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转化医学科研组织模式构建的研究
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摘要
近年来,为了解决基础和临床“两张皮”的困境,提高生物医学科技投资效益,促进向生物医学研究为人类健康服务的原始目的回归,“转化医学”的概念被提出。但转化医学作为生物医学发展的新模式和科技管理的新理念,涉及整个医学科研管理体系的变革,目前发展仍然面临着很多问题。当前有关转化医学科研组织模式研究很少开展且多集中于基础到临床、临床到应用障碍的横断面研究,尚未见到基于转化医学整个发展体系的科研组织模式的系统研究。研究符合转化医学发展特征的科研组织管理模式对推动转化医学的快速发展具有重要意义。
     本研究采用文献研究、个人深入访谈、案例研究和问卷调查等方法,在充分了解转化医学发展现状和存在问题的基础上,剖析影响转化医学发展的理论和实践因素,解析转化医学的本质特征及其对科研组织创新的内在要求,比较分析现有转化医学科研组织模式,总结组织管理经验和策略,现场研究调查科研人员对转化医学科研组织模式的认识和意见,创建符合转化医学发展特征的科研组织模式和转化医学中心建设构想,为推动转化医学的进一步发展提供决策依据和管理参考。论文共分七章:
     第一章是导论。总结分析转化医学的提出背景、发展现状、面临的挑战、科研组织管理现状,提出本课题的研究意义。通过检索相关文献,归纳国内外对于转化医学、科研组织管理、管理模式、协同创新等的相关概念和理论研究的成果,并阐述研究方法,提出本课题的主要研究内容、研究思路,制定技术路线。
     第二章是影响转化医学科研组织模式形成及发展的理论因素研究。提出科学管理理论、系统理论、国家创新体系理论和现代管理理论等管理理论为转化医学科研组织模式的创新提供了理论指导和系统借鉴。总结分析当代生物医学发展影响转化医学发展的实践因素,提出了当代生物医学的发展对科研组织管理创新的新要求,为研究转化医学科研组织模式提供理论支撑和实践依据。
     第三章是转化医学内涵本质及其对管理创新影响的研究。对转化医学概念进行了深化和拓展,认为转化医学是一个致力于克服基础研究与临床和公共卫生应用严重失衡的医学发展新模式,其核心是在“健康问题-基础研究-临床应用-人群健康-卫生政策”(T1-T2-T3-T4)之间,建立“连续、双向、开放和循环”的研究促进过程。提出要从4T模式来认识转化医学的观点,并在此基础上阐述了转化医学发展对科研组织模式创新的要求,明确了转化医学科研管理模式构建应重点关注的内容。
     第四章是转化医学科研组织管理现状的案例研究。通过中外11个转化医学中心的案例研究,展示国内外转化医学现实运行模式的特征,指出美国已建成“新型医学研究合作的孵化中心”,中国主要是“临床医学研究中心模式”,且尚未建立针对性的管理机制。提出建设转化医学中心是推进转化医学发展的一个有益载体,明确转化医学发展的理念引导、建设途径、政策机制、人才培养等关键问题,为转化医学科研组织模式的构建提供现实参考。
     第五章是转化医学科研组织管理模式构建的问卷调查研究。从转化医学的理念、组成要素、管理机制等方面对15个单位360名科技人员问卷调查,重点阐述转化医学的理念普及范围、发展体系主要内容、机制创新和改革重点,并以这三个方面要素为主体内容提出了构建转化医学科研组织模式的设想方案,为转化医学科研组织模式的构建提供基本框架和要素。
     第六章是模式构建。明确提出系统化、开放性、质量效益、可行性和指导性是转化医学科研组织模式构建应遵循的基本原则,并依据转化医学发展内涵确定用综合法构建其组织管理模式;用“管理理念+管理体系+管理机制”来认识和理解转化医学科研组织模式的构建框架。综合分析前面几部分研究结果,构建了“全维式交叉协同”转化医学科研组织模式,并提出转化医学中心的建设构想方案,为转化医学的组织管理提供了思维范式和方法参考。并在模式构建的基础上,提出对中国转化医学科研组织模式改革的建议。
     第七章是全文总结。对全文进行总结和讨论,展望转化医学的发展,总结本研究的创新点和不足之处。
     本课题从转化医学的基本特征和内涵本质出发,立足于转化医学提出和发展的特定需求,以整体和系统的理论和观点进行课题设计和思考,研究了基于转化医学整个发展体系的科研组织管理要素,对转化医学科研组织管理的目标进行了准确定位,创新提出转化医学科研组织管理模式和转化医学中心建设构想,为转化医学的快速发展提供决策依据和管理参考,也为丰富和完善转化医学的发展理论作出一定贡献。
Translational medicine was put forth to deal with the awkwardness of “the valley ofdeath” between basic bio-medicine research and clinic practice, improve the interest ofbiomedicine research investment and recall to the ultimate aim of medical research:protecting population health. However, translational medicine, a new mode of bio-medicinedevelopment and the new perception of scientific research management, is facing manychallenges at present. To date, few studies of the scientific research management oftranslational medicine was carried out on the interfaces between basic research, clinicpractice, and population health, and no systematic research has been done in concerningwith its development on the whole. Therefore, to undertake this study on the scientificresearch management in line with the characteristics of transitional medicine may shed lighton remarkable improvement of the development of translational medicine.
