At the 4th China International Import Expo (referred to as the Expo), "Patient-centered, Empowering Clinical Research Development" - the 2021 Clinical Research Quality Management Summit Forum was successfully held.
Promote the "zero time difference" of new drug listing in China
Wang Li, senior vice president of Eli Lilly China and head of the Drug Development and Medical Affairs Center, sighed that once Eli Lilly, it took us 8 years to approve a drug in the past, but in 2019, Eli Lilly achieved a breakthrough of 8 new products including new indications in one year. Whether it is the default system of clinical approvals, or the speed of emergence of new products and the output of new drugs, it shows that China's research and development has entered a new stage.
Dr. Li Wang, Senior Vice President of Eli Lilly China and Head of The Center for Drug Development and Medical Affairs
Benefiting from the impact of China's incentive policies, Eli Lilly China's current pipeline portfolio is delivering 16 new compounds to the Chinese market from 2019 to 2025. The Eli Lilly China Pipeline project, which was developed simultaneously by the headquarters, accounted for 74% of the projects under research. At the same time, the number of clinical studies in Eli Lilly China has more than tripled in the past three years. In the past three years, more than 300 hospitals have participated in clinical studies initiated by Eli Lilly China (including: Phase I, Ii, III, and Postmarket Safety Studies).
Wang Manrong, senior director of clinical operations at Eli Lilly China, believes that in a favorable policy environment, multinational pharmaceutical companies will participate in the global clinical research of key new drugs as soon as possible, which will bring impetus to China's clinical research. As a sponsor, from clinical trial design to implementation, in-depth and strengthen communication with research institutions, including investigators and institutional offices, to understand the practical needs of front-line clinical research links and subjects. In addition, Eli Lilly continues to expand its cooperation with industry,300,000 and carries out the "Eli Lilly Learning" clinical research talent training program nationwide to provide high-value learning opportunities for Chinese clinical researchers to improve the overall level and quality of clinical research in China. ”
Wang Manrong, Senior Director of Clinical Operations at Eli Lilly China
"China's innovative pharmaceutical industry needs more capable clinical research institutions and researchers. To this end, Eli Lilly will spare no effort to rely on our professional clinical research capabilities and clinical research teams with rich clinical research experience to strengthen strategic cooperation with important clinical research institutions in China to create a strong clinical trial ecosystem and promote the common growth of Chinese clinical researchers. "China is one of Eli Lilly's important strategic markets in the world. We will practice the concept of 'rooted in China, benefit China' and help advance pharmaceutical innovation so that Chinese patients can simultaneously benefit from internationally leading innovative drugs." At the same time, it will contribute to the transformation and upgrading of the entire medical industry to help achieve the great goal of 'Healthy China 2030'." ”
Clinical studies should be patient-centered
In recent years, the state has successively issued policies to regulate drug clinical trials, emphasizing patient-centered and strengthening the rights and interests of subjects. In July 2020, the new version of the Good Management Practice for Drug Clinical Trials (GCP) was promulgated, clarifying the responsibilities and requirements of all parties in drug clinical trials and strengthening the protection of the rights and interests of subjects.
In July this year, the Drug Evaluation Center (CDE) of the State Drug Administration issued the "Notice on PublicLy Soliciting Opinions on the Guiding Principles for clinical Research and Development of Anti-tumor Drugs Oriented to Clinical Value", pointing out that the determination of research and development topics and clinical trial design should be guided by clinical needs to maximize the benefits of patients.
Professor Shen Yifeng, chief physician of shanghai mental health center, director of the office of drug clinical trial institutions and ethics committee member, pointed out: "Clinical research, like clinical diagnosis and treatment, needs to emphasize the needs of patients. As an institution, the hospital is not only the source of the closest to the needs of patients, but also the main battlefield for completing clinical research tasks. Any clinical question that has not yet been satisfactorily answered is the source of the design of the research protocol, and the data obtained from it to form evidence and finally obtain reliable conclusions can guide clinical practice. Based on the present, we need to respect diversity, embrace innovation, and actively explore the use of new methods, new technologies and new tools for clinical research. Leading hospitals should provide more professional support and academic services, effectively ensure the rights and safety of subjects, and work with sponsors to promote the continuous optimization of the industry ecology. ”
Professor Shen Yifeng, chief physician of Shanghai Mental Health Center, director of the Office of Drug Clinical Trial Institutions, and member of the Ethics Committee
Chen Jinhao, head of Aikunwei's management consulting business, believes that the health industry urgently needs patient-centered services, "All parties in the medical and health industry are advocating the transformation from the traditional medical system to the value-oriented medical system, 'patient-centered' mainly lies in responding to the medical needs and emotional needs of individual patients, from drug research and development to the use of the entire chain to achieve 'for the patient, take the patient as the teacher'." Patient-centered clinical research requires technology to empower and create a remote intelligent connection platform, while further improving efficiency and optimizing clinical resources. ”
Chen Jinhao, head of Management Consulting Business at IQVIA
"Emphasizing patient-centeredness means that we need to put patients at the center of clinical research, take patient benefits as the primary consideration, strengthen communication with patients, pay attention to patient safety in clinical studies, and improve subject compliance." In order to maximize the benefits of clinical research patients, Professor Yu Jintai, executive deputy director of the Institute of Neurology of Fudan University and leader of the department of neurology cognitive impairment and dementia in huashan Hospital affiliated to Fudan University, believes that when designing clinical research, the most basic thing is to identify groups that can benefit from clinical research through preliminary research.
Professor Yu Jintai, Executive Deputy Director of the Institute of Neurology of Fudan University and Leader of the Department of Neurology, Department of Neurology, Huashan Hospital, Fudan University, is the leader of the sub-specialty of cognitive impairment and dementia
(Editor-in-charge: Li Anning)