6th Annual Scientific Meeting
plus 2010 National Mental Health Research-to-Policy Forum
22 – 24 February, 2010 // Washington DC, USA
Poster Awardees |
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| Do Recruitment Sources Impact Study Outcome: Assessment by Computer and Site-Based Raters B Kasuba, S Edman |
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| “Reporting Adverse Event Data From Clinical Trials of Antipsychotic Agents” I Turkoz |
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| Placebo Response Assessed by Site and Blinded Remote Centralized Raters in a GAD Trial J Williams |
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| All poster abstracts are available for public viewing. Link found at end of Day 1. | ||
Day 1 (22 February 2010) |
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| President’s Welcome | L Alphs | |
| SESSION 1: New Approaches to Assessing the Safety of Marketed Drugs – FDA, Industry and Academic Perspectives
SESSION SUMMARY
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Chairs:
S Marder |
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| Approaches to Safety Assessment: A Pharmacoepidemiological Perspective | P Wang* | |
| Current Approaches to Pharmaceutical Benefit-Risk Assessment | B Levitan | |
| Approaches to Marketing Medical Product Safety Assessment: An FDA Perspective | A McMahon (Racoosin) | |
| Panel and General Discussion | C Bowden
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| SESSION 2: Translational and Cultural Adaptation of Key Outcome Measures in International CNS Trials
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Chairs:
A Kalali |
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| The Current Reality of Outcome Measures in International Clinical Trials: Should We Be Doing Things Differently? | A Kalali | |
| Challenges and Best Practices in Training and Monitoring Measurement of Psychopathology in Linguistically and Culturally Diverse Settings | D Daniel
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| Translating and Implementing Measures of Neurocognition in Eastern Europe and Asia | R Keefe | |
| Cultural Considerations of Functional Outcomes in Chinese and Other Cultures | P Harvey
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| Cultural Aspects of Outcome Measures – European and US Regulatory Viewpoints | K Broich
T Laughren
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| Discussant | R Anand | |
| Poster Session | View All Poster Abstracts
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Day 2 (23 February 2010) |
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| ISCTM 2010 National Mental Health Research-to-Policy Forum: The Role of Comparative Effectiveness Research in Future Mental Health Policy Decision Making
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Chairs:
R Ferziger |
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| SESSION 3a: The Role of CER in Future Mental Health Policy Decision Making | Chair:
D Steinwachs |
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| CER 2010: Overview and Critical Review of the Current Science and Politics of Comparative Effectiveness | B Luce | |
| Keynote Address: The Role of CER in Future Mental Health Policy Decision Making | M Rawlins | |
| Discussant | J Slutsky
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| Panel Discussion | M Schoenbaum D Shern |
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| Relating the Science of CER to Mental Health Policy and Clinical Care
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Chair:
B Druss |
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| Locations, Populations and the Generalizability of Data for Policy Decisions in Mental Health | R Frank* | |
| Discussant | M Rawlins
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| Panel Discussion | J Parks K Broich D Jarvis |
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| Hitchhikers Guide to System Comparative Effectiveness | S Leff
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| Panel Discussion |  video
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| SESSION 3b: Comparative Effectiveness Trials in CNS Disorders: Rationale, Elements and Challenges | Chairs:
N Schooler |
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| What Constitutes Comparative Effectiveness Research? NIH and Inferential Perspectives | C Bowden | |
| Key Issues in CER for Design and Analysis | T Ten Have | |
| Goals and Strategies of the NIMH Recovery After an Initial Schizophrenia Episode (RAISE) Initiative | B Heinssen
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| The NIMH RAISE Initiative. Two Parallel Approaches to a CER Question: | ||
| Case Study I | N Schooler
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| Case Study II | L Dixon
(H Goldman) |
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| Academic Discussant | D Meltzer | |
| NICE Discussant | M Rawlins | |
| Panel and Participants Discussion | ||
| Summary | ||
| Dinner Symposium: Industry/Academic Relationships: Continuing Collaboration in an Era of Evolving Standards | Chairs:
R Keefe |
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| Principled Research in the Face of Conflicts of Interest | R McKinney | |
Day 3 (24 February 2010) |
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| SESSION 4: Clinical Trials in the Prodromal Phase of Alzheimer’s Disease-Methodological Challenges and Clinical Outcomes
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Chairs:
G Garibaldi M Davidson |
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| Challenges Faced when Identifying and Providing Prodromal Disease treatments: The Problems of Preserving Wellness | M Davidson | |
| Keynote Address: “Antecedent Biomarkers in Prodromal Alzheimer’s Disease – Now is the Time” | J Morris | |
| Clinical Correlations with Postmortem Findings: Clues to Identifying the Prodrome for AD-Age Matters | V Haroutunian | |
| How Recent Developments in Biomarkers Have Changed Clinical Trials Design-from the Perspective of the Trialist | R Schindler
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| Neuroroimaging as a Marker for Prodromal Treatment: Evidence, Value and Limitations | M Cantillon*
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| Clinical Trials in Prodromal AD: An Industry Viewpoint | R Anand
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| Prodromal Alzheimer’s Disease-EU Regulatory Point of View | K Broich | |
| Roundtable Discussion | video |
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| Adjourn | ||
| * Presentation materials have not been released for posting. | ||
