The Team
This project is a collaborative initiative involving the University of Sheffield, Sheffield Clinical Trials Research Unit (CTRU) and Health Economics and Decision Sciences (HEDS); Cardiff University, Centre for Trials Research; Lancaster University, Department of Mathematics and Statistics; University College London; and the University of Western Australia. Contributors are:
Dr Munya Dimairo
Dr Munya Dimairo is a Trial Statistician and Research Fellow at the Sheffield CTRU, University of Sheffield. Munya is involved in the design, conduct, analysis, and reporting of several trials including adaptive trials. His research interests include novel statistical methods to improve trial efficiency (such as adaptive designs), approaches to improve and accelerate the appropriate uptake of these methods into practice, and how to improve the reporting of trials using such methods. He serves as an Independent Statistician on several data monitoring and trial steering committees.
Dr Philip Pallmann
Dr Philip Pallmann is a Senior Trial Statistician and Research Fellow at the Centre for Trials Research at Cardiff University, and the Deputy Director of the Research Design and Conduct Service for South East Wales. Having a strong interest in efficient trial designs, Philip is a member and former outreach officer of the Adaptive Designs Working Group of the MRC Trials Methodology Research Partnership (previously Network of Hubs for Trials Methodology Research). His current work is focused on clinical trials of sepsis and neurological disorders, using innovative designs, as well as the development of reporting and costing guidance for adaptive design trials.
Thomas Jaki
Thomas Jaki is Professor of Statistics at Lancaster University and Programme Leader at the MRC Biostatistics Unit at the University of Cambridge. His work focuses on efficient trials using adaptive and Bayesian methods. He is also the Director of the Medical and Pharmaceutical Statistics Research Unit which offers advice on the design and analysis of clinical studies and develops relevant novel statistical methods. He is an NIHR senior research fellow and Co-I of the Trials Methodology Research Partnership and co-leads its adaptive designs working group.
Dr Graham Wheeler
Dr Graham Wheeler is a Senior Statistician at the Cancer Research UK and UCL Cancer Trials Centre at University College London. He is the lead statistician on several cancer trials, many of which are investigating the safety and benefit of advanced or targeted therapies, and is an Independent Statistician on several data monitoring committees for both cancer and non-cancer studies. Graham’s research interests lie in the design, analysis and application of novel and adaptive trial designs, particularly in early phase clinical trials and Bayesian methods. He is a committee member for both the Early Phase Trials section of the NIHR Statistics Group and the NCRI’s Teenage & Young Adult and Germ Cell Tumours group, a member of the Adaptive Designs Working Group of the MRC Trials Methodology Research Partnership, and a Statistical Ambassador for the Royal Statistical Society.
Mr Mike Bradburn
Mr Mike Bradburn is a Senior Statistician at the Clinical Trials Research Unit at the University of Sheffield. Mike has extensive experience of RCTs and joined this project in his role of a generalist trial statistician to make the content as accessible as possible to those tasked with implementing novel designs.
Dr Laura Flight
Dr Laura Flight is a Research Associate in Health Economics and Statistics at the School of Health and Related Research (ScHARR), University of Sheffield. Laura is interested in innovative approaches to the design and conduct of clinical trials with an emphasis on how novel statistical methods can be applied in practice. In 2016 Laura was awarded an NIHR Doctoral Research Fellowship exploring the use of health economics in the design, monitoring and analysis of adaptive clinical trials. She is currently co-leading the Economics of Adaptive Clinical Trials (ENACT) project exploring how value-based adaptive clinical trial designs can be used in the efficient delivery of NIHR research.
Cindy Cooper
Cindy Cooper is Professor of Health Services Research and Clinical Trials and Director of the University of Sheffield Clinical Trials Research Unit (CTRU) based at ScHARR. She has been involved in designing and delivering health services research and clinical trials for over twenty years.
Cindy is currently involved in oversight of 17 studies within the CTRU, mainly randomised controlled trials. She is also chair of independent governance committees for other NIHR funded trials. Cindy is Deputy Director of the Design, Trials and Statistics Section, ScHARR and a member of the Programme Grant for Applied Research Funding Programme panel. She is currently a member of a number of other NIHR Committees including NIHR CTU Directors Executive Committee.
Dr Julie Marsh
Dr Julie Marsh is a Senior Research Fellow at the Telethon Kids Institute, University of Western Australia and Lecturer at the School of Mathematics and Statistics, University of Western Australia. We are grateful for her support and contribution during the grant application stage.
