14th Annual Scientific Meeting
Wednesday, July 26th, 2017
Distinguished Poster Award Recipients:
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| Use of a Prediction Algorithm for Randomized Stratification in an Amyotrophic Lateral Schlerosis Study (VanMeter) | |||
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All Poster PDFs and Abstracts are available at the end of the second day. |
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20 February 2018 |
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| Welcome from the President | S Marder slides video |
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| Unresolved Problems in Neuroscience Drug Development: Point/Counterpoint | Chair: A Kalali video |
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Is it time to move past the amyloid hypothesis: An affirmative response? Is amyloid a good AD drug target? |
Lead: A Butler |
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Does increasing the sample size provide greater precision for detecting treatment effects? Why simply increasing sample size for obtaining greater trial power often does not work: caveats you should know |
Lead: G Sachs |
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Working Group Sessions |
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| Abuse Liability: The functional excipient conundrum | Chairs: M Klein B Setnik M Sokolowska summary |
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| Adaptive Design | Chairs: J Kando R Marcus slides-Marcus slides-Wathen |
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| Addressing Methodological Challenges in International CNS Clinical Trials | Chairs: A Kalali E Pappadopulos |
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| Algorithms/Flags | Chairs: J Rabinowitz N Schooler summary |
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| Behavioral and Psychiatric Symptoms of Dementia-Apathy Subgroup | Chairs: K Lanctôt D Miller slides/summary |
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| Behavioral and Psychiatric Symptoms of Dementia – Agitation Subgroup | Chairs: C O’Gorman P Rosenberg slides/summary |
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| Estimands and Missing Data | Chairs: P Lim E Polverejan summary |
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| Late-Onset Depression | Chair: H Martynowicz slides |
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| Negative Symptoms | Chairs: D Daniel S Marder summary |
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| Prevention Trials in Alzheimer’s Disease – Design Considerations | Chairs: P Harvey H Posner summary |
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21 February 2018 |
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| Andrew C. Leon Distinguished Career Award Presentation | S Marder S Romano slides videoW Potter |
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| Use of Regulatory Databases as Exemplars for Improving RCT Efficiency and Guidance Development: Can the Model Be Extended? | Chairs: T Farchione H Martynowicz |
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| Session Objectives | T Farchione slides video |
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| Clinical trial database analyses to inform regulatory guidances: Improving the efficiency of schizophrenia clinical trials | I Younis slides video |
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| Clinical trial database analyses to inform regulatory guidances: Suicidal ideation and behavior assessment | J Kim slides video |
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| Opportunities for the use of regulatory data | F Pétavy slides video |
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| Statistical challenges of meta-analyses of randomized clinical trials in a regulatory setting – US Perspective
Statistical challenges of meta-analyses of randomized clinical trials in a regulatory setting – EU Perspective |
E Andraca-Carrera slides F Pétavy slides video (Includes Andraca-Carrera) |
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| Improving the specificity and precision of PANSS factors: One approach to facilitate development of novel treatments in schizophrenia | S Hopkins slides video |
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| Panel Discussion | Facilitator: N Schooler slidesPanelists: T Farchione H Martynowicz F Pétavy W Potter video |
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| Methodological Challenges Related to Rare and Orphan Disease Drug Development | Chairs: J Busner J Dunn R Anand |
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| Introduction | J Busner slides video |
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| The unmet need – Partnership with patient advocate groups | R DeBellis slides video |
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| Clinical outcome assessment endpoints for rare diseases: Challenges and methods for clinical trials | D Revicki slides video |
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| Statistical challenges: Designs for clinical trials with limited patient populations | S Day slides video |
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| Clinical and Regulatory Challenges in Developing New Treatments for Rare Diseases | R Anand slides video |
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| Rare Disease Clinical Research: Collaboration is the key to success | J Ng-Cashin slides video |
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| Orphan Drug Topics: Discovery of FDA’s flexibility/Evolving voice of the patient in drug review | F Sasinowski slides video |
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| Panel Discussion | video |
