临床试验机构
上海市精神卫生中心临床试验机构秉承“安全第一，质量为先（Safety Based, Quality Driven）”的价值观，注重能力建设，强调质量意识。牵头和参加各期国内国际临床试验，为开展精神药物临床试验项目最多的机构之一。迄今已进行了179项精神药物临床试验，涉及抗抑郁药、抗精神病药、抗焦虑药、镇静催眠药、促智药、心境稳定剂、儿少期精神药物、戒毒药和戒酒药等。负责/参加一类新药临床试验18项，其中2项为FDA关键临床试验(pivotal clinical trial)中国牵头单位。近5年来牵头开展我国创新精神药物多中心临床试验11项。其中牵头临床研究的GV-971即将获批治疗阿尔兹海默病，为全球该领域近20年的唯一新化合物。
Clinical Trial Institution
The Clinical Trial Institution of Shanghai Mental Health Center (SMHC) sticks to the value of "Safety Based, Quality Driven", focusing continually on capacity development and quality awareness . The Clinical Trial Institution is the largest psychiatry institution with experience of leading or participating all kinds of drug clinical trials, covering phaseⅠ-Ⅳ, domestic and international. Totally 179 clinical trials of psychotropic drugs include antidepressants, antipsychotics, anti-anxiety agents, sedative hypnotics, nootropics, mood stabilizers, psychotropic drugs for children and adolescents, detoxification drugs and antialcoholics. So far, the Clinical Trial Institution has already been leading or participating in 18 clinical trials of first-class new drugs. Among these studies, the Clinical Trial Institution was in charge of two pivotal clinical trials for FDA NDA. In the past five years, the Institution has led 11 multi-center clinical trials of innovative psychotropic drugs in China. For example, GV-971, a unique new compound in the world for recent two decades, is expected to be approved for the treatment of Alzheimer's Disease.
伦理委员会
上海市精神卫生中心伦理委员会1998年成立，已建立一整套标准操作规程。2002年在United State Department of Health and Human Service，Office for Human Research Protections (OHRP) 注册，2002年以来，总评审项目达459项，其中精神药物临床研究193项，医疗器械7项，医疗新技术1项，非药物的临床研究258项。“十二五”期间，参照ICH-GCP，更新伦理委员会针对精神药物临床研究的规章制度和伦理审查工作的SOP；增加了儿童和老年人群为研究对象的药物临床试验伦理规范。2011年7月顺利通过WHO-FERCAP的Strategic Initiative for Developing Capacity in Ethical Review(SIDCER)认证，成为西太平洋和亚洲地区首家通过认证的精神卫生机构，于2014年9月、2018年11月顺利通过复核。
Institutional Review Board (IRB)
The Institutional Review Board of SMHC (SMHC-IRB), established in 1998, has developed a set of standard operating procedures (SOP). IRB was registered in the United States Department of Health and Human Services, Office for Human Research Protections (OHRP) in 2012. Since then, It has reviewed 459 projects, including 193 psychotropic drug clinical trials, 7 medical device clinical trials, 1 new medical technology study and 258 clinical studies. During the National “12th-Five-Year Plan”, IRB updated the rules and regulations for clinical trialson psychotropic drug and SOPs for ethical review, according to ICH-GCP. It also developed the ethical guidances of clinical trials for children subjects and elderly subjects. In July 2011, IRBsuccessfully passed capacity assessment survey of WHO-FERCAP Strategic Initiative for Developing Capacity in Ethical Review (SIDCER), becoming the first certified psychiatric hospital in the Western Pacific and Asia. It passed re-survey and second re-survey in September 2014 and November 2018.
主要研究者团队与专家团队
主要研究者团队专业领域明确，分布在不同的专业和亚专业中，包括：普通精神科（精神分裂症、抑郁症、双相情感障碍等）、I期、老年精神科、儿少精神科、戒毒等。这些主要研究者，是各自学科领域的带头人，也是行业的关键意见领袖（KOL），为牵头开展不同精神药物的临床研究奠定了学术和专业基础。
机构在长期的临床试验过程中，与领域相关专家和兄弟机构保持了密切的合作关系，包括精神卫生领域的药械审评专家、KOL、数据管理和统计学专家、国内外药企、研发机构及CRO的行业专家等。协作网与国家药品审评中心（CDE）建立了“外聘合作计划”，自2011年以来，先后有9名精神科医生作为外聘审评员在CDE工作6月以上，既支持了国家局审评工作，又培养了各机构骨干，获得CDE高度评价。
Principal Investigator (PI) and Experts Team
Every Principal Investigator (PI) has a clear field of expertise. PIs are distributed across different specialties and sub-groups, including general psychiatry (schizophrenia, depression, bipolar disorder, etc.), phase I, geriatric psychiatry, pediatric psychiatry, drug addiction. PIs are leaders in their respective disciplines and the Key Opinion Leaders (KOLs) in the profession. They have laid an academic and professional foundation for leading clinical trial on different psychotropic drugs.
