New models for large prospective studies: is there a better way?
New models for large prospective studies: is there a better way?
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DOI：
10.1093/aje/kwr453
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发表时间：
2012-05-01
影响因子：
5
通讯作者：
Collins FS
中科院分区：
文献类型：
--
作者：
Manolio TA;Weis BK;Cowie CC;Hoover RN;Hudson K;Kramer BS;Berg C;Collins R;Ewart W;Gaziano JM;Hirschfeld S;Marcus PM;Masys D;McCarty CA;McLaughlin J;Patel AV;Peakman T;Pedersen NL;Schaefer C;Scott JA;Sprosen T;Walport M;Collins FS
大型前瞻性队列研究对于确定疾病的病因至关重要，但它们需要大量的长期研究投资。这类研究可以通过学术医疗中心的多站点联盟、正在进行的小型研究的组合或单一大型站点（如占主导地位的区域卫生保健提供者）进行。还有一种策略是通过多个临时评估中心集中进行大部分或所有方面的招聘。这是英国一个被称为“英国生物银行”的大型国家资源所采用的方法，该资源在2007年至2010年期间在预算范围内提前完成了503,000名参与者的招募/检查。英国生物银行和类似研究的一个关键教训是，大型研究不是简单地将小型研究扩大，而是需要根本不同的方法，在这种方法中，“过程”专业知识与科学严谨性一样重要。在有利于结果确定的结构中嵌入招聘，利用全面和灵活的信息技术，自动化生物标本处理，确保广泛同意，建立具有适当监督的基本自治领导，这些都是成功的关键。这些方法是否以及如何适用于美国仍有待探索，但它们在英国生物银行等研究中的成功为此类探索的开始提供了令人信服的理由。
Large prospective cohort studies are critical for identifying etiologic factors for disease, but they require substantial long-term research investment. Such studies can be conducted as multisite consortia of academic medical centers, combinations of smaller ongoing studies, or a single large site such as a dominant regional health-care provider. Still another strategy relies upon centralized conduct of most or all aspects, recruiting through multiple temporary assessment centers. This is the approach used by a large-scale national resource in the United Kingdom known as the “UK Biobank,” which completed recruitment/examination of 503,000 participants between 2007 and 2010 within budget and ahead of schedule. A key lesson from UK Biobank and similar studies is that large studies are not simply small studies made large but, rather, require fundamentally different approaches in which “process” expertise is as important as scientific rigor. Embedding recruitment in a structure that facilitates outcome determination, utilizing comprehensive and flexible information technology, automating biospecimen processing, ensuring broad consent, and establishing essentially autonomous leadership with appropriate oversight are all critical to success. Whether and how these approaches may be transportable to the United States remain to be explored, but their success in studies such as UK Biobank makes a compelling case for such explorations to begin.
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影响因子：
2.3
作者：
McCarty, Catherine A;Wilke, Russell A;Caldwell, Michael D
通讯作者：
Caldwell, Michael D
影响因子：
13.4
作者：
Murphy, Juli;Scott, Joan;Hudson, Kathy
通讯作者：
Hudson, Kathy
DOI：
10.1111/j.1751-7141.2009.00055.x
发表时间：
2010-01-01
期刊：
Preventive cardiology
影响因子：
--
作者：
Wilke, Russell A;Berg, Richard L;McCarty, Catherine A
通讯作者：
McCarty, Catherine A
DOI：
10.1177/1740774508100974
发表时间：
2009-02
期刊：
Clinical trials (London, England)
影响因子：
--
作者：
Gren L;Broski K;Childs J;Cordes J;Engelhard D;Gahagan B;Gamito E;Gardner V;Geisser M;Higgins D;Jenkins V;Lamerato L;Lappe K;Lowery H;McGuire C;Miedzinski M;Ogden S;Tenorio S;Watt G;Wohlers B;Marcus P
通讯作者：
Marcus P
影响因子：
6.7
作者：
Roden, D. M.;Pulley, J. M.;Masys, D. R.
通讯作者：
Masys, D. R.