Placebo response remains one of the most significant challenges in Major Depressive Disorder (MDD) clinical trials, often obscuring true treatment effects and delaying the approval of promising new therapies. Despite being widely recognized, the placebo effect is still not fully understood. It refers to a measurable improvement in a participant’s condition following an inactive treatment and is particularly impactful in psychiatric trials where clinician-administered outcomes are central to study success. The subjective nature of these assessments, combined with rater variability and participant expectations, makes MDD trials especially vulnerable to elevated placebo response rates and inconsistent outcome signal detection.
This webinar is designed to help attendees think about and improve the quality, reliability, and interpretability of clinician-rated outcomes in MDD trials. Participants will gain foundational knowledge of the placebo effect, its origins, mechanisms, and relevance to current trial design, while exploring modern, evidence-based strategies to minimize its impact. Through a combination of expert guidance, real-world case examples, and practical tools, the session will focus on strengthening rater performance, reducing data variability, and improving trial signal detection.
WHAT YOU WILL LEARN:
- Explore methods to mitigate placebo response via, rater-focused education and calibration, structured interview guides, and specialized mitigation training
- Examine central monitoring approaches, including, algorithmic and data-based review, and risk-based expert analysis
- Understand centralized rating and scoring models using trained clinicians
- Identify best practices for managing participant expectations
- Learn how eCOA design can prevent common rater errors before they impact data
JANUARY 27 @ 11:00 AM ET
Speakers
Luka Lucić, PhD
Senior Director, Clinical Science, Psychiatry
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. 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).
Svenja Wacker, PhD
Neuropsychology Science Director
Svenja Wacker, PhD is a bilingual (German/English), licensed clinical neuropsychologist with expertise in global clinical trial management and consultation, as well as extensive experience in hospital-based rehabilitation neuropsychology, neuropsychological assessment and intervention, program development, and medical staff training. Dr. Wacker has supported a diverse research portfolio in international clinical trials. As a cultural-linguistic expert consultant she contributed to the training, certification, and remediation of site raters and data validation protocols. As Associate Director of Clinician Network with Cogstate, she grew a global expert consultant pool of 150 neuropsychologists, and managed all aspects of recruitment, training, certification, performance monitoring, and operational logistics for their work on a broad portfolio of clinical trials.
Dr. Wacker graduated from George Mason University with a PhD in clinical psychology and a fellowship in clinical neuropsychology at Yale University School of Medicine. She completed a postdoctoral residency at Harvard Medical School in neuropsychological assessment.
