Policiuc Liliana, Nutu Andreea, Zanoaga Oana, Mehterov Nikolay, Braicu Cornelia, Berindan-Neagoe Ioana
Research Center for Functional Genomics, Biomedicine and Translational Medicine, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.
Research Institute, Medical University of Plovdiv, Plovdiv, Bulgaria.
Med Pharm Rep. 2023 Jul;96(3):235-245. doi: 10.15386/mpr-2647. Epub 2023 Jul 27.
BACKGROUND/AIM: A biobank is an organization that gathers, refines, preserves and provides access to biospecimens along with relevant clinical data that can be used in applied or clinical research. Biobanking is a critical component of the scientific foundation for personalized medicine; this implies the accessibility of high-quality human biospecimens, such as blood, tissue, and other body fluids, along with the patient clinical data that goes with them.
This paper summarizes the function of biobanks in oncology and the requirements for biobank development in translational and clinical research.
Biobanks raise numerous ethical issues that government agencies address by enacting particular laws. To develop personalized medicine, biobanks are crucial, given that the availability of an extensive collection of patient samples with thoroughly annotated clinical and pathological data is an essential necessity. Also, data related to biobanking raises complex ethical, legal, and social issues, particularly concerning the protection of donor privacy and the appropriate use of collected samples. International standards have been developed to address these issues to ensure biobanking practices' quality, safety, and integrity.
Biobanking is vital in advancing biomedical research, supporting clinical applications, and enhancing our understanding of human health and disease. Using real-world data and biobanking can accelerate medical research, support personalized medicine initiatives, and improve patient care.
背景/目的：生物样本库是一个收集、提纯、保存并提供生物样本以及相关临床数据以供应用研究或临床研究使用的组织。生物样本库建设是个性化医疗科学基础的关键组成部分；这意味着要有高质量的人体生物样本，如血液、组织和其他体液，以及与之相关的患者临床数据可供使用。
本文总结了生物样本库在肿瘤学中的作用以及转化研究和临床研究中生物样本库发展的要求。
生物样本库引发了众多伦理问题，政府机构通过制定特定法律来加以解决。对于个性化医疗的发展而言，生物样本库至关重要，因为拥有大量带有详尽注释的临床和病理数据的患者样本是必不可少的。此外，与生物样本库相关的数据引发了复杂的伦理、法律和社会问题，尤其是在捐赠者隐私保护和所采集样本的合理使用方面。已制定国际标准来解决这些问题，以确保生物样本库操作的质量、安全性和完整性。
生物样本库建设对于推进生物医学研究、支持临床应用以及增进我们对人类健康和疾病的理解至关重要。利用真实世界数据和生物样本库建设能够加速医学研究、支持个性化医疗举措并改善患者护理。
