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. Participants 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.
WHAT YOU WILL LEARN:
- Distinguish between True Placebo Response (Type 1 placebo) and Pseudo-Placebo Response (Type 2 placebo)
- Examine how protocol design, risk-based monitoring and expert clinical review can support targeted, mechanism specific interventions during an ongoing trial
- Understand how study design, patient selection, blinding, treatment allocation, endpoint selection and measurement practices all influence drug placebo separation
- Distinguish genuine clinical improvement from regression toward the mean, baseline inflation, scoring variability, and other sources of pseudo improvement
- Recognize participant, rater, site, and study level patterns that may indicate risk to endpoint quality
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.
