Statisticians

The unit’s Medical Statisticians play a key role throughout the running of our studies.  They advise on how the study should be designed, the statistical methods that should be used and sample size requirements.  Whilst the study is in recruitment they conduct data quality monitoring and interim analyses if appropriate.  At the end of a study the Statisticians perform the final data analyses and reporting of results, and contribute to the writing of publications.

Members of the team are also involved in teaching statistics modules in undergraduate and postgraduate programmes at the University of Bristol.

The Unit is led by co-directors Chris Rogers, Reader in Medical Statistics, and Barney Reeves, Professorial Research Fellow in Health Services Research.  They are joined in the management team by Manuela Antognozzi, CTEU and BRU manager.

Co-directors

Professor Chris Rogers is the co-director of the Clinical Trials and Evaluation Unit Bristol.  She is also co-director, with Professor Jane Blazeby, of the Bristol Surgical Trials Centre.  She is a co-author on more than 75 peer-reviewed publications, the majority of which are related to cardiovascular medicine.  Chris is a reader in Medical statistics with over 25 years’ experience in the design, conduct, analysis and reporting of clinical studies.  She has a particular interest in trials in surgery in general; and cardiac surgery specifically.  She has been statistical lead for several multi-centre trials, including the CRISP and IVAN trials.

Professor Barney Reeves is co-Director of the Clinical Trials and Evaluation Unit Bristol.  He has designed many RCTs and other studies, both on cardiovascular disease and in other health fields, and is Chief Investigator on a number of NIHR-funded projects.  He is a health services researcher and trialist, carrying out Health Technology Assessment primarily in hospital settings.  He is one of the seven research area leaders in both the previous (2008-2012) and current (2012-2017) NIHR Bristol Biomedical Research Units in Cardiovascular Disease.  He is co-convenor of the Cochrane non-randomised studies group and a member of the NIHR-HTA Commissioning Board.

 

Co-ordinators

Our team of clinical trial co-ordinators are responsible for the day-to-day management of the unit’s studies.  They assist investigators in the logistical aspects of the set-up, conduct and close down of studies.  The tasks undertaken include:

  • Protocol development
  • Design of study documentation
  • Submitting applications to regulatory bodies for approval
  • Arrangement of trial-related patient tests and visits
  • Monitoring of trial progress and data collection
  • Organising and minuting study meetings
  • Creating and maintaining trial site files
  • Collating trial update reports

The team is led by Lucy Culliford, Graziella Mazza, Rachel Brierley and Sarah Baos.

Research Nurses

Research nurses are involved in identifying patients to take part in the trials, talking patients through complex procedures and interventions, supporting them in their decision making processes and ensuring they are appropriately informed to give consent for treatment.  Once a patient has been recruited, they are involved in coordinating tests and interventions, see patients at study visits and comfort, advise and treat in a similar way to the ward. If the clinical trial involves administering drugs or devices, more often than not the research nurse will carry out this function.  It is also their responsibility to monitor side effects directly after administration, and to make sure that staff caring for the patient are aware of the requirements for the clinical trial.  The team is led by Emma Hopkins.

 

The paediatric research nurse team is led by Karen Sheehan. 

Database Managers

Database Managers plan, develop and maintain database systems used to store information from clinical studies, and create user interfaces to enable data entry and reporting for University of Bristol employees and users in external organisations.  They ensure that information is managed securely by planning and implementing backup routines and controlling access to databases.  They also create public web sites to provide patients, academic and clinical staff with information on our work and objectives.

General Administration

Our general administration team support the CTEU Co-Directors, CTEU and BRU manager and CTEU staff.  They are responsible for generic administrative work, such as  arranging meetings, maintaining diaries, taking minutes, organising travel etc. They are also the first point of contact for anyone wishing to collaborate with the CTEU.

Please contact the administration team via email - bristol-cteu@bristol.ac.uk 

Research Administration

Our research administrators provide administrative support to our trial team.  They assist with the day to day running of our trials and carry out tasks such as data entry, archiving, preparation of sample packs for theatre and sample collection.

Research Fellows

The unit is supported by four Research Fellows: Lucy Culliford, Jess Harris, Katie Pike and Maria Pufulete.  Each has their area of expertise: Lucy leads the Clinical Trial Coordinator team, Jess and Katie are Medical Statisticians and Maria focuses on grant proposals and systematic reviews.