Expression of interest and commissioning
At the early stages, investigators are encouraged to fill in what they can to enable initial dialogue. This EOI form may be submitted partially completed to facilitate initial engagement with the group. Its completion can then be an iterative, cumulative process in line with engagement with the CSG and as the study becomes more defined over time.
The CSG works in the following way:
How does it work?
1. We receive expressions of interest from individuals wishing to apply for a clinical study grant. These can be received from any source including, but specifically not limited to, committee members. The critical components of the proposal for a clinical trial/study at this stage are:
- What question is being asked?
- Approximately how many patients will be needed to answer it?
- What resources will be required? (though these may only be estimated at this stage)
The expression of interest form can be found on our applicant information webpage.
Note that our remit is not confined to large multi-centre control trials; we are equally keen to receive proposals for pilot studies which may only involve a single centre, as these may later lead to larger definitive trials. Furthermore, we are happy to receive proposals for single centre studies and to treat any intellectual property contained in such proposals with full confidentiality.
2. The committee looks at all the proposals which have been received at a particular time from a strategic point of view, asking questions such as:
- How important is the question being asked?
- Is the trial do-able, or will it target the same patient populations which are involved in other studies? [this is important in relation to therapeutic trials since recruitment to major trials, such as those on biologics, may jeopardise other smaller trials]
- Will the trial answer the question, or prepare the ground for a later more definitive trial?
At present this process is non-competitive i.e. we wish to develop as many high quality trials in Spondyloarthropathies as possible, so that Arthritis Research UK's wish to fund these trials is met. As time goes on it is likely to be necessary to prioritise the proposals received according to the strategy developed by the CSG, i.e. favouring trials which ask the questions which are agreed by patients and researchers to be the most pressing.
3. The CSG commissions international peer review of its strategy by getting relatively brief comments on the studies which it is proposing to include on its portfolio and form which experts fill in - Expert commentary form (DOC 220 KB).
4. Studies which command international support will then go forward to a full application, using the new Arthritis Research UK's application form for this purpose, accompanied by a letter of support (DOC 199 KB) from the CSG.
In formulating the full proposal applicants will be expected to enlist the help of a Clinical Trials Unit and to work out the implications of running the trial through the Clinical Research Network – i.e. the resources which will be requested from the network. For more information on CTUs, please visit www.crncc.nihr.ac.uk
5. Full applications will be considered at one of the tri-yearly meetings of the Clinical Studies Subcommittee (chaired by Professor Janet Darbyshire). It is hoped that a high proportion of studies which have gone through this process will be funded, since they will already be known to be strategic and have been designed to the highest possible standards with the help of Clinical Trial Units.