Event

PSI Training Course: Adaptive Designs

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Dates: 
Session 1 - Tuesday 20th October 2026
Session 2 - Wednesday 21st October 2026
Time: 13:00 - 16:00 BST | 14:00 - 17:00 CET | 08:00 - 11:00 EET
Location: Online via Zoom

Who is this event intended for?

Fully open. Statisticians in clinical research, all stages of career

What is the benefit of attending?

Gain a practical understanding of adaptive clinical trial designs and the principles of ICH E20, enabling you to make more informed contributions to the planning, conduct, and evaluation of adaptive clinical studies within modern drug development.

Overview

This two-afternoon virtual course provides a practical introduction to adaptive clinical trials, focusing on the concepts, applications, and regulatory principles outlined in ICH E20 through real-world examples and case studies.

Abstract

Adaptive clinical trials have moved from being viewed as specialized methodological innovations to becoming an increasingly important component of modern drug development. When appropriately planned, conducted, and interpreted, adaptive designs can improve the efficiency of clinical drug development, make better use of accumulating information, and support more informed decision-making. At the same time, they raise important statistical, operational, and regulatory considerations, particularly in confirmatory settings where control of error rates, trial integrity, and interpretability remain paramount. This virtual course, delivered over two afternoons, provides a structured introduction to adaptive clinical trials for participants seeking a scientifically grounded and practice-oriented overview of the field. Rather than focusing on technical derivations, the course will emphasize conceptual understanding, practical design considerations, and learning through examples.

A central component of the course will be an introduction to ICH E20 and its implications for the design, conduct, analysis, and interpretation of adaptive clinical trials. The course will explain the underlying rationale of the guideline and discuss how it frames adaptive design principles within a broader regulatory and scientific context. Particular attention will be given to principles such as adequacy within the development program, adequacy of trial planning, limiting the chances of erroneous conclusions, reliability of estimation, and maintenance of trial integrity. The aim is not to summarize the main themes of the guidance, but how to place adaptive designs into the wider landscape of a clinical development strategy and cross-functional decision-making.

The course will discuss common types of adaptations, with a focus on specific considerations relevant to the principles. The methodological component is intentionally selective and accessible rather than exhaustive. It will cover early, among others, trial stopping, sample size adaptations, population selection, and treatment selection. Applications and case studies will form an important part of the training. Realistic examples will be used to illustrate when adaptive approaches can add value, when they may be less useful, and how design choices should be aligned with the scientific question, the stage of development, and the practical realities of trial conduct. These examples will also show how adaptive designs are evaluated by different stakeholders, including statisticians, clinicians, regulators, and development teams.

Finally, the course will address the broader strategic value of adaptive designs in drug development. Adaptive methods should not be viewed merely as technical tools, but as part of a broader framework for managing uncertainty, improving development efficiency, and aligning evidence generation with decision-making needs. Participants will come away with a clearer understanding of the opportunities, limitations, and implementation requirements of adaptive clinical trials, as well as a more informed perspective on when their use is scientifically and strategically justified.

Cost

Early Bird PSI Members: £180 +VAT
PSI Members: £210 +VAT

Early Bird Non-PSI Members: £290 +VAT
Non-PSI Members: £320 +VAT
*Please note: Non-Member rates include PSI membership until 31 Dec. 2027.

Registration

Early Bird registration closes on Friday 28th August.
To register for this event, please click here.

Speaker details

SpeakerBiography

Frank Bretz, Novartis

Frank Bretz is a Distinguished Quantitative Research Scientist at Novartis. He has contributed to methodological advancements in several areas of drug development, including adaptive designs, dose finding, estimands, and multiple testing. He was a member of the ICH E9(R1) Expert Working Group on “Estimands and sensitivity analysis in clinical trials”, a subject matter expert for the ICH M11 Expert Working Group on “Clinical electronic structured harmonised protocol”, and currently serves on the ICH E20 Expert Working Group on “Adaptive designs for clinical trials”.

Speaker 2 details coming soon

 

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