上海市精神卫生中心积极响应上海市科学委员会号召,为推进实施创新驱动发展战略,加快建设具有全球影响力的科技创新中心,根据《上海市科技创新“十三五”规划》,按照《上海市临床医学研究中心发展规划(2019-2023年)》(沪科合〔2019〕5号)的总体部署和《上海市临床医学研究中心管理办法(试行)》(沪科规〔2019〕1号)的要求,在院领导及各职能科室的支持和通力合作下,以李华芳主任为负责人申请了上海市精神心理疾病临床医学研究中心(SCRC-MH,19MC1911100)。成为本市第一批上海市临床医学研究中心。
SCRC-MH将发挥与各大顶尖高校科研院所学科交叉及医疗机构网络优势,借助人工智能和5G等前沿科技,以未被满足的精神心理疾病防治需求为切入点,主攻创新精神药物和新技术临床研发、真实世界诊疗实践与比较和研究者发起的多中心研究。拓展临床研究协作网络和技术应用推广网络。按照“平台为基础、网络为支撑、人才为核心、项目为载体、制度为保障”的基本原则,努力建设代表上海实力、中国水平、国际一流的上海市精神心理疾病临床医学研究中心。
SCRC-MH的总目标为建设国际领先的精神心理疾病临床医学研究中心,包括:1、创新药械的策源地和转化医学研究示范平台;推动我国原创精神药物上市,实现零的突破;2、针对精神疾病临床重大需求,提升诊疗能力,改善预后,优化指南;3、培养引领行业的研究团队和国际领军人才,支撑上海科创中心建设;4、依托长三角构建专业特色鲜明的临床研究协作网路和技术应用推广网络。
SCRC-MH的功能定位为:精神心理疾病的产学研医综合性平台,实现协同创新、成果转化和应用、以及国际人才培养,成为上海市临床医学科技创新体系的核心组成部分。研究中心由依托单位(上海市精神卫生中心)、4家核心单位、临床研究协作网络及技术应用推广网络单位构成,主要开展针对精神心理疾病领域临床重大需求的新药和器械临床试验、真实世界研究和研究者发起的多中心临床研究。主要功能包括:专业领域总体规划和优先任务的制订者;协同创新网络的设计师、协调者、媒介和绩效评估人;创新精神药械和新技术研发的全球合作伙伴、专业和管理支撑者;国际多中心临床研究发起人,相关诊疗规范和政策建议的制订者;可扩展的临床诊疗与预防康复融合研究模式的开拓者和实施者;资源样本库、大数据、药械临床评价等公共服务平台的统领者;国际领先团队的汇集地,复合型人才孵化器;临床研究成果评估、转化、应用和推广的引领者。
SCRC-MH的建设原则为: 按照“平台为基础、网络为支撑、人才为核心、项目为载体、制度为保障”的基本原则,推动“基础科创临床社区政策”的双向和多向转化研究。
SCRC-MH的近期目标和远期设想为:“建设一个平台”、“构建两个网络”、“实施三个规划”。
一个平台——将“上海市精神心理疾病临床医学研究中心”建设成为对标国际的精神心理疾病临床与转化医学研究开放式的产学研医综合性平台;
两个网络——除依托单位和核心单位外,构建研究中心的协同创新网络,分为“临床研究协作网络”和推动研究成果转化的“技术应用推广网络”;
三个规划——
项目规划:针对精神心理疾病领域重大临床问题和新药械研发“未满足的需求”,凝练临床研究和转化研究方向,制定项目规划。
人才规划:引进和培养高端跨学科人才,建立跨学科博士后流动站。通过用人机制创新,使平台成为高端人才和专业化人才的聚集地,培养学科领军团队和人才。
机制规划:涉及网络管理和运行、人才培养和培训、绩效激励、项目管理、经费管理、多元化人才聘用和管理等。
Shanghai Clinical Research Center for Mental Health (SCRC-MH)
Dr. Li Huafang applied for the Shanghai Clinical Research Center for Mental Health (SCRC-MH) with the support and cooperation of the hospital leaders and functional departments, which was Shanghai Mental Health Center active respond to the call of Shanghai Science Committee, in order to promote the strategy of innovation-driven development and accelerate the construction of a science and technology innovation center with global influence, according to the 13th five-years plan of Shanghai Science and Technology Innovation and the overall development plan of Shanghai Clinical Research Center (2019-2023) (HKH [2019] No.5), as well as in line with the guidance requirements of Shanghai Clinical Research Center (Trial Edition) (HKG [2019] No.1). It has become one of the first pioneers of Shanghai Clinical Research Center(SCRC-MH,19MC1911100).
