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 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.
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 the following areas, among others:
- Phobias
- Crohn’s Disease
- Cystic Fibrosis
- Diabetes
- IVF
- Amyotrophic Lateral Sclerosis (ALS)
- Autism
- Major Trauma Triage
- Pandemic Respiratory Infection
- Ulcerative Colitis
- Multiple Sclerosis (MS)
- Ovarian HyperStimulation Syndrome
- Venous Thromboembolism (VTE)
This unit receives National Institute for Health Research CTU Support Funding. This funding has been awarded to support the unit in developing and supporting NIHR trials.
If you have a study in mind, please contact us to discuss your requirements: ctru@sheffield.ac.uk.
Current Trials and Studies
| Title | Chief Investigator/ Organisation | Funding Body | Status |
|---|---|---|---|
| ASPECT: Alleviating Specific Phobias Experienced by Children Trial | Professor Barry Wright, Leeds and York Partnership NHS Foundation Trust | Health Technology Assessment | Reporting |
| AWARE-IBD: Putting people with inflammatory bowel disease (IBD) in control of their care. | Professor Alan Lobo, Sheffield Teaching Hospitals | The Health Foundation | Recruitment |
| BASIS: Bracing Adolescent Idiopathic Scolio-sis | Mr. Ashley Cole, Sheffield Children’s NHS Foundation Trust | Health Technology Assessment | Recruitment |
| COMMEND: A feasibility study and randomised controlled trial of acceptance and COMmitment therapy for people with Motor nEuroN Disease | Dr Rebecca Gould, University College London | Health Technology Assessment | Recruitment |
|
DAFNEplus: Developing and trialling the DAFNEplus (Dose for Adjustment for Normal Eating) intervention. A lifelong approach to promote effective self-management in adults with type 1 diabetes |
Prof Simon Heller, Sheffield Teaching Hospitals NHS Foundation Trust / University of Sheffield | NIHR Programme Grant for Applied Research | Recruitment |
| DIAMOND: Development of generalisable methodology for n-of-1 trials delivery for very low volume treatments (DIAMOND) |
Liv Hawksworth (Research Assistant at Sheffield Clinical Trials Research Unit) |
NIHR CTU Support Funding. | |
| HELP Infertility?: What is the clinical and cost-effectiveness of hysteroscopic removal of submucosal fibroids and polyps in women presenting with infertility and recurrent miscarriage? |
Mostafa Metwally Sheffield Teaching Hospitals |
National Institute for Health Research, Health Technology Assessment | Recruitment |
|
OptiCALS: A programme to develop and evaluate a complex intervention to improve nutritional management for people with Amyotrophic Lateral Sclerosis (ALS) |
Professor Christopher McDermott, Sheffield Teaching Hospitals NHS Foundation Trust / University of Sheffield | National Institute for Health Research | Recruitment |
| MAGIC: Melatonin for Anxiety prior to General anaesthesia In Children | Professor Chris Deery, School of Clinical Dentistry | Health Technology Assessment | Recruitment |
| MATTS: Major Trauma Triage Tool Study | Gordon Fuller, University of Sheffield | Health Technology Assessment | Analysis |
| MEErKAT: MEsenteric Excision and Kono-S Anastomosis Trial (MEErKAT). | Steven Brown, Sheffiield Teaching Hospitals NHS Foundation Trust | EME | Recruitment |
|
MissionEB: Double blinded placebo control study of Mesenchymal Intravenous Stromal cell Infusions in children with recessive dystrophic Epidermolysis Bullosa. |
Dr Anna Martinez, Great Ormond Street Hospital | The Efficacy and Mechanism Evaluation (EME) Programme, NHS England and Cure EB | Recruitment |
| MSS3: Multiple Symptoms Study 3: Pragmatic trial of a community based clinic for patients with persistent (medically unexplained) physical symptoms | Professor Chris Burton, Academic Unit of Primary Medical Care, University of Sheffield | NIHR Health Services and Delivery Research (NIHR HS&DR) Programme | Follow-Up |
| OPTION-DM: Optimal Pathway for TreatIng neurOpathic paiN in Diabetes Mellitus trial | Professor Solomon Tesfaye, Sheffield Teaching Hospitals | NIHR Health Technology Assessment | Reporting |
|
ORION: RadiO fRequency ablatION for haemorrhoids |
Professor Steven Brown, Sheffield Teaching Hospitals | NIHR Health Technology Assessment (HTA) | Recruitment |
