Workshop: Ethics and Innovative Clinical Trial Design: Adaptive and Fixed Designs in Confirmatory Clinical Trials

Join us for a half-day workshop in the Big Data Institute, University of Oxford focused on ethical and methodological issues surrounding innovative clinical trial designs. Please see below for registration details.

The workshop will consist of three interactive parts:

1. A brief introduction presenting the core, classical ethical concepts relevant for clinical trials and establishing some baseline terminology of modern trial elements;
2. An in-depth presentation of the recent milestone paper: “Adaptive versus Fixed Designs in Confirmatory Clinical Trials: Centering the Choice on Ethics.”;
3. A forward-looking roundtable focused on operationalizing these concepts and consider particular case studies. We will consider immediate translational next steps, including integrating ethical-justification frameworks into standard protocol templates, the consequences for institutional review board (IRB/REC) workflows, and regulatory submission dossiers and begin to outline a collaborative interdisciplinary research agenda.

Background

Clinical trials play a crucial role in advancing medical knowledge and managing uncertainty by systematically comparing the effects of various interventions. In a confirmatory setting, they provide a structured approach that enables reliable conclusions about the relative safety and efficacy of treatments. However, these trials are complex, require significant time and resources and raise ethical concerns, particularly due to practices such as randomizing participants to different interventions and implementing additional procedures like blood draws or biopsies. While the urgency to gain insights and accelerate learning is important, it must be carefully balanced with the need for reliability, generalizability, and the ethical treatment of participants.
Recently, innovative statistical methods have been proposed to allow clinical trials to adapt in various ways. Some forms of adaptation are already widely accepted and commonly used, such as stopping a trial early when treatments are statistically effective or ineffective. However, other forms of adaptation are more controversial. The controversy surrounding these methods raises both ethical and methodological questions. There is ongoing debate about whether, when and which of such methods are more efficient, meaning they can answer research questions with fewer participants without compromising reliability or generalizability. Adaptive trials played a crucial role in addressing the COVID-19 pandemic, leading to increased public interest in this methodology and highlighting the need to resolve outstanding uncertainties about their statistical and ethical implications.
A gathering at the University of Cambridge in 2025 brought together leading statisticians, ethicists, industry representatives, policymakers (including the WHO), regulators (including the FDA), and patient advocacy groups to discuss the evolving landscape of adaptive clinical trial designs and their ethical implications. The result of that meeting was the recent milestone paper “Adaptive versus Fixed Designs in Confirmatory Clinical Trials: Centering the Choice on Ethics.”

Link to the paper preprint

More information on the Cambridge workshop

Event details

Date: 6th July 2026

Time: 13:00 to 16:30

Venue: Seminar Room 1, Big Data Institute, Old Road Campus, Roosevelt Drive, Oxford OX3 7LF

Registration: Please register by completing the online registration form by Thursday 2nd July

Contact: If you have any queries, please contact admin@ethox.ox.ac.uk