pharmaphorum January 14, 2022
The European Commission, EMA and national regulators within the EU have launched an initiative to change the way clinical trials are designed and run in order to position the bloc as an international “focal point” for clinical research.
The broad strokes of the proposals are laid out in a document entitled Accelerating Clinical Trials in the EU (ACT EU) that lists priority actions that will be taken, including measures to allow greater use of innovative clinical trial designs.
One objective is to increase the number of larger, multinational trials – specifically in the academic setting – that can take advantage of the scale afforded by organisations across member states acting together.
The paper notes that the COVID-19 pandemic has exposed...