| PRIEST: Pandemic Respiratory Infection Emergency System Triage | Professor Steve Goodacre, University of Sheffield | NIHR Health Technology Assessment | Reporting |
| PITSTOP: PIlonidal sinus Treatment: STudying the OPtions | Professor Steven Brown, Sheffield Teaching Hospitals | NIHR Health Technology Assessment | Follow-Up |
| PHEWS: (Pre-Hospital Early Warning scores for Sepsis) Accuracy, impact and cost-effectiveness of pre-hospital clinical early warning scores for adults with suspected sepsis | Prof. Steve Goodacre, University of Sheffield | NIHR Health Technology Assessment | Analysis |
| STAR MS: Autologous stem cell transplantation versus alemtuzumab or ocrelizumab in relapsing remitting multiple sclerosis | Prof John Snowden, Sheffield Teaching Hospitals NHS Foundation Trust | EME Programme | Recruitment |
| STOP-OHSS: Shaping and Trialling Outpatient Protocols for Ovarian HyperStimulation Syndrome | Mostafa Metwally, Sheffield Teaching Hospitals NHS Foundation Trust | NIHR Health Technology Assessment | Recruitment |
| TUDCA: Testing the safety and effect of tauroursodeoxycholic acid on disease progression | Prof Chris McDermott , University of Sheffield | Horizon 2020 Research and Innovation Programme | Recruitment |
Methods projects
| Title | Chief Investigator / Organisation | Funding Body |
|---|---|---|
| ACCESS: A collaborative study between CTUs and other researchers to identify the activities needed to improve representation of under-served groups in trials and understand their implementation |
Katie Biggs, University of Sheffield |
NIHR |
| BRAINS: Benefit-risk is a methodology used to simultaneously evaluate multiple aspects of a treatment i.e. the effectiveness on the primary health outcome, safety and cost. | Professor Steven Julious, University of Sheffield | Medical Research Council |
| ENACT: EcoNomics of Adaptive Clinical Trials | Laura Flight, University of Sheffield | NIHR CTU Support Funding (2019 call) |
| Equality, diversity and inclusion (EDI) in early phase trials | Robin Chatters | NIHR |
| Robin Chatters, University of Sheffield | NIHR CTU Support Funding | |
| RHABIT: Recording HArms in Behavioural change Intervention Trials |
Diana Papaioannou, University of Sheffield |
NIHR CTU Support Funding |
PhD supervised projects
| Title | Chief Investigator/ Organisation |
CTRU Supervisor |
Funding Body |
|---|---|---|---|
| Evaluating the intervention fidelity of computer therapy for aphasia post-stroke | Madeleine Harrison | Prof. Cindy Cooper | Stroke Association Fellowship |
| ILAT: Pilot trial of Intensive Language Action Therapy | Nicola Crook | Dr. Daniel HInd | Health Research Authority |
| The implementation and acceptability of a Minimum Intervention Care pathway for children with carious permanent teeth attending NHS dental practice – a feasibility study. | Bhupinder Dawett | Diana Papaioannou | National Institute for Health Research |
Completed Trials and Studies
| Title | Chief Investigator | Funding Body |
|---|---|---|
| 3MG (Magnesium sulphate for treatment of severe acute asthma) | Prof Steve Goodacre MCRU Emergency & Immediate Care, ScHARR |
Health Technology Assessment |
| The ACE Project | Dr. Munya Dimairo, University of Sheffield | National Institute for Health Research CTU Funding |
| ACUTE: Use, Treatment effect and Economics) feasibility study: A pilot randomised controlled trial of prehospital CPAP for acute respiratory failure | Gordon Fuller, University of Sheffield | Health Technology Assessment |
| ASTIClite: Autologous Stem cell Transplantation In refractory Crohn’s disease – Low Intensity Therapy Evaluation | Prof James Lindsay, Bart's Health NHS Trust | Efficacy and Mechanism Evaluation (EME) Programme |
| BEADS: Behavioural Activiation therapy for Depression After Stroke | Shirley Thomas, Division of Rehabilitation & Ageing, University of Nottingham | Health Technology Assessment |
| Big CACTUS: A study to assess the clinical and cost effectiveness of aphasia computer treatment versus usual stimulation or attention control long term post stroke (CACTUS) | Dr Rebecca Palmer, Rehabilitation and Assistive Technology (RAT) group, ScHARR | Health Technology Assessment |
