Spondyloarthropathies Clinical Studies Group
The Spondyloarthropathies CSG is chaired by Professor
Hill Gaston.
Annual report 2009
For more information on the recent activities of the
Spondyloarthropathies CSG please read the
latest annual report.
Steering group
The current membership is:
Hill Gaston (Chair)
Professor of Rheumatology, University of Cambridge |
Philip Helliwell (Vice-Chair)
Senior Lecturer in Rheumatology, University of Leeds |
Andrew Keat
Consultant Rheumatologist, Northwick Park, London |
Paul Wordsworth
Professor of Rheumatology, University of Oxford |
Jane Skerrett
Director of NASS |
David Chandler
Chief Executive, Psoriasis and Psoriatic Arthritis Alliance –
PAPAA |
Matt Homfray
NASS patient representative |
Margaret Hughes
NACC patient representative |
Dr Lesley Kay
Honorary Clinical Senior Lecturer in Rheumatology, Newcastle
University |
Dr. Stefan Siebert
Senior Lecturer in Rheumatology, Swansea University |
David Blythe
Provider Support Manager, Caring with Confidence |
The steering group consists of academic rheumatologists, all
still committed to clinical services and patient-oriented research
(so not too ivory-tower-ish), along with people representing
patients with different forms of SpA either through their
involvement with a patient organization or because they have the
condition (or both).
The importance of the patient perspective in clinical research
is constantly emphasized at a national level, and we have been
fortunate to attract the active participation of these steering
group members. Their input to the research proposals and priorities
which we been considering has already been useful and
distinctive.
As time goes on, we will need to co-opt additional members to
the CSG, and its membership will be expected to evolve over time
rather than being determined for a fixed time period. In order to
allow effective working, it will always remain a relatively small
steering group, rather than a representative body.
Group meetings
The first meetings of the CSG have outlined the aims and
future plans of the CSG, considered the research
proposals which have been received, and discussed ways of
determining the research questions which have highest priority in
the patient and scientific communities, and ways of addressing
them.
We are also very anxious to foster and mentor younger
investigators who might make one of the research priority areas a
major plank in their academic and professional development.
The CSG meets
several times a year and is in frequent email contact as
required.
We will try to keep this website continuously updated, and use
it as a forum for gathering proposals and responses to
proposals.
We will use the BSR SpA SIG membership list to
communicate with the SpA community by email.
Strategy
Read the strategy.
As part of Arthritis Research UK's new strategy for funding
clinical trials, Clinical Studies Groups (CSGs) have been set up in
seven major clinical areas, one of which is spondyloarthritis (SpA)
– i.e. ankylosing spondylitis, psoriatic arthritis, the arthritis
of inflammatory bowel disease, reactive arthritis and
undifferentiated spondyloarthritis.
No decisions on whether other forms of arthritis (e.g.
SAPHO) might be within our remit have been made
and the CSG is
open to suggestions on this.
Our principal goal is to devise a strategy for clinical studies
in
SpA
which will result
in well designed clinical trials which Arthritis Research UK will
wish to fund and which can be delivered with the help of the
infrastructure put in place by the UK government in the form of
clinical research
networks.
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 Arthritis
Research UK
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? (though these may only be
estimated at this stage).
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 SpA 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 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.
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
PDF and Expert Commentary Letter
PDF).
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 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.
5. 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.
Proposals under consideration
Ankylosing spondylitis
- Cardiovascular risk in ankylosing spondylitis (AS): expression of interest
supported by CSG and full application in preparation.
- Identification and treatment of early AS: application currently under
consideration by HTA as part of the HTA/ Arthritis Research UK
initiative.
- Reducing therapy for patients with AS who have achieved an
acceptable disease state: currently under discussion.
- Cohort recruitment for genetic studies of clinical
manifestations of and susceptibility to ankylosing spondylitis -
funded by Arthritis Research UK via Scientific Strategy Committee
(not clinical trials).
Psoriatic arthritis
- Tight control of early psoriatic arthritis (modelled on TICORA)
– funded by Arthritis Research UK clinical trials.
- Withdrawal of therapy in people with psoriatic arthritis who
have achieved an acceptable minimal disease activity state – for
submission to HTA early 2010, as part of the HTA/Arthritis
Research UK initiative.
Further details of any of these studies can be made available to
anyone who is interested.
This portfolio of studies is expected to be expanded
significantly following the SpA CSG Strategy Meeting, held on
March 17th at Burleigh Court, Loughborough University.
Read the outcomes from this
meeting.
Contact details
The Chair is always happy to receive proposals and comments.
For all enquiries and additional information, please contact:
Professor Hill
Gaston, chair of the Spondyloarthropathies CSG or his secretary
Ms Hazel Mould.