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| Summary | |||
| Poster Session/Reception | Poster PDFs and Abstracts | ||
22 February 2018
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| Innovative Approaches for Slowing Disease Progression in Parkinson’s Disease | Chairs: K Budur I Turkoz I Shoulson M Frasier |
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| Welcome from the President | C Canuso video |
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| Introduction | K Budur slides video |
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| Parkinson’s Disease: Current concepts of pathophysiology and disease modification | A Lang* | ||
| Moving treatment earlier: Disease modification in early PD | R Postuma slides video |
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| Novel targets of disease modifying therapy of Parkinson’s disease | D Standaert slides video |
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| Role of biomarkers and clinical markers in patient selection and monitoring in PD | K Marek slides |
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| Panel Discussion | Facilitator: M Frasier slides video |
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| Clinical trial measures to capture important motor and non-motor outcomes in PD | K Kiebertz slides video |
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| Innovative statistical design and analysis in PD | C Coffey slides video |
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| Panel Discussion | Facilitator: I Turkoz slides video |
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| A perspective on “preclinical” Alzheimer’s disease trials | P Tariot slides video |
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| Regulatory perspectives on interventions to slow progression in PD | A Bhattaram C Leptak |
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| Panel Discussion | Facilitator: Ira Shoulson slides video Panelists: K Jin L Pani D Stephenson |
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| Summary | K Budur Karl Kiebertz video |
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| Meeting Adjourned
*Slides not released |
C Canuso | ||
ISTAART NPS PIA day at AAIC 2017 – ISCTM session
Thursday, July 20th, 2017| How do we get the pharmaceutical industry off the couch? | David Miller, MD slides |
| Overcoming challenges in developing pharmacotherapies for NPS: Apathy in Alzheimer’s disease | Krista Lanctôt, PhD slides |
| Examining the neurocircuity of apathy and markers of neurodegenertion in early Alzheimer’s disease | Gad Marshall, MD slides |
| Treatment of apathy in psychiatric and neurodegenerative disorders: Are positive valence systems of reward shared in control | Larry Ereshefsky, PharmD slides |
Consensus Meeting on Clinical Assessment of Response to Treatment of Cognitive Impairment in Schizophrenia
Thursday, August 25th, 2016Report on Consensus Meeting on Clinical Assessment of Response to Treatment of Cognitive Impairment in Schizophrenia
Schizophrenia Bulletin / Permission granted for public access
Case Studies in Adaptive Design
Wednesday, June 22nd, 2016
2017 Autumn Conference includes Joint Day with ECNP
Thursday, June 16th, 2016
Distinguished Poster Award Recipients: |
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| Effect of High within Subject Variance at Research Sites on Placebo Response and Drug Placebo Separation in Acute Schizophrenia Trials – A Post Hoc Analysis (Kott)
Replication of a Statistical Method to Reduce Pseudospecificity and Enhance Understanding of Score Changes Among PANSS Factors (Mahableshwarkar) |
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All Poster PDFs and Abstracts are available at the end of the second day. |
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31 August 2017 |
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| Welcome Reception | ||
1 September 2017
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| Welcome from the Presidents | S Marder slides C Arango slides video |
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| Beyond Efficacy: Hard Outcomes in Treatment Studies | Chairs: N Schooler G Goodwin |
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| Introduction | G Goodwin slides video |
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| Within-subject comparison as a tool to explore effectiveness in register studies | M Landén slides video |
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| Relapse prevention studies: What happens after drop out? | S Leucht slides video |
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| Industry Perspective: Risk characterization utilizing external data sources: A methodological consideration for clinical trials with high subject drop-out | J Geier slides video |
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| Regulatory Comment/Panel Audience Discussion | M Tome video Speakers video |
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| Clinician Reported Outcomes in Multinational CNS Trials: Practical Guidance on Translation and Cultural Adaptation | Chairs: A Kalali E Vieta |
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| Introduction and background | A Kalali video |
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| The impact of language and culture on implementing multinational clinical trials | M Vance slides video |
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| Cultural learnings implementing multinational clinical trials | E Vieta slides video |
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| Guidance document – overview and highlights | E Pappadopulos slides video |
