Clinical Study Groups

Proposals for clinical studies are submitted via strategic Clinical Study Groups (CSGs). The CSGs are engaging with the musculoskeletal community widely to define, on a national basis, research priorities in 7 disease areas/groupings. Each CSG has documented the priorities in their area as a Research Strategy. Funding applications for clinical studies must be in line with the national strategy and be submitted with CSG support.

Proposals for clinical trials are no longer accepted as routine Project Grants.

Extensions or substantive additions to currently funded trials (awarded either as Clinical Trial Grants by the previous Clinical Trials Collaboration or as Project Grants by the Research Sub Committee) are to be considered within the new structure.

You can find more information in these six areas:

• Principles of Clinical Research Funding
• National Prioritisation Clinical Research
• Clinical Study Groups and Research Strategies
• Working with the National Institute for Health Research Clinical Research Network (NIHR CRN)
• Arthritis Research UK Clinical Studies Subcommittee
• Arthritis Research UK funding of clinical data and sample collections

We permit, where appropriate, industrial partner involvement.

We are committed to maximising our support for activity in clinical trials and this depends on increasing the support opportunities from NHS NIHR sources.

We encourage opportunities for research ‘add ons’ to clinical trials and related studies to be taken.

We acknowledge the complexity of running a clinical trial and the input required from a multidisciplinary team with relevant expertise. Thus every study, whilst remaining under the scientific control of the Chief Investigator (CI), must be managed by an UKCRC-registered CTU or affiliated personnel or be engaged in a mentorship arrangement. http://www.ukcrc-ctu.org.uk