Clinical Trials Unit

Clinical Trials Unit (CTU) the First Affiliated Hospital of Sun Yat-sen University was formally established in 2014. CTU is public platform, specializing in the design, conduct and analysis of definitive clinical studies. We currently have trial offices, a statistical consulting office, archives and a big data machine room. Staffs are divided into specialist multi-disciplinary teams of director, deputy director, clinicians, biostatisticians, epidemiologists, trial management and nursing staff, quality management and monitor and etc.

In 2013, the First Affiliated Hospital of Sun Yat-sen University signed a cooperation contract with University of Birmingham over the development of a clinical trials unit, based on which CTU develops close links with Birmingham Clinical Trials Unit (BCTU) and Cancer Research Clinical Trials Unit (CRCTU). Staffs of CTU are regularly sent to these two centers to be educated and trained systematically. Under the guidance of mentors of these two centers, staffs are fully involved in putting forward research ideas, writing and improving trial protocols, writing trial management plans and implementing all the plans, thus ensure the standardization and normalization of each trial.

At this stage, CTU majorly focus on clinical problem-driven real world big data integration and data mining and the design and conduct of phase II and phase III trials. We open to all clinical research projects of our hospital, and our major responsibility is to supervise, to coordinate and to serve these projects. We provide project approval, protocol review, costing, project implementation, quality control, statistical analysis and other professional services. Meanwhile, driven by the real world big data, CTU are committed to developing a high-efficiency, high-quality clinical research public platform by combining real world data and precision medicine.

Collaboration with?the University of Birmingham,?UK

The co-operative relationship between the First Affiliated Hospital of Sun Yat-sen University (SYSU 1st?hospital) and the University of Birmingham (UoB) began in 2012. SYSU 1st?hospital had signed several Memorandums of Understandings with UoB in recent years, for example Memorandum on scientific research, education and clinical trials, and Memorandums on comprehensive cooperation on medical science, teaching and research. Based on years of cooperation，SYSU 1st?hospital and UoB have maintained good bilateral relations.

In 2013, SYSU 1st?hospital and UOB signed a Memorandum on joint initiative of Clinical Trials Unit, which tend to explore collaboration concerning the establishment of a Clinical Trials Unit in SYSU 1st?hospital. Under the terms of this memo, UoB will offer customized training courses appropriate for the staff of SYSU 1st?hospital focused on building the capacity and experience for the development and conduct of clinical trials. This joint initiative aims to draw support from global resources and experience of UoB, combing with rich case resources of SYSU 1st?hospital and to develop a clinical trials unit that meets international standard.

Experts from UoB were sent to SYSU 1st?hospital to conduct on-site inspection and complete site selection in 2015. A formal agreement was signed the next year. Following this agreement, the first cohort of trainees including clinicians, statisticians and trial coordinators were sent to UoB in July 2016 and the second cohort are ready to be sent later in 2017.

Radiofrequency ablation combined neo-MASCT for primary hepatocellular carcinoma: a phase II trial (RAMEC) is the first trial conducted by Clinical Trials Unit of SYSU 1st?hospital with guidance of UoB on trial design and protocol planning. The trial protocol was submitted to and approved by the Research Ethics Committee of SYSU 1st?hospital in February 2017, and Guangzhou Science Technology and Innovation Commission provided funding for this trial, and it will open for recruitment around July 2017.