6th CEN Conference

Session

TC3: Estimation after Adaptive Testing

19 May 2026, 15:45

Room 1 B

Conveners

TC3: Estimation after Adaptive Testing

• Werner Brannath (University of Bremen)

55. Estimation after an adaptive design

Chris Jennison (University of Bath, UK)

19/05/2026, 15:45

oral presentation

When estimating the treatment effect after a group sequential test or a more complex adaptive design, the maximum likelihood estimate is liable to be biased. The ICH E20: Guideline on Adaptive Designs for Clinical Trials has “reliability of estimation” as a key topic. Methods have been developed to reduce the bias in estimators after group sequential and adaptive designs – or even eliminate...

33. Estimation in confirmatory clinical trials planned with an adaptive design - a regulatory perspective

Florian Klinglmueller (Austrian Agency for Health and Food Safety)

19/05/2026, 16:03

oral presentation

Reliable estimation of treatment effects is essential for the benefit–risk assessment supporting the approval of new drugs and for the communication of trial results in the European Public Assessment Report (EPAR) and Summary of Product Characteristics (SmPC). In adaptive designs, where trial adaptations such as sample size re-assessment, population enrichment, or treatment arm selection are...

47. Estimation for adaptive designs - a methodological overview

David Robertson (MRC Biostatistics Unit, University of Cambridge)

19/05/2026, 16:21

oral presentation

In adaptive clinical trials, the conventional point estimators of the treatment effect are prone to bias. Similarly, the conventional confidence intervals are prone to incorrect coverage, as well as other undesirable statistical properties. Recent regulatory guidance, such as ICH E20, has highlighted the need to use adjusted estimators and confidence intervals for adaptive designs in order to...

48. Point and interval estimation of treatment effects in adaptive clinical trials – past experiences and future developments

Ekkehard Glimm (Novartis Pharma)

19/05/2026, 16:39

oral presentation

Clinical trials have become more complex in recent decades. They have gradually become longer, involving more centers and more patients. With these tendencies, interim analyses of ongoing trials have become much more common and much research has been done on the design and analysis of data from adaptive trials. By now group-sequential trials are probably more frequent than single-stage...

249. Discussant

Frank Bretz

19/05/2026, 16:57

oral presentation