Design and Conduct of High Quality Randomised Clinical Trials

Clinical trials are the cornerstone of evidence-based medicine. Well-designed and well-conducted trials can positively impact patients, healthcare professionals, and providers. They evaluate a wide range of interventions—including drugs, therapies, procedures, and medical devices—throughout their development, from early stages to real-world application in health systems. However, trials must be conducted efficiently, rigorously, and transparently to protect participants' safety and rights and to prevent research waste. Before designing or managing a clinical trial, proper training is essential.

“Design and conduct of high quality randomised clinical trials” is a hybrid training programme, designed and delivered by a team based in the Nottingham Clinical Trials Unit, Nottingham, UK, who have substantial expertise in clinical trial design and management. The programme training is designed for health professionals and researchers who are interested in undertaking a preliminary course in clinical trials.

Its primary aim is to ensure that course participants fully understand core concepts in clinical trial design, including basic statistical considerations, management and oversight. 

Target Audience

This training program is open to a diverse range of participants in the clinical trials field and is particularly well-suited for the following groups:

• Hospital Researchers, Clinicians, and Nurses: Healthcare professionals seeking an in-depth understanding of clinical trial design principles, data analysis methods, and quality control processes to conduct or participate in high-level clinical research; including hospital research administration personnel, clinicians and researchers from clinical research departments.
• Researchers from Medical Institutions: Master's students, PhD candidates, postdoctoral researchers, and early-career research faculty from medical schools and research institutions.
• CRO (Contract Research Organisation) Practitioners: Project managers, monitors (CRAs), and data managers undertaking or collaborating on clinical trial projects, aiming to enhance capabilities in project design, execution, and quality oversight.
• Biostatisticians and Epidemiologists: Individuals with backgrounds in statistics, bioinformatics, or epidemiology who wish to strengthen skills in randomisation design, sample size estimation, and statistical analysis, and engage in interdisciplinary team collaboration.
• Research Coordinators and Project Managers: Research management personnel responsible for project coordination and site management, seeking to improve project execution efficiency and oversight capabilities.
• Public Health and Health Policy Researchers: Scholars focused on clinical evidence generation and translation, desiring to master methods for trial evaluation and result interpretation to support policy formulation and evidence-based decision-making.

This course, delivered through a combination of online theoretical instruction and offline practical exercises, is designed to help the aforementioned groups develop comprehensive competencies spanning design, implementation, and oversight, enabling them to rapidly become proficient in the full lifecycle of clinical trial work.

Based on extensive feedback from potential course participants, the programme has been designed to be hybrid, incorporating a one-day in-person training session at the University of Nottingham Ningbo Campus, followed by eight live online lectures and four pre-recorded lectures that can be accessed at delegates' convenience.

The draft programme, which may be subject to minor changes, is below:

* Subject to change

World-leading clinical research system

Drawing on decades of mature and leading expertise in UK clinical medicine, this course has been meticulously developed by authoritative experts. Its core content originates from the highly-regarded clinical trials training programme developed by one of the UK’s top clinical trials units, Nottingham Clinical Trials Unit at the University of Nottingham, UK. The UK holds a globally leading position in designing and delivering high-quality, high-impact clinical trials, with these trial outcomes not only transforming clinical practice but also being published in world-leading journals.

Customised debut course exclusively for China

This course has been specifically developed for the Chinese market, exclusively designed to meet the needs of Chinese learners. Adapted from our premium UK course continuously delivered since 2017, it makes its debut delivery in China. The content thoroughly considers China’s medical research environment, regulatory frameworks, and practitioner requirements, directly responding to the learning preferences expressed by Chinese clinicians and healthcare professionals. It delivers expertise in designing and managing high-quality large multi-centre randomised clinical trials, ensuring practical applicability and local relevance of knowledge and skills.

World-class faculty

Training delivered by a world-class Faculty of professors, academics, and practitioner-experts, with decades’ of expertise in the design and conduct of large, pragmatic randomised trials. Leading academic staff based in one of the UK’s most active and leading UKCRC-registered Clinical Trials Units will be on hand to share their expertise throughout the programme.

Hybrid Delivery (Online and In-Person) with English-Language Instruction and British Pedagogy

As a flagship programme within the University of Nottingham's global network, this course delivers authentic British higher education while creating a comprehensive English-immersion learning environment. The course will commence with in-person instruction in Ningbo, focusing on fundamental clinical trial design training. This on-site intensive component will establish knowledge foundations, build professional networks, and foster peer support systems. Subsequent content will be delivered online through live interactive sessions and pre-recorded modules.

Open and shared training resources

All training materials will be made accessible to course participants.

 Complete the project and receive the official certificate from UNNC

After the successful completion of the programme, an official programme certification from the University of Nottingham Ningbo China can be obtained.  

Professor Alan Montgomery

Professor Alan Montgomery is Professor of Medical Statistics and Clinical Trials, and Director of the Nottingham Clinical Trials Unit. Professor Alan has served on national clinical trial funding bodies in the UK for many years, deeply involved in shaping the UK’s clinical trials framework. and has completed over 40 major clinical trials that test the effectiveness of complex interventions, drugs and devices across a range of clinical areas and settings. Additionally, as one of the UK’s leading clinical trials methodologists, Alan collaborates on methodology research to improve the design, conduct and reporting of randomised trials. He has published more than 200 peer- reviewed articles, and has extensive experience as an independent chair and member of trial data monitoring and steering committees.

