On August 9, 2020, Liu Yueguang, Director of the Urology Surgery Department of our hospital, and Qin Guicheng, Secretary of the GCP Office, attended the Finalization and Launch Meeting for the Phase III Clinical Trial of Udenafil Hydrochloride Tablets held at the Beijing Kuangou Conference Center. This is a nationwide multicenter collaborative study involving 49 research sites. The sponsor is Yangtze River Pharmaceutical Group Co., Ltd., the lead clinical research institution is Peking University Third Hospital, and the contracted research organization (CRO) is Beijing Haisha Consulting Co., Ltd. More than 70 investigators and GCP administrators from over 30 clinical trial institutions across the country attended the meeting, which featured abundant high-quality discussions. As the principal investigator of our hospital, Director Liu Yueguang was invited to discuss the trial protocol together with renowned national urological experts.

The conference centered on a multicenter, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of udenafil hydrochloride tablets for the treatment of male erectile dysfunction. All participating investigators, sponsor R&D staff and institutional administrators held in-depth exchanges on protocol design, subject inclusion and exclusion criteria, trial procedures and other key issues, with authoritative guidance and suggestions put forward by experts from all regions of China.

This is the first Phase III drug clinical trial undertaken by our hospital, as well as our first large-scale national multicenter trial. Director Liu’s participation in panel discussions with top national experts fully demonstrates the comprehensive strength of our Urology Surgery Department and carries far-reaching significance. Our hospital’s Clinical Trial Institution will cooperate closely with the Urology Surgery Department to accelerate project filing and ethical review procedures. Meanwhile, the clinical research team of the Urology Surgery Department will conduct trials in strict compliance with the latest version of GCP, relevant laws and regulations, the trial protocol and standard operating procedures (SOP), so as to protect the rights and safety of trial subjects and guarantee authentic, accurate and complete clinical trial data.

Participation in this national multicenter trial has elevated the national reputation and influence of our Urology Surgery Department and boosted our clinical research capacity. Taking this project as an opportunity, our hospital will consolidate the foundation of clinical trials, continuously improve overall trial capacity and accelerate clinical service and discipline development. In addition, it will motivate the five other clinical specialties qualified for drug clinical trials (Gastroenterology Dept, Respiratory Medicine Dept, Pediatrics Dept, Cardiology Dept, Gynecology Dept) to actively undertake trial projects and complete clinical trial filing tasks. This will support our development as a teaching and research hospital and contribute to the advancement of medical and health services in Shenzhen.