EU Guide Outlines Important Considerations For Submitting Complex Trials In CTIS
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.
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New EU-wide guidance describes the factors that sponsors should consider when designing and conducting trials with complex innovative designs.
The European Medicines Agency expects its new guideline will improve planning of confirmatory trials that include non-inferiority and therapeutic equivalence comparisons.