The RCS Head and Neck Surgical Trials Unit
NFORC is the UK’s Head and Neck Surgical Trials Unit dedicated to Prospective Cohort and Randomised Trials in this anatomical domain.
It results from a collaboration between the British Association of Maxillofacial Surgeons (BAOMS), the Saving Faces - The Facial Surgery Research (SF-FSRF), the CRUK Cancer Prevention Trials Unit (CPTU), the Barts Clinical Trials Unit (BCTU) and the Health and Social Care Information Centre (HSCIC). The intellectual leadership for NFORC trials emanates from the BAOMS Research and Clinical Effectiveness Committees. The imprimatur of BAOMS decision-making should ensure that all BAOMS members participate in these trials resulting in rapid recruitment and trial closure. The generic research skills are provided by SF-FSRF, CPTU and BCTU. Professor Peter Sasieni is Director of CPTU and BCTU whilst a consultant oral and maxillofacial surgeon, Professor Iain Hutchison, is NFORC’s Director. HSCIC provide web-based data systems and secure data transfer and storage for the cohort studies.
The Royal College of Surgeons of England (RCS) have appointed Professor Jim McCaul to be NFORC’s Surgical Research lead and BAOMS Council have appointed him as Chair of its Research Committee. James Gallagher is Chair of the BAOMS Clinical Effectiveness Committee. They play leadership roles assisting applicants in the clinical aspects of trial development through their committee structure.
NFORC has recognised from previous trial experience that some clinical surgical dilemmas do not easily lend themselves to solution by randomised study. Therefore NFORC has:
- Created a method for developing prospective cohort studies with the BAOMS clinical effectiveness committee for those clinical dilemmas where it might be difficult for surgeons to recruit to randomised trials.
- Encouraged 10 surgeons with national and international reputations, but no previous experience of leading multi-centre randomised trials, to develop the first national pragmatic randomised studies on their area of expertise.
- Initiated GCP training courses for Oral and Maxillofacial (OMF) surgeons.
- Organised 2 closed “research summits” for the 10 Chief Investigators (CI) to develop their randomised trials with the NFORC and Barts CTU staff.
- Organised 1 open “research summit” for all-comers to listen to presentations from the CI or present their own ideas for study.
- Assisted the CI develop pilot studies and build patient advisory groups.
- To help surgeons develop cohort and randomised studies covering all aspects of OMF surgery.
- To ensure all OMF trainees participate in clinical trials and have this enshrined in their training programme.
- To encourage every patient being treated by OMF surgeons to participate in one of these studies.
- To enable clinically valuable and scientifically excellent surgical studies to be successfully completed.
- To develop a national network of consultants and trainees who will deliver trials within their specialist field.
- To provide research training for consultant surgeons, trainees and undergraduate medical and dental students.
NFORC and BCTU can also provide investigators with bespoke web-based systems for clinical data management. Systems developed offer the following features:
- Online screening and randomisation
- Secure patient data management
- Online clinical data collection and management
- Online tools for managing study centre and staff information
- Realtime reporting, for example current recruitment
- Safety reporting
- Full audit trails
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