News & Events
August 12, 2022
Consortium-based approach to receiving an EMA qualification opinion on the use of islet autoantibodies as enrichment biomarkers in type 1 diabetes clinical studies
C-Path’s Type 1 Diabetes Consortium (T1DC) is pleased to announce that “Consortium-based approach to receiving an EMA qualification opinion on the use of islet autoantibodies as enrichment biomarkers in type 1 diabetes clinical studies” has been published in Diabetologia. The article reports on the work of the consortium and T1DC’s approach to obtaining regulatory endorsement of a model-based drug development tool.
March 28, 2022
Digital Health Technologies for Remote Data Acquisition in Clinical Investigations
The Clinical Outcomes Assessment (COA), Critical Path for Parkinson’s Digital Drug Development (3DT) Initiative, and Type 1 Diabetes (T1D) Consortia all contributed to this effort, resulting in a combined set of comments on behalf of C-Path. By bringing together stakeholders across industry, regulatory agencies, patient groups, academic researchers and clinicians, disease foundations and other organizations aiming to improve patients’ lives, C-Path hopes these comments will provide helpful feedback on how DHT (Digital Health Technologies) are used to accelerate a path to a healthier world.
We thank and commend FDA for the opportunity to provide comments and look forward to future developments in this area.
March 11, 2022
Leveraging Real-World Data for EMA Qualification of a Model-Based Biomarker Tool to Optimize Type-1 Diabetes Prevention Studies
The development of therapies to prevent or delay the onset of type 1 diabetes (T1D) remains challenging, and there is a lack of qualified biomarkers to identify individuals at risk of developing T1D or to quantify the time-varying risk of conversion to a diagnosis of T1D. To address this drug development need, the T1D Consortium (i) acquired, remapped, integrated, and curated existing patient-level data from relevant observational studies, and (ii) used a model-based approach to evaluate the utility of islet autoantibodies (AAs) against insulin/proinsulin autoantibody, GAD65, IA-2, and ZnT8 as biomarkers to enrich subjects for T1D prevention.
Jagdeep T. Podichetty, Patrick Lang, Inish M. O’Doherty, Sarah E. David, Rhoda N. Muse, Stephen R. Karpen, Laura Sue Song, Klaus Romero, Jackson K. Burton, on behalf of the Type-1 Diabetes Consortium (T1DC)
Effective Data Sharing as a Conduit for Advancing Medical Product Development
Karpen SR, White JK, Mullin AP, O’Doherty I, Hudson LD, Romero K, Sivakumaran S, Stephenson D, Turner EC, Larkindale J. Effective Data Sharing as a Conduit for Advancing Medical Product Development. Ther Innov Regul Sci. 2021 May;55(3):591-600