In 1900, Tongji Hospital was founded by Dr. Erich Paulun, a German doctor, in Shanghai, and then moved to Wuhan in 1955. After 120 years of construction and development, it has grown into an innovative modern hospital integrating medical care, teaching and scientific research with a complete array of disciplines, a distinguished gathering of experts, a strong teaching force, exquisite medical techniques, state-of-the-art diagnostic and therapeutic equipment, outstanding research capabilities and sophisticated scientific management, ranking among the top of domestic hospitals in terms of comprehensive strength.

Over the one hundred years of development, Tongji Hospital has witnessed a gathering of famous doctors. Tongji Hospital is a cradle for a large number of experts and professors who enjoy reputation at home and abroad, including Chen Xiaoping who was elected as an academician of the Chinese Academy of Sciences in 2015, Ma Ding who was elected as an academician of the Chinese Academy of Engineering in 2017, 2 chief scientists of "973 Program", 8 recipients of the National Science Fund for Distinguished Young Scholars, 12 young and middle-aged experts with outstanding contributions awarded by the Ministry of Health, 11 New Century Excellent Talents awarded by the Ministry of Education, 37 specially-invited academicians as part-time professors, 317 professors who also serve as Ph.D. supervisors, and 95 people who enjoy special government allowances from the State Council.

The Hospital has three campuses, the Main Branch, Optical Valley Branch and Sino-French New City Branch, with 62 clinical and medical departments and 1 national clinical research center, of which the Department of Obstetrics and Gynecology is selected as the National Clinical Research Center for Obstetrics and Gynecology (the only national clinical research center in Hubei Province), and the Rehabilitation Department is a research and training center designated by the WHO. Besides, the Hospital offers 11 national key disciplines and 30 national key clinical specialties (the second in China). The number of patients visiting Tongji Hospital hit a new high in Hubei regions again and again, and the annual number of patients accepting outpatient/emergency services has remained the first in Hubei Province for more than 20 consecutive years.

In April 2006, as Tongji Hospital Drug Clinical Trial Institution passed the qualification accreditation of clinical trial institutions by the Ministry of Health and CFDA, the Hospital was approved to carry out clinical trials for a total of 25 disciplines, including cardiovasology, respiration, digestion, infection, dermatology, nephrology, rheumatism, endocrinology, allergy, oncology, neurology, obstetrics and gynecology, transplantation, trauma, general surgery, urology, oral cavity, pediatric genetics and metabolism, pediatric endocrinology, pediatric infection, otorhinolaryngology, TCM rheumatism, TCM endocrinology, ophthalmology, and phase I clinical laboratory. In February 2010, the above 25 disciplines passed the re-accreditation of clinical trial institution qualification by the CFDA. In May 2014, the Hospital was approved to carry out clinical trials for additional 6 disciplines by CFDA, including anesthesia, orthopedics, neurosurgery, hematology, TCM obstetrics and gynecology and geriatrics (geriatric cardiovascular diseases). In March 2017, all disciplines in the Hospital passed the re-accreditation of qualification by the CFDA. Tongji Hospital has qualified in the national drug clinical trial institution qualification for a total of 31 disciplines, including cardiovasology, respiration, digestion, infection, dermatology, nephrology, rheumatism, endocrinology, allergy, oncology, neurology, obstetrics and gynecology, transplantation, trauma, general surgery, urology, oral cavity, pediatric genetics and metabolism, pediatric endocrinology, pediatric infection, otorhinolaryngology, TCM rheumatism, TCM endocrinology, ophthalmology, anesthesia, orthopedics, neurosurgery, hematology, TCM obstetrics and gynecology, geriatrics (geriatric cardiovascular diseases), and phase I clinical laboratory, getting ahead of other medical institutions in China as for the number of disciplines qualified in the national drug clinical trial institution qualification accreditation.

