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) | |||
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![]() ![]() |
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Unresolved Problems in Neuroscience Drug Development: Point/Counterpoint | Facilitator: Amir Kalali ![]() |
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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![]() ![]() Discussants: Jill Harkavy-Friedman ![]() ![]() Tom Laughren ![]() ![]() |
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Panel/Audience Discussion | Panelists: Jean Kim ![]() ![]() Galia Siegel ![]() |
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Are acute rapid onset anti-depressant results valid or just a consequence of functional unblinding? | Chair: Steve Brannan![]() Discussants: Mark Opler ![]() ![]() Torsten Madsen ![]() ![]() |
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Panel/Audience Discussion | Facilitator: Steve Brannan![]() |
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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 ![]() summary |
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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 ![]() |
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Orphan Diseases | Chairs: Joan Busner Ravi Anand ![]() ![]() |
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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![]() ![]() |
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US perspective: Real world outcome needs of payers current and anticipated | Jennifer Graff![]() ![]() |
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When novelty is not enough: Assuring adoption, access as well as approval within the clinical development process | Michael Murphy ![]() ![]() |
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Models for increasing real world evidence in registration and post-approval clinical trials | Larry Alphs![]() ![]() |
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Health economics and outcomes research: What can be done differently in registration trials and in post-approval trials | Steven Kymes![]() ![]() |
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Regulatory Perspective | Peter Stein![]() ![]() |
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Panel Discussion | Facilitator: Dawn Velligan ![]() |
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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![]() ![]() |
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ADCOMS, new composite score, demonstrates improved sensitivity to disease progression and treatment effects in early AD | Veronika Logovinsky![]() ![]() |
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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![]() ![]() |
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Is there a cognitive test that can detect cognitive impairment associated with AB+ in the absence of dementia? | Jason Hassenstab![]() ![]() |
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Informant report to detect amyloid related cognitive decline in the absence of dementia | Anna-Karin Berger![]() |
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Panel / Audience Discussion | Discussant: Judith Jaeger ![]() ![]() |
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Andrew C. Leon Distinguished Career Award Presentation | Steve Marder Carla Canuso ![]() Janet Williams ![]() ![]() |
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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 | ![]() Tim Mariano ![]() Sian Ratcliffe ![]() |
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Case studies on how stakeholders (sponsors, sites, patients) influence risks | Steve Brannan![]() ![]() |
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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![]() ![]() |
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Panel / Audience Discussion Site and patient perspectives: Balancing risk mitigation with site/patient burden and acceptability |
Panelists: Lori Davis, facilitator ![]() ![]() Sarah Atkinson ![]() ![]() Penney Cowan ![]() ![]() David Walling ![]() ![]() Panel ![]() |
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Regulatory perspective on design and method solutions Panel / Audience Discussion |
Tom Laughren![]() ![]() Valentina Mantua* Panel ![]() |
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Concluding Remarks | Tim Mariano Sian Ratcliffe ![]() |
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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 ![]() |
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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 ![]() |
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Prevention Trials in Alzheimer’s Disease | Chairs: Holly Posner Philip Harvey ![]() |
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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![]() ![]() |
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Prospects for a disease-modifying claim in neurodevelopmental disorders | Tiffany Farchione![]() ![]() |
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Prospects for a disease-modifying claim in schizophrenia: Prevention, effects on cognitive function | David Millis![]() ![]() |
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Clinical trials that demonstrate disease modification: The challenges and a possible solution for schizophrenia | Larry Alphs![]() ![]() |
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Application of doubly-randomized delayed-start, matched control designs to demonstrate disease modification | Ibrahim Turkoz![]() ![]() |
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Statistical challenges of proposed modification approaches | James Hung![]() ![]() |
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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 |