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| Panel and audience discussion | Speakers video |
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| Drug Development for Negative Symptoms in Schizophrenia: What Have We Learned? What Can We Do Better? | Chairs: D Umbricht C Arango |
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| Welcome and introduction | D Umbricht video |
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| Negative symptoms: Prevalence, specificity, course and other characteristics | M Weiser slides video |
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| Preclinical models of negative symptoms and their implications for clinical trials | M Kas slides video |
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| Negative symptoms: Clinical assessments, biomarkers and the role of reward processing | J Gold slides video |
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| Lessons learned in recent trials in negative symptoms | D Umbricht slides video |
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| Conclusion and next steps | J Lieberman slides video |
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| Panel discussion/Regulatory Comment | Moderator: J Lieberman video |
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| Concluding remarks | C Arango |
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| Joint meeting adjournment | S Marder C Arango video |
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| ISCTM Poster Session | Poster PDFs and Abstracts | |
2 September 2017 |
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| Behavioral and Psychiatric Symptoms in Dementia (BPSD): A Way Forward? | Chairs: L Ereshefsky L Pani |
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| Background, brief overview and session’s purpose | L Ereshefsky L Pani |
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| Segment 1- Agitation in Alzheimer’s Disease | ||
| Lessons Learned – Part One – Agitation in Alzheimer’s Disease – Progress in Trials Designs | B Creese slides video |
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| Lessons Learned – Part Two – Agitation in Alzheimer’s Disease – Developing New Treatments | P Rosenberg slides video |
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| Comments from Industry Perspective | S Dube slides video |
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| Regulatory Viewpoints – Agitation in AD | V Mantua slides video T Farchione slides video |
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| Panel – Audience discussion – Agitation in AD | Facilitators: J Rasmussen J Bell Agitation Panel video |
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| Segment 2 – Apathy in Alzheimer’s Disease | ||
| Why focus on apathy? Diagnosis, symptoms assessment, methodology framework | D Miller slides video |
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| Neuro-circuitry and implications for drug development: ADMET trials, and study designs for treatment of apathy | K Lanctot slides video |
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| Quantifiable assessment of motivational deficits and apathy in dementia – and beyond | S Pollentier slides video |
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| Treatment of apathy in psychiatry and neurodegenerative disorders: Are positive valence systems of reward shared in common? Early drug development implications | L Ereshefsky slides video |
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| Concluding Discussant | Discussant: L Pani slides video |
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| Regulatory Viewpoints/Panel – Audience discussion – Apathy in AD | Facilitators: L Ereshefsky S Pollentier Panel: T Farchione V Mantua slides Apathy speakers video |
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| Meeting Adjourns | S Marder | |
13th Annual Scientific Meeting
Tuesday, June 14th, 2016
Distinguished Poster Award Recipient:
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| Estimating Treatment Effect Heterogeneity in Cognitive Training Programs (Khan) | ||
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All Poster PDFs and Abstracts are available at the end of the second day. |
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Day 1 (21 February 2017) |
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| Presidential Welcome | S Marder slides video |
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| Advantages and Challenges of Adaptive CNS Trials: Real World Lessons | Chairs: R Marcus J Kando |
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| Introduction/Brief update | R Marcus slides video |
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| Adaptive Population Enrichment Design: Drug Development Efficacy in Rare Epileptic Symptoms | J Segieth slides video |
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| Adaptive Design Comparative Effectiveness in Status Epilepticus | K Broglio slides video |
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| Identification of Meaningful Cognitive Endpoints in Studies of Pharmacological Therapies for Cognitive Impairment in Schizophrenia | M Sand slides video |
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| Layers of an Onion: Considerations for a Confirmatory, Adaptive CNS Trial | B Millen slides |
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| Update from FDA Statistician on Adaptive Design Methodology | H M Hung* |
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| Panel Discussion | Speakers video |
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Working Group Dinners |