| Booster Trial: A randomised controlled trial and cost-effectiveness evaluation of 'booster' interventions to sustain increases in physical activity in middle-aged adults in deprived urban neighbourhoods | Prof Liddy Goyder Public Health, ScHARR |
Health Technology Assessment |
| CACTUS (Computerised assisted language therapy pilot study) | Dr Rebecca Palmer Sheffield Teaching Hospitals |
Research for Patient Benefit |
| CFHealthHub Data Observatory | Dr Martin Wildman, Sheffield Teaching Hospitals | NIHR Programme Grant for Applied Research |
| CFHealthHub RCT: Development and evaluation of an intervention to support adherence to treatment in adults with Cystic Fibrosis | Dr Martin Wildman, Sheffield Teaching Hospitals | NIHR Programme Grant for Applied Research |
| CoSMoS: CBT Software for the treatment of depression in people with MS | Dr Cindy Cooper CTRU |
MS Society Symptom Relief Research Initiative |
| DAVROS: Development and validation of risk-adjusted outcomes for systems of emergency medical care | Prof Steve Goodacre MCRU Emergency & Immediate Care, ScHARR |
Medical Research Council |
| DiPALS - A Randomised Controlled Trial Evaluating NeuRx/4 Diaphragm Pacing in Patients with Respiratory Muscle Weakness Due to Motor Neurone Disease | Dr Chris McDermott, Sheffield Institute of Translational Neuroscience | NIHR Health Technology Assessment |
| DiPEP: Diagnosis of Pulmonary Embolism in Pregnancy | Prof. Steve Goodacre, University of Sheffield | Health Technology Assessment |
| Endometrial Scratch: The Endometrial Scratch Trial | Mostafa Metwally Sheffield Teaching Hospital |
Health Technology Assessment |
| E-SEE: Enhancing Social-Emotional Health and Wellbeing in the Early Years: A Community-based Randomised Controlled Trial (and Economic) Evaluation of the Incredible Years Infant and Toddler (0-2) Parenting Programmes | Dr Tracey Bywater Institute for Effective Education, University of York |
National Institute for Health Research |
| HubBLe - Haemorrhoidal Artery Ligation (HAL) versus Rubber Band Ligation (RBL) for haemorrhoids | Steven Brown, Sheffield Teaching Hospitals NHS Foundation Trust |
Health Technology Assessment |
| HydroDMD - Hydrotherapy for Duchenne Muscular Dystrophy (DMD): a pilot and feasibility randomised controlled trial in children | Dr Peter Baxter, Sheffield Children's NHS Foundation Trust |
Health Technology Assessment |
| JtD: Journeying Through Dementia | Professor Gail Mountain, University of Bradford | Health Technology Assessment |
| I-Socialise: Investigating SOcial Competence and Isolation in children with Autism taking part in LEGO-based therapy clubs In School Environments | Prof. Barry Wright, University of York | NIHR Public Health Research Programme |
| Lifestyle Matters | Professor Gail Mountain, ScHARR, The University of Sheffield | Medical Research Council |
| MERIDIAN: Magnetic Resonance Imaging to Enhance the Diagnosis of Fetal Development Brain Abnormalities In Utero | Professor Paul Griffiths, Academic Unit of Radiology, The University of Sheffield | NIHR Health Technology Assessment |
| PANDA: A Practical Adaptive and Novel Designs Toolkit (PANDA) | Dr Munya Dimairo, University of Sheffield | NIHR CTU Support Funding |
| PLEASANT - Preventing and Lessening Exacerbations of Asthma in School-age children Associated with a New Term | Prof Steven Julious, ScHARR, The University of Sheffield | NIHR Health Technology Assessment |
| PLINY (Putting Life in Years): Evaluation of the Comparative Effectiveness and Cost Effectiveness of an Intervention to Promote Mental Wellbeing in Community Living Older People | Prof Gail Mountain Health Services Research, ScHARR |
NIHR Public Health Research Programme |
| PoPSTER: Patient preferences and current Practice for adults with STERoid resistant ulcerative colitis | Professor Alan Lobo, Sheffield Teaching Hospitals NHS Foundation Trust | NIHR Health Technology Assessment |
| PRACTICE: Pulmonary Rehabilitation and ACTIvity after COPD Exacerbations | Dr Rodney Hughes Sheffield Teaching Hospitals NHS Foundation Trust |
Health Technology Assessment |
| RATPAC: Randomised Assessment of Treatment using Panel Assay of Cardiac markers | Prof Steve Goodacre MCRU Emergency & Immediate Care, ScHARR |
Health Technology Assessment |
| REEACT: The randomised evaluation of the effectiveness and acceptability of computerised therapy.
