6th CEN Conference

Session

Clinical trials 3

21 May 2026, 10:45

Room 13 B

Conveners

Clinical trials 3

• Florian Frommlet (Medical University Vienna)

18. A randomized basket trial design for dose optimization based on Bayesian model averaging using spike-and-slab priors

Belay Birlie Yimer (1. Astellas Pharma Europe Ltd., Addlestone, United Kingdom)

21/05/2026, 10:45

oral presentation

The FDA initiated Project Optimus and issued guidance for dose optimization, recommending randomized parallel dose-response cohorts to generate additional data at promising dose levels and implies that different dosages may be needed for different indications. In addition to dose optimization, with recent advancements in precision medicine and cancer biology, the development of cancer...

69. A Basket Trial Design for Unequal Sample Sizes Based on Power Priors

Lukas Baumann (Institute of Medical Biometry, University of Heidelberg)

21/05/2026, 11:03

oral presentation

Basket trials examine the efficacy of a single intervention simultaneously in several patient subgroups. They are currently mostly applied in oncology, where the subgroup assignment is based on medical characteristics such as a common biomarker. This can result in small sample sizes within subgroups that are also likely to differ. Several designs for the analysis of basket trials have been...

26. How to optimize dynamic borrowing in basket trials – A utility-based framework.

Lukas D Sauer (Institute of Medical Biometry, Heidelberg University)

21/05/2026, 11:21

oral presentation

Modern therapeutic agents in cancer therapy often target specific genetic traits of the tumor. Whenever these traits are independent of the tissue in which the tumor is located, the therapeutic agent may be tissue-agnostic, meaning that it can be applied regardless of location. Clinical trials for such tissue-agnostic therapies often have small sample sizes. Hence, it is efficient to recruit...

147. AI-Assisted Methodology Validation Before Data Collection: The E-PICOS Framework for Robust Clinical Trials

Arzu Kanik (AB Health Tech)

21/05/2026, 11:39

oral presentation

Background:
A substantial proportion of clinical research waste originates from fundamental methodological flaws—improper study design, insufficient power, inappropriate statistical methods, and non-compliance with reporting guidelines. While many AI tools attempt to support data analysis, none address the critical upstream phase: validating methodology before data collection. To address this...

137. Using Confidence Distributions in Final and Interim Analyses for Single-Arm Studies or Platform Trials Consisting of Single-Arm Studies

Günter Heimann (Independent Consultant)

21/05/2026, 11:57

oral presentation

Confidence distributions are a frequentist alternative to Bayesian posterior distributions. They summarize the knowledge and uncertainty about an unknown model parameter in the form of a probability distribution on the parameter space, just like a posterior distribution, without assuming that the parameter of interest is a random variable. Although confidence distributions are a relatively old...