NBS / MRC Clinical Studies Unit
About the CSU
|
Developing a Clinical Study Proposal with the NBS/MRC Clinical Studies Unit (CSU)
Guidelines for Submission of Outline Proposals
Clinical Study Outline Application Form
|
|
| |
A Joint Venture Between the National Blood Service and the Medical Research Council
There are many new scientific developments within the sphere of transfusion medicine with the potential for clinical use, and studies are needed to determine the benefits and risks of applying these developments in clinical practice. There is also an increasing demand for the evaluation of existing components, and alternatives to the transfusion of donor blood. Many organisations e.g. Medical Research Council (MRC) have set up Clinical Trials Units to support the carrying out of well designed clinical trials.
The Clinical Studies Unit was set up in April 2001 as a joint venture with the MRC Clinical Trials Unit (CTU) to provide a national resource to support high quality clinical trials in transfusion medicine within the NBS. A ´hub and spoke´ model has been adopted with the CTU (the hub) providing expertise in data management, statistical support, health economic input, and randomisation facilities and the NBS (the spoke) providing clinical expertise in transfusion medicine and a co-ordinating site in East Anglia where a clinical studies manager and a research nurse will act as the link between the MRC and front-line hospitals participating in clinical studies. CSU staff comprising a statistician based at CTU and a Clinical Studies Manager based at East Anglia will be available to support all stages of a clinical study, from planning and design, through recruitment and monitoring, to data analysis. However, as limited resources are available, grant funding for individual trials will still have to be obtained from external sources or NBS R&D.
A joint MRC/NBS Steering Committee which meets quarterly has been established to oversee the running of the Clinical Studies Unit. Applicants wishing to carry out clinical studies within the new unit are invited to complete Section 1 of the outline application form giving brief details of the proposed study in order to establish whether the proposals are feasible. Completed outline forms will be reviewed by the Steering Group who will be able to provide feedback and advice. Successful applicants will then be invited to submit a full proposal for consideration by the NBS/R&D Planning Group.
|
|
| |
Members of MRC/NBS Steering Committee
Professor Janet Darbyshire (Head MRC Clinical Trials Unit)
Dr Andrew Nunn (MRC Clinical Trials Unit - Head Division without Portfolio)
Dr Tony Johnson (Senior Medical Statistician - MRC Biostatistics Unit, Cambridge)
Ms Angela Casbard (NBS Statistician - MRC Clinical Trials Unit)
Professor Marcela Contreras (Director Diagnostics Development & Research, NBS)
Dr Mike Murphy (Lead Consultant Hospital Liaison, NBS/University Oxford Lecturer)
Dr Lorna Williamson (Lead Consultant Components, NBS/University of Cambridge Lecturer)
Dr Charlotte Llewelyn (Clinical Studies Manager, NBS)
Dr Neil Soni (Consultant Anaesthetist & Director of Intensive Care, Chelsea & Westminster Hospital & Imperial College School of Medicine)
|
|
| |
List of current studies
| 1. |
Epidemiology and long-term outcome of transfusion recipients (BS00/1) |
| 2. |
Comparison of the clinical efficiency between standard and epitope-matched platelets in haemato-oncology patients with platelet antibodies (BS00/2) |
| 3. |
An observational study of peri-operative transfusion support in patients with sickle cell disease (BS00/7) |
| 4. |
The role of blood transfusion and leucocyte antibodies in the development of acute respiratory distress syndrome and acutelLung injury |
| 5. |
Transfusion medicine epidemiology review (NBS/CJD Surveillance Unit)
|
|
|
| |
|
|
