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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European YPAG Network

Published by

The network was established to support the development of new Young Person Advisory Groups (YPAGs) within Europe. The main aim of eYPAGnet is to provide researchers with a variety of opportunities to work with children and young people in the design and conduct of paediatric clinical trials.  Here are just some of the services we offer.

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SPIRIT PRO Extension for inclusion of patient-reported outcomes in clinical trials protocols

Published by ECRIN

Clinical Trials ToolkitPCOM

Extension of the SPIRIT (Standard protocol items: recommendations for interventional trials) guideline, SPIRIT PRO provides guidelines for inclusion of patient-reported outcomes in clinical trial protocols.

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PROMs Repository

Published by ECRINERICA

Clinical Trials ToolkitPCOM

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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PedCRIN list of Tools

Published by ECRIN

PediatricClinical Trials Toolkit

PedCRIN developed a series of tools (WP3) and procedures to support the setup and the management of multinational neonatal and paediatric clinical trials in Europe. These tools are developed to train and support researchers and clinicians so they can establish, run, and manage both paediatric and neonatal multinational clinical trials in a more effective and easier way. The removal of barriers to trial management will speed up the evaluation of new and improved therapies.

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ICH Statistical Principles for clinical trials E9

Published by International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)ECRIN

Clinical Trials Toolkit

This guidance is intended to give direction to sponsors in the design, conduct, analysis, and evaluation of clinical trials of an investigational product in the context of its overall clinical development. The document will also assist scientific experts charged with preparing application summaries or assessing evidence of efficacy and safety, principally from clinical trials in later phases of development.

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