Ref: J06-021 |
Dr Simon Gilbody, University of York | Health Technology Assessment |
| REPOSE - The Relative Effectiveness of Pumps over MDI and Structured Education for Type-1 Diabetes | Professor Simon Heller, School of Medicine, The University of Sheffield | Health Technology Assessment |
| SABRE: Hypertonic Saline in Acute Bronchiolitis: A Randomised Controlled Trial and Economic Evaluation | Kelechi Ugonna, Sheffield Children's Hospital | Health Technology Assessment |
| STEPWISE: STructured Education for People WIth SchizophrEnia | Professor Richard Holt, University of Southampton | Health Technology Assessment |
| TABUL (The role of ultrasound compared to biopsy of tempural arteries in the diagnosis and treatment of giant cell arteritis) | Dr Raashid Luqmani, University of Oxford | Health Technology Assessment |
| TiM: Telehealth in Motor Neurone Disease | Dr. Chris McDermott, University of Sheffield | National Institute for Health Research |
| VTEAM: Venous Thromboembolism Assessment Model Study. The cost-effectiveness of venous thromboembolism risk assessment tools for hospital inpatients | Prof. Steve Goodacre, University of Sheffield | NIHR Health Technology Assessment |
Chief Investigator (CI) Guidance
Guidance for clinical investigators on CTRU and investigator roles and responsibilities in the research application and implementation processes.
Chief Investigator (CI) Guidance
PhD projects
| Title | Chief Investigator | Funding Body |
|---|---|---|
| POLAR: Physiotherapy for Sciatica - Is Earlier Better? | Michael Reddington | National Institute for Health Research |
Data Management
We can provide expertise in data management and database design.
Using Prospect, our in house web-based electronic data capture system, we will work with you to design a bespoke database to allow you to meet your data collection and management needs.
Prospect is designed specifically to support remote data input for clinical studies. It provides user friendly data collection with validation features to promote high quality data.
Prospect allows for comprehensive privilege management, enabling custom access control on a per user basis. The system also incorporates a user activity log and a data audit trail.
How do I find out more?
Email us on ctru-dm-group@sheffield.ac.uk.
Key Partnerships
- EpiGenesys
- Medical Care Research Unit (MCRU)
- Medical Statistics Group (MSG)
- Sheffield CCG
- Sheffield Health and Social Care NHS Foundation Trust
- Sheffield Institute for Translational Neuroscience (SITraN)
- Sheffield Teaching Hospitals (STH)
CTRU governance
Advisory board
- Chair: Alan Montgomery - Professor of Medical Statistics and Clinical Trials, Nottingham Clinical Trials Unit
- External Advisor: Catherine Hewitt - Deputy Director and Senior Statistician, York Trials Unit
- External Advisor: Professor Graeme Maclennan,Professor of Medical Statistics and the Director of the Centre for Health Care Randomised Trials (CHaRT)
Internal attendees
- Cindy Cooper - Director, Sheffield Clinical Trials Research Unit
- Daniel Hind - Assistant Director, Sheffield Clinical Trials Research Unit
- Lucy Carr - CTRU Manager, Sheffield Clinical Trials Research Unit
Sheffield Teaching Hospitals Research and Development
- Simon Heller - Director of Research & Development at Sheffield Teaching Hospitals, and Professor of Clinical Diabetes
- Chris Newman - Director, National Institute for Health Research, Sheffield Clinical Research Facility and Dean of The Medical School, University of Sheffield
School of Health and Related Research (ScHARR)
- Mark Strong - Dean of the School of Health and Related Research (ScHARR)
- Chief Investigator Expertise: Liddy Goyder - Professor of Public Health and Director of Staff Development
- Chief Investigator Expertise: Steve Goodacre - Professor of Emergency Medicine & Director of Research
- Industry Expertise: Steven Julious - Professor of Medical Statistics & Design,Trials & Statistics Section Director
- Research Design Service: Wendy Baird - Director of NIHR Research Design Service for Yorkshire and the Humber & Faculty Director of Research & Innovation
CTRU Staff
- Cindy Cooper (Director)
- Daniel Hind (Assistant Director)
- Diana Papaioannou (Assistant Director)
- Katie Biggs (Assistant Director)
- Hannah Berntsson
- Mike Bradburn
- Becky Brown
- Matthew Bursnall
- Tia Callaghan
- Mike Campbell
- Lucy Carr
- Robin Chatters
- Heather Dakin
- Lauren Desoysa
- Munya Dimairo
- Shamila Ditta
- Caroline Dix
- Zoe Furniss
- Carla Girling
- Rachel Glover
- Sarah Gonzalez
- Daniel Gottschalk
- Gemma Hackney
- Jamie Hall
- Sienna Hamer-Kiwacz
- William Hartley
- Holly Haynes
- Liv Hawksworth
- Esther Herbert
- Jane Hughes
- Katie Hullock
- Marie Hyslop
- Steven Julious
- Ellen Lee
- Amanda Loban
- Kirsty McKendrick
- Cara Mooney
- Emma Morvan
- Arron Peace
- Kirsty Pemberton (on MAT leave)
- Jennifer Petrie
- Katie Ridsdale
- Ines Rombach
- Jack Rose
- Elaine Scott
- Elena Sheldon
- Richard Simmonds
- Emily Strong
- Katie Sutherland (on MAT leave)
- Laura Sutton
- Lizzie Swaby
- Ben Thomas
- Ben Thompson
- Louise Turner
- Emily Turton
- Chris Turtle
- Stephen Walters
- Simon Waterhouse
- Jessica Welburn
- David White
- Jonathan Woodward
Standard Operating Procedures
The Sheffield Clinical Trials Research Unit runs studies/trials according to the Standard Operating Procedures below.