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| Abuse Liability: A Lethal Combination: Clinical Trial Design Considerations to Elevate the Nature of Opioid and Benzodiazepine Interactions | Chairs: B Setnik M Sokolowska M Klein Working Group Slides: slides |
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| Behavioral and Psychiatric Symptoms in Dementia | Chairs: L Ereshefsky D Miller L Pani Working Group Summary: slides |
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| Prevention Trials of Alzheimer’s Disease- Ongoing Optimization and the Roles of Biomarkers and Cognitive, Performance, and Functional Assessments | Chairs: H Posner P Harvey Working Group Slides: Arrighi Beckett Bilgel |
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| Cognitive Dysfunction | Chairs: J Parker M Fava Working Group Summary: slides |
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| Methodological Challenges in International CNS Clinical Trials | Chairs: A Kalali E Pappadopulos Working Group Summary: slides |
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| Missing Data | Chairs: P Lim N Samad Working Group Summary: slides |
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| Negative Symptoms | Chairs: S Marder D Daniel Working Group Summary: slides |
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| Mitigating Nonadherence | Chairs: T Shiovitz D McCann Working Group Summary: slides |
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Day 2 (22 February 2017) |
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| Optimizing Use of ‘Big Data’ for Patient Identification and Disease Management: Separating Signal from Noise- Part 1 | Chairs: L Alphs G Wittenberg |
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| Introduction | L Alphs slides video |
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| The ‘Big Data’ Transformation of Drug Development: From Promise to Practice | G Wittenberg slides video |
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| Generating Reliable Evidence from Real-World Data: Lessons from the Observational Health Data Sciences and Informatics (OHDSI) | P Ryan slides video |
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| A Model of Virtual Learning Health System for Mood Disorders | P Zandi slides video |
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| Harnessing Mobile and Sensor Technology to Help Patients with Diseases of the Brain and Central Nervous System | V Narayan slides video |
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| ADNI as a Model of ‘Big Data’ Collaboration | S Potkin slides video |
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| Data Linkage Methods and Challenges | A Kress slides video |
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| Panel Discussion | Speakers video |
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| Optimizing Use of ‘Big Data’ for Patient Identification and Disease Management: Seperating Signal from Noise- Part 2 | Chairs: L Alphs G Wittenberg |
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| Review of Morning Session | L Alphs video |
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| Challenges/Opportunities in the use of ‘Big Data’ for the FDA | B Temple slides video |
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| Regulatory Opportunities and Challenges in Europe: From Registries to PRIority MEdicines (PRIME) and Return | L Pani slides video |
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| Optimizing Use of ‘Big Data’ for Patient Identification and Disease Management—An Example from the Department of Veterans Affairs | R Bossarte*
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| Challenges/Opportunities in the Use of ‘Big Data’ in Health Care Services Setting (pharmacy/insurer) | A Contreras slides video |
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| Public Policy Around ‘Big Data’ | A Basu slides video |
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| Panel Discussion and Open Discussion Summary |
G Wittenberg Speakers video |
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| Poster Session/Reception | Poster PDFs and Abstracts | |
Day 3 (23 February 2017) |
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| Presentation of the Andrew C. Leon Distinguished Career Award | S Marder slides L Alphs slides video |
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| Silver Linings Playbook: The Positive Side of Negative Trials | Chairs: R Keefe S Romano |
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| Introduction | R Keefe slides video |
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| “The Set-Up”: Skimping on the Fundamentals Can Lead to Failure | S Romano slides video |
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| Failures of Translation in Stroke and Cerebrovascular Disease: What Can Be Learned? | D Laskowitz slides video |
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| The Difficulties in Going from P2 To P3 in CNS Trials: Red Flags from a Recent CIS Program | S Brannan slides video |
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| How Molecules that Fail can Influence Future Research: Semagacestat and BACE Inhibitors |
R Mohs slides video |
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| A New PANSS Factor Analysis Intended to Reduce Pseudospecificity Among Domains and Enhance Understanding of Symptom Change in Antipsychotic-Treated Patients with Schizophrenia | T Loebel/ S Hopkins* |
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| Panel and Regulatory Discussion | R Keefe T Laughren L Pani video |
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| Meeting Adjourned |
S Marder | |
| *Presentation not released | ||
Are Adaptive Trials an Appropriate Design Choice in Neuroscience?
