Consortium-based approach to receiving an EMA qualification opinion on the use of islet autoantibodies as enrichment biomarkers in type 1 diabetes clinical studies
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,J. Dunne,4 Authors,Inish O'Doherty
2022 · DOI: 10.1007/s00125-022-05751-0
Diabetologia · 9 Citations
TLDR
The Type 1 Diabetes Consortium has now received a qualification opinion from the European Medicines Agency for the use of islet autoantibodies as enrichment biomarkers for patient selection in type 1 diabetes prevention trials, a major success for the field ofType 1 diabetes.