[Current Condition and Issues of Clinical Biobanks in Japan -From the Point of View of Laboratory Medicine-].

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.