Placebo response remains one of the most significant challenges in Major Depressive Disorder (MDD) clinical trials, often obscuring the ability to detect true treatment effects. This webinar explores placebo response not as a single psychological phenomenon, but as an emergent property of the clinical trial system. Factors including study design, patient selection, blinding, treatment allocation, endpoint selection and measurement practices all influence the observed drug-placebo difference.
Rather than focusing exclusively on reducing placebo response, the challenge lies in distinguishing meaningful clinical change from measurement noise and other non-treatment influences captured by clinical outcome assessments. Attendees will be introduced to a signal intelligence framework for interpreting these influences. The session will examine how trial teams can assess whether observed improvement is clinically coherent, identify where treatment signal may be weakened and use participant-, rater-, site- and study-level data to guide targeted interventions.
Register for this webinar to learn how MDD trials can improve signal detection by distinguishing meaningful clinical change from placebo response and measurement noise.
Speakers
Luka Lucić, PhD, Senior Director, Clinical Science, Psychiatry, Cogstate
Dr. Luka Lucić specializes in the administration of psychiatric scales (e.g., PANSS, MADRS, CDRS-R and HAM-D) in support of global biopharmaceutical projects. Dr. Lucić has more than 10 years of experience serving as a Scientific Lead and Lead Trainer on global clinical trials, primarily directing and supporting the training of investigators engaged in international research programs in psychiatry, neurodevelopment and rare & orphan disorders. He provides protocol consultation and develops rater-training curricula across various modalities, ranging from didactic modules to applied rater performance training for raters and clinicians.
Dr. Lucić applies his scientific research to develop optimized data analytics services tailored to the specific needs of unique clinical trials. Training approaches adopted by Dr. Lucić have minimized the time raters spend in training while utilizing contemporary educational curricula to maximize the knowledge gained.
Dr. Lucić is an Associate Professor in the Department of Social Science and Cultural Studies at the Pratt Institute in Brooklyn, New York. Dr. Lucić received his PhD in Developmental Psychology from The City University of New York (CUNY).
Message Presenter
Svenja Wacker, PhD, Neuropsychology Science Director, Cogstate
Dr. Svenja Wacker is a licensed Clinical Neuropsychologist specializing in business development for global clinical trials, bridging cognitive science and business strategy, collaborating with pharmaceutical and biotech companies to optimize trial strategy, implement innovative assessment solutions optimized for trial strategy and improve the delivery of clinical and diagnostic tools for CNS diseases.
Dr. Wacker’s clinical trial activities are grounded in a solid foundation of hands-on clinical work. She has provided neuropsychological assessments and interventions to patients with CNS diseases and injuries and to their families to guide them toward resilience and empowerment. This clinical expertise informs her strategic approach to clinical trials, ensuring that patient-centric and scientifically rigorous solutions are integrated across all phases of research.
Dr. Wacker holds a PhD in Clinical Psychology from George Mason University and completed a Clinical Neuropsychology Fellowship at Yale University School of Medicine. She further honed her skills through a postdoctoral residency in Neuropsychological Assessment at Harvard Medical School.
Message PresenterWho Should Attend?
This webinar will appeal to Executives, Directors, Scientists and Managers from pharma, biotech and CROs responsible for global psychiatric clinical trials, including:
- Clinical Operations
- Clinical Science
- Clinical Trial Planning and Optimization
- Medical Affairs
- Outcomes Research
- Outsourcing and Procurement
- Project Management
- Research and Development
What You Will Learn
Attendees will gain insight into:
- Distinguishing between True Placebo Response (Type 1 placebo) and Pseudo-Placebo Response (Type 2 placebo)
- Examining how protocol design, risk-based monitoring and expert clinical review can support targeted, mechanism-specific interventions during an ongoing trial
- How study design, patient selection, blinding, treatment allocation, endpoint selection and measurement practices all influence drug placebo separation
- Distinguishing genuine clinical improvement from regression toward the mean, baseline inflation, scoring variability and other sources of pseudo improvement
- Recognizing participant, rater, site and study level patterns that may indicate risk to endpoint quality
Xtalks Partner
Cogstate
Cogstate Ltd (ASX:CGS) is a leading science and technology solutions provider dedicated to optimizing the measurement of cognition in clinical trials, academic research and healthcare. Cogstate provides enabling technologies and professional services for higher quality neuropsychological assessments and is a pioneer in commercializing rapid, reliable and highly sensitive computerized cognitive tests. Cogstate customers include the world’s leading biopharmaceutical companies; elite sporting organizations and military; physicians and patients; renowned academic institutions and public-private partnerships. For more information, please visit www.cogstate.com.
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