The NINDS intends to fund a multi-site, multi-project network (Parkinsons Disease Biomarker Identification Network, or PD-BIN) devoted to identifying biological markers for PD risk, onset, and/or progression, in order to facilitate development of disease-modifying treatments.
The purpose of this FOA is to solicit linked cooperative agreement (U01) applications for the establishment of a Clinical Coordinating Center (CCC) and a Data Coordinating Center (DCC).
The PIs for the DCC and CCC must coordinate their submissions.
The CCC will be responsible for the oversight of all aspects of subject recruitment and specimen acquisition, including the management of multiple clinical sites (to be identified by the CCC applicant), enrollment of a core cohort of newly diagnosed patients with PD and matched controls, and accurate collection of all clinical and biological data.
The DCC will provide all data management aspects for standardized acquisition, quality control, dissemination and public accessibility.
The CCC and DCC must be flexible enough to accommodate and support a wide range of future add-on research projects seeking to utilize and augment the core PD-BIN data.
Individual hypothesis-driven studies are not a component of this FOA.
It is anticipated that all data and biospecimens acquired will be used to create a publicly available resource for biomarker validation and discovery.
The CCC and the DCC will be expected to advance the general scientific goal of identifying and validating useful PD biomarkers.