Clinical Trials Unit

Overview

The Clinical Trial Unit (CTU) at the First Affiliated Hospital of Sun Yat-sen University (FAH-SYSU) is a public platform dedicated to providing professional research services for clinical studies within the hospital. In 2012, the First Affiliated Hospital of Sun Yat-sen University cooperated with the University of Birmingham to formally initiate a collaborative partnership. In 2016–2017, CTU dispatched team members in two batches to the University of Birmingham for professional training. The team successfully established a highly professional clinical research team.

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Our team

A professionally complete clinical research team is formed by CTU, which is furnished with clinical research physicians, statistical specialists, epidemiologists, clinical research coordinators, etc. Professor KK Cheng is the team's chief scientist and a Fellow of the British Academy of Medical Sciences.

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Professor KK Cheng

Chief Scientist of CTU, FAH-SYSU
Fellow, Academy of Medical Sciences, UK
Director of the Institute of Applied Health Research, University of Birmingham
KK Cheng has published over 160 articles in international journals, including NEJM, Lancet, BMJ, and others.
KK Cheng plans to establish a representative cohort of middle-aged and elderly individuals in the Greater Bay Area, starting with the health examination center at the First Hospital of Sun Yat-sen University and the key cooperative community health center in Guangzhou. The initiative aims to cover 10 community centers, encompassing a total of 20,000 elderly individuals.

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Scope of Services

CTU is a public platform devoted to provide professional research services for hospital-based clinical investigations. Its primary responsibilities include offering clinical departments a comprehensive variety of scientific research services, including study design, project implementation, quality control, and statistical analysis. Over thirty clinical departments have benefited from CTU's in-person statistical analysis advice and research design services in the past few years, reaching 129 projects. The services offered cover the following areas: consulting and advising on clinical study design, sample size calculations, case report form design, and research protocol writing; assisting with literature retrieval and clinical trial registration; advising on mid-term and final analyses in clinical trials; and advising on statistical analysis for observational studies. High-impact publications like JCO and Lancet Digital Health have published research findings that CTU and clinical departments collaborated on.
In addition to conducting more than 20 international collaborative training sessions on topics like observational research, randomized controlled trials, single-arm trials, adaptive design, etc., CTU regularly arranges clinical research training. It has collaborated on these training sessions with institutions like Harvard University and the University of Birmingham. Furthermore, tailored courses and specialized lectures are offered in response to the particular requirements of fields like surgery, intensive care, and internal medicine.
The scientific evaluation of Investigator-Initiated Trials (IITs) falls under the purview of CTU as well. CTU processes more than 900 IITs a year. In addition, CTU offers project application support and has successfully supported 15 clinical research projects under the FAH-SYSU 2030 Program and SYSU 5010 Program.

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