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.
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EU regulators have issued a new Q&A document on the key aspects that sponsors of complex trials should consider when making new submissions or moving ongoing studies to the Clinical Trials Information System.
A survey undertaken last year on the implementation of the EU Clinical Trials Regulation drew some positive feedback from study sponsors but also threw light on well-known concerns with the legislation. Some of the highlighted issues are being addressed on a priority basis.
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.