Consortium-based approach to receiving an EMA qualification opinion on the use of islet autoantibodies as enrichment biomarkers in type 1 diabetes clinical studies
Authors' conclusion
The Type 1 Diabetes Consortium has now received a qualification opinion from the European Medicines Agency for the use of these biomarkers, a major success for the field of type 1 diabetes.
Study context
- Population
- Individuals positive for ≥2 islet autoantibodies; data from TEDDY, Diabetes Autoimmunity Study in the Young (DAISY) and TrialNet Pathway to Prevention (TN01)3 observational studies
- Outcome
- EMA qualification of islet autoantibodies as enrichment biomarkers for T1D prevention trials
Methodological detailspre-competitive public-private partnership, model-based qualification, aggregated data from three longitudinal observational studies, Critical Path Institute's Type 1 Diabetes Consortium, launched in 2017
- Pre-competitive public-private partnership
- Model-based qualification
- Aggregated data from three longitudinal observational studies
- Critical Path Institute's Type 1 Diabetes Consortium, launched in 2017
Main finding
As reported in the abstract
- The Type 1 Diabetes Consortium received a qualification opinion from the European Medicines Agency for the use of islet autoantibodies as enrichment biomarkers for patient selection in T1D prevention trials, including registration studies
Observational data: associations, not effects.
Original publication
Consortium-based approach to receiving an EMA qualification opinion on the use of islet autoantibodies as enrichment biomarkers in type 1 diabetes clinical studies. Diabetologia. Published 22 July 2022. doi:10.
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