Consortium-based approach to receiving an EMA qualification opinion on the use of islet autoantibodies as enrichment biomarkers in type 1 diabetes clinical studies
Stephen R. Karpen, Jessica L. Dunne, Brigitte I. Frohnert, Marjana Marinac, Claudia Richard, Sarah E. David, Inish O’Doherty
Topics & Concepts
MedicineType 2 diabetesClinical trialType 1 diabetesDiabetes mellitusAutoantibodyObservational studyResearch designIntensive care medicineInternal medicineImmunologyEndocrinologySociologyAntibodySocial scienceDiabetes and associated disordersDiabetes Management and ResearchPancreatic function and diabetes