China-Japan Hospital Drug Clinical Trial Research Center

The Drug Clinical Trial Institution of China-Japan Friendship Hospital was established in 1990 and renamed in August 2017 as the Drug Clinical Trial Research Center of China-Japan Friendship Hospital (hereinafter referred to as the “GCP Center”). In 2022, it was approved as a construction unit for research wards in Beijing. The GCP Center centrally manages registration-related clinical trials of drugs, medical devices, and in vitro diagnostic reagents throughout the hospital, as well as sponsor-initiated post-marketing studies. The GCP Center comprises the Institution Office, the Phase I Clinical Trial Research Ward, the Quality Control Department, and the Data Statistics Center. Upholding the principle of “improving quality and accelerating progress, and safeguarding high-quality clinical trials,” the GCP Center has established a full-chain clinical trial service platform, is committed to substantially improving service capacity and efficiency, continuously enhances its technical service capabilities, and promotes the high-quality development of clinical trials. Relying on the hospital’s advantageous disciplinary groups in respiratory medicine, endocrinology, dermatology, pain medicine, Phase I studies, and other fields, the GCP Center and its clinical specialties have now become an important force among China’s clinical trial teams. There are currently 25 drug clinical trial specialties and 71 principal investigators (PIs); 45 medical device clinical trial specialties and 269 principal investigators (PIs).

Department Personnel Structure:

The Institution Office management team consists of 9 people, including 1 office director, 1 secretary/drug project administrator, 1 device project administrator, 3 drug administrators (1 full-time/2 part-time), 1 financial administrator, 1 records administrator, and 1 CRC administrator. Among them are 3 deputy chief pharmacists, 2 supervising pharmacists, 1 pharmacist, and others.

The Phase I Clinical Trial Ward research team consists of 12 people, including 1 specialty director, 2 full-time principal investigators, 2 full-time research physicians, 1 full-time pharmacist, 4 full-time research nurses, 2 research assistants, and 2 quality control personnel. Among them are 1 research fellow, 1 deputy chief pharmacist, 1 associate research fellow, 2 attending physicians, 4 supervising nurses, and others.

The Quality Control Department has 1 director and 2 full-time quality control personnel. Among them are 1 associate research fellow, 1 supervising nurse, and others.

Department Achievements:

Over the past five years, the GCP Center has undertaken 458 clinical trials. In 2023, the number of clinical trial projects and the contract value increased by approximately 30% compared with 2022, achieving the best results in the hospital’s history. In addition, the proportion of high-level clinical trials, including international/domestic multicenter projects (32.5%) and Class 1 innovative drug projects (63.5%), has continued to increase.

Over the past five years, the GCP Center has led 1 project under the 2020 annual program of the National Science and Technology Major Project for Major New Drug Development, “Construction of a Demonstration Clinical Evaluation Technology Platform for New Drugs for Respiratory Diseases and Metabolic Diseases such as Diabetes,” and 1 project under the 2020 central government-funded project of the National Health Commission, “Capacity and Quality System Development Project for the Clinical Pharmacology Trial Institution of China-Japan Friendship Hospital,” and has received approved funding of more than 20 million yuan. In 2022, it was successfully approved as a demonstration construction unit for research wards in Beijing. It is currently undertaking multiple regulatory science research projects, including the Ministry of Science and Technology’s 14th Five-Year Plan Key Research and Development Program and the Chinese Academy of Medical Sciences’ Major Collaborative Innovation Project under the Innovation Program.

Department Teaching:

The GCP Center undertakes teaching and supervision for the Advanced Clinical Pharmacy Practice (Clinical Trial Specialty) program of the School of Pharmaceutical Sciences of Peking University, the eight-year Clinical Medicine program of Peking Union Medical College, and other programs.

Location Within the Hospital:

GCP Center Office: Preparation Building, Main Campus, China-Japan Friendship Hospital, Room 409

Ethics Office: Preparation Building, Main Campus, Room 415

GCP Center Reception Room: Preparation Building, Main Campus, Room 105

GCP Pharmacy: Preparation Building, Main Campus, Rooms 411 and 412

Phase I Clinical Trial Ward: Seventh Floor, West Area

Contact Information:

GCP Center Office Tel: 84205645 Email: [email protected]

Ethics Office Tel: 84206086 Email: [email protected]

GCP Center Reception Room Tel: 13141038320

GCP Pharmacy Tel: 84205645 Email: [email protected]

Quality Control Department Tel: 84206086/13141038320 Email: [email protected]

Phase I Nurses’ Station: 53236571

Department WeChat Official Account Name: China-Japan Friendship Hospital GCP Center