Brief Introduction of the Institution
Beijing Tiantan Hospital affiliated to the Capital Medical University, is a large upper first-class general hospital with the characteristic of neuroscience especially associated with neurosurgery serving as a precursor, and it consists of the institute of Neuroscience, Chinese Academy of Medical Sciences. The drugs’ clinical trials organization in our hospital was founded in 1997, and it was renamed as Beijing Tiantan Hospital National Drug Clinical Trial Institution (hereinafter referred to as the Institution) after the approval by the State Food and Drug Administration (SFDA) in 2004.
Our institution was re-checked by the SFDA in 2008, and the certificate was issued in 2011. 10 professional disciplines were certified to have the professional qualification of taking drugs’ phaseⅡ-IV clinical trials by the SFDA, and the 10 professional disciplines contained neurology department, neurosurgery, vasculocardiology deparment, endocrine, gastroenterology, anesthesia, medical imaging (diagnosis), obstetrics and gynecology, general surgery and orthopedics. After the institution’ certification, 11 projects have been completed, 10 projects are being studied, 7 projects are being prepared to carry out. The hospital has advanced medical equipments, and there are many patients came from all over the country each year, which could provide sufficient patients for drugs’ clinical trials. The hospital established the Drug’s Clinical Trial Institution Office, and the Institution established the corresponding management system, design specification and standard operating procedures associated with the drug’s clinical trials. They have a wealth of clinical trials experiences. The management personnel and professional technical personnel accept the drugs’ clinical trials’ technology and knowledge of GCP training. The procedures of the drugs’ clinical trials are strictly complied with GCP.
The hospital has a comprehensive clinical drug research infrastructure and technical conditions, and has the prerequisites to carry out the drugs’ clinical trials, in order to ensure the quality of the drugs’ clinical trials.
The new drugs’ clinical studies in the field of neurology have a high reputation at home and abroad, which could ensure the successful implementation of the projects.
The Institution has much experience on domestic clinical research and international multi-center clinical studies for many years. The Institution also undertakes the responsibility for establishing the technology platform (ie the GCP platform for cerebrovascular drugs’ research) for the clinical evaluation of the innovative drugs on cerebrovascular diseases during the period of Eleventh Five and Twelve Five. The Institution has the ability to chair or participate in the international multi-center clinical trials, and it can independently design, organize and implement and complete the drugs’ clinical trials in accordance with international principles and norms.
The hospital was recently named as the only one research center in China- "the National Research Center for Clinical neurological diseases." The center was formally approved in August, 2013. It is a major initiative of deepening of the national medical system reform and carrying out the《Medical science and technology development of “the twelfth five-year plan"》. It is also the clinical medicine and translational research center on neurological diseases founded by the Ministry of Science and the National Health and Family Planning Commission, in order to strengthen medical science innovation system construction and enhance the clinical research capacity. The responsibility of the center is to promote clinical studies and technology popularization of neurological diseases.
Medical Ethics Committee in our hospital applied for and obtained thecertification from SIDCER / FERCAP ethics committee in 2010. The workflow and work procedures of the ethics committee were standardized through the international cooperation and exchanges. The responsibility system of the presiding commissioner was carried out for the ethics committee. It has passed the three years’ re-check, and it could provide the good ethical review for clinical trials, in order to protect the welfare and safety of human subjects and ensure the quality of the drugs’ clinical trials.