热度 1
转化或转换医学(Translational Medicine)是近两三年来国际医学健康领域出现的新概念,同个性化医学(Personalized Medicine)、可预测性医学等一同构成系统医学(systems medicine,包括系统病理学、系统药物学、系统诊断与综合治疗等)的体系,建立在基因组遗传学、组学芯片等系统生物学与技术基础上的现代医学,系统科学理论与自动化通讯技术之间的互动密切,从而使科学研究向工程技术应用的产业化过程快速实施,系统科学应用于医药学而将导致基础与临床之间的距离迅速缩短。
它是医学研究的一个分支,试图在基础研究与临床医疗之间建立更直接的联系。转化医学在健康产业中的重要性不断提升,而它的精确定义也不断变化。在药物的研发过程中,转化医学的典型含义是将基础研究的成果转化成为实际患者提供的真正治疗手段,强调的是从实验室到病床旁的联接,这通常被称为“从实验台到病床旁”定义。
转化医学还有更广泛的意义,这里指从患者出发开发和应用新的技术,强调的是患者的早期检查和疾病的早期评估。在现代的医疗中,我们看到研究进程向一个更加开放的、以患者为中心的方向发展,以及对于从研究出发的医学临床实践的包容。
传统的基础研究与临床实践被一系列的障碍分隔,这些障碍就像“篱笆墙”。新药的研发隔离于临床在实验室中进行,而当需要进行安全测试和临床试验时才不可避免地被“扔过篱笆”。许多制药公司正在建立转化医学团队,来增强基础研究和临床医学的沟通。
从上述定义可以看出,转换医学倡导以患者为中心,从临床工作中发现和提出问题,由基础研究人员进行深入研究,然后再将基础科研成果快速转向临床应用,基础与临床科技工作者密切合作,以提高医疗总体水平。因此转换医学研究主张打破以往研究课题组单一学科或有限合作的模式,强调多学科组成课题攻关小组,发挥各自优势,通力合作。
例如,诊断及监测人类疾病的新参数——生物标志物的研究,是由基础医学、临床医学和生物信息学等专业研究人员共同组成,定期讨论和沟通,及时解决研究过程中遇到的问题,不仅为开发新药及研究新的治疗方法开辟出一条具有革命性意义的新途径,而且有助于探索新的治疗方法,缩短新的治疗方法从实验到临床阶段的时间,进而快速提高医护和治疗工作的质量。
对于上述定义中的“新药”,我们认为应把医疗器械包含其中,更合理的表述应为“新医疗产品”。这里不仅涉及新医疗器械研发的问题,也包含影像设备等医疗器械在新医疗产品的研发过程中,有可能起到重要的作用。
转化医学B2B医疗新模式 聚焦重大疾病参考文献: 1 http://www.chinabai.com/Html/2008719144235-1.Html
Translational medicine
http://en.wikipedia.org/wiki/Translational_medicine
Translational medicine is an emerging view of medical practice and interventional epidemiology, as a natural 21st century progression from Evidence-Based Medicine. It integrates research inputs from the basic sciences, social sciences and political sciences to optimise both patient care and also preventive measures which may extend beyond the provision of healthcare services.[citation needed] Is the process of turning biological discoveries into drugs and medical devices that can help patients. [1]
Translational research
Translational Research is the underlying basis for Translational Medicine 'the process which leads from evidence based medicine to sustainable solutions for public health problems[2]. Fulfilling the promise of translational research for improving the health and longevity of the world's populations depends on developing broad-based teams of scientists and scholars who are able to focus their efforts to link basic scientific discoveries with the arena of clinical investigation, and translating the results of clinical trials into changes in clinical practice, informed by evidence from the social and political sciences.* It has three phases[2]:
[edit] Phase one researchPhase 1 Translational Research is the research process that explores needs, develops potential treatments in basic laboratory research, and tests safety and efficacy, principally in randomised clinical trials. The concept arose from research into pharmacotherapy and formed the initial basis for evidence-based practice and clinical guidelines, now incorporated into Translational Medicine. In the case of drug discovery and development, translational research typically refers to the translation of laboratory-based research into real therapies for real patients. This is often called the "bench to bedside" definition. Many pharmaceutical companies are building (phase 1) translational medicine groups to facilitate the interaction between basic research and clinical medicine, particularly in clinical trials. The clinical evaluation of therapies drawn from other disciplines (eg psychology, physical activity, nutritional) can also be included within Phase 1 Translational Research.
[edit] Phase two researchPhase 2 Translational Research examines how findings from clinical science, shown to be efficacious and safe treatments established in phase 1 translational research, function when they are applied in routine practice, as first described by Hiss RG[3]. It thus addresses development and application of new technologies in a patient driven environment - where the emphasis is on real patients in real-life situations, where demographic factors and competing priorities modify clinical decisions, and treatment responses. Phase 2 Translational Research thus informs guidelines about needs, acceptability, effectiveness, and cost efficiency in ecological settings and policies to promote uptake for optimal management and resource use. As examples, consumer research explores patients’ behavioural responses to interventions and provides important insights into compliance; health economics adds the evaluation of cost effectiveness and cost avoidance. These needs challenge hierarchical views of "research quality" and funding allocation, traditionally dominated by randomised controlled trials, and point to the need for non-hierarchical typological approaches[2][4].
[edit] Phase three researchPhase 3 Translational Research adds the necessary information to convert treatments and prevention strategies, shown to be effective and cost-effective in Phase 2 Translational Research, into sustainable solutions[2]. Thus governments can generate enduring evidence-based policies. These require different types of research processes to evaluate the complex interacting environmental and policy measures that affect susceptibility to disease and the sustainability of clinical and public health management and prevention strategies. Achieving sustainability depends on evidence from two fronts. Firstly, closed-loop audit approaches are needed within Continuous Improvement Methodology to refine the intervention. Lessons can be learned from successful commercial and product developments, which use multidisciplinary non-experimental research to inform incremental improvements [2]. Continuous improvement methodology is known as "kaizen" in Japanese, where it originated. Secondly, research is needed to obtain evidence for making changes to multiple environmental and policy factors which will reduce the need for funding to sustain the intervention.
[edit] An example - ObesityControlling the mounting prevalence of obesity and its secondary diseases will require new multicomponent methods for effective treatments, based on randomized clinical trials and continuous improvements of community-based approaches, and also effective and sustainable approaches for prevention. This needs an integrated view of educational and environmental actions to facilitate greater physical activity, together with fiscal and regulatory changes to promote production, promotion, and delivery of healthier meals and total food supply. Practitioners, policy makers, and the public need sound evidence from different and new research methods, involving both experimental and non-experimental methodologies, that are sensitive to cultural and ethnic priorities.
[edit] CampusesAndy Grove has pledged $1.5 million so that the University of California campuses in San Francisco and Berkeley can start a joint master’s degree program aimed at translational medicine. [5]
A master's degree programme in translational medicine, TRANSMED, was started in University of Helsinki in 2010.
[edit] Implications of translational medicineReliance on actions within health services will be insufficient to control rising obesity, diabetes, and associated diseases. Clinical science and ecological support from effective policies cannot continue to be regarded as independent disciplines. Integrated training in translational research methods is needed for clinicians, guideline writers, grant awarding bodies, and policy makers, in order to redress current biases in funding and research publications, in order to reflect better the balance of research efforts which are necessary for better assessment of complex evidence-bases, to integrate effective and culturally sensitive interventions with supporting environmental changes, and to encourage continuous improvement of evidence based public policies[2].
[edit] See also
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