CORE Summit

China Outcomes Research and Evidence-Based Medicine

Summit

Successfully Held in Shanghai

Yuhui Zeng, MD, Danyi Zhang, MD

VitalStrategic Research Institute

On March 18^th and 19^th, the first China Outcomes Research and Evidence-based Medicine (CORE) Summit, jointly organized by the Chinese Medical Doctor Association (CMDA) and US-based Vitalstrategic Research Institute, was successfully held in Shanghai International Convention Center.

Nearly 200 participants attended the meeting. Among them were experts and scholars from many academic institutions and government agencies, including Peking University, Fudan University, Cornell University, Harvard University, Chinese Ministry of Health, US FDA, UK National Institute for Health Clinical Excellence (NICE). Many executives and experts from top international pharmaceutical companies also attended the summit.

Professor Cai Zhongjun, the Vice President of Chinese Medical Doctor Association (CMDA) and co-chairperson of the meeting, made the opening remarks. Chinese Medical Doctor Association (CMDA) is a national, voluntary, not-for-profit, professional association of 2.1 million practicing physicians in China. CMDA is committed to advocating for btter public healthcare and providing leadership for the Chinese medical community. In his speech, Professor Cai pointed out that outcomesresearch and evidence-based medical research is a rapidly developing field, and it has become an international hot spot in medical research. Outcomes research and evidence-based research can help better understand regional and national health issues, including unmet population health needs, thus contributing to more informed decision-making by medical professionals and health authorities. It will also help the government determine priorities, measure response, and make rational allocation of resources.

Dr. Zhang Danyi, President and Chief Medical Officer of Vitalstrategic Research Institute, also served as co-chairperson of the conference. She remarked in the opening speech that while outcomes research and evidence based medicine are increasingly valued in the US and Europe, Chinese scholars and policy-makers have also been interested in establishing processes to better integrate real-world evidence into real-life medical practice, and the CORE Summit was intended to create a platform where leaders and experts from government, academic, medical community and industry could share their vision, knowledge, and processes on how to better evaluate clinical outcomes, assess practice gaps, reduce medical costs, enhance values of medical intervention and improve quality of health care.

The first keynote speaker at the meeting was Dr. Danica Marinac-Dabic

, head of epidemiology, U.S. Food and Drug Administration (FDA). She focused mainly on the U.S. medical device regulatory framework for post-marketing studies and the importance of cooperation from all stakeholders in health care. Later, Dr. Art Sedrakyan, Director of Comparative Effectiveness Research Program at Cornell University provided examples of when observational studies were more appropriate than Randomized Controlled Trial (RCT) to estimate the effectiveness of medical interventions. Dr. Sarah Garner, Associate Director of Research and Development of UK’s National Institute for Health and Clinical Excellence (NICE), introduced how UK’s health system had changed with the increasing influence of the concept of evidence-based medicine in the past 10 years. Their speeches gave the audience an overall understanding of why and how western countries has strengthened outcomes research in recent years.

In order to gain industry perspective on outcomes research, several research and development and outcomes research leaders of various multinational pharmaceutical companies were invited to share their insight, including Dr. Catherine Melfi, Senior Director of Global Health Outcomes from Eli Lilly, Dr Joanne Chang, Chief Medical Officer from Novartis China, Dr. Zheng Gu, Senior Medical Director from Sanofi-Aventis, Dr. Manny Papadimitropoulos, Director of Outcomes Research ofEli Lilly and Dr. Wang Dan, Chief Medical Director of Express Script China. A panel discussion on RCT vs outcomes research with leaders from Merck, Astra-Zeneca, Eli Lilly and Venturepharm was very well received. Those experts from the industry agreed that Outcomes Research could have the same level of significance as RCT when used to adequately assess the efficacy, effectiveness and safety of new pharmaceutical products. The industry will increase their support for outcomes research in China and utilize real-world data to guide the direction of their research activities.

Among the attendees were also many from the government.Ms Kong Linzhi, Deputy Director of Chronic Disease Control, Ministry of Health, emphasized the importance of using evidence-based medicine to help improve the level of disease control in China. Mr. Hongxiang Fu, Director of Human Resource and Social Security Bureau of Zhejiang province, posited that evidence-based policy-making in the government-managed medical insurance program will be the future direction of reform. “Integrating Real World Evidence into Real Time Practice” is the major theme of this conference. Practicing medical doctors could play the most important role in advancing this concept. Many physicians spoke on their experience and understandings of conducting outcomes research.

Among the speakers were Dr. Hu Dayi and Dr, Ji Linong, from People’s Hospital, Beijing University, Dr Li Guanghui from Huashan Hospital, Fudan University, Dr. Wang Yilong from Beijing Tiantan Hospital, Dr. Huang Wei from Chongqing Medical University. The physicians, from many different angles, talked about that data from outcomes research has helped make better clinical decisions and will help better establish medical guidelines and decision pathways. Dr. Hu and Dr. Ji also introduced the China Cardiometabolic Registries (CCMR) organized by Chinese College of Cardiovascular Doctors affiliated to CMDA and Chinese Endocrinologists affiliated to CMDA. CCMR is a serial of outcomes studies on cardiometabolic diseases in China, the result of which will greatly influence the practice patterns of Chinese physicians.

The conference also included a session on technology use in data capturing and methodology issues in outcomes research. Speakers in this session included Prof Wang Jiyao from Fudan University, Prof Zhan Siyan from Beijing University, Dr. William Wang from Merck, Dr. Daniel Liu from Medidata. Their presentations also generated many discussions on those important issues.