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在大流行期间建立生物样本库。

Building biorepositories in the midst of a pandemic.

作者信息

Croker Jennifer A, Patel Robin, Campbell Kenneth S, Barton-Baxter Marietta, Wallet Shannon, Firestein Gary S, Kimberly Robert P, Elemento Olivier

机构信息

Center for Clinical and Translational Science, University of Alabama at Birmingham, Birmingham, AL, USA.

Division of Clinical Microbiology, Division of Infectious Diseases, Mayo Clinic, Rochester, MN, USA.

出版信息

J Clin Transl Sci. 2021 Feb 5;5(1):e92. doi: 10.1017/cts.2021.6.

Abstract

Biospecimen repositories play a vital role in enabling investigation of biologic mechanisms, identification of disease-related biomarkers, advances in diagnostic assays, recognition of microbial evolution, and characterization of new therapeutic targets for intervention. They rely on the complex integration of scientific need, regulatory oversight, quality control in collection, processing and tracking, and linkage to robust phenotype information. The COVID-19 pandemic amplified many of these considerations and illuminated new challenges, all while academic health centers were trying to adapt to unprecedented clinical demands and heightened research constraints not witnessed in over 100 years. The outbreak demanded rapid understanding of SARS-CoV-2 to develop diagnostics and therapeutics, prompting the immediate need for access to high quality, well-characterized COVID-19-associated biospecimens. We surveyed 60 Clinical and Translational Science Award (CTSA) hubs to better understand the strategies and barriers encountered in biobanking before and in response to the COVID-19 pandemic. Feedback revealed a major shift in biorepository model, specimen-acquisition and consent process from a combination of investigator-initiated and institutional protocols to an enterprise-serving strategy. CTSA hubs were well equipped to leverage established capacities and expertise to quickly respond to the scientific needs of this crisis through support of institutional approaches in biorepository management.

摘要

生物样本库在促进生物机制研究、识别疾病相关生物标志物、推动诊断检测技术进步、认识微生物进化以及确定新的干预治疗靶点等方面发挥着至关重要的作用。它们依赖于科学需求、监管监督、采集、处理和追踪过程中的质量控制以及与可靠表型信息的关联等多方面的复杂整合。新冠疫情加剧了许多此类考量,并凸显了新的挑战,与此同时,学术健康中心还在努力适应前所未有的临床需求以及100多年来未曾见过的更严格的研究限制。此次疫情爆发要求迅速了解严重急性呼吸综合征冠状病毒2(SARS-CoV-2)以开发诊断方法和治疗手段,这促使人们迫切需要获取高质量、特征明确的与新冠病毒相关的生物样本。我们对60个临床与转化科学奖(CTSA)中心进行了调查,以更好地了解在新冠疫情之前及应对疫情期间生物样本库建设中所采用的策略和遇到的障碍。反馈结果显示,生物样本库模式、样本采集和知情同意流程发生了重大转变,从研究人员发起和机构协议相结合的方式转向了企业服务战略。CTSA中心具备充分条件,可通过支持生物样本库管理中的机构方法,利用既有能力和专业知识迅速应对这场危机的科学需求。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ed72/8134891/4396ecd2f681/S2059866121000066_fig1.jpg

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