Matsushita Kazuyuki
Rinsho Byori. 2017 Feb;65(2):181-189.
The final goal or aim of clinical biobanks is to share sample data and feed back their results to the public. For this purpose, it is essential to establish sustainable systems to share clinical samples among researchers of academic institutes as well as commercial companies. So far, clinical biobanks have been considered an infrastructure that is advantageous or valuable for checking developing reagents, searching for companion biomarkers for diseases, cohort research, and constructing medical big data. However, easy-to-approach systems to access clinical samples between academia and commercial companies have yet to be established in Japan. The major reasons are ethical, legal, and social issues (ELSI), the lack of simple procedures to evaluate stored samples, and the financial burden among participants. Additionally, the cultivation/training of human resources in related fields is also required. Needless to say, laboratory medicine is expected to play responsible roles in this field. Recently, next-generation DNA sequencers (NGS) have begun to be used in clinics, called clinical sequences, based on the samples of clinical biobanks. Clinical biobanks that preserve standardized and/or high-quality clinical samples are required. Further, to accomplish "precision medicine" or "individualized medicine", NGS/clinical sequence/genetic testing by high-quality DNA samples is required. The authors discussed the problem lists and ELSI to overcome these situations in order to establish commercially available clinical biobank networks in Japan. Since so-called "medical big-data" based on personal data will lead to the development of future medicine, the rules or consensus in clinical biobanks for treating and/or sharing personal clinical data is also discussed. Furthermore, the concepts of clinical biobanks and clinical sequencing are considered regarding their ability to accelerate clinical biomarker research in this manuscript.
临床生物样本库的最终目标是共享样本数据并将结果反馈给公众。为此，建立可持续的系统以在学术机构和商业公司的研究人员之间共享临床样本至关重要。到目前为止，临床生物样本库一直被视为一种基础设施，对于检查开发中的试剂、寻找疾病的伴随生物标志物、队列研究以及构建医学大数据具有优势或价值。然而，日本尚未建立学术界和商业公司之间易于使用的临床样本获取系统。主要原因包括伦理、法律和社会问题（ELSI）、缺乏评估储存样本的简单程序以及参与者的经济负担。此外，相关领域人力资源的培养/培训也很有必要。不用说，检验医学有望在该领域发挥应有的作用。最近，基于临床生物样本库的样本，下一代DNA测序仪（NGS）已开始在临床中使用，即临床测序。需要保存标准化和/或高质量临床样本的临床生物样本库。此外，为了实现“精准医学”或“个性化医学”，需要高质量DNA样本进行NGS/临床测序/基因检测。作者讨论了问题清单和ELSI，以克服这些情况，从而在日本建立可商业化的临床生物样本库网络。由于基于个人数据的所谓“医学大数据”将推动未来医学的发展，本文还讨论了临床生物样本库在处理和/或共享个人临床数据方面的规则或共识。此外，本文还从加速临床生物标志物研究的能力方面考虑了临床生物样本库和临床测序的概念。
