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