The IDDI’s team of expert biostatisticians are excited to present their posters at the PSI Annual Conference 2026 taking place in Belfast, Northern Ireland on 15-17 June!
Join the IDDI team’s posters presentation at this year’s PSI Annual Conference as our experts are sharing our experience on how we build, manage, and continuously improve Data Monitoring Committees (DMCs)!
P076 – From Signals to Insight: Integrated Approaches for Improved IDMC Safety Evaluation
Presented by Nicolas Dubois, Senior Innovation Engineer & Senior Biostatistician, IDDI and Céline Mauquoi, Team Leader, Biostatistical Services, IDDI.
Abstract:
The identification of potential safety concerns is a central responsibility of Independent Data Monitoring Committees (IDMCs). Effective evaluation requires integration of disease‑specific expertise, a solid understanding of the investigational medicinal product (IMP), and appropriate biostatistical support.
Several complementary analytical strategies may be applied. First, assessments of statistical significance testing may highlight potentially meaningful imbalances; however, their interpretation is limited by low statistical power, multiplicity issue, and the data-driven nature of such analyses. Second, external contextual information—such as the Investigator’s Brochure, evidence from prior or ongoing trials involving the same IMP, or real‑world data in the same indication—can help distinguish adverse events arising from the natural course of the disease from those potentially related to treatment. Such comparisons enrich IDMC assessment but must be made cautiously to avoid misleading conclusions due to different contexts. Third, in-depth clinical exploration—including unblinded patient‑level review, targeted tables and figures, and narrative case assessments—can provide critical insights into events of interest.
This poster presents a case study demonstrating how combining these approaches produced a richer, more reliable evidence base to support IDMC deliberations. The example illustrates how close collaboration between the independent statistician, the IDMC statistician and clinical experts strengthens committee’s ability to interpret safety signals and formulate well‑reasoned, patient‑focused recommendations.
P078 – Beyond Tables: Visualization as a Decision-Support Tool for IDMCs
Presented by: Samantha Cambier, Senior Biostatistician, IDDI; Lava Timsina, Senior Biostatistician, IDDI and Shweta Srikanth, Asociate Biostatistician, IDDI
Abstract:
Independent Data Monitoring Committees (IDMCs) operate under strict time constraints to rapidly determine whether emerging data raise safety or efficacy concerns. Interim safety reviews often involve large, complex datasets, and excessive tabular reporting may obscure clinically relevant patterns. For IDMC members, the complexity is not the volume of data available, but whether potential issues can be identified quickly and reliably. Well-designed graphical displays can support the IDMC members in navigating this complexity in timely and informed decision-making process of a clinical trial.
This poster proposes a curated set of graphical approaches specifically tailored to IDMC review needs by transforming raw data into intuitive, interpretable insights. Through cases examples and best practices, the selected graph in this session are designed to balance clarity and completeness, allowing both high-level assessment and focused examination of atypical patterns or patient trajectories. Each visualization is presented with its intended purpose and practical contribution to committee review, such as faster signal identification, improved interpretability, and more transparent communication of a clinical trial data.
Visualizations that emphasize temporal evolution, between-group comparison, and deviation from clinical thresholds enable reviewers to detect trends and anomalies more efficiently than tables alone. In addition to the static traditional visual methods, interactive visual tools further supplement IDMCs to explore data dynamically, drill down into relevant subsets, and compare evolving patterns across time thus modernizing data presentation. Examples include longitudinal laboratory profiles with reference ranges, shift plots summarizing baseline-to-postbaseline changes, and adverse event displays structured to highlight frequency, severity, and timing. When thoughtfully constructed, such graphs reduce cognitive burden, direct attention toward potential safety signals, and preserve clinical context in making evidence-based recommendations.
By prioritizing concise and clinically meaningful visualization strategies, this work illustrates how graphical reporting can evolve from descriptive output to a central decision-support tool for IDMCs, ultimately strengthening the quality and decision making efficiency of trial oversight.
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IDDI is a trusted clinical data science partner. With 35+ years of research-driven experience, we combine therapeutic expertise, biostatistical leadership, and regulatory insight to mitigate risk from design to registration and beyond. We deliver uncompromising excellence in biostatistics, strategic consulting, clinical data management, IDMCs, and supporting eClinical technologies, because when every data point represents a patient, perfection is the only option.
About the event:
The PSI 2026 Annual Conference is taking place from 15th – 17th June at the ICC in Belfast, an award winning venue, and Belfast itself promises to be a great city to host. Organized by Statisticians in the Pharmaceutical Industry (PSI), this premier event brings together professionals from across the pharmaceutical and healthcare sectors to explore the latest advancements in statistical methodologies and their applications in drug development. More information about the event and the full program can be found here.
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