Table 1 Identified skills required and members of DevelopAKUre consortium
Expertise | Partner |
|---|---|
Leading clinical disease expertise and coordination | Royal Liverpool University Hospital (RLUH) (consortium coordinator, study co-sponsor) |
Leading scientific disease expertise | University of Liverpool (study co-sponsor) |
Patient perspective and network, advocacy | AKU Society, United Kingdom |
Operational clinical study expertise (including Data Management) to conduct complex international clinical studies in rare diseases | PSR, the Netherlands |
Clinical research from a regulatory perspective, managing regulatory authority interactions and applications, expertise in the investigational drug and pharmacovigilance | Swedish Orphan Biovitrum (Sobi), Sweden |
Medical monitoring expertise | Cudos, the Netherlands |
Biomarker analysis expertise | Nordic Biosciences, Denmark |
Inflammatory markers analysis expertise | Universita degli studi di Siena, Italy |
Genetic analysis expertise | Biomedical Research Center of the Slovak Academy of Sciences, Slovakia |
Clinical expertise and study conduct (in addition to RLUH) | Hôpital Necker, France (study site) |
Clinical expertise and study conduct (in addition to RLUH) | National Institute of Rheumatic Diseases, Slovakia (study site) |
Additional clinical study participants’ support and communication with study participants | ALCAP, France |