PREVENTABLE Administrative and Trial Management

杜克临床研究所(DCRI)和维克森林医学院(WFSM)将结合他们世界知名的专业知识和特殊资源来领导这项可预防的试验。这项试验将确定中等强度的他汀类药物在预防痴呆症(包括阿尔茨海默病和阿尔茨海默病相关痴呆症)和延长75岁及以上没有临床明显冠心病的患者(包括虚弱、身体功能受损、轻度认知障碍、多药联用和多种疾病)患者中的作用。DCRI是世界上最大的学术研究组织，也是与WFSM进行多点临床试验的领先者，此次合作将DCRI及其在涉及大量高危老年人的临床试验设计、实施、分析以及认知和残疾评估方面的公认专业知识结合在一起。可预防的团队将利用与PCORnet、波士顿退伍军人研究所(BVARI)、NIA、NHLBI和NINDS建立的和重叠的合作伙伴关系，促进这一大型、务实的多中心试验。该团队在试验方面具有开创性创新的悠久历史。杜克大学在1968年开发了第一份电子病历，最近DCRI领导了简化临床试验的努力，方法是：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)；2)电子同意(可适应)；3)监测和收集患者数据，以定义健康和发现生物标记物。WFSM在整合和分析对老年人和老龄化社会重要的认知和身体功能结果方面拥有国际知名的创新专业知识，并在SPRINT、ACCORD、LIFE、LOOK和GEM等试验中展示了这种专业知识。DCRI和WFSM将在临床协调中心(CCC)活动和数据协调中心(DCC)活动的传统拆分中进行合作。每个协调中心将负责各自在每个核心内的组成部分。目标1：提供内部管理结构，以支持研究领导进行可预防的试验以及确定和应对风险和障碍。目标2：确保在试验的整个生命周期内进行成功的沟通和财务管理，不超出预算，并按计划完成关键试验里程碑。目标3：预测风险并及时采取干预措施，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.