Friday, May 20th, 2016View Webinar Online
If you were a registrant of the live webinar:
Members: (You must be logged in to access the video – Select Member Access upper right of page)
Member Access Webinar Video and Question Responses – Fee Waived
Non Members: Non Member Access Login
If you did not register for the ‘live’ webinar and wish to view:
Members: Log in and Select link above
Non-members – Register to View (Fee $35) or Join/Renew and view fee-waived
Webinar details:
Presented by ISCTM Adaptive Design Working Group
Co-chairs: Ron Marcus, MD; Judy Kando, PharmD
with Judith Quinlan, MSc
What You’ll Learn:
An overview of adaptive designs and how they can be used within the Neuroscience area will be presented. Key points will be illustrated through several adaptive design case studies from Neuroscience. Importantly, not ALL adaptive trials are the same, and therefore these case studies have been purposely selected to not only illustrate different adaptive approaches, but to also show how adaptive designs can be applied across the whole development space from early development through to late phase confirmatory studies.
An overview of adaptive designs and how they can be used within the Neuroscience area will be presented. Key points will be illustrated through several adaptive design case studies from Neuroscience. Importantly, not ALL adaptive trials are the same, and therefore these case studies have been purposely selected to not only illustrate different adaptive approaches, but to also show how adaptive designs can be applied across the whole development space from early development through to late phase confirmatory studies.
Additional questions? Email the Secretariat
Consensus Meeting on Methodological Considerations for Suicide Assessment and Clinical Trial Design
Wednesday, July 8th, 2015Statements:
Nomenclature & Classification
Instrumentation & Special Populations
Analysis of SIB Data
Design and Methodology for SIB Treatment Studies
Developing Policy and Education on SIB Assessment
Steering Committee:
Phillip Chappell
Michelle Stewart
Larry Alphs
Stephen Marder
Objective:
Convene a wide variety of stakeholders such as representatives from governmental, pharmaceutical, academic, patient, and clinical trial study settings to discuss and reach consensus on approaches to resolve key outstanding issues confronting the field.
Working Goals:
Develop consensus on
–Principles and characteristics of a standardized nomenclature and classification scheme for SIB
–Best approaches to the detection and assessment of SIB across different patient populations
–Analysis of SIB data at the study, program and meta-analytic level and the uses of Big Data methods to better understand SIB
–Design of clinical studies and drug development programs for regulatory approval of medicines to treat SIB
–Approaches to developing policies and educational initiatives to support adoption of consensus recommendations
Working Subgroups
–Nomenclature & Classification
–Instrumentation & Special Populations
–Analysis of SIB Data
–Design and Methodology for SIB Treatment Studies
–Developing Policy and Education on SIB Assessment
Meeting Structure:
Day 1:
8:00-Morning Break – Plenary Session
Post Break – 5:30 pm – Working Group Breakouts
Day 2:
8:00-1:15 – Plenary Session
2016 Autumn Conference
Wednesday, July 8th, 2015
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 | ||
12th Annual Scientific Meeting
Monday, July 6th, 2015
Distinguished Poster Award Recipients:
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All Poster PDFs and Abstracts are available at the end of the second day. |
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Day 1 (16 February 2016) |
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| Presidential Welcome | S Romano slides video |
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| Improving Transparency of Clinical Trial Data | Chairs: M Weiser A Kalali |
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| Session Overview | ||
| A Holistic Approach to Data Transparency: Raising the Standard for All Stakeholders | A Kalali* |
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| Rates of Non-Publication of Trials Funded by the Stanley Medical Research Institute | M Weiser slides video |
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| Data Transparency Changes in NIMH Clinical Trials | N Gogtay slides video |
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| Data Transparency: A View from Industry | R Lasser slides video |
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| Regulatory Perspective on Complete Data for Registration Trials: Transparency, Access and Interpretation | T Laughren slides video |
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| Practical Issues for Patients, Family and the Public | D Fuller slides video |
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| Panel Discussion | Speakers |
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| Concluding Comments | M Weiser video (includes panel) |
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Working Group Dinners |
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| Adaptive Design | Chairs: J Kando R Marcus Working Group Slides: slides |
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| Addressing Methodological Challenges in International CNS Clinical Trials | Chairs: R Keefe A Kalali Working Group Summary: slides |
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| Algorithms/Flags to Identify Clinical Inconsistency in the Use of Rating Scales in CNS RCTs | Chairs: J Rabinowitz N Schooler Working Group Slides: slides |
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| Biomarkers in Schizophrenia | Chairs: S Potkin D Goff Working Group Slides: slides |