SCRC-MH will take advantage of its good relationship with different top universities and research institutions on interdisciplinary cooperation and network, with the help of advanced technologies such as Artificial Intelligence and 5G, and take the unmet needs for the prevention and treatment of mental disorders as the starting point, focusing on the clinical research and development of innovative psychotropic drugs and new technologies, real world diagnosis and treatment practice and comparison, and multi-center Investigator Initiated Study (IIS). SCRC-MH will also expand clinical research collaboration network and technology application promotion network. In accordance with the primary principles of "platform as the basis, network as the support, talent as the core, project as the carrier, and system as the guarantee", efforts have been made to build the Shanghai Clinical Research Center for Mental Health, which represents Shanghai's capacity, Chinese level and international leading position.
The general objective of SCRC-MH is to build an international leading clinical research center for mental health, including:
1. Innovation of the origin of new drugs and medical devices and the demonstration platform for translational medical research; promote innovative psychotropic drugs on market to achieve a breakthrough of zero;
2. Exaltation of diagnosis and treatment capacity, improvement of prognosis and optimization of guidelines in response to the major clinical needs of mental health;
3. Training of research team and global top leader who lead new tendency, support the construction of Shanghai Science and Technology Innovation Center;
4. Rely on the Yangtze River Delta to build a professional and distinctive clinical research cooperation network and technology application and promotion network.
The Functional orientation of SCRC-MH is a comprehensive platform of Industry -University-Research-Hospital for Mental Health, which realizes collaborative innovation, achievement transformation and application, and international research team training, and becomes the core component of Shanghai Clinical Medicine Science and Technology Innovation System. SCRC-MH is composed of Responsible Unit (Shanghai Mental Health Center), four Core Units, several Network Units with clinical research cooperation and technology application and promotion. It mainly carries out clinical trials of new drugs and medical devices for major clinical needs in mental health, real world study and multi-center IIS. Its essential functions include: overall planner and priority task maker of professional field; designer, coordinator, media and performance evaluator of collaborative innovation network; global partner, professional and management supporter of innovative new drug, medical devices and new technology R&D; initiator of international multi-center clinical research, maker of relevant diagnosis and treatment guidance, and policy advisor; pioneer and implementer of new research mode integrating clinical diagnosis & treatment and prevention & rehabilitation; leader of public service platforms such as resource sample bank, big data, clinical evaluation for drugs and medical devices; pooling ground of international leading teams, inter-disciplinary talent incubator; the leader of evaluation, transformation, application and promotion of clinical research results.
The construction principle of SCRC-MH is in accordance with the primary principle of "platform as the basis, network as the support, talent as the core, project as the carrier, and system as the guarantee", promote mutual and multi-directional transformation research model of integrating basic science, technology innovation, clinical practice, community and policy.
The short-term goal and long-term vision of SCRC-MH are: "building one platform", "creating two networks" and "implementing three plans".
One platform: to build an international first-class standard platform, SCRC-MH, an open comprehensive Industry -University-Research-Hospital platform for clinical and translational medicine study of mental health;
Two networks: in addition to Responsible Unit and Core Units, to build a collaborative innovation network of research center, which is divided into "clinical research collaborative network" and "technology application and promotion network" to promote the transformation of research results;
Three plans:
Project Plan: in view of the major clinical problems in the field of mental health and the "unmet needs" of new drugs and medical devices R&D, refine the direction of clinical and transformation research, and formulate the project plan.
Talent Plan: introduce and cultivate high-level inter-disciplinary talents, and establish inter-disciplinary postdoctoral mobile stations. Through the innovation of employment mechanism, the platform will become a pooling ground for high-level talents and specialized experts, and cultivate discipline leading teams and talents.
Mechanism Plan: involving network management and operation, talent training and incubating, performance incentive, project management, finance affairs, diversified talent recruitment and service, etc.