6th CEN Conference

Session

Clinical trials 1

19 May 2026, 15:45

Room 13 B

Conveners

Clinical trials 1

• Franz König (Medical University of Vienna)

57. A novel method for inserting dose levels mid-trial in early phase combination studies

Matthew George (Phastar)

19/05/2026, 15:45

oral presentation

The use of combination treatments in early phase oncology trials is growing. The objective of these trials is to search for the maximum tolerated dose combination from a pre-defined set. However, cases in which the initial set of combinations does not contain one close to the target toxicity level pose a significant challenge. There is uncertainty around how to handle these situations...

183. Adaptive Designs in Fast-Track Registration Processes for Digital Health Applications

Liane Kluge (University of Bremen)

19/05/2026, 16:03

oral presentation

Fast-track procedures play an important role in the registration of health products, such as registration processes for digital health applications. These procedures offer the potential for patients to access innovative products earlier. The procedures involve two registration steps. Applicants can first apply for conditional registration. A successful conditional registration provides a...

201. adagraph: An R Package for Graph-Based Multiple Testing in Adaptive Trial Designs

Benjamin Fallmann (Medical University of Vienna, Center for Medical Data Science, Institute of Medical Statistics)

19/05/2026, 16:21

oral presentation

Graph-based multiple testing procedures provide an intuitive way to define closed testing strategies that control the family-wise error rate (FWER) in fixed sample settings [1]. They have been extended to adaptive trial designs based on the (partial) conditional error rate (CER) method [2]. These procedures control the FWER in two-stage designs where the trial is adapted after an interim...

126. An adaptive design for interim dose selection and addition for the treatment of whorm infections

Sonja Zehetmayer (Medical University of Vienna City: Vienna)

19/05/2026, 16:39

oral presentation

We propose a frequentist, adaptive trial design to investigate the safety and efficacy of three dose levels compared to placebo for the treatment of worm infections. As the safety of the highest dose is not yet established, the study starts with the two lower doses and the control arm. Based on safety and efficacy endpoints observed in an interim analysis, it is decided to either continue...

195. Confidence intervals for two-stage adaptive designs with subpopulation selection

Enyu Li (Clinical Trials Unit, University of Warwick)

19/05/2026, 16:57

oral presentation

Background: We consider clinical trials in which the experimental treatment may have heterogeneous effects across pre-specified patient subpopulations. In such settings, two-stage adaptive enrichment designs allow the enrolled population to be modified at an interim analysis. In stage 1, patients are enrolled from the full population, and based on interim data and preplanned selection rules,...