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PubMed ID:
35867129
Public Release Type:
Journal
Publication Year: 2023
Affiliation: Critical Path Institute, Tucson, AZ, USA. skarpen@c-path.org.; Janssen Research & Development, Raritan, NJ, USA.; Barbara Davis Center, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.; JDRF International, Washington, DC, USA.; Janssen Research & Development, Toronto, ON, Canada.; Critical Path Institute, Tucson, AZ, USA.; Critical Path Institute, Tucson, AZ, USA.
DOI:
https://doi.org/10.1007/s00125-022-05751-0
Authors:
Karpen Stephen R., Dunne Jessica L., Frohnert Brigitte I., Marinac Marjana, Richard Claudia, David Sarah E., O’Doherty Inish M.
Request IDs:
22856
Studies:
Diabetes Control and Complications Trial / Epidemiology of Diabetes Interventions and Complications
The development of medical products that can delay or prevent progression to stage 3 type 1 diabetes faces many challenges. Of note, optimising patient selection for type 1 diabetes prevention clinical trials is hindered by significant patient heterogeneity and a lack of characterisation of the time-varying probability of progression to stage 3 type 1 diabetes in individuals positive for two or more islet autoantibodies. To meet these needs, the Critical Path Institute’s Type 1 Diabetes Consortium was launched in 2017 as a pre-competitive public–private partnership between stakeholders from the pharmaceutical industry, patient advocacy groups, philanthropic organisations, clinical researchers, the National Institutes of Health and the Food and Drug Administration. The Type 1 Diabetes Consortium acquired and aggregated data from three longitudinal observational studies, Environmental Determinants of Diabetes in the Young (TEDDY), Diabetes Autoimmunity Study in the Young (DAISY) and TrialNet Pathway to Prevention (TN01), and used analysis subsets of these data to support the model-based qualification of islet autoantibodies as enrichment biomarkers for patient selection in type 1 diabetes prevention trials, including registration studies. 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. This endorsement will improve product developers’ ability to design clinical trials of agents intended to prevent or delay type 1 diabetes that are reduced in size and/or length, while being adequately powered.
