How clinical pharmacologists might prepare for change


The latest issue of Journal Frontiers in Pharmacology has just published the proceedings of the second biennial conference of the European Federation for Exploratory Medicines Development (EUFEMED; [1].

EUFEMED is a not-for-profit association that aims to improve the early phase clinical drug development process in Europe. The conference was the result of a continued effort of EUFEMED to gather all stakeholders of exploratory clinical drug development to evaluate and discuss recent developments in the field. The conference focused on how the landscape around early clinical development is changing and how clinical pharmacologists might prepare for these changes. The pace of change seems unprecedented in the history of clinical trials. Is it possible to predict what clinical trials will look like in the next 30 years, or 10 or even 5 years time? 

A preconference workshop gave consideration to the impact that modelling and simulation, including physiology-based pharmacokinetic strategies, is having on the practice of clinical development. A second workshop looked at the challenges introduced by biological agents. The keynote address explored the potential role of virtual trials in early medicines development with emphasis on how models can help to understand and inform the drug development process. 

Presentations that followed covered a broad range of subjects including the potential impact of digital support on study performance in early phase development, extending from recruitment to remote data collection, lay person summaries, data transparency, and ethical considerations for trials in healthy subjects. The second day of the conference focused on future regulatory challenges in the field of early clinical development (including Brexit) and how to prepare for changes in the landscape. Subjects covered included new approaches and designs in oncology, the introduction of more complex study designs and digital biomarkers.

The meeting format was open and discussions were informative, friendly and lively – promoted by a well-attended poster session sharing recent work by attending groups. Overall, it was generally accepted stakeholders need to continue in a process of engagement and discussion, particularly on critical safety issues. Such an approach allows partners to adopt a proactive approach to sharing best practice in the changing landscape. Change is coming, though its precise form will likely depend on the creativity and vision not only of the scientists driving science forward but also the sponsors, regulator and payers. The article is provided as Open Access so anyone can engage with the ideas that were discussed.

[1] Hardman T, Caplain H, Rottey S, Douglas D, Stringer S, Sourgens H. European Federation for Exploratory Medicines Development Lyon Conference 2019: The Changing Landscape of Early Medicines Development—Be Prepared. Front. Pharmacol., |