Published by IRDiRC
Adaptative PathwayClinical DevelopmentClinical Trial DesignEarly Access SupportRegulatory AffairsThe 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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Clinical DevelopmentClinical Trial DesignRegulatory AffairsThe 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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Clinical DevelopmentClinical Trial DesignEffectiveness TrialEndpoint COMETOutcome MeasureResearch and Drug DevelopmentThe 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 resourceDecentralized trials aim to improve patient access to trials by enabling patient follow-up from home or community care, increase the participation of more diverse populations, and enhancing data collection by combining the adoption of digital endpoints and telemedicine as applied to trials, decentralized trials aim
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BiomarkerClinical Trial DesignEndpointResearch and Drug DevelopmentA biomarker discovery and validation guideline for clinical trial design and the drug development.
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