The Gut Brain Parkinson's Disease Consortium (GBPDC): Coordinating and Data Management Center (CDMC)

Parkinson's disease (PD) is an intractable disorder characterized by progressive loss of dopaminergic neurons in the substantia nigra, resulting in tremor, rigidity, bradykinesia, and postural instability. By the time a clinical diagnosis is confirmed, a considerable proportion of dopaminergic neurons have degenerated. Gastrointestinal

(GI) dysfunction may be an early manifestation of the disease and the gut may be an unexplored diagnostic and/or therapeutic target. In response, the Gut Brain Parkinson's Disease Consortium (GBPDC) will build an annotated repository of biospecimens to allow for the identification, development and validation of innovative

early-phase GI-based diagnostic tools and biomarkers for PD. To support the creation of this valuable resource, we will develop a Coordinating and Data Management Center (CDMC) that addresses the resource sharing, data science and analytical challenges unique to this consortium. Our team brings immediate expertise in key

areas of biorepository management, data science and analysis, combined with an operational structure and guiding principles of the Duke Clinical Research Institute (DCRI). Our vision is to employ a team science approach to establish an innovative, efficient, flexible, and metric driven CDMC designed to support the

establishment of the GBPDC biorepository and accelerate development of innovative early-phase GI- based diagnostic tools and biomarkers for PD. To achieve our vision, we will establish a program framework of three Cores: Research and Resources, Data Management, and Biorepository to execute the three main

CDMC functions outlined in our aims: 1) provide program leadership and expertise; assistance in study and protocol design; and study implementation, monitoring, and management for GBPDC awardees; 2) support the creation and maintenance of a harmonized GBPDC data and research ecosystem; facilitate compliant and

seamless data sharing and dissemination; 3) provide scientific and laboratory expertise and leadership to coordinate the receipt, processing, storage, and distribution of biospecimens. The Cores will be supported by the Web-based Activities and Dissemination Program Core that will ensure a rich research communication plan

to facilitate the sharing of resources with the internal consortium and broader scientific communities. Our proposed CDMC will establish the required functions to efficiently support the establishment of the GBPDC program with a focus on expanded reach, efficiency, and accelerated data analysis and result dissemination.

This program is possible because of the unparalleled breadth of complementary services and expertise offered by our collaborative team.