临床研究管治国际会议暨

国际临床试验中心联盟论坛2023

临床研究 · 良好管治 · 成功共创


2023年11月29日 | 香港

上午9时30分 – 下午5时 (GMT+8)

香港尖沙咀金域假日酒店 / 线上

英语 — 普通话即时传译

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登记链接:即将公布


简介


临床研究管治国际会议暨国际临床试验中心联盟论坛2023为国际生物医学研究界提供绝佳机会,促进他们之间的沟通和知识交流。会议汇集了来自学术机构、医疗机构、临床及医学研究组织、生物医药行业和政府机构的专业代表,一同探讨了临床试验管治的最新趋势。


会议将以混合模式(线上及线下)进行。


演讲嘉宾



议程


08:45 – 09:30

登记(只适用于现场参与)

09:30 – 10:00

开幕式

欢迎致辞

刘泽星教授,香港大学李嘉诚医学院院长,香港特别行政区

开幕致辞

卢宠茂教授,香港特别行政区医务卫生局局长

10:00 – 11:00

主旨报告

主持人:

张文勇教授,创新科技署生物科技总监,香港特别行政区

Mr Robbie Chana, Syneos Health 亚太区业务发展副总裁,新加坡

10:00 – 10:20

世界卫生组织(WHO)如何推动提升临床试验实证的质量?—

关于世界卫生大会2022年的临床试验决议的最新消息

Dr Vasee Moorthy,世界卫生组织科学部高级顾问,瑞士

Dr Moorthy has a senior position within the Science Division at WHO. This is a corporate division of WHO’s headquarters created by the current Director-General to ensure that science and evidence lies at the heart of everything that WHO does. Dr. Moorthy is situated in a central Research for Health department that he helped create in 2019, which provides technical support to all of WHO’s disease and service delivery programmes on all matters related to research. He has over 25 years experience as a clinical researcher as follows: qualification in Natural Sciences (first class honours) from the University of Cambridge, UK; a medical degree from University of Oxford; a PhD in clinical trials of malaria vaccines from University of Oxford; 5 years of clinical research based in Africa (South Africa and The Gambia); making decisions about funding clinical trials working for PATH, an NGO based in USA; a career as a clinical academic at the University of Oxford, UK where he completed his internal medicine (FRCP) and infectious diseases subspecialty training; a total of 7 years as a practicing physician. Dr Moorthy joined WHO in 2008 as their lead on malaria vaccines, being promoted to positions of greater responsibility. He is now the lead coordinator on implementation of the World Health Assembly resolution on clinical trials passed in 2022. He has been involved in prioritization, funding, design and implementation of clinical trials that have recruited in over 50 countries, in all 6 WHO regions related to COVID-19, Ebola, Mers-CoV, Lassa fever, malaria, and many other infectious diseases.

演讲摘要

The World Health Assembly passed reolution WHA 75.8 on strengthening clinical trials in 2022. This resolution highlighted the benefits of the few well-designed and well-implemented clinical trials that achieved sufficient scale during the pandemic. These saved many millions of lives through identify safe, effective interventions. The resolution also highlighted the thousands of uninformative trials that wasted resources and took participants away from potentially useful trials. Several reforms to the ecosystem are suggested in the resolution which center around efficiencies in approval processes, better prioritization and use of resources, and ensuring trials are well-designed and well-implemented.


The speaker will summarise the background to the resolution and the actions being taken by WHO in line with requests of Member States.

10:20 – 10:40

寒耕暑耘、茁壮成长:构建一站式临床试验中心,赋能生物医药研发生态圈

游广智总监,香港大学临床试验中心执行总监,香港特别行政区

游广智现为香港大学临床试验中心 (中国) (HKU-CTCC) 首席执行官、香港大学临床试验中心 (HKU-CTC) 执行总监及澳门科技大学医学院客座助理教授,拥有理学士 (生物化学) 及工商管理硕士 (金融财务) 学位。他早于90年代初已开始服务医药界,并从2000年起专注于临床研究管理达二十多年。游广智自2023年初起更获认可为中华人民共和国科学技术部高端外国专家引进计划下的高端外国专家 (临床试验管理),多年来亦于多个本地及国际组织担任多项公职,包括国际临床试验中心联盟 (ICN) 指导委员会委员及前主席、国际医学科学组织理事会 (CIOMS) 研究机构良好管治规范工作组委员、及研究伦理评估学习与资源计划 (TRREE) 亚洲区顾问等。游广智亦一直致力于整合及推广临床试验之管理与运営的实战经验。他曾获邀以讲者、导师或论坛专家的身份主持或参与世界各地一百六十个论坛、研讨会及培训班。

