Adaptive Assessment | R Morlock slides video |
| General Discussion | G Awad |
| Summary of Session | N Schooler |
| SESSION III: Methodological Challenges in Clinical Trials to Develop Devices for CNS Indications | Co-chairs: R Keefe S Lilienfeld |
| Objectives and Introduction | S Lilienfeld slides video |
| FDA Perspective: The Role of Basic Science in the Design of Clinical Trials of CNS Devices | V Krauthamer slides video |
| General Statistical Challenge for CNS Devices – A Regulatory Perspective | G Campbell slides video |
| Clinical Trail Methodology Challenges Faced in Evaluating a Medical Device for Diagnosis and Medication Response Monitoring: Regulatory Issues Encountered | M Teicher video |
| Clinical Trial Methodology Challenges in a Device Used in Chronic Neurological/Psychiatric Disorders |
S Brannan slides video |
| Clinical Trial Methodology and the Study of Medical Devices in Major Depression |
M Demitrack slides video |
| Panel and General Discussion video |
S Lilienfeld M Teicher M Demitrack S Brannan |
| SUMMARY OF SESSION | R Keefe S Lilienfeld |
Day 3 (27 February 2008) |
|
| SESSION IV: Strategies For Using Data From Large Clinical Trials To Develop Public Health Policy | Co-chairs: L Alphs R Ferziger |
| Introduction and Objectives | R Ferziger slides video |
| Designing Clinical Research to Inform Mental Health Policy | P Wang video |
| Value of Research Analysis on the Comparative Cost Effectiveness of Antipsychotic Drugs | D Meltzer video |
| National Comparative Effectiveness Policy: The Case for Antipsychotic Drugs | D Polsky slides video |
| The Changing Landscape of Stakeholders and Collaborators in Psychiatry Clinical Trials | H Goldman |
| Panel Discussion video |
R Ferziger D Meltzer M Schoenbaum J McNulty R Manderscheid D Regier S Gottlieb |
| SUMMARY OF SESSION | R Ferziger |
| SESSION V: Methodological Challenges in Neuropathic Pain Trials Assessments | Co-chairs: R Anand P Marchettini |
| Introduction and Objectives | R Anand |
| New Approaches to Nosology, Diagnosis, and Treatment of NP | R Anand |
| Challenges in the Nosology, Diagnosis and Treatment of NP | P Marchettini slides video |
| Pharmaceutical Industry Perspective and Developing Treatments for NP | J Messina slides |
| Limitations of the New Definition of Neuropathic Pain | D Bouhassira slides video |
| Roundtable Discussion video |
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| Alternative Approaches to Nosology and Diagnosis of Neuropathic Pain: Perspective of a Neurologist | J Serra slides video |
| Regulatory Concepts of NP: An EU Perspective | C Sampaio slides video |
| Roundtable Discussion video |
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| Closing Remarks | L Alphs video |
| Adjourn | |