In accordance with the Conditions for Medical Device Clinical Trial Institutions and Filing Management Measures and the Regulations on the Administration of Drug Clinical Trial Institutions, the clinical trial institution qualification was changed from accreditation to filing. Tongji Hospital was filed as a medical device clinical trial institution and a drug clinical trial institution in April 2018 and July 2020, respectively.

Up to now, Tongji Hospital has been filed as a medical device clinical trial institution for a total of 51 disciplines, including cardiovasology, respiration, geriatrics, immunology, endocrinology, neurology, nephrology, digestion, allergy, hematology, orthopedics, liver surgery, trauma surgery, biliopancreatic surgery, general surgery, thyroid and breast surgery, urinary surgery, organ transplantation, gastrointestinal surgery, neurosurgery, cardiovascular surgery, thoracic surgery, plastic and aesthetic surgery, pediatric general surgery, obstetrics, gynecology, gynecological oncology, reproductive medicine, pediatric infection, pediatric endocrinology, pediatric genetics, neonatology, pathology, infection, otolaryngology-head and neck surgery, emergency medicine, rehabilitation medicine, stomatology, anesthesia, dermatology, blood transfusion, ophthalmology, refractive therapy, clinical laboratory, ultrasound diagnosis, nuclear medicine, radiology, TCM gynecology, TCM rheumatism, TCM endocrinology and oncology. The Hospital has been filed as a drug clinical trial institution for a total of 54 disciplines, including cardiovasology, respiration, digestion, infection, dermatology, nephrology, rheumatism, endocrinology, hematology, allergy, oncology, neurology, transplantation, trauma, liver surgery, thoracic surgery, urology, gastrointestinal surgery, thyroid and breast surgery, orthopedics, neurosurgery, plastic and aesthetic surgery, gynecology, obstetrics, gynecological oncology, reproductive medicine, pediatric genetics and metabolism, pediatric endocrinology, pediatric infection, pediatric digestion, pediatric respiration, pediatric cardiology, pediatric nephropathy, pediatric hematology, pediatric neurology, pediatric immunology, pediatric surgery, child health care, neonatology, oral cavity, otolaryngology, ophthalmology, TCM rheumatism, TCM endocrinology, TCM gynecology, TCM digestion, TCM oncology, anesthesia, geriatrics (geriatric cardiovascular diseases), rehabilitation medicine, emergency medicine, intensive care medicine, nuclear medicine and phase I clinical laboratory. Given this, the Hospital mainly undertakes Phase I, II, III and IV clinical trials for drugs, medical devices and diagnostic reagents. In 2014-2018, the Hospital undertook a total of 421 registered clinical trials, ranking fifth in China for the number of clinical trials undertaken as certified by the Center for Drug Evaluation (CDE) of CFDA in 2019.

The Hospital, as a national demonstration clinical trial institution in compliance with GCP, has successfully applied for the Project of Significant New Drugs Development during the 12th Five-year Plan period Construction of An International Platform of New Drug Clinical Evaluation and Research Technology for Urogenital Tumors and the Project of Significant New Drugs Development during the 13th Five-Year Plan period Construction of An Innovative and Technologically Advanced Platform of New Drug Clinical Evaluation and Integrated Service for Diabetes.

Multiple departments in the Hospital have participated in the platform construction. The research group has published a total of 29 SCI papers, introduced 5 creative talents from abroad, obtained three patents including the "MBD2 expression inhibitor and its application", and carried out studies on the inhibitory effect of Zilongjin Tablets on the proliferation and invasive mechanism of bladder cancer. In addition, the Hospital has established clinical evaluation systems and standard specifications for different diseases to accelerate the founding of the Chinese Urological Oncology Consortium and the formulation of relevant guidelines, and then established an individual safety event reporting system based on ICH standards and a world-leading sentinel system for drug discovery and pharmacovigilance. Besides, a mother & infant cohort for gestational diabetes and a child & adolescent cohort for type 1 diabetes have been established.

