The IDDI team is excited to present our latest scientific poster highlighting the value of close collaboration between statisticians and clinical experts in Independent Data Monitoring Committees (IDMCs) safety evaluation.
Identifying and interpreting potential safety signals is one of the key responsibilities of IDMCs. This poster presents a case study demonstrating how statistical analyses, external contextual evidence, and detailed clinical review can be combined to provide a more comprehensive assessment of emerging safety concerns. The work was presented at the PSI Annual Conference 2026 by:
- Nicolas Dubois, Senior Innovation Engineer & Senior Biostatistician, IDDI
- 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.