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| Behavioral and Psychiatric Symptoms and Dementia | Chairs: L Ereshefsky D Miller Working Group Slides: slides |
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| Cognitive Assessment in CTs of AD and its Precursors | Chairs: H Posner P Harvey Working Group Slides: Ryan Hendrix Walton Lasser |
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| Identifying and Analyzing Adverse Events Related to Abuse and Dependence Potential in CTs | Chairs: B Setnick M Sokolowska M Klein Working Group Slides: slides |
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Day 2 (17 February 2016) |
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| Drug Repositioning in CNS: Can We Give a Hand to Serendipity and Promiscuity? | Chairs: M Davidson C Canuso |
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| Introduction | M Davidson slides video |
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| Accessing Compounds: Partnering with Industry | C Canuso slides video |
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| NIH Drug Repositioning Mechanisms: Examples that Support CNS Indications from NCATS and NIMH | W Potter slides video |
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| What to Try When you Are Out of Ideas: Repositioning—The Stanley Experience | M Weiser slides video |
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| What Can Be Learned from Observational Patient-Level Databases? | P Stang slides video |
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| Drug Repositioning Platforms to Predict Drug-Disease Signatures | S Dakshanamurthy slides video |
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| Panel | M Davidson Speakers video |
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Parallel Sessions |
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| Session A: Novel Developments to Address Methodological Issues in Autism Spectrum Disorders | Chairs: L Alphs L Gault G Pandina |
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| Introduction | L Alphs slides video |
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| Challenges to Patient Identification in Clinical Trials for the Treatment of Autism Spectrum Disorder | L Gault slides video |
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| Lessons Learned: Development of a GABA-B Receptor Agonist for ASD and Fragile X | P Wang slides video |
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| Autism Spectrum Disorder (ASD): Outcome Measures and Potential Biomarkers | G Pandina slides video |
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| The Translational Neurobiology of Autism | D Murphy slides video |
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| Regulatory considerations when conducting clinical trials for the treatment of Autism Spectrum Disorder | T Farchione slides video |
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| Panel Discussion: How Do We Partner with Stakeholders to Move Autism Research Forward, and Facilitate Biomarker Validation and Endpoint Development? | Speakers S Zukin slidesL Brady slides video (includes panel) |
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| Session B: Mitigating the Effects of Nonadherence in Clinical Trials | Chairs: T Shiovitz E Bain |
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| Introduction | T Shiovitz | |
| Artifactual Nonadherence: Inappropriate Behavior Specific to the Clinical Trial Setting | T Shiovitz slides video (includes intro) |
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| The Impact of Noninformative Data on Clinical Trials | E Bain slides video |
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| Adherence Biomarkers, Technologies and Subject Registries | P Skolnick slides video |
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| Where and How to Act to Identify and Mitigate the Effects of Nonadherence | D McCann slides video |
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| Regulatory Considerations in Addressing Nonadherence in Clinical Trials | T Laughren slides video |
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| Summary of Working Group Recommendations | E Bain slides video |
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| Panel Discussion | A Hanina Speakers slides video |
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| Poster Session/Reception | Poster PDFs (linked to abstract titles) |
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Day 3 (18 February 2016) |
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| Presentation of the Andrew C. Leon Distinguished Career Award | ||
| Network Meta-Analysis: Integrating Results of Direct and Indirect Treatment Comparisons | Chairs: N Schooler M Stewart G Haynes |
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| Introduction | N Schooler video |
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| Network Meta-Analysis: A Brief Tutorial | J Cappelleri slides video |
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| Critical Issues Raised by Network Meta-Analysis: Examples from Anti-Depressants and Anti-Manic Drug Analyses | A Cipriani slides video |
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| Network Meta-Analysis of Anti-Psychotics for Schizophrenia: Clinical Implications | J Davis slides video |
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| Panel Presentations | A Nierenberg slides video J Kane videoL Alphs slides videoR Goldman slides videoG Haynes slides videoPanel Discussion video |
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| Meeting Adjourned |
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| *Presentation not released | ||