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;www.eufemed.eu) [1].
EUFEMED is a non-profit group whose goal is to make the early stages of clinical drug research better in Europe. The conference was the result of EUFEMED's ongoing efforts to bring together everyone involved in exploratory clinical drug research to look at and talk about the latest changes in the field. The meeting was mostly about how early clinical development is changing and how clinical pharmacologists can get ready for these changes. The rate of change in clinical studies seems to be at a level that has never been seen before. Is it possible to guess what clinical studies will be like in 30 years, 10 years, or even 5 years?
A workshop before the meeting talked about how modelling and simulation, such as physiology-based pharmacokinetic strategies, are changing the way clinical development is done. In a second meeting, the problems that biological agents cause were looked at. The main speech talked about the possible role of virtual trials in the early stages of drug development. It focused on how models can help people understand and shape the drug development process.
The next presentations talked about a lot of different topics. Some of them were the possible effects of digital support on study performance in the early stages of development, from recruiting participants to collecting data remotely, as well as issues like data transparency, layperson summaries, and ethical concerns for trials involving healthy people. Future regulatory challenges in the field of early clinical development, such as Brexit, and how to get ready for them were the main topic of the second day of the meeting. New approaches and designs in oncology, the use of more complicated study designs, and digital biomarkers were some of the things that were discussed.
The meeting was open, and the talks were helpful, friendly, and lively. A poster session with new work from groups that were there helped the discussions along. Mainly, everyone agreed that stakeholders need to keep working together and talking, especially about important safety problems. This way of doing things lets partners share best practices in a strategic way as the situation changes. There will be change, but the exact form will rest on the creativity and vision of not only the scientists who are moving science forward, but also the sponsors, regulators, and people who pay for it. The piece is available to everyone as Open Access, so anyone can read it and think about the ideas that were talked about.
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