Adaptive Pathways

Published by IRDiRC

Clinical Development Regulatory Affairs Early Access Support Adaptative Pathway Clinical Trial Design

The 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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EU Compassionate Use Programs

Published by IRDiRC

Clinical Development Regulatory Affairs Research and Drug Development Orphan Drug Early Access Support European Union Compassionate Use EMA Compassionate Use

Compassionate use is a treatment option that allows the use of an unauthorised medicine. Under strict conditions, products in development can be made available to groups of patients who have a disease with no satisfactory authorised therapies and who cannot enter clinical trials.

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Core Outcome Measures in Effectiveness Trials

Published by IRDiRC

Research and Drug Development Clinical Development Clinical Trial Design Endpoint COMET Outcome Measure Effectiveness Trial

The 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.

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