PREVENTABLE Administrative and Trial Management

点击翻译按钮获取中文摘要

Duke Clinical Research Institute (DCRI) and Wake Forest School of Medicine (WFSM) will combine their world-renowned expertise and exceptional resources to lead the PREVENTABLE trial. This trial will determine the role of a moderate-intensity statin in preventing dementia, including Alzheimer’s disease and Alzheimer’s disease-related dementias, 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. This collaboration joins together the DCRI, the world’s largest academic research organization and a leader in the conduct of multi-site clinical trials with WFSM, and its recognized expertise in clinical trial design, conduct, analysis, and cognitive and disability assessment for trials involving large populations of at-risk older adults. The PREVENTABLE team will leverage established and overlapping partnerships with PCORnet, Boston VA Research Institute (BVARI), NIA, NHLBI, and NINDS to facilitate this large, pragmatic, multicenter trial. The team has a long history of pioneering innovation in trials. Duke developed the first electronic medical record in 1968 and more recently the DCRI has led efforts to streamline clinical trials through 1) large-scale integration of electronic health records for clinical trials (NIH HCS Collaboratory and PCORnet); 2) electronic consents (ADAPTABLE); and 3) monitoring and collecting patient data to define health and discover biomarkers. WFSM has internationally acclaimed innovative expertise in the integration and analysis of cognitive and physical function outcomes important to older adults and an aging society, having demonstrated this expertise in trials such as SPRINT, ACCORD, LIFE, LookAHEAD, and GEM. DCRI and WFSM will partner in a traditional split of Clinical Coordinating Center (CCC) activities and Data Coordinating Center (DCC) activities. Each coordinating center will be responsible for their respective components within each core. AIM 1: Provide the internal administrative structure to support study leadership in conducting the PREVENTABLE trial as well as identifying and responding to risks and barriers. AIM 2: Ensure successful communication and financial management throughout the trial’s life cycle staying within budget and on schedule for key trial milestones. AIM 3: Anticipate risks and execute timely interventions to mitigate their potential impact on successful completion of the trial.