This project from Duke University, Duke Clinical Research Institute (DCRI), and the Wake Forest School of Medicine (WFSM) describes plans by experienced investigators and staff to serve as the Data Coordinating Center (DCC) for the PRagmatic EValuation of evENTs And Benefits of Lipid-lowering in oldEr adults (PREVENTABLE) trial, which will determine the role of a moderate-intensity statin in preventing dementia (including Alzheimer?s disease) and prolonging disability-free survival in patients 75 years and older without clinically evident coronary heart disease, including those with frailty, impaired physical function, mild cognitive impairment, polypharmacy, and multi-morbidity. Our DCC experience will help ensure success in the implementation of PREVENTABLE by overseeing all data related aspects of the trial. We have a single specific aim: to provide project coordination, administration, data management, and biostatistical support for PREVENTABLE. We will accomplish this by facilitating and guiding the protocol development process, by providing scientifically sound study design, excellent operational and analytical methodology, a dedicated focus on recruitment, high quality follow-up and fidelity to the intervention, monitoring safety and working with the DSMB to ensure participant safety and careful study management, working with the CCC to monitor the clinical sites, and by leading development and maintenance of the protocols, manual of procedures, statistical analysis plan (SAP), forms, and other study documents. We have several strengths: (1) a team whose members are experts in the coordination of multi-center trials, (2) experience with cardiovascular disease (CVD) trials (SPRINT, ACCORD, and Look AHEAD) and trials involving cognitive and physical outcomes in large populations of at-risk older adults (SPRINT, ACCORD, Look AHEAD, LIFE, and GEM), (3) experience with blinded intervention trials in lipid management (ACCORD), (4) success working in pragmatic clinical trials (PCTs) within the National Patient-Centered Clinical Research Network (PCORnet) infrastructure (ADAPTABLE), (5) successful previous collaborations with the VA central pharmacy for drug distribution, (6) established security plan and web-based trial management system proven in many RCTs, (7) specific project management expertise, and (8) a history of efficient and effective communication with field centers, the executive committee, and the project office. Both WFSM and DCRI have long histories serving as DCCs. WFSM coordinated ACCORD, which was the first large-scale randomized clinical trial (RCT) coordinated primarily over the web. Duke and DCRI are leaders in PCTs, currently serving as the DCC for PCORnet which centrally collects electronic health record (EHR) data via an established common data model (CDM) from 35 partner networks. Expertise within the DCC will be further enhanced via collaboration with the Massachusetts Veterans Epidemiology Research and Information Center (MAVERIC), which will support the identification and recruitment of participants from the Veterans Affairs (VA) system and the integration of EHR data from the VA.
