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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  2. Research and Drug Development
  3. Clinical Development
All SubjectsClinical Trial

Procedural document: data collection and registration of clinical trials

Published by Orphanet

Patient EngagementClinical TrialOrphanet

Orphanet offers, amongst a range of expert resources on rare diseases, a directory of national and multinational clinical trials aiming to help: – clinical investigators working in the field of rare diseases find each other, establish collaborations, recruit patients; – patients and general public retrieve information on ongoing clinical trials for a particular disease, and stay informed on clinical trials that are recruiting; – experts, funding agencies and pharmaceutical industry obtain visibility on therapeutic development in the field of rare disease.

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Feasibility-Patient engagement in trial endpoint selection 

Published by IRDiRC

Trail Endpoint SelectionOutcome MeasureClinical TrialResearch and Drug DevelopmentPatient EngagementEndpointClinical Development

Guidance on the pivotal clinical trials outcomes measures .The important of the patient’s feedback. Academics can then assess whether there is an outcome measure available that can measure this – if not, outcome measure(s) may need to be developed.

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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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