15th Annual Scientific Meeting
19 – 21 February, 2019 // The Fairmont, Washington DC
Distinguished Poster Award Recipient:
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| Trials, errors, and placebo prediction: Tradeoffs between effect size and sample size in machine learning models to mitigate the placebo response (Anderson) | |||
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All Poster PDFs and Abstracts are available at the end of the second day. |
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19 February 2019 |
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| Welcome from the President | Carla Canuso slides video |
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| Unresolved Problems in Neuroscience Drug Development: Point/Counterpoint | Facilitator: Amir Kalali video |
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| Are patients with any degree of suicidal ideation or behavior acceptable for inclusion in clinical trials?
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Chair: Carla Canuso slides video Discussants: Jill Harkavy-Friedman slides videoTom Laughren slides video |
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| Panel/Audience Discussion | Panelists: Jean Kim slides videoGalia Siegel video |
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| Are acute rapid onset anti-depressant results valid or just a consequence of functional unblinding? | Chair: Steve Brannan slides Discussants: Mark Opler slides videoTorsten Madsen slides video |
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| Panel/Audience Discussion | Facilitator: Steve Brannan video |
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Tuesday Working Group Sessions |
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| Assessment Methods and Endpoints for Rapid-Acting Antidepressants-RAADs | Chairs: Mark Opler Dawn Ionescu summary |
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| Behavioral and Psychiatric Symptoms in Dementia—Apathy Subgroup | Chairs: Krista Lanctôt David Miller slidessummary |
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| Cognitive Trajectories in Schizophrenia | Chairs: Philip Harvey Kiri Granger summary |
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| Estimands and Missing Data | Chairs: Pilar Lim Elena Polverejan slides |
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| Orphan Diseases | Chairs: Joan Busner Ravi Anand Patient Centricity Subgroup summary Case Histories Subgroup summary |
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20 February 2019 |
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| Strategies for Generating Meaningful Data for Payers: Methodological Challenges | Chairs: Dawn Velligan Rob Epstein |
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| Introduction | Rob Epstein |
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| European perspective: Real world outcome needs of payers current and anticipated | Emma Medin slides video |
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| US perspective: Real world outcome needs of payers current and anticipated | Jennifer Graff slides video |
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| When novelty is not enough: Assuring adoption, access as well as approval within the clinical development process | Michael Murphy slides video |
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| Models for increasing real world evidence in registration and post-approval clinical trials | Larry Alphs slides video |
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| Health economics and outcomes research: What can be done differently in registration trials and in post-approval trials | Steven Kymes slides video |
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| Regulatory Perspective | Peter Stein slides video |
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| Panel Discussion | Facilitator: Dawn Velligan video |
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| Methodological Issues Associated with the New Alzheimer’s Draft Guidance | Chairs: Judith Jaeger Adam Butler |
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| Introduction | Adam Butler slides video |
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| ADCOMS, new composite score, demonstrates improved sensitivity to disease progression and treatment effects in early AD | Veronika Logovinsky slides video |
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| Bayesian adaptive design employing ADCOMS for dose selection | Chad Swanson* |
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| Cognitive composites for preclinical and early AD derived from longitudinal registries: PACC-R and EMACC | Clint Hagen slides video |
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| Is there a cognitive test that can detect cognitive impairment associated with AB+ in the absence of dementia? | Jason Hassenstab slides video |
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| Informant report to detect amyloid related cognitive decline in the absence of dementia | Anna-Karin Berger slides |
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| Panel / Audience Discussion | Discussant: Judith Jaeger slides video |
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| Andrew C. Leon Distinguished Career Award Presentation | Steve Marder Carla Canuso slidesJanet Williams slides video |
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| Finding the Signal: Strategies for Achieving Participant-Centric Trials in the Face of Participant-Introduced Validity Changes | Chairs: Sian Ratcliffe Tim Mariano Kari Nations |
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| Introduction and goals | slides Tim Mariano videoSian Ratcliffe video |
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| Case studies on how stakeholders (sponsors, sites, patients) influence risks | Steve Brannan slides video |
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| Evidence-based, data-driven design examples from various MDD programs | Eva Kohegyi* | ||
| Testing our assumptions: Moving from speculative to evidence-based trial design | Fabrizio Benedetti slides video |
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| Panel / Audience Discussion Site and patient perspectives: Balancing risk mitigation with site/patient burden and acceptability |
Panelists: Lori Davis, facilitator slides videoSarah Atkinson slides videoPenney Cowan slides videoDavid Walling slides videoPanel video |
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| Regulatory perspective on design and method solutions Panel / Audience Discussion |
Tom Laughren slides video Valentina Mantua* Panel video |
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| Concluding Remarks | Tim Mariano Sian Ratcliffe slides |
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| Poster Session/Reception | Poster PDFs and Abstracts | ||
21 February 2019 |
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Thursday Working Group Sessions (summaries to be posted) |
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| Algorithms/Flags | Chairs: Jonathan Rabinowitz Nina Schooler |
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| Autism Spectrum Disorder | Chairs: Valentina Mantua Tiffany Farchione Celso Arango summary |
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| Behavioral and Psychiatric Symptoms in Dementia—Agitation Subgroup | Chairs: Cedric O’Gorman Paul Rosenberg |
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| Innovative Technologies for Clinical Trials | Chairs: Richard Keefe Michael Davis |
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| Late Onset Depression: A Distinct Indication? | Chairs: Patricia Capaccione Peter de Boer summary |
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| Prevention Trials in Alzheimer’s Disease | Chairs: Holly Posner Philip Harvey slides |
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| Untangling the Regulatory and Statistical Challenges When Designing Trials for Disease Modification | Chairs: Larry Alphs Luca Pani |
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| Introduction and reprise of prior ISCTM work | Luca Pani slides video |
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| Prospects for a disease-modifying claim in neurodevelopmental disorders | Tiffany Farchione slides video |
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| Prospects for a disease-modifying claim in schizophrenia: Prevention, effects on cognitive function | David Millis slides video |
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| Clinical trials that demonstrate disease modification: The challenges and a possible solution for schizophrenia | Larry Alphs slides video |
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| Application of doubly-randomized delayed-start, matched control designs to demonstrate disease modification | Ibrahim Turkoz slides video |
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| Statistical challenges of proposed modification approaches | James Hung slides video |
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| Regulatory reflections on disease modification: EU perspective | Valentina Mantua* |
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| Panel / Audience Discussion | |||
| Meeting Adjourned
*Slides not released |
Carla Canuso | ||