Womack Christopher, Mager S Rachel
AstraZeneca Oncology Innovative Medicines, Mereside, Alderley Park, Macclesfield, Cheshire SK10 4TG, UK.
AstraZeneca Discovery Sciences Innovative Medicines, Mereside, Alderley Park, Macclesfield, Cheshire SK10 4TG, UK.
Methods. 2014 Nov;70(1):3-11. doi: 10.1016/j.ymeth.2014.01.014. Epub 2014 Jan 30.
Advances in the understanding of molecular pathology and thereby the mechanisms that could be amenable to therapeutic manipulation are the reason that pharmaceutical research and development is focused increasingly on measurement of molecular biomarkers in human biological samples. Obtaining direct or indirect access to sufficient samples that are fit for research purposes can be a major challenge. A biobanking infrastructure has a significant role in the acquisition, storage and usage of human biological samples and here we review some key requirements for establishing a biobank. These include ensuring; that appropriate governance mechanisms are in place, that samples available are appropriate and fit for the intended research purposes that the infrastructure is sustainable in the future and that use of the biobank assets meets the strategic aims of the host organisation. Finally we present a case study--the STRATUM project which has recently completed and through a collaborative approach involving six industry and public partners drawing on a network of experts, examined biobank policies, public attitudes to biobanking, donor consent, sample and data standards, technical requirements for a register and biobanking financial models, albeit from a UK perspective.
对分子病理学认识的进展以及因此对可通过治疗手段操控的机制的了解，是药物研发越来越关注在人类生物样本中测量分子生物标志物的原因。获取直接或间接的、足够数量且适合研究目的的样本可能是一项重大挑战。生物样本库基础设施在人类生物样本的采集、存储和使用方面发挥着重要作用，在此我们回顾建立生物样本库的一些关键要求。这些要求包括确保：建立适当的管理机制；现有样本合适且适合预期的研究目的；基础设施在未来具有可持续性；生物样本库资产的使用符合主办机构的战略目标。最后，我们介绍一个案例研究——STRATUM项目，该项目最近已完成，通过一种涉及六个行业和公共合作伙伴并借助专家网络的协作方法，审视了生物样本库政策、公众对生物样本库的态度、捐赠者同意书、样本和数据标准、登记册的技术要求以及生物样本库财务模型，尽管是从英国的角度进行审视。
