Published by EMA
Clinical DevelopmentRegulatory AffairsClinical Trial DesignThe goal of the Clinical Trial Regulation is to create an environment that is favourable to conducting clinical trials in the EU, with the highest standards of Safety for participants and increased transparency of trial information.
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Regulatory AffairsClinical DevelopmentClinical Trial DesignAdaptative PathwayEarly Access SupportThe adaptive pathways approach is part of the European Medicines Agency’s (EMA) efforts to improve timely access for patients to new medicines
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Research and Drug DevelopmentClinical DevelopmentClinical Trial DesignEndpoint COMETOutcome MeasureEffectiveness TrialThe COMET (Core Outcome Measures in Effectiveness Trials) Initiative brings together people interested in the development and application of agreed standardised sets of outcomes, known as ‘core outcome sets’ (COS). These sets represent the minimum that should be measured and reported in all clinical trials of a specific condition, and are also suitable for use in clinical audit or research other than randomised trials.
View this resource Bookmark this resourceThe Regulation will ensure a greater level of harmonisation of the rules for conducting clinical trials throughout the EU. It introduces an authorisation procedure based on a single submission via a single EU portal, an assessment procedure leading to a single decision, rules on the protection of subjects and informed consent, and transparency requirements
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