Clinical Trails
The clinical trial institution of PKUPH is responsible for the management of clinical trials of the whole hospital. The clinical trial institution of PKUPH is able to carry out phase I-IV drug clinical trials and may also undertake clinical trials of medical devices in vitro diagnostic reagents. In recent years, the institution has undertaken multiple international multi-center trials.
The clinical trial institution of PKUHP has been carrying out drug clinical trials since the 1980s and was one of the first pharmacology bases approved by the Ministry of Health. In 2007, 17 majors were certified granted by the State Food and Drug Administration (SFDA). In 2011 and 2015, 17 new majors passed the inspection of the drug clinical trial organization qualification certificate separately. In 2019, 10 new drug majors were approved by the National Medical Products Administration (NMPA). In July 2021, all of the 41 departments of the 27 majors of the hospital successfully filed on the website of the National Medical Products Administration (Record Number 2020000497).
PKUPH has won financial support from three special programs for construction from various superior supervision management departments:
1) National Major Special Science & Technology Program of the "Twelfth Five-year Plan" Period—construction of the international platform for clinical evaluation and research of new drugs against major diseases such as autoimmune diseases and viral hepatitis;
3) Beijing Science & Technology Project—Consistency evaluation and key technology research on major varieties of Beijing generic drugs such as Gliquidone and Pitavastatin.
Drug clinical trial institution continues to improve the organizational structure and quality control system, strive to provide sponsors and investigators with efficient services, ensure the standardization of the trial process, the truthfulness and reliability of the trial results and protect the rights and interests of the subjects.
