The Clinical Trial Research Center of Tianjin Medical University Cancer Institute & Hospital was founded in 1996 and was approved by the Ministry of Health in 1998, respectively. It is one of the earliest clinical trial research center established in China. In May 2015, it passed the re-inspection of CFDA.
The concept of the Center is "scientific management, standardized operation, and true evaluation". The Center has been developing rapidly based upon the 11th Five-Year Plan to 13th Five-Year Plan. Anti-cancer drug clinical trials conducted in our hospital have been increasing year by year and the quality of clinical trials has been highly appreciated. So far, the Center has undertaken more than 500 clinical trials from Phase I to Phase IV, including nearly 300 State Category I New Drug. Approximately 15 000 cases were completed and more than 50 new anticancer drugs have been approved.
The Center is one of the earliest clinical trial research centers in China to adopt clinical trial information Management system (CTIMS) and centralized management of experimental drugs, and is now leading the country in these aspects. The experiences have been forward to other centers, including Cancer Hospital Chinese Academy of Medical Sciences, Beijing Cancer Hospital, Hunan Cancer Hospital, Jiangxi Cancer Hospital, and Shandong Cancer Hospital. In 2015, the centralization pharmacy was under on-site inspection and was rated as excellent by the “Clinical Investigational Drug Centralized Management Project” initiated by the GCP Alliance of China. The center participated in the establishment of the Tianjin Clinical Research Technology Service Innovation Center, and established a joint laboratory for the analysis and testing of new drug clinical research samples, and developed the front-end technology development of AI-assisted clinical trials based on big data to empower clinical trials with quantity, quality and efficiency.
Through hard work, the Center has become the governing unit of China GCP Alliance, China Cancer Clinical Trial Auditing Collaboration Group, China Tumor Phase I (BE/Consistency Evaluation) Collaborative Group, China Anti-Cancer Association Cancer Drug Clinical Research Committee, China Anti-Cancer Association Medical Ethics Committee Tianjin Hospital Association, Clinical Trial Special Committee and Clinical Research Coordinator (CRC) platform of the main unit. Based upon the accumulated academic status and rich experience over the years, the Center has played a leading role in Tianjin and even in China, which promotes the development of cancer clinical trials in China.