Our Background

We are a UKCRC fully registered Clinical Trials Unit based in the heart of Bristol.  We are situated within Bristol Royal Infirmary, and many of our trials are based in cardiac surgery and cardiology. Our portfolio also includes studies in ophthalmology, general surgery, bariatric surgery, infection control and cancer.  “We are delighted to be awarded full registration.
UKCRC registration is a measure of quality and
only awarded to CTUs that can demonstrate a
track record of experience in co-ordinating
multi-centre trials, expert staff to develop studies,
robust quality assurance systems and evidence
of long-term viability of capacity for trials
co-ordination.” 
- Professor Chris Rogers, 2012
We are part of the National Institute for Health Research (NIHR) Bristol Biomedical Research Centre (Cardiovascular Theme), an exciting joint venture between University Hospitals NHS Trust and the University of Bristol. The NIHR awarded this to us in 2007, 2012 and five year funding has recently been awarded to start in April 2017.  The aim of the BRC is to promote translational research, utilising the wealth of academic laboratory research that takes place and using it to improve patient treatment and health.

We are part of the Bristol Academic Clinical Trials within the University of Bristol, along with our sister unit Bristol Randomised Trials Collaboration (BRTC).

In addition, we are also part of the Bristol Surgical Trials Centre, with funding from the Royal College of Surgeons of England that aims to enable surgeons to learn more about how to deal with a range of conditions, assess new surgical techniques and discover surgical breakthroughs.  It designs and delivers studies to evaluate new operations, and answer research questions that are important to patients and the NHS.

We are a multidisciplinary team led by medical statistician Professor Chris Rogers and health services researcher Professor Barney Reeves.  Our team consists of trial co-ordinators and managers, research nurses, statisticians, database managers and administration.

 

What we do

We have a wide range of expertise in the fields of study design, study management, statistical analyses and data management including bespoke database design.  If you are interested in collaborating with us on a study involving one or all of these areas please contact us via Bristol Research Support Partners webpage.  On this page you will also find a link to our sister unit in Bristol, the Bristol Randomised Trial Collaboration, and CONDUCT II, an MRC Hub for Trials Methodology Research, which specialises in complex trials and the Research Design Service in the South West.

Some descriptionGeneSYS is our flagship data collection and management tool, developed in-house as a cost effective solution allowing study managers, co-ordinators and statisticians to collect, manage and analyse data recorded from a variety of sources for a clinical study.  We now offer GeneSYS to other Units and Organisations on a hosted basis, please contact us to discuss how we can help you.

Quick feature list

  • Fully customisable form layouts allow any form, for instance Case Report Forms (CRFs) and questionnaires, to be faithfully recreated and represented
  • Clear and concise overviews at each stage display what point in the data collection process a study participant has reached
  • Powerful validation rules can be applied to each form, visually prompting users when an entered data item is invalid
  • Customisable searching allows study participants to be found quickly and easily
  • Multi-centre enabled, allowing you to store data from any number of participating sites
  • Scheduled data exports allow data to be extracted and presented in comma separated (csv) format for processing and analysis
  • A system of managed permissions means individual users only see forms and system features based on the role(s) they are assigned to
  • Themes allow you to change the look of your copy of GeneSYS with a custom logo, colours and styles

 

Examples of work 

Study  Full Title  Sponsor 
ARENA  ARENA - Effectiveness and cost-effectiveness of outpatient physiotherapy after knee replacement: A randomised controlled trial North Bristol NHS Trust   
Cat-PROM Measuring Visual Disability due to Cataract: Development of a cataract patient-reported outcome measure (Cat-PROM) University Hospitals Bristol NHS Foundation Trust 
IPC-PLUS The efficacy of Indwelling Pleural Catheter placement versus IPC placement PLUS sclerosant (talc) in patients with malignant pleural effusions managed exclusively as out-patients (IPC-PLUS Trial) North Bristol NHS Trust 
MiTS Metformin in Tuberous Sclerosis Complex (MiTS)  University Hospitals Bristol NHS Foundation Trust 
PREDICT-CAT Predicting Self-Reported Benefit, Supporting Decision Making and Calibrating Health Utilities for Cataract Surgery University Hospitals Bristol NHS Foundation Trust
REDUCE A Randomised Controlled Trial Evaluating the Efficacy of Indwelling Pleural Catheters in Persistent Non-Malignant Symptomatic Pleural Effusions North Bristol NHS Trust 
ROBINS-I    
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