National Drug Clinical Trial Institution (GCP)

The National Drug Clinical Trial Institution of Peking University Cancer Hospital, established in 1999, has for many years consistently pursued the goal of helping to build a world-class research hospital and is committed to providing high-quality clinical research services for the research and development of innovative oncology drugs and the translation of research outcomes. It has now become one of China’s leading institutions for the research and development of new anticancer drugs, has reached a world-leading level in clinical research, and is also one of the first demonstration units in Beijing for the construction of research wards, as well as a practical training base for inspectors of the Center for Food and Drug Inspection of the National Medical Products Administration and a practical training base for inspectors of the Beijing Municipal Medical Products Administration.

The institution conducts its daily work under the leadership of the Hospital Clinical Research Management Committee. Its director is Academician Ji Jiafu of the Chinese Academy of Engineering; its deputy directors are Professor Li Jian and Professor Wang Kun; the director of the institution’s office is Professor Jiang Min; and it currently has 36 full-time staff members.

The institution’s current specialties are: oncology, nuclear medicine, ultrasound, and anesthesiology; 1,200+ clinical trials are currently ongoing, an average of 300+ IND trials are initiated each year, approximately 100 IIT trials are initiated annually, clinical trial services are provided to 110,000 participant-visits per year, 2,800 new participants are enrolled per year, and there are more than 600 collaborating sponsors in China and abroad. The institution has successfully passed every on-site inspection conducted to date by domestic and international regulatory authorities and has cumulatively helped bring more than 200 new drugs to market, benefiting large numbers of patients.

To better serve patients, medical scientists, and the pharmaceutical industry, the institution has for many years explored the development of a clinical research management system, systematically advanced comprehensive iterative upgrading and systematic restructuring of its hardware and software facilities, focused on developing core capabilities in clinical research and translational medicine, optimized the layout of clinical trial platforms, improved innovation incentive mechanisms, strengthened the development of a tiered talent pipeline, and implemented other key measures. It has continued to deepen an integrated development model linking clinical research and industry, has innovatively led the development of clinical trial informatization in China, and has received high recognition from the industry both domestically and internationally.

Particularly in the informatization of clinical research, the institution has now established a HIS-based clinical trial management system and a one-stop intelligent CTMS platform covering the entire process, and has explored and implemented intelligent screening, intelligent study visits, direct delivery of drugs to participants, remote monitoring, digital quality control, eSource, and other initiatives. The institution is steadily promoting the transformation of the hospital into a research hospital with high-level clinical research capabilities, a distinctive diagnosis and treatment system, and innovative pathways for translating achievements into practice, thereby making a core contribution to the national endeavor of new drug research and development.

On November 15, 2024, MK-6204, for which a clinical trial was being conducted at our hospital, became the first “pilot project for the review and approval of clinical trials of optimized innovative drugs” in the country to receive an NMPA clinical trial approval, in only 21 days.

In May 2025, the Organizing Committee for Clinical Research Capability Enhancement and Participant Protection Practice (CCHRPP) published the “National Guide to the Tiered Development of Drug Clinical Trial Volume and Value at GCP Institutions.” Our hospital was rated A+++++ and continues to rank in the top tier among hospitals nationwide. All data in this ranking are sourced from the Drug Clinical Trial Registration and Information Disclosure Platform of the Center for Drug Evaluation of the National Medical Products Administration (CDE), directly reflecting the institution’s level of support for and advancement of biopharmaceutical research and development and its quality management capabilities.