PREVENTABLE Administrative and Trial Management

杜克临床研究所（DCRI）和维克森林医学院（WFSM）将结合其世界知名的专业知识和卓越的资源来领导这项可预防的试验。该试验将确定中等强度他汀类药物在预防痴呆（包括阿尔茨海默病和阿尔茨海默病相关痴呆）和延长75岁及以上无临床明显冠心病（包括虚弱、身体功能受损、轻度认知障碍、多种药物和多种疾病）患者的无残疾生存期中的作用。DCRI是世界上最大的学术研究组织，也是与WFSM开展多地点临床试验的领导者。WFSM在临床试验设计、实施、分析以及涉及大量高危老年人的认知和残疾评估方面拥有公认的专业知识。可预防小组将利用与PCORnet、波士顿VA研究所（BVARI）、NIA、NHLBI和NINDS建立的重叠合作伙伴关系，促进这项大型、实用的多中心试验。该团队在试验创新方面有着悠久的历史。杜克大学于1968年开发了第一个电子医疗记录，最近DCRI通过1)大规模整合临床试验的电子健康记录（NIH HCS合作实验室和PCORnet），领导了简化临床试验的努力；2)电子同意书（可修改）；3)监测和收集患者数据，以定义健康状况并发现生物标志物。WFSM在对老年人和老龄化社会至关重要的认知和身体功能结果的整合和分析方面拥有国际知名的创新专业知识，并在SPRINT、ACCORD、LIFE、LookAHEAD和GEM等试验中证明了这一专业知识。DCRI和WFSM将在临床协调中心（CCC）活动和数据协调中心（DCC）活动的传统分离中合作。每个协调中心将负责每个核心内各自的组成部分。目标1：提供内部管理结构，以支持研究领导进行可预防试验，以及识别和应对风险和障碍。目标2：在整个试验生命周期内确保成功的沟通和财务管理，保持在预算范围内，并按计划完成关键的试验里程碑。目标3：预测风险并及时实施干预措施，以减轻其对成功完成试验的潜在影响。

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.