Webinar on Key Statistical Issues in Clinical Trials

Date: January 15,2025

Agenda:

14:00-14:05   Welcome Remarks & Introduction of participants, speakers and schedule

14:05-14:30    Statistics of vaccine clinical trials

14:30-14:55   Statistical considerations in the Innovative vaccine research and development

14:55-15:20   Statistical design in real-world studies of vaccines

15:20-15:25    Q&A

15:25-15:30    Closing Remarks

Speakers introduction:

Dr. Fu Rong

Deputy Chief Statistician, Biostatistics and Scientific Decision Making Department at MSD, who mainly supports the research and development of vaccine products in China and globally. Prior to joining MSD, she served as a statistical reviewer for vaccine products in the Center For Biologics Evaluation And Research at FDA. During 12 years in the field of vaccine statistics, she has participated in the academic research of HIV vaccine, the approval of influenza vaccine, herpes zoster vaccine, anthrax vaccine, and the research and development of pneumococcal vaccine, HPV vaccine, rotavirus vaccine, and dengue vaccine.

Dr. Jiang Zhiwei

PhD of of Health Statistics,graduated from the Fourth Military Medical University, he has worked in Jinan Military Region General Hospital, MSD etc. He has rich experience in statistical analysis of vaccines, oncology, mental/neurological diseases, infectious diseases and other therapeutic fields.Responsible for and participated in the statistical analysis of more than 50 vaccine products at home and abroad, including the first international hand-foot-mouth disease vaccine, Sabin IPV vaccine, the first 13-valent pneumococcal vaccine in China, etc. ,relevant studies have been published in top medical journals such as NEJM, Lancet and JAMA.In addition, he has carried out statistical methodological research on group sequential and adaptive design methods, design and statistical analysis of international multi-center clinical trials, and application of tumor biomarkers in clinical trials, and the related results have been published in the journals Statistics in Medicine, JBS, etc.

Dr. Qi Yangyang

PhD, Fudan University. She has worked in the field of drug and vaccine clinical trials for 8 years and participated in the design and statistical analysis of more than 40 clinical trials,of which six vaccines have been approved for marketing (varicella vaccine, quadrivalent influenza vaccine, bivalent HPV vaccine, sIPV vaccine,  herpes zoster vaccine, and COVID-19 inactivated virus vaccine).From December 2021 to June 2023 at Fudan University, she participated in the program design and statistical analysis of the national key research and development plan (Overseas Real World research on COVID-19 vaccine), and participated in the writing of “Real world Research on Vaccine Effectiveness” in “Vaccine Innovation Technology”.

Original links: https://mp.weixin.qq.com/s/RFN-T3rPZAJhyiM-uW7wxQ