2016 Autumn Conference
26 – 27 September, 2016 // Philadelphia, PA
Distinguished Poster Award Recipients: |
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| Comparison of Social Cognitive Profiles Across Assessment Models in Treatment Resistant Schizophrenia (Lindenmayer) Identification of Meaningful Cognitive Endpoints in Studies of Pharmacological Therapies for Cognitive Impairment in Schizophrenia (Sand) |
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Day 1 (26 September 2016) |
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| Presidential Welcome | S Marder slides video |
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| Missing Data in Neuroscience Clinical Trials: Truth or Consequences | Chairs: P Lim G Haig |
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| Introduction | G Haig slides video |
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| US Regulatory concerns about missing data: Problems of interpretation; goals and considerations for addressing the problem | R Temple slides video |
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| EU Regulatory concerns about missing data: Issues of interpretation and considerations for addressing the problem | K Broich slides video (Permutt comments) |
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| Let’s get down to what is really wrong: What makes clinical sense when a neuroscience trial has missing data? | M O’Kelly slides video |
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| Quantifying the clinical measure of interest in the presence of missing data: Choosing primary and sensitivity analyses in neuroscience clinical trials | E Polverejan slides video |
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| The clinical dilemma: How to prevent and address important clinical and public health questions | M Lee slides video |
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| Panel Discussion | P Lim– Moderator Speakers and V Dragalin, T Permutt slides video |
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Workshop Sessions |
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| Addressing Methodological Challenges in International CNS Clinical Trials | Chairs: A Kalali E Pappadopulos Summary |
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| Algorithms/Flags to Identify Clinical Inconsistency in the Use of Rating Scales in CNS RCTs | Chairs: J Rabinowitz N Schooler Summary |
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| Biomarkers in Psychosis | Chairs: S Potkin D Goff Summary |
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| Cognitive Assessment in CTs of Alzheimer’s Disease | Chairs: H Posner P Harvey Workshop Slides Arrighi Sabbagh |
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| Mitigating Nonadherence in Clinical Trials: Future Directions | Chairs: T Shiovitz D McCann Summary |
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Day 2 (27 September 2016) |
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Parallel Sessions |
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| Session A: Update from IOM meeting “Neuroscience Trials of the Future” |
Chairs: R Keefe A Pande |
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| Introduction | A Pande video |
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| Lessons learned from cardiovascular trials: Getting to the heart of the matter in uniting patients, clinicians and systems for evidence generation | A Hernandez slides video |
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| Biomarkers and clinical trials in neurodegenerative diseases | A Chen-Plotkin slides video |
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| Neuroscience trials of the future: Lessons from oncology | P Nisen slides video |
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| The interaction of placebos and treatment: Implications for power and trial design | E Snowberg slides video |
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| Transforming clinical research: The return of the house call | K Kieburtz slides video |
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| Panel Discussion | Speakers video |
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| Session B: Should the Randomized Withdrawal Design for Relapse Prevention Studies in Mood Disorders be Updated? | Chairs: A Mahableshwarkar G Sachs |
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| Introduction | G Sachs |
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| Relapse lessons from STEP-BD and other naturalistic studies | G Sachs slides video includes introduction |
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| FDA review of maintenance trials for Major Depressive Disorder: A 25 year perspective | T Laughren slides video |
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| A novel outcome measure: Necessary Clinical Adjustments (NCA) | A Nierenberg slides video |
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| Industry perspective: Randomized withdrawal study with Vilazodone in adult patients with Major Depressive Disorder | S Durgam* |
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| Industry perspective: Novel trial design to assess long-term efficacy for add-on treatment for Bipolar Disorder: Lessons learned | A Mahableshwarkar* | |
| Relapse design endpoints survey results | G Sachs slides video |
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| Regulatory Views | K Broich slides video T Laughren video |
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| Panel/Audience Discussion | Speakers video |
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| Poster Session/Luncheon | Poster PDFs and Abstracts |
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| Kickstarting the Brain: Methodological Challenges of Emerging Technologies | Chairs: J Rasmussen D Velligan |
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| Background | J Rasmussen slides video |
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| Regulatory Views | W Heetderks slides video K Broich slides video |
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| Electroconvulsive Therapy (ECT): Learning from recent trials | C Kellner slides video |
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| Transcranial Magnetic Stimulation (TMS) for the treatment of depression | P Holtzheimer slides video |
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| Intranasal Esketamine: Methodological challenges for a global development program in treatment resistant depression | J Singh* |
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| Statistical challenges for novel technologies | R White slides video |
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| Discussant | P Holtzheimer slides video |
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| Panel Discussion | D Velligan– Facilitator slides video |
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| Meeting Adjourned |
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| *Presentation not released | ||