Clinical Development

In this section you may find indication on the role and function of clinical studies in research and drug development.

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Patient Engagement Resource Center

Published by EATRIS

Research and Drug DevelopmentPatient EngagementPatient Information

The Patient Engagement Resource center is an easy to navigate platform to help researchers get started with patient engagement in research. This toolbox provides helpful resources to help researchers understand the basics of patient engagement, and guide them through the different phases of patient engagement, from planning to conducting and evaluating.

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PROMs Repository

Published by ERICAECRIN

PCOMClinical Trials Toolkit

The ERICA Patient Reported Outcome Measures (PROMs) Repository is the first attempt to identify and centralize Clinical Assessment Outcomes questionnaires of relevance for rare diseases and constitutes a milestone in the Europe-wide standardization of Patient-Centered Outcome Measures (PCOMs) and PROMs for rare diseases.

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Core Outcome Measures in Effectiveness Trials

Published by IRDiRC

Endpoint COMETResearch and Drug DevelopmentClinical DevelopmentClinical Trial DesignOutcome MeasureEffectiveness 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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Clinical trials – Regulation EU No 536/2014

Published by EMA

Clinical TrialRegulation

The 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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