黄嘉慧博士,香港大学临床试验中心副执行总监,香港特别行政区

黄嘉慧现为香港大学临床试验中心(中国) (HKU-CTCC) 首席运营官、香港大学临床试验中心 (HKU-CTC) 副执行总监及澳门科技大学医学院客座助理教授,拥有理学士(食物及营养学)、哲学硕士及哲学博士学位。她从2006年起专注临床研究管理达十七年。黄嘉慧自2023年初起更获认可为中华人民共和国科学技术部高端外国专家引进计划下的高端外国专家 (临床试验管理), 多年来亦于多个本地及国际组织担任多项公职,包括国际医学科学组织理事会 (CIOMS) 研究机构良好管治守则议案工作组委员、香港特别行政区渔农自然护理署基因改造生物(管制释出)专家小组委员及研究伦理评估学习与资源计划 (TRREE) 亚洲区顾问等。黄嘉慧亦一直致力于整合及推广临床试验之管理与运営的实战经验。她曾获邀以讲者、导师或论坛专家的身份主持或参与世界各地约一百个论坛、研讨会及培训班。

10:40 – 11:00

实践伦理精神,预防无效研究;机构良好管治,共献社会价值

Prof Dominique Sprumont,瑞士瓦州研究伦理委员会主席及国际医学科学组织理事会研究机构良好管治规范工作组主席

Prof Dominique Sprumont is a Professor of Health Law, President of the Research Ethics Committee of Vaud, founding member of the Institute of Health Law of the University of Neuchâtel, and past Vice-Director of the Swiss School of Public Health. He collaborated in the drafting of many legislations in the field of health and healthcare at the cantonal, Swiss and European levels. He is also regularly invited by scientific and professional associations in developing their guidelines in those fields, such as the WMA 2008, 2013 and ongoing revisions of the Declaration of Helsinki and the WMA 2016 Declaration of Taipei on Health Databases and Biobanks. Expert in the field of public health law with special interest in the regulation of research involving human participants, patient’ rights, the regulation of healthcare professionals, pharmaceutical and food stuff regulation, he has written more than 180 scientific publications, articles and book chapters on those issues. He is a board member of the European Network of Research Ethics Committees (EUREC), as well as the Council for International Organizations of Medical Sciences (CIOMS) and coordinator of Training and Resources in Research Ethics Evaluation Program (TRREE), a free and open access e-learning program in research ethics and regulation available in 7 languages including Chinese(http://elearning.trree.org).

演讲摘要

Clinical research is necessary for advancing medical sciences and human healthcare, for the benefits of people worldwide. It is however recognized that a significant proportion of clinical studies produced “research waste”. For instance, due to inappropriate design, conduct or dissemination of the results, some research projects may fail to advance scientific knowledge or provide a social return on the resources invested. During the COVID pandemic, with support of clinical trial centers around the world, the scientific community demonstrated its capacity to work collectively at the international level and provide the world population much needed preventive and protective measures to mitigate the impact of the disease. Yet, on the more than 20,000 research projects worldwide related to COVID, a material percentage did not create useful scientific or social value in terms of knowledge generation, clinical services or policy making. In this regard, the World Health Organization (WHO) has adopted a resolution to improve the research ecosystem and to limit research waste. Other organizations have also adopted guidelines for best practices regarding clinical trials, such as the 2022 Good Clinical Trials Collaborative for good randomized clinical trials. Hopefully by the end of the year, CIOMS should adopt a new set of international guidelines on Good Governance Practice for Research Institutions (GGPRI) that will fill up an important gap. Today, researchers are mostly left alone to cope with their responsibilities in terms of GCP and research ethics. The new CIOMS guidelines aim at helping the research institutions better support the researchers in their activities to promote better research that advance scientific knowledge and is relevant to the needs of the health of individuals and the populations.

11:00 – 11:30

茶歇

11:30 – 12:30