Abstract
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In order to initiate the top-down design of biobanking in China, several facilities were established to overcome existing challenges, such as ineffective management and the lack of standardization. The project known as “Beijing Biobanking for Major Diseases” was launched, as well as the informatics platform necessary for integrating the data from both basic and clinical research studies. When Phase One of the Project was completed in 2012, data from 50,000 cases had been collected, and 100,000 clinical samples were stored in the biobank. Similar to the project in Beijing, in 2012 the Shanghai Biobank Engineering Research Center, which is affiliated with the Shanghai Clinical Research Center, was officially designated as the Shanghai Municipal Biobank Center, and the construction of the Shanghai Clinical Biobank for Significant Diseases was launched. It is worth mentioning that the Shanghai biobanking project could be one key component contributing to the ‘Shanghai Clinical Information Platform’ initiated by the Shanghai Shenkang Hospital Development Center. Up to 2014, the Platform has collected clinical data from 40 million cases from 38 leading hospitals in Shanghai. Also, following approval by multiple national agencies, the China National Genebank (Shenzhen) was established in 2011 and is currently operated by BGI-Shenzhen. The National Genebank will be developed into a gene information database and repository of traceable biological samples, in order to provide access to genetic information data, to build a fundamental platform for excavation of genetic resources, and to promote the innovation capabilities of bio-industry.
The goal of this Special Issue of Biopreservation and Biobanking is to emphasize that biobanking in China is not about modern buildings and other new infrastructure, but rather is an essential component of a road map for the health management industry in China. Therefore, specimen management and quality control research studies need to be done as a critical step for the current stage of development of biobanking. In this issue, we collected articles from biobanks in hospitals and non-clinical institutes, focusing on the management and scientific evaluation of biobanking in China. We will not define this as a summary of profiles of various biobanks, but rather as the introduction of the concept of biobanking science in China. Among the contributions is a general introduction regarding China's biobanking initiatives, from institutions and investigators representing the country's major biobanking centers. Other articles focus on a variety of technical and ethical/regulatory issues. The article concerning “Ethical Management Guidelines for the Shanghai Disease-Based Biobank Network” introduces an approach in China as an example of the regulation of ethical issues for a defined project. An integrated platform for bio-samples and relevant informatics is presented as well. For the management of biobanking in a hospital setting, an approach to an intra-hospital virtual system and sample management are described with an emphasis on practical applications. A new technique involving metabolomics analysis offers an approach to relieve problems caused by freeze-thaw cycles in sample management. Other scientific aspects of biobanking are discussed in individual articles, including methodological studies for RNA extraction, tumor tissue assessment, and peripheral blood leucocyte collection. It is worthwhile to note that the application of biobanking science in translational research should be emphasized in personalized diagnosis and potential treatment in the clinic. An article on this topic uses a specialized protocol for molecular diagnostics for brain gliomas.
Clinical research in China is approaching a turning point. The requirements for innovation will accelerate the development of modern translational research, including robust medical data accumulation. Both policy makers and clinical researchers in China need to prepare to face emerging challenges that will be unique for China, such as the rapid growth of chronic non-communicable diseases and an aging population. It is not difficult for the scientists to realize that the size of ‘big data’ and the standardization of laboratory analyses will be bottlenecks for the future of globalization in research. But the production of reliable data is always based on qualified research materials, especially with respect to the development of population-based personalized medicine. We could follow the unfocused approach of traditional medical advances, however the rules of the game have changed and there is no short cut for Chinese researchers.
Many thanks to all authors for their contributions, and we hope these articles will provide readers with a good overview of current and future approaches to biobanking in China, as well as ideas and support for starting points for new biobanking operations and businesses.