Establish Research Hospital Setting to
Accelerate Translational Research and
Standardize Clinical Trails
Abstract: Last decade witnesses many major breakthroughs and unparalleled advance in biomedical sciences and technologies, providing an unprecedented level of understanding in many fundamental areas of biology and medicine, including molecular biology, cell biology, genetics, genomics and pathogenesis of many diseases. However, transforming these research achievements and knowledge of basic biomedical science into improving clinical research and better patient care, such as more accurate diagnosis and more effective treatment of human diseases to benefit of all human beings, still imposes tremendous challenges to today’s biomedical and translational researchers. Translational medicine and clinical trials are the bridging clinical sciences including multidisciplinary biology theoretical components and practical medicine. The aim is to promote cooperation and information exchange platform to accelerate the translational process of scientific research to clinical implementation, such as the “Bench-to-Bedside” concept; in parallel, to conduct the basic scientific research based on clinical questions, such as the “Bedside-to-Bench” concept. The complexity and variability of translational medicine and clinical trials dictate the process generally more costly and time consuming. Therefore, successfully conducting translational research and clinical trials require in-depth understanding the principles of clinical trials and translational research, precision designing translational and clinical experimental procedures, establishing the efficient clinical set-ups and teams, and assurance of studies to reach statistically significant conclusions. In order to promote translational research and standardize clinical trials for acceleration and improvement of the study development, in this article, we briefly summarized our own work knowledge and hand-on experience involved in the translational research and clinical trials. The contents include: the background and significance of translational research and clinical trials; the infrastructure and achievements of translational research and clinical trials at the National Institutes of Health Clinical Research Center; clinical research hospital management team and scientific and transparent decision-making mechanisms; hospital-level scientific advisory and regulatory committees; medical ethics review committee to ensure the safety and rights of human subjects; data and safety monitoring committee to ensure the research data security and integrity; selecting outstanding principal clinical researchers and building efficient research teams; assessing milestones and achievements of translational research and clinical trials; as well as training scientists and clinicians specialized in translational research and clinical trials. This article also briefly describes the essential facilities of research hospitals, including basic and clinical laboratories. As China’s huge population grows and rapidly ages, the incidence of cardiovascular diseases, cancers and other chronic diseases has increased significantly in recent years. Thus, an urgent need of new drugs and novel medical diagnostic and treatment methods is present, with unforeseen demands of more effective resolutions to these medical problems. The establishment of new types of research hospitals aimed to promote translational research and clinical trials exhibits promising prospects, with important clinical and scientific implications.
文章引用: 孙 蔚 , 杨宏钧 , 陈 中 (2014) 建立新型的研究型医院，加速和提高转化医学及临床实验的研究水平。 生物医学， 4， 7-16. doi: 10.12677/HJBM.2014.42002
 Woolf, S.H. (2008) The Meaning of Translational Research and Why It Matters. JAMA, 299, 211-213.
 Sung, N.S., Crowley, W.F., et al. (2003) Central Challenges Facing the National Clinical Research Enterprise. JAMA, 289, 1278-1287.
 Zerhouni, E.A. (2005) Translational and Clinical Science—Time for a New Vision. The New England Journal of Medicine, 353, 1621-1623.
 Gallin, J.I. and Ognibene, F.P. (2012) Principle and Practice of Clinical Research. 3rd Edition, Academic Press. http://www.cc.nih.gov/training/training.html
 Littman, B.H. and Krishna, R. (2011) Translational Medicine and Drug Discovery. Cambridge University Press, New York.
 Robertson, D. and Williams, G.H. (2008) Clinical and Translational Science. http://www.sciencedirect.com/science/book/9780123736390
 Szalma, S., Koka, V., Khasanova, T. and Perakslis E.D. (2010) Effective Knowledge Management in Translational Medicine. Journal of Translational Medicine, 8, 68.
 U.S. Food and Drug Administration (FDA) (2013) Conducting Clinical Trials. http://www.fda.gov/drugs/developmentapprovalprocess/conductingclinicaltrials/default.htm