Proactively Establishing a Biologic Specimens Repository for Large Clinical Trials: An Idea Whose Time has Come
Proactively Establishing a Biologic Specimens Repository for Large Clinical Trials: An Idea Whose Time has Come
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DOI：
10.3109/19396368.2011.604818
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发表时间：
2011-10-01
影响因子：
2.4
通讯作者：
Eisenberg, Esther
中科院分区：
文献类型：
--
作者：
Casson, Peter R.;Krawetz, Stephen A.;Eisenberg, Esther
大型随机临床试验的成本越来越高，支持它们的资源也越来越稀缺。作为这些研究的组成部分收集和储存的生物材料，如血液、DNA、体液或组织样本，是一种宝贵的资源，不仅可以回答直接的次要假设，而且可以作为存档材料，与研究数据相关联，供研究人员在未来很长一段时间内使用。围绕生物材料的储存和未来不受限制的利用的监管环境正在迅速发展。简单地储存样品并以不受约束和不受管制的方式使用它们不再是可以接受的。因此，为了充分利用从大型临床试验及其相关数据库中产生的生物样本的巨大潜力，研究者应该考虑主动创建生物样本库或生物库。储存库可能确保适当的受试者同意、样本来源、安全储存以及样本和数据检索和共享的编码程序，以保护受试者的机密性、研究者对准确数据的需求以及有限的资源。重要的是，除了为母研究获得的局部和核心标本外，通常还采集生物储存库标本/样本，以提供安全性和有效性结局的基线评估。
Large randomized clinical trials are becoming more costly, and resources to support them increasingly scarce. Biologic materials, such as blood, DNA, body fluids, or tissue samples collected and stored as a component of these studies represent an invaluable resource, to answer immediate secondary hypotheses, but also as archived material, linked to the study data, for the use of investigators long into the future. The regulatory climate surrounding the storage and future unconstrained utilization of biologic materials is evolving quickly. It is no longer acceptable simply to store samples and use them in an unbridled and unregulated fashion. Thus, to fully utilize the tremendous potential of biologic samples generated from large clinical trials and their related databases, investigators should consider proactively creating a biologic specimen repository, or biorepository. A repository likely assures appropriate subject consent, sample provenance, secure storage, and codified procedures for sample and data retrieval and sharing that protect the subject's confidentiality, the investigator's need for accurate data, and the limited resource. Importantly, the biorepository specimens/samples are typically collected in addition to local and core specimens obtained for the parent study that provide baseline assessments for safety and efficacy outcomes.