Basing on the long-term clinical trials experience, our team has maintained closely cooperation relationship with different partners, including experts in drug and medical device reviewof mental health, KOLs, data management and statisticians, domestic and international pharmaceutical companies, Research and Development institutions and CROs , etc. China Clinical Trial Network of Psychotropic (CCTN-P) has been collaborating with the Center for Drug Evaluation (CDE) to develop and implement the "External Reviewer Cooperation Plan ".. Nine psychiatrists from SMHC and other hospitals have worked in CDE as external reviewers for more than six months since 2011. This Plannot only supports drug evaluation for regulatory department but also trains core backbones of many hospitals, receiving a high appreciation from CDE.
GCP平台和精神药理学学科建设
2008年在院领导支持下，李华芳主任领衔承担了国家十一五“重大新药创制”科技重大专项——精神药物新药临床评价研究技术平台，并于2012年和2018年获得十二五、十三五持续资助，把该平台打造为国内精神药物临床试验的示范工程。同时研究团队开展精神药理学及转化医学研究，近3年主要成员承担各级科研课题多达十余项。
GCP Platform and Discipline Construction of Psychopharmacology
In 2008, with the support of SMHC leaders, Prof. Li Huafang took the lead in undertaking the "Major New Drug Innovation and Development" of National Science and Technology MajorProjects – Clinical Tech-Platform for Evaluation of IND in Psychiatry in the “11th-Five-Year Plan”. This Platform has developed into a demonstration project for clinical trials of psychotropic drugs in China, being continuously funded by the “12th- and 13th-Five-Year Plan” in 2012 and 2018, respectively. At the same time, the platform team carried out the research in psychopharmacology and transformational medicine. The core members have undertaken more than ten scientific research projects at different levels in the past three years.
中国精神药物学术研究组织
利用平台优势，整合国内领先的精神药物研究团队和相关学术力量，2012年成立的中国精神药物学术研究组织（ChinaARO-P），为国内创新精神药物的研发提供全方位的学术支撑，“十二五”期间在研究方案设计、项目实施、医学审查、专业培训（量表、精神医学、GCP和伦理、技术指导原则、质量管理等）、实验室、电子网络系统、质量保证、人才建设、管理协调中提供技术服务达126次，促进行业持续发展进步。
China Academic Research Organization of Psychotropic (ChinaARO-P)
The ChinaARO-P was established in 2012. Relying onthe platform advantages, Integrating the leading domestic psychotropic drug research team and related academic power, ChinaARO-P provides a full range of academic support for research in development of innovative psychotropic drugs in China. During the “12th-Five-Year Plan” period, 126 technical services were provided, including study protocol design, clinical trial conducting, medical review, professional training (rating scale, psychiatry, GCP and ethiccal principles, guidelines, quality management, etc.), laboratories, electronic network systems, quality assurance, talent development and management coordination. ChinaARO-P promotes the sustainable development and progress of the industry.
精神药物临床试验协作网
2014年4月成立中国精神药物临床试验协作网，成为中国GCP联盟中，继血液专业、儿童药物、肿瘤药物协作网之后的第四个专业协作组织，课题负责人李华芳为首任工作组组长。通过深入规范和优化管理体系，不断扩大平台的影响力与辐射效应。
China Clinical Trial Network of Psychotropic (CCTN-P)
CCTN-P, established in April 2014, became the fourth professional collaborated organization in the China GCP Union, following the Hematology, Pediatric Drugs and Tumor Drugs collaboration network. Li Huafang, the project leader, was the first Head of working group. By in-depth standardization and optimization of management system, the influence and spread effect of the platform are continuously expanded.