With the support provided by the platform, the clinical trial management system of the Hospital has passed the national ISO-9001 quality system certification; the biobank has passed the quality control certification of International Society for Biological and Environmental Repositories (ISBER) and Integrated BioBank of Luxembourg (IBBL), and passed the Third-party Quality Control Certification of Biobank organized by China Medical Association. The Clinical Laboratory has passed the NewCap system certification in the United States; the routine pathological techniques, immunohistochemistry and molecular pathology of the Pathology Department have all passed the PQCC quality control of the National Health and Family Planning Commission (NHFPC), of which the molecular pathology has also passed the UK-NEQAS and EMQN quality control in the United Kingdom. Besides, the Pathology Department has been set as a Telepathology Consultation Center in Hubei by the NHFPC.

In terms of the construction of SOP system for clinical trials, the Hospital, along with the Hannover Medical School in Germany, has established an SOP system for institutions featured by international interoperability, and a "Sino-German Clinical Trial Center". It also has established an SOP system along with the Harvard Medical School, especially for urogenital tumors. A total of 25 experts have been sent to Harvard Medical School for further study on clinical researches and then managed to graduate.

In terms of information construction, the Hospital has set up AbsCTMS system for clinical trial data management, and EDC system for drug clinical trial data management.

The Phase I Clinical Trial Laboratory of Tongji Hospital, established in 2004, is located in Sino-French New City Branch, covering a building area of 1700 m2, equipped with an independent subject screening area, informed consent room, activity area for subject, working area, rescue room, catering room, dispensing room, drug room, sample processing room, sample storage room, data room, physical examination room, monitoring room and blood collection room. The Laboratory is set up to carry out phase I clinical trials, bioequivalence studies and consistency evaluations of new drugs. With 15 wards and more than 60 beds, it can handle multiple projects at the same time, satisfying the needs of different types of clinical studies.

The Laboratory currently employs 1 director, 1 deputy director, 3 principal investigators (PI), 8 full-time and part-time doctors, 3 full-time nurses, about 50 part-time nurses, 1 full-time medical technician, 2 full-time QAs and 6 pharmacists. All have passed the GCP training organized by CFDA, some have passed the ICH-GCP examination organized by ACRP, and some have participated in the Harvard Medical School Global Clinical Scholars Research Training (GCSRT).

The wards in Phase I Clinical Laboratory are well-equipped and well-organized. With etrial system for electronic whole-process management, well-established standard operating procedures (SOPs) and well-controlled forms, the integrity, authenticity and traceability of trial data and the quality of clinical trials can be guaranteed.

Since its establishment, the Laboratory has completed more than 100 projects, including tolerance trials (including injections and oral agents), pharmacokinetic trials, bioequivalence trials and consistency evaluations. Since the 722 Event, it has undertaken more than 50 projects, including targeting preparations, anti-tumor preparations, biological agents, psychiatric drugs, cardiovascular drugs, anti-infective drugs, diabetes drugs, digestive system drugs, vitamins and other endogenous substances, involving intravenous injections, intravenous installations, subcutaneous injections, suppositories, oral tablets, capsules, syrups, orally disintegrating tablets, films, aerosols, etc. After the 722 Event, 17 items have been qualified in the verification by CFDA.

Address and contact:

Address of institution office: 10F, Administrative Building of Tongji Hospital, No. 1095 Jiefang Avenue, Wuhan, Hubei.

Director of institution office: Du Aihua
Secretary of institution office: Shu Chang
Tel/Fax: 027-83663940

Email: tongjigcp@163.com

Address of Phase I Clinical Trial Laboratory: 7F, Outpatient Area A, Sino-French New City Branch of Tongji Hospital, No. 288 Xintian Avenue, Caidian District, Wuhan, Hubei Province

Director of Phase I Clinical Trial Laboratory: Liu Dong

Tel: 027-83663643

Contact person of Phase I Clinical Trial Laboratory: Ren Xiuhua/Chen Qian

Tel: 15902713190/13477019908