     The methods taken in this study were literatures review, in-depth interview, case studyand questionnaires. The scientific research management mode of translational medicineand mode of the translational medicine center were proposed to be set up based on fullyunderstanding the development, characteristics and nature of translational medicine,reviewing the theory for health research management and its influencing factors; analyzingthe present scientific research management of the centers of translational medicine homeand abroad and summarizing their managing experiences and strategies, and surveying thecomments for translational research management from the health researchers. Totally thisstudy included7parts as follows:
     Part1is the preface. By reviewing the background, development and challenges oftranslational medicine, the current situation of scientific research management, andprevious studies on scientific research management of translational medicine, this prefaceput forward the research aim, methods, content and flow chart of the whole study.
     Part2is the introduction of theoretical factors associated with the scientific research management for translational medicine. This part reviewed theories of scientificmanagement, systematic management, National System of Innovation and modernmanagement, to provide the theoretical guidance for innovative scientific researchmanagement mode of translational medicine; summarized the influential factors of modernbio-medical science development on scientific research management; and finally identifiedthe requirement of translational medicine for scientific research management, providingtheoretical support and practical guidance for the new mode of scientific researchmanagement of translational medicine.
     Part3is about the characteristics of translational medicine and its influence onscientific research management innovation of translational medicine. This part identifiedthat translational medicine actually is a new mode of medicine, and new conception formedical research management; and enlarged the meanings of translational medicine; anddefined translational medicine as a continue, two-way circle, open process among humanhealth-basic research-clinic practice-population health-health policy(T1-T2-T3-T4)andput forth that the new4T laid at the core of the mode of translational medicine research.Altogether, this part demonstrated the requirements for innovation of the scientific researchmanagement for translational medicine and clarified the key points of constructing ascientific research management mode.
     Part4is the case study on the present scientific research management fortranslational medicine home and abroad. In this part, the management and organizationof11translational research centers home and abroad were described in details andanalyzed, and the differences between them were identified; USA established theirtranslational medicine centers as the centers for hatching new research cooperation,however, translational research centers in China were centers for clinic study in fact;the translational medicine center is identified as a good carrier to improve thedevelopment of translational medicine; this part emphasized the importance to enlargeconcept of translational medicine, policy and training of translational researchers,providing crucial evidence for new scientific research management mode oftranslational medicine.
     Part5is the survey on the scientific research management of translational medicineresearch. This part covered surveys of360researchers from15medical research units.Results identified the coverage of enlarging concept of translational medicine, key elements of the scientific research management mode for translational medicine; andput forth the main part of management mode for translational medicine, providingcritical evidence for policy making and framework related to translational medicine.
     Part6is the development of the management mode for translational medicine. Thispart gave the principles used for scientific research management mode establishment;summarized and analyzed the results from the above5parts; then put forth the mode oforganizing and managing translational medicine research from the view of the researchstrategy and scheme of establishment of translational medicine centers; finally themode graph for translational medicine and graph for specific center of translationalmedicine were given and the comments for translational medicine in China weresummarized
     Part7is the conclusion. This part dealt with the conclusion and discussion of thewhole study, drew a blue print for translational medicine, and summarized theinnovation, strengthens and weakness of the whole study.
     Taken together, under the guidance of systematic theory on scientific researchmanagement, this study novelly put forth the mode of scientific research management fortranslational medicine and translational medical center in China by understanding thenature and characteristics of translational medicine, investigating key elements for themode of scientific research management for translational medicine, and correctlyretargeting the goal of scientific research management for translational medicine. Inaddition, this study further developed meanings of translational medicine, providingevidence for further policy making and management as well as new concepts of the theoryof translational medicine.
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