Professor Ed Juszczak

Professor Ed Juszczak is Professor of Clinical Trials and Statistics in Medicine, and Research and Knowledge Exchange Lead at Nottingham Clinical Trials Unit. Ed has over 25 years of experience in the design, conduct, analysis, interpretation and reporting of clinical trials, specialising in the perinatal field and multi-arm trial methodology. He was a key member of the RECOVERY COVID-19 trial team. Ed has 11 trial publications in The New England Journal of Medicine and is a co- author of numerous reporting guidelines including CONSORT extensions for reporting multi-arm parallel-group and factorial randomised trials and trial conducted using routinely collected health data.

Professor Jane Daniels

Professor Jane Daniels’ early career was in molecular biology and immunology. She left laboratory research to become a clinical trial manager at BCTU. Over 20 years she became an experienced academic clinical trialist and established its reputation as the leading trials unit for women’s health in the UK. She was integral to the development of a clinical trials partnership between the University of Birmingham and Wenzhou Medical University. In 2017, Jane was appointed as Professor of Clinical Trials and Deputy Director of NCTU, where she continues to develop her portfolio of research in women's health and complement this with trials in new clinical areas. She undertakes translational and definitive randomised controlled trials and test evaluation studies, and complements this primary research with systematic reviews and meta-analyses. Her research has been published in all major general medical journals and she is a member of national funding committees.

Dr Eleanor Mitchell

Professor Eleanor Mitchell is Professor of Clinical Trials and Global Health. Eleanor has over 20 years’ experience in the design and conduct of large, pragmatic randomised trials, particularly in maternal and newborn health. She is the Chief Investigator of several large publicly-funded RCTs. Eleanor is passionate about ensuring the patient voice is heard in the design and conduct of trials and leads patient and public engagement initiatives in the trials she leads. She also leads trials and mixed- methods studies collaborating with clinicians in low and middle income countries, particularly in Africa. She is the Director of Global Engagement in the School of Medicine at the University of Nottingham, and until recently Chair of the UK Trial Managers’ Network, a leading network of trial management professionals.

Dr Chris Partlett

Dr Chris Partlett is Assistant Professor of Medical Statistics and Clinical Trials. He has 10 years’ experience collaborating on various projects, predominantly randomised trials, in a variety of clinical areas. Chris also leads and collaborates on methodology research to improve the design, conduct and reporting of trials. He is a member of the research advisory board for a funding panel and is the chair and independent member of several Trial Steering and Data Monitoring committees.

Mr Garry Meakin

Mr Garry Meakin is a Senior Trial Manager with over a decade of experience in clinical research. Starting his career as a scientist specialising in respiratory medicine he has since gone onto play a key role in delivering multi-centre randomised controlled trials across diverse therapeutic areas, gaining extensive expertise in the full lifecycle of clinical trials. Garry is a co-investigator on several publicly-funded multi-centre trials. He has a strong interest in trials methodology, with a particular focus on risk-based monitoring. He is a member of several large national clinical trial networks and is Deputy Chair of the NCTU Research and Knowledge Exchange Committee.

Programme fee: 6,000 RMB

Early bird fee: 5,000 RMB 

*This charge encompasses the course fee and related materials cost.Excluding unspecified costs including but not limited to transportation, accommodation, and dining.

Scan the QR code above to complete the registration information.  

• Upon receiving your registration form, we will promptly get in touch with you and assist in finalizing the subsequent payment formalities. 
• E-mail：claudia.cai@nottingham.edu.cn
• Tel：88180000-8355/88180016

The Nottingham Clinical Trials Unit (NCTU) is part of the School of Medicine, within the Faculty of Medicine and Health Sciences at the University of Nottingham, UK. The School ranked 67th globally in the field of Medicine & Life Sciences in the 2024 QS World University Rankings. It was ranked first in the UK for real-world impact in Public Health and Primary Care in the 2021 Research Excellence Framework (REF) assessment, and also ranked top in the UK for Anatomy, Physiology & Pathology in the 2024 National Student Survey (NSS). NCTU has expertise in the core competencies required for design and conduct of high-quality, high-impact trials: including experienced trialists, trial management, data management and systems programming, statistics, health economics and quality assurance. 

The University of Nottingham Ningbo China was approved by the Ministry of Education in 2004 and is the first Sino-foreign cooperative university in China with independent legal person status and its own campus, offering undergraduate and postgraduate education including master’s and doctoral degrees. The university consists of three colleges: the University of Nottingham Business School (China), the College of Science and Engineering, and the College of Humanities and Social Sciences, as well as an independent English Language Teaching Center. It shares the abundant resources of the University of Nottingham in the UK, its Malaysia campus, and global partners, including Fortune 500 companies, renowned business consulting firms, and 140 partner universities in 41 countries.

The Nottingham Ningbo GRADE Centre, established through a collaboration between the University of Nottingham Ningbo China and the GRADE Working Group, serves as a hub for advancing evidence-based research and decision-making. Specializing in evidence synthesis and guideline development, it promotes rigorous methodology in health, social sciences, and policy research. By fostering interdisciplinary collaboration and capacity-building workshops, the Centre empowers researchers and policymakers to apply GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) frameworks, ensuring transparent, high-quality evidence and trust-worthy guidelines to address global and local challenges.