PREVENTABLE Administrative and Trial Management

可预防的行政和审判管理

• 批准号: 10021543
• 负责人: KAREN P ALEXANDER
• 金额: $ 101.92万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-30 至 2027-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10021543
• 关键词: Advocate; Aging; Alzheimer' s Disease; Alzheimer' s disease related dementia; Biological Markers; Boston; Budgets; Clinic; Clinical; Clinical Research; Clinical Trials; Clinical Trials Design; Clinical and Translational Science Awards; Collaborations; Communication; Computerized Medical Record; Consent; Coronary heart disease; Data; Data Coordinating Center; Dementia; Doctor of Philosophy; Elderly; Electronic Health Record; Ensure; Evaluation; Event; Health; Healthcare Systems; Impairment; Individual; Institutional Review Boards; International; Intervention; Lead; Leadership; Life; Life Cycle Stages; Lipids; Monitor; Multi-Institutional Clinical Trial; Multicenter Trials; National Heart, Lung, and Blood Institute; National Institute of Neurological Disorders and Stroke; National Institute on Aging; Occupational activity of managing finances; Outcome; Participant; Patients; Pharmacy facility; Physical Function; Polypharmacy; Populations at Risk; Protocols documentation; Recording of previous events; Reporting; Research; Research Institute; Resources; Risk; Role; Schedule; Site; Societies; Structure; Time; United States National Institutes of Health; adjudication; biobank; cognitive disability; cognitive function; collaboratory; cooperative study; data integration; data quality; disability; experience; forest; frailty; innovation; medical schools; mild cognitive impairment; multiple chronic conditions; patient oriented; pragmatic trial; prevent; programs; recruit; statistical service

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.

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非凡资源，以领导可预防的试验。该试验将确定现代强度他汀类药物在预防痴呆症中的作用，包括阿尔茨海默氏病和阿尔茨海默氏病与疾病相关的痴呆症，以及75岁及以上的患者延长无疾病的生存率，而没有临床上的冠心病，包括那些具有脆弱，身体障碍，身体障碍，轻度认知的障碍，轻度障碍，多型，多人，多人症和多种疾病。这项合作将DCRI（全球最大的学术研究组织DCRI）融为一体，并且是WFSM进行多站点临床试验的领导者，以及其在临床试验设计，行为，分析，分析以及涉及大量高危老年人群体的试验中的公认专业知识。可预防的团队将利用与PCORNET，BOSTON VA研究所（BVARI），NIA，NHLBI和NINDS建立并重叠的合作伙伴关系，以促进这项大型，务实的多中心试验。该团队在试验中有悠久的开创性创新历史。杜克（Duke）于1968年开发了第一个电子病历，最近DCRI领导了通过1）临床试验的电子健康记录进行大规模整合（NIH HCS协作和PCORNET）的大规模整合； 2）电子同意（适应性）； 3）监视和收集患者数据以定义健康并发现生物标志物。 WFSM在对老年人和衰老社会重要的认知和身体机能成果的融合和分析方面拥有国际知名的创新专家，并在Sprint，Accord，Accord，Life，Lookahead和Gem等试验中证明了这一专业知识。 DCRI和WFSM将与传统的临床协调中心（CCC）活动和数据协调中心（DCC）活动合作。每个协调中心将对每个核心内的各自组成部分负责。目标1：提供内部行政结构，以支持研究领导力，以进行可预防的试验以及确定和应对风险和障碍。目标2：确保在整个审判的生命周期中确保成功的沟通和财务管理，并按照预算范围内的计划，并按计划进行关键试验里程碑。目标3：预期风险并及时执行干预措施，以减轻其对成功完成试验的潜在影响。