Webinar on Key Statistical Issues in Clinical Trials (3rd. Session-Statistical Guidelines for Vaccine Clinical Trials)

Date：July 31^st，2025

Agenda

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

14:05-14:30 Introduction to the basic concepts and handling methods of missing data

14:30-14:55 Case sharing of handling missing data in vaccine clinical studies

14:55-15:20 Statistical Considerations in the design of international multi-center clinical trials for vaccines

15:20-15:35  Q&A

15:35-15:45  Closing Remarks

Speakers introduction

• Dr. Yu Yongpei

Assistant Researcher at the Clinical Research Institute of Peking University. With over 10 years of experience in clinical trial design and analysis, he has provided statistical design and analysis services for more than 300 new drug and medical device clinical trials in China. He has participated in several national-level projects such as major science and technology projects, national major new drug creation projects, and national natural science foundation projects.

• Mr. Luo Yi

Biostatistician with 9 years of experience in clinical trial design and statistical analysis. He has participated in over 100 domestic and international clinical trials, covering multiple therapeutic areas such as vaccines (including RSV, shingles, COVID-19, HPV, norovirus, mumps, influenza, rabies, pneumonia, rotavirus, etc.), oncology, psychiatric/neurological disorders, metabolism, and autoimmune diseases.

• 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.

Original links: https://mp.weixin.qq.com/s/n-2Zt_cRtOp6M8q1zrrrYg