European Centre for Clinical Trials in Rare Diseases- Why we do it

European Centre for Clinical Trials in Rare Diseases

Centre Européen pour les Essais Cliniques Maladies Rares

Because

Failure to receive marketing authorisation for orphan medicines prevents the timely availability of valuable medicines to patients

Orphan medicines need to demonstrate acceptable risk/benefit to CPMP if they are to receive marketing authorisation

Sponsors can experience difficulty in conducting clinical trials due to

-High cost of clinical trial services when outsourced to CROs

-Small and widely dispersed groups of patients

-Lack of geographical reach

-Lack of regulatory skills

-Difficulties of bio-statistical study design for small cohort sizes.

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National University of Ireland, Cork