Phase I Clinical Trail Ward in Tianjin medical university tumor hospital was established on September 8, 2015, the only single ward available for both anti-tumor phase I clinical trail and bioequivalence trails in Tianjin ,as well as one of the most advanced and large phase I clinical trail ward in China. Our ward is equipped with complete hardware and software, including advanced facilities, excellent medical research team, systemic management system and standard operating procedures in line with international standard. We make sure to provide a complete protection for the rights and interests of subjects. At present, there are more than 20 projects in our center, all of which are carrying out successfully without any treatment- related death. All the treatment- related expenses in hospital are paid by the sponsors, so the subjects need not to afford the expense.
Faculty / Staff
There are 28 beds in total, each ward occupied an area of more than 20 square meters, including a TV and a single bathroom. Our medical equipments is complete and advanced, including 1 first aid facility, 1 respirator, 2 ECG, 5 electric monitor, 8 infusion pump, 2 refrigerator: one is -4℃, another is -80℃, and 2 centrifuge. We prepare a room specially for storing the specimen, and we also have a private conversation room, a meeting room, a examination room, as well as CRC room. GPS satellite synchronous clock system is installed around our wards to make sure clinical trail proceed strictly on time, and the ward is also equipped with a perfect video monitoring system, so as to facilitate the research medical staff to monitor the subjects.
There are more than 10 medical staff in the phase I clinical ward, consisted of 1 head of the department, 3 doctors, 8 nurses and 20 CRC. All the medical staff have received GCP training, and are skilled in clinical trails and emergency rescue with rich experience. Meanwhile, we formulated SOP with our ward characteristics and strictly implemented in clinical trails. The staff in phase I clinical trail ward follow the principles of science and ethics, take the rights and safe of subjects as the primary consideration, hold a considerable and rigorous attitude, to make contribution to the research of new anti-tumor drugs in China.
Since our department was established in 2015, we have accepted nearly 30 projects till now, 20 of them are still under research. From 2017, we took on larger amounts of projects than 2016.We screened 538 subjects and 186 of them have enrolled in the clinical trail successfully. On july 2017, our first BE trail of 40 health subjects was carried out in our department successfully, after that 160 health subjects in total participated in the Phase I clinical trails in our department . 2018 continues the excellent performance in 2017and the workload is almost in line with that in 2017, our ward will make greater progress in the future.