Project Collaborators
Sheffield Clinical Trials Research Unit
The Clinical Trials Research Unit (CTRU) is a UKCRC Registered Clinical Trials Unit providing high-quality support in running clinical trials in line with international regulatory standards, from the planning stages right through to analysis and reporting. Support is offered to investigators for trial design and protocol development, trial management, statistical advice and analysis, economic evaluation and data management (including randomisation and database development), along with advice on funding sources and the preparation of grant applications. The unit also supports methodological research alongside trials.
Where an application is successful, the unit will support the implementation of trials including ethics, research governance and MHRA submissions, together with site setup and monitoring, participant recruitment and dissemination. The unit is currently supporting research in several areas.
Cardiff Centre for Trials Research
The Centre for Trials Research (CTR) at Cardiff University is the largest group of academic clinical trials staff in Wales, with over 160 staff, and growing. The CTR is a UK Clinical Research Collaboration (UKCRC) registered clinical trials unit and home to researchers, trial managers, computer systems experts, data managers, administrators, quality assurance managers and statisticians. It is core-funded by Health and Care Research Wales and Cancer Research UK to enable applied research that informs policy in health and social care in Wales and the UK. The CTR research portfolio includes drugs trials and complex interventions, mechanisms of disease and treatments, cohort studies and informing policy and practice.
CTR researchers, professional staff and PhD students work across four divisions (Infections, Inflammation and Immunity; Mind, Brain and Neuroscience; Population Health; Cancer) to tackle the big diseases and health concerns of our time, including growing resistance to antibiotics, early cancer diagnosis and how to eliminate health inequalities. This is achieved by forming strategic partnerships with external investigators, both seasoned and new, and building lasting relationships with the public, whose participation is essential for the success of these studies.
Lancaster University
Lancaster is a research-intensive university that combines world-class research with excellent teaching and high levels of student satisfaction. Lancaster University is among the best in the UK. Top 10 in all three major national league tables, it is also highly ranked in international league tables such as the QS World Rankings, and it holds a Gold rating in the UK government’s Teaching Excellence Framework for the quality of its teaching.
The Medical Statistics group within the Department of Mathematics and Statistics provides an excellent environment for collaborative interdisciplinary research. The research ethos of the group is firmly based on the interface of theory and practice.
MRC Biostatistics Unit
The Medical Research Council (MRC) Biostatistics Unit (BSU) is one of the largest groups of biostatisticians in Europe, and a major centre for research, training and knowledge transfer in biostatistics.
The Unit was founded in 1913 at the same time as the MRC. The BSU is internationally renowned for the strength of its research and its successful strategy of maintaining a unique balance between statistical innovation, dissemination and engagement with making an impact in biomedical and public health issues. The BSU’s mission is to promote the development and application of innovative statistical methods in the health sciences for the improvement of health.
The Cancer Research UK & UCL Cancer Trials Centre
The Cancer Research UK & UCL Cancer Trials Centre (CRUK & UCL CTC) designs, develops, and conducts national and international trials and research projects to the highest quality and standards. The Unit currently has more than 100 staff and is running between 100-120 trials, with the care of patients on trials provided by hospitals and clinics in the UK and abroad.
The CRUK & UCL CTC is a research department within the University College London (UCL) Cancer Institute and is part of the Cancer Research UK Centre at UCL. We are a UK Clinical Research Collaboration (UKCRC) registered Clinical Trials Unit and NCRI Cancer Clinical Trials Unit group member recognised for its experience and expertise in the development and delivery of clinical trials and research projects about cancer.
The CRUK & UCL CTC has five key aims. These are:
- To develop and conduct high-quality trials to update clinical practice and improve outcomes for patients
- To evaluate new ways of treating or detecting a wide variety of cancers using multi-modal approaches
- To encourage and nurture national and international collaboration with other researchers in cancer
- To translate laboratory innovations into clinical trials and generate new treatments
- To train and develop a new generation of cancer clinical trials specialists
Health Economics and Decision Science (HEDS), School of Health and Related Research, University of Sheffield
HEDS makes major contributions in areas that include the valuation of health, the analysis of health policy, welfare and equity, technology appraisal, evidence synthesis, econometrics and information sciences. Within our economic evaluation portfolio we undertake both prospective evaluations alongside trials and model-based evaluations based on existing evidence.
We are involved in over 50 economic evaluations every year, ranging from small study evaluations through to programmes of research and randomised controlled trials lasting several years. In addition to these current evaluations, we are world-leaders in the development of cutting-edge research methods that are shaping the way that evaluations will be undertaken in the future