Re-Engineering Alzheimer Clinical Trials: Global Alzheimer's Platform Network.
Re-Engineering Alzheimer Clinical Trials: Global Alzheimer's Platform Network.
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DOI：
10.14283/jpad.2016.93
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发表时间：
2016-06
影响因子：
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通讯作者：
Vradenburg G
中科院分区：
文献类型：
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作者：
Cummings J;Aisen P;Barton R;Bork J;Doody R;Dwyer J;Egan JC;Feldman H;Lappin D;Truyen L;Salloway S;Sperling R;Vradenburg G
阿尔茨海默病（AD）药物开发成本高，耗时且效率低。试验中心的职能、试验设计和试验的患者招募都需要改进。全球阿尔茨海默病平台（GAP）就是为了应对这些挑战而发起的。在美国，为了应对不同的试验挑战，发展了四个GAP工作流程：1）注册到队列的网络招募; 2）临床试验中心激活和中心网络建设（GAP-NET）; 3）适应性概念验证临床试验设计; 4）融资和筹资。GAP-NET建议建立一个标准化的网络，由连续供资的试验中心组成，这些试验中心具有进行试验的高资质（具有既定的临床、生物标志物、成像能力;经过认证的评分员;先进的管理系统）。GAP-NET将使用标准化仪器版本和管理为学术和生物制药行业合作伙伴进行试验。与创新药物倡议（IMI）、欧洲阿尔茨海默病预防（EPAD）计划、加拿大衰老神经退行性疾病联盟（CCNA）和其他类似国际倡议的合作将允许进行全球试验。GAP-NET旨在提高试验效率和质量，减少试验冗余，加速队列开发和试验招募，并降低试验成本。研究中心的价值主张包括稳定的资金和统一的培训和试验执行;对试验申办者的价值是降低试验成本、缩短试验执行时间和提高数据质量。对患者和社会的价值是更快地获得AD的新治疗方法。
Alzheimer’s disease (AD) drug development is costly, time-consuming, and inefficient. Trial site functions, trial design, and patient recruitment for trials all require improvement. The Global Alzheimer Platform (GAP) was initiated in response to these challenges. Four GAP work streams evolved in the US to address different trial challenges: 1) registry-to-cohort web-based recruitment; 2) clinical trial site activation and site network construction (GAP-NET); 3) adaptive proof-of-concept clinical trial design; and 4) finance and fund raising. GAP-NET proposes to establish a standardized network of continuously funded trial sites that are highly qualified to perform trials (with established clinical, biomarker, imaging capability; certified raters; sophisticated management system. GAP-NET will conduct trials for academic and biopharma industry partners using standardized instrument versions and administration. Collaboration with the Innovative Medicines Initiative (IMI) European Prevention of Alzheimer’s Disease (EPAD) program, the Canadian Consortium on Neurodegeneration in Aging (CCNA) and other similar international initiatives will allow conduct of global trials. GAP-NET aims to increase trial efficiency and quality, decrease trial redundancy, accelerate cohort development and trial recruitment, and decrease trial costs. The value proposition for sites includes stable funding and uniform training and trial execution; the value to trial sponsors is decreased trial costs, reduced time to execute trials, and enhanced data quality. The value for patients and society is the more rapid availability of new treatments for AD.