6th CEN Conference

Session

Clinical trials 5

21 May 2026, 15:45

Room 13 B

Conveners

Clinical trials 5

• Tomasz Burzykowski (Hasselt University)

39. Assessment of Global Evidence Against Homogeneity for Exhaustive Subgroup Treatment Effect Plots

Björn Bornkamp (Novartis Pharma AG)

21/05/2026, 15:45

oral presentation

Assessment of treatment effect heterogeneity is a challenging problem in biostatistics, particularly in clinical trials: Estimation of treatment effects within subgroups in an exploratory setting is often unreliable due to limited sample sizes and multiplicity issues. Through the past decades, many efforts have been made to address this problem. Among them, Muysers et al. (2020) considered...

83. Comparing adverse event probabilities in a hypothetical world without consent withdrawals or treatment switches

Judith Vilsmeier (Institute of Statistics, Ulm University)

21/05/2026, 16:03

oral presentation

A question that arises in the analysis of adverse events is how to account for patients who withdraw their consent or switch treatment. One approach is to consider consent withdrawal and treatment switch as competing events. Alternatively, patients who withdraw from the study or switch treatment could be censored, but this implies that one assumes censoring due to treatment switch or consent...

202. Continuous Monitoring in Early Phase Oncology: A Standardized, Patient-Centric Approach

Kuzko Aleksandra (AstraZeneca)

21/05/2026, 16:39

oral presentation

Continuous monitoring (CM) at AstraZeneca is the systematic review and evaluation of accumulating study data to inform timely decisions. Rather than waiting for formal interims or study completion, our CM approach in early phase oncology studies, enables earlier data-driven decisions to stop for futility or safety, minimising exposure to ineffective or unsafe treatments, and to accelerate...