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.

SCHARR Regent Court building and courtyard
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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.

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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 Follow Up
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 Recruitment
CFHealthHub Data Observatory Dr Martin Wildman, Sheffield Teaching Hospitals NIHR Programme Grant for Applied Research Recruitment
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 Reporting
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 Set Up

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
Endometrial Scratch: The Endometrial Scratch Trial Mostafa Metwally
Sheffield Teaching Hospital		 Health Technology Assessment Reporting
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 Reporting
HELP Infertility?: What is the clinical and cost-effectiveness of hysteroscopic removal of submucosal fibroids and ployps in women presenting with infertility and recurrent miscarriage?

Mostafa Metwally

Sheffield Teaching Hospitals

 National Institute for Health Research, Health Technology Assessment Set Up
HighCALS: 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 Set Up
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 Follow Up
JtD: Journeying Through Dementia Professor Gail Mountain, University of Bradford Health Technology Assessment Reporting
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 Samuel Keating, University of Sehffield Health Technology Assessment Set Up
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 Recruitment
OPTION-DM: Optimal Pathway for TreatIng neurOpathic paiN in Diabetes Mellitus trial Professor Solomon Tesfaye, Sheffield Teaching Hospitals NIHR Health Technology Assessment Follow Up
PRIEST: Pandemic Respiratory Infection Emergency System Triage Professor Steve Goodacre, University of Sheffield NIHR Health Technology Assessment Hibernation
PITSTOP: PIlonidal sinus Treatment: STudying the OPtions Professor Steven Brown, Sheffield Teaching Hospitals NIHR Health Technology Assessment Recruitment
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 Set Up
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 Set Up
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 Set Up
STOP-OHSS: Shaping and Trialling Outpatient Protocols for Ovarian HyperStimulation Syndrome Mostafa Metwally, Sheffield Teaching Hospitals NHS Foundation Trust NIHR Health Technology Assessment Set Up
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
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 Set Up

Methods projects

Title Chief Investigator / Oranisation Funding Body
The ACE Project Dr. Munya Dimairo, University of Sheffield National Institute for Health Research CTU Funding
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)
PANDA: A Practical Adaptive and Novel Designs Toolkit (PANDA) Dr Munya Dimairo, 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
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
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
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
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
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
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
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

 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

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)

  • John Brazier - 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

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 Richard Eyre, Quality Assurance Officer, on r.j.eyre@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 Study Outputs

Project management

  • Shef/CTRU/PM003 Developing and Using a Protocol
  • Shef/CTRU/PM004 Adverse Events and Serious Adverse Events
  • 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

Regulatory authority approval

  • Shef/CTRU/RA003 Regulatory and Ethical 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/QA004 Risk Assessment

Information services

  • Shef/CTRU/IS001 Computer System Validation
  • Shef/CTRU/IS002 Computer System Security
  • Shef/CTRU/IS003 Computer System Disaster Mitigation and Recovery

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

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