U-CARE BrainPub: Adaptive designs in action: efficiencies, limitations, and practical challenges

Adaptive designs can make clinical trials more efficient, informative and ethical compared to traditional fixed designs, thus providing benefits not only to investigators, sponsors and the scientific community but also, crucially, to patients. This includes both current patients taking part in trials being conducted efficiently and ethically, as well as future patients benefitting from trial findings which may become available sooner due to increased efficiencies and better use of scarce resources.

However, despite statistical theory for many types of adaptive designs being well developed and user-friendly software being widely available, there are still many pitfalls around the practical implementation of adaptive methodology which, if unresolved, can prevent these designs from maximising their full potential.

In this seminar, Dr Philip Pallmann will provide a quick overview of adaptive designs, followed by a more in-depth discussion of their statistical and operational efficiencies as well as their methodological and logistical challenges and limitations. Using examples of real trials with adaptive designs, he will give practical guidance for planning and conducting adaptive trials and share some ‘top tips’ on key aspects such as applying for funding, trial and data management, interpretation and reporting of results and communicating findings to diverse audiences.

The online seminar will be held in English and is open to anyone interested.

About Philip Pallmann

Philip Pallmann is a Principal Research Fellow and Deputy Director of the Infection, Inflammation and Immunity Division in the Centre for Trials Research at Cardiff University. He works as a medical statistician on the design, conduct, analysis and reporting of randomised controlled trials and other well-designed studies across a wide range of clinical areas including sepsis, neurodegenerative diseases, vascular surgery and population health, as well as on the advancement of clinical trials methodology, in particular adaptive designs. He co-leads the Adaptive Designs Working Group of the MRC-NIHR Trials Methodology Research Partnership and is a member of the European Huntington’s Disease Network’s Advanced Therapies Working Group and Clinical Trial Design Task Force. He sits on the MRC-NIHR Efficacy and Mechanism Evaluation and Postdoctoral Award funding committees, an associate editor for Trials, and a statistical advisor for The Lancet Child and Adolescent Health.