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作者信息

Verstuyft Céline, Antoun Zeina, Deplanque Dominique

机构信息

Inserm U1178, CRB Paris Sud, université Paris-Sud, hôpitaux universitaires Paris Sud, CHU Bicêtre, AP-HP, 94275 Le Kremlin Bicêtre, France.

Glaxosmithkine, direction médicale, 92500 Rueil Malmaison, France.

出版信息

Therapie. 2018 Feb;73(1):73-81. doi: 10.1016/j.therap.2018.01.001. Epub 2018 Feb 12.

Abstract

The development and the access to collections of human biological samples is one of the major challenges for health research. In recent years, biological resource centres (BRCs) have developed in such a way that they provide all activities relating to the handling of samples. In this context, France is undoubtedly a pioneering country, because most of the biological collections available were created on the basis of themed research projects, which involved a particular donor phenotype. The round table was an opportunity to emphasise the persistence of some pitfalls particularly in relation to ensuring the consistency of different regulatory pathways. It also gave the opportunity to question and make recommendations on aspects of governance of biological collections and the BRCs, to state the challenges linked to scientific and economic valorisation and to consider the place of patients and the general public. The development of specific education in public health and research is essential to underline that these initiatives are necessary for developing new diagnostic and therapeutic procedures.

摘要

人类生物样本库的建设与获取是健康研究面临的主要挑战之一。近年来,生物资源中心(BRC)不断发展,提供与样本处理相关的所有活动。在这种背景下,法国无疑是一个先驱国家,因为现有的大多数生物样本库都是基于主题研究项目建立的,这些项目涉及特定的捐赠者表型。这次圆桌会议是一个契机,强调了一些陷阱的持续性,特别是在确保不同监管途径的一致性方面。它还为就生物样本库和BRC的管理方面提出问题并给出建议、阐述与科学和经济增值相关的挑战以及考虑患者和公众的地位提供了机会。开展公共卫生和研究方面的特定教育至关重要,以强调这些举措对于开发新的诊断和治疗程序是必要的。

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