This U19 mechanism is designed to support large multi-site prospective clinical validation of standardized imaging and biospecimen assay batteries to differentially diagnosis two or more ADRDs from related conditions in large prodromal and/or early symptomatic clinical cohorts that reflect real world patient diversity for the context of use and in alignment with the NIH policy for inclusion of women and minorities as participants in research.
Differential Diagnostic Biomarker Qualification: Projects should propose to clinically validate three or more biomarkers (including at least one imaging biomarker and one biospecimen biomarker or biomarker signature) that already have significant evidence of their potential diagnostic utility and have undergone analytical validation of the detection method used to measure each biomarker. Studies must plan to evaluate the diagnostic accuracy, including addressing the positive predictive value and negative predictive value of each of the proposed biomarker modalities alone, and as a combined multi-modal combined biomarker battery for differential diagnosis. Studies must engage with the FDA’s Biomarker Qualification Program and, at minimum, plan to complete both stage 1 (letter of intent) and 2 (qualification plan) of the biomarker qualification process during the project period. Data generated over the course of the project should be submitted as part of the full qualification package to the FDA BQP. Studies must share the final standardized protocols with the research community along with any non-proprietary data and analyses at the end of the project. Projects may also seek to qualify any associated technologies (such as imaging protocols or assays) as assistive diagnostics through the FDA’s Center for Devices and Radiological Health (CDRH); however, this is not a requirement for this RFA.
Community engagement plan: Applications must include a detailed community engagement plan that outlines collaborations with study-relevant organizations, groups representing health disparity populations and populations with limited English proficiency, patients with lived experience, patient or consumer advocacy groups, community champions, community-based organizations, faith-based organizations and/or other relevant stakeholder groups. Projects must provide evidence of relationship development or collaboration, such as through letters of support.
Awards:
Application budgets are limited to up to a total of $4,700,000 in direct costs per year, but must reflect the actual needs of the proposed project.
Letter of Intent:
May 1, 2023
Full Proposal Submission Deadline:
June 01, 2023
Contacts:
Carol Taylor-Burds, PhD, National Institute of Neurological Disorders and Stroke (NINDS)
