Poster session information:
Date: Friday, October 10 2025
Time: 17:45 – 19:15 PM CEST
Poster Session 1
Title: From Paper to Precision: Improved MADRS Scoring Accuracy with eCOA Implementation
Abstract:
This study investigates whether using electronic clinical outcome assessments (eCOA) can reduce scoring errors in the Montgomery–Åsberg Depression Rating Scale (MADRS) compared to traditional paper-based methods. In clinical trials for depressive disorders, data variability and rater errors often compromise the reliability of results, with paper-based assessments being particularly prone to mistakes due to manual calculations and transcription. The eCOA platform, by contrast, offers automated scoring, real-time data validation, and built-in consistency checks, which help standardize the assessment process and minimize errors. The researchers analyzed MADRS assessments from two large clinical trials – one using paper and the other eCOA – and found that scoring discrepancies were dramatically lower with eCOA. The findings highlight the clinical and operational benefits of eCOA, such as improved data quality, reduced administrative burden, and greater reliability in psychiatric clinical trials, despite potential methodological differences between the studies.
Authors:
- Stacey Rumerman
- Chris Brady
- Selam Negash
- Igal Seagal
- Mark Opler
Speaker
Dr. Chris Brady
VP, Clinical Solutions at Clario
Dr. Chris Brady is a licensed clinical psychologist with over 25 years of clinical experience and more than 20 years in clinical research and global operations. As Vice President of Clinical Science, she leads strategic initiatives across psychiatry, neurology, oncology, pediatric trials, analgesia, and rare diseases. Dr. Brady is known for transforming complex scientific strategies into actionable processes and delivering evidence-based recommendations. She has directed global Phase I–IV trials, developed industry-standard training programs for Autism Spectrum Disorders (ADI-R, ADOS), and overseen protocol development and clinical outcome assessment (COA) selection.
Her background includes psychological assessment, rater training, and scale implementation. She is recognized for her innovative vision, attention to detail, and ability to communicate effectively across all levels of an organization. Dr. Brady’s special interests include language assessment, protocol design, training in symptom rating scales and diagnostic tools, and interviewer skills development.
Poster Session 2
Title: Impact of rater change in schizophrenia clinical trials using the PANSS
Abstract:
This study examines how changing raters between visits affects the variability of scores on the Positive and Negative Syndrome Scale (PANSS) in schizophrenia clinical trials. The PANSS is a complex tool that relies heavily on the judgment of clinicians, which can introduce subjectivity and inconsistency. Researchers analyzed data from seven large multi-site trials, comparing cases where the same rater conducted consecutive assessments to those where different raters did. Both site raters and independent raters were included in the analysis. The results showed that changing raters led to significantly greater fluctuations in PANSS scores from one visit to the next, regardless of whether the rater was based at the site or independent. This effect was observed across all study visits, though some differences emerged between rater types during the screening to baseline period. The findings highlight the importance of maintaining rater consistency in schizophrenia trials using the PANSS, as rater changes can introduce unwanted variability into the data.
Authors:
- Barbara Echevarria
- Matt Welch
- Selam Negash
- P. Molero
- Kazunori Tatsumi
- Mark Opler
Speaker
Dr. Barbara Echevarria
Senior Director, Clinical Science at Clario
Dr. Barbara Echevarria is a clinical psychologist with over 20 years of experience in neuroscience-focused clinical research. As Senior Director of Clinical Science at Clario, she leads a global team of scientists in designing and executing rigorous methodologies to enhance signal detection and data quality in clinical trials for psychiatric and neurodegenerative disorders. Dr. Echevarria is widely recognized for her expertise in clinical assessment, rater training and surveillance methodology, and her commitment to implementing evidence-based solutions that elevate trial integrity.