Europe
EMA has released a new initiative called ‘Accelerating Clinical Trials in the EU (ACT EU)’. According to the paper it will adapt some of the methods used in COVID trials to modernise clinical trials. There is also plan for implementing metrics system to analysis data and performance. The initiative plans better involvement of patients in clinical trials design.
European Commission has implemented a new process for safety oversight of clinical trials in EU. According to the new process a member state regulator will be allocated to perform safety oversight for each individual trial.
Parkinson’s UK and Research Ethics Committee members have developed a tool to help researchers working with patients with Parkinson’s to improve communication and help them be more involved in research.
North and South America
FDA latest guideline for clinical trials with cell and gene therapy suggest that they can use ‘umbrella’ design to allow all studies to run in parallel.
FDA has issued a draft guideline on using digital tech in remote clinical data collection.
