In this piece, we highlight topics in the medical publishing industry that we think are helpful for ongoing professional development.
The European Medicines Agency has released a reminder that there is less than a year until all ongoing clinical trials in the European Union must transition to the Clinical Trials Information System. The authorisation process can take up to three months, with best practice guidance available for sponsors to facilitate the transition.
On 5th March, 2024, the FDA is conducting a public workshop (online and in-person) to discuss complex adaptive, Bayesian, and other novel clinical trial designs. This is being conducted to facilitate discussion on the use of external data sources, Bayesian statistical methods, and simulations in complex innovative trials. The meeting will be conducted in two sessions, with the first focusing on case studies and the second consisting of panel discussions. Registration for online attendance will remain open throughout the 5th March.
European Medicines Agency clinical trials analytics workshop
The EMA conducted a two-day clinical trials analytics workshop on the 25–26th January. The regulatory network has collected large quantities of data about clinical trials in the EU. This session allowed stakeholders to present how they are using or planning to use the data, including in the application of artificial intelligence for novel insights. The discussions highlighted the desire for up-to-date clinical trial data, the importance of patient involvement, and the identification of the right data sources. The sessions are available as slides and video recordings at the above link.
