Rigor and Reproducibility for Biomarkers in Type 1 Diabetes Clinical Research
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This contract aims to create a consortium focused on improving the identification, evaluation, validation, and harmonization of biomarkers essential for preventing, diagnosing, and managing Type 1 Diabetes (T1D). Recognizing the current gaps in reliable and reproducible biomarkers due to the complexity of autoimmune processes and patient variability, the initiative will utilize cutting-edge techniques across multiple disciplines, including clinical chemistry, genomics, proteomics, metabolomics, immunophenotyping, and imaging. It will also employ longitudinal patient data and electronic health records to enhance research efforts. A critical component of the project is harmonizing established assays such as HbA1c and c-peptide to ensure consistency and reproducibility in both research and clinical practice through standardized reference materials and metrological methods. Additionally, the consortium will focus on validating other key biomarkers, including glucagon, amylin, chromogranin, insulin, and pro-insulins, whose current assays lack reproducibility across different platforms and laboratories. The initiative emphasizes rigorous validation and reproducibility testing across multiple laboratories using a metrology-driven approach. This concerted effort by the National Institutes of Health under the Department of Health and Human Services seeks to establish reliable biomarker assays, ultimately enhancing the accuracy and effectiveness of T1D clinical research and patient care.
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The main goal of this initiative is to establish a consortium with the overarching goal to advance the systematic identification, rigorous evaluation, validation, and assays harmonization of biomarkers that are critical to the prevention, diagnosis, and clinical management of Type 1 Diabetes (T1D). Despite significant advances in T1D research, there remains an urgent need for reliable and reproducible biomarkers that can capture the complexity of autoimmune processes, metabolic dysregulation, and individual patient variability. This initiative will leverage state-of-the-art methodologies in clinical chemistry, genomics, proteomics, metabolomics, immunophenotyping, and imaging, coupled with longitudinal patient cohorts and mining of Electronic Health Records (EHR). Within this consortium major efforts will be devoted to: 1) Harmonize established assays for biomarkers such as HbA1c and c-peptide, making sure that these assays are performed in a rigorous and reproducible manner in the clinical research community and in clinical practice. For this purpose, reference methods and materials will use a metrology approach and will be made available to the community; 2) Identify and validate other biomarkers that can be used for the prevention, diagnosis, and clinical management of T1D. It has been reported that the assays for several biomarkers routinely used in clinical research such as glucagon, amylin, chromogranin, insulin, pro-insulin and other pro-hormones are not reproducible across platforms or laboratories. For this purpose, this consortium will ensure that all assays for biomarkers routinely used in clinical research and for newly identified biomarkers are rigorously validated and assessed for reproducibility across several laboratories following a metrology approach.