标题:
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Establish Research Hospital Setting to
Accelerate Translational Research and
Standardize Clinical Trails
作者:
孙蔚, 杨宏钧, 陈中
关键字:
转化医学, 临床研究, 临床试验, 研究型医院Translational Medicine, Clinical Research, Clinical Trial, Research Hospital
期刊名称:
《Hans Journal of Biomedicine》, Vol.4 No.2, 2014-04-21
摘要:
近年来，生物医学科学技术的飞速发展促进了许多基础生物医学研究的重大的突破。医学研究者对许多疾病的发病机制从其分子生物学，细胞生物学，遗传学和基因组学的水平上都有了前所未有的深入理解，并积累了大量的生物学和基础医学研究的数据。然而，如何将这些研究成果迅速转化为可以诊治人类疾病的有效方法，仍然是当今医学科研工作者所面临的难题之一。而新兴的转化医学(Translational Medicine)，将医学和生物学等多学科的理论和实践相结合，是解决这些问题的桥梁学科。转化医学旨在建立基础研究至临床实践多学科之间的技术合作及信息交流平台，以加速科研成果至临床实施的进程，既试验台到病床的理念(Bench-to-Bedside)。临床试验(Clinical Trial)作为转化医学研究的重要领域，是由病人参与的复杂、耗时、耗资的但同时又是任何最终成功应用于临床的诊疗手段必须通过的实验过程。由于转化医学和临床实验的复杂性和多变性，加之以病人为研究对象，所以深入地理解转化医学和临床实验的理论，正确设置需要解决的临床问题，精密地设计转化医学和临床实验的实验进程，以及得出具有统计学意义的结论，是摆在我们每一个参与转化医学和临床实验的科学工作者面前的巨大挑战。在此综述中，本文作者简要阐述了转化医学的产生，发展和意义并介绍了美国国家卫生研究院临床研究中心在转化医学方面的投入和成果。同时，作者对如何建立临床研究型医院的管理团队及科学透明的决策机制，院级科学顾问委员会及监管系统，医学伦理审查委员会，数据与安全监查委员会，选择杰出的首席临床研究员及组建优秀的研究团队以及临床研究及转化医学人才的培养，也做出了系统性的阐述。本文还简要介绍了研究型医院医疗设施及运行。由于中国庞大的人口基数以及快速的老龄化进程，心血管疾病、肿瘤及其他慢性疾病的发病率日益增长，并严重危害人群的健康。在中国建立新型的临床试验型医院将会为加速新型医学诊疗方法的研究开发提供平台，无疑对防治疾病，提高人群的健康水平至关重要。
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.