If you would like access to any of the Standard Operating Procedures please contact the QA team on ctruqa@sheffield.ac.uk.
Data management
- Shef/CTRU/DM001 Data Protection
- Shef/CTRU/DM003 Case Report Form Development
- Shef/CTRU/DM004 Study Database Development
- Shef/CTRU/DM005 Central Data Validation
- Shef/CTRU/DM006 Data Entry and Import
- Shef/CTRU/DM009 Data Management Plan
- Shef/CTRU/DM012 Study Database Lock and Retention
- Shef/CTRU/DM014 Data Protection for NHS Staff
General
- Shef/CTRU/GEN001 SOP requirements for non-CTRU statisticians, health economists and modellers
- Shef/CTRU/GEN002 SOP Management
- Shef/CTRU/GEN003 Training Records and Staff Training
- Shef/CTRU/GEN004 Quality Checking of Study Outputs
Project management
- Shef/CTRU/PM003 Developing and Using a Protocol
- Shef/CTRU/PM005 Investigational Medicinal Product Management
- Shef/CTRU/PM008 Periodic Safety Reporting
- Shef/CTRU/PM009 Urgent Safety Measures
- Shef/CTRU/PM010 Delegation of Duties
- Sheff/CTRU/PM011 Non-Compliances and Serious Breaches
- Shef/CTRU/PM012 Archiving
- Shef/CTRU/PM013 Document Control
- Shef/CTRU/PM014 End of Trial Reporting
- Shef/CTRU/PM015 Study Files and Filing
- Shef/CTRU/PM016 Adverse Events and Serious Adverse Events for CTIMPs
- Shef/CTRU/PM017 Adverse Events and Serious Adverse Events for non-CTIMPs
Regulatory authority approval
- Shef/CTRU/RA003 Obtaining Ethical and Regulatory Approvals
Statistics
- Shef/CTRU/ST001 The Statistical Analysis Plan
- Shef/CTRU/ST003 Data Evaluation
- Shef/CTRU/ST004 Interim Data Analysis
- Shef/CTRU/ST006 Undertaking a Statistical Analysis
- Shef/CTRU/ST007 Randomisation using the CTRU randomisation system
- Shef/CTRU/ST008 Sample Size
- Shef/CTRU/ST009 Blinding
Study governance
- Shef/CTRU/GOV001 Trial Management Group
- Shef/CTRU/GOV002 Trial Steering Committee
- Shef/CTRU/GOV003 Data Monitoring and Ethics Committee
Study set-up
- Shef/CTRU/SSU001 Informed Consent Procedures
- Shef/CTRU/SSU003 Participant Discontinuation and Withdrawal of Consent
- Shef/CTRU/SSU004 Assessment of Investigator Sites
- Shef/CTRU/SSU005 Proposal Development
- Shef/CTRU/SSU006 Contracting
Quality assurance
- Shef/CTRU/QA001 Site Monitoring
- Shef/CTRU/QA002 Audits
- Shef/CTRU/QA005 Site Initiation
- Shef/CTRU/QA004 Risk Assessment
Information services
- Shef/CTRU/IS001 Computer System Validation
- Shef/CTRU/IS002 Computer System Security and Continuity
Contact the Clinical Trials Research Unit
Clinical Trials Research Unit
ScHARR
The University of Sheffield
Regent Court
30 Regent Street
SHEFFIELD
S1 4DA
Telephone: +44 (0) 114 222 0866
Fax: +44 (0) 114 222 0870 (confidential)
Email: ctru@sheffield.ac.uk