Spondyloarthropathies CSG strategy

Core values for the CSG

  • Transparency and openness
  • Inclusiveness
  • Goal–oriented – we must facilitate the development, in a useful time frame, of robust clinical trial proposals which command wide support in the SpA community and will be very fundable by arc

How does it work?

The CSG works in the following way:

  1. We receive outline proposals of possible clinical studies. 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?

All this is ideally expressed in 1-2 sides of A4. 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.

  1. 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 SpA as possible, so that arc’s wish to fund these trials is met. As time goes on it is likely to be necessary to prioritize 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.

  1. 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.

  1. Studies which command international support will then go forward to a full application, using the new arc application form for this purpose (link to form to follow).

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.

  1. Full applications will be considered at the bi-yearly international committee for clinical studies (chaired by Prof. Leo van de Putte). 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.