EU Offers Advice On Running Complex Clinical Trials Under CTR
New EU-wide guidance describes the factors that sponsors should consider when designing and conducting trials with complex innovative designs.
You may also be interested in...
The European Medicines Agency believes that a scientific guideline on clinical trials incorporating a platform design is needed because such studies are expected to play an increasingly important role in future marketing authorization applications.
The new workplan for the EU's initiative on accelerating clinical trials lays out the timelines for a set of “priority actions,” such as mapping the European clinical trial environment and establishing a consolidated process for more efficiently managing scientific advice on trials.
From grappling with a never-ending list of conflicting national requirements to dealing with numerous technical issues, a research project manager at Norway’s Oslo University Hospital talks about the hiccups faced by their multinational COVID-19 platform trial that was among the first studies submitted for approval under the EU Clinical Trial Regulation.