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Clinical Trials

The Clinical Pharmacology Research Center of PUMCH was founded in 1995, developed from a clinical pharmacology base for endocrinology approved by the Ministry of Health in 1983. It is responsible for clinical drug trials of the whole hospital, and also functions as a clinical pharmacology base of the Ministry of Health and a clinical trial institution of the China Food and Drug Administration (CFDA). Administratively it is under the leadership of the PUMCH president and in business it is under the guidance and supervision of CFDA. For more than two decades, the Center has been under the support of PUMCH leaderships. Funds were allocated to improve its facilities. Now it covers an area of 2,469 square meters, being one of the largest clinical drug trial institutions in China.

The Center established in 1996 an independent Ethics Committee, to be responsible for examining all trials of drugs at I, II, III and IV phases and of medical devices. The Committee is highly reputed for its adherence to strict examination and independent judgment. In 1998, the Center was approved by the Ministry of Health to own special groups for 17 kinds of drugs. In 1999, it passed a joint inspection of the Ministry of Science and Technology and CFDA to become a national GCP center, being the only comprehensive one among China's 10 GCP centers. Its 25 special groups, upon an on-site inspection of CFDA in 2008, received qualifications for clinical trial of drugs, and passed re-inspections in 2012, and approval was granted to 11 special groups newly applied. Presently the Center houses 36 special groups, being the largest one of its kind in China. In the recent three years the Center ran nearly 300 projects annually, and received approval for nearly 150 new projects annually.

Its Phase I Clinical Research Office, founded in 1996, is devoted to the phase I clinical trial of new drugs and the analysis, testing of biological specimens. Now it houses a phase I ward of 40 beds and a biological analysis lab with advanced equipment and strict management. After more than a decade's development, the Office has in recently years gradually shifted to first-time-in-man and data intensive trials, and has grown into a professional phase I clinical research institution that is first-class in China and internationally competitive.

Ever since its founding, the Center has been strictly adhering to state laws and regulations, and has established and maintained various managerial rules and SOPs. Under the motto of "scientific methods, standard operations, complete management and quality services", the Center has been striving to improve the conditions and capacity for research, and steadily improved the quality and quantity of clinical trials in the hospital. It contributed significantly to the clinical drug research in China and has grown into a first-class clinical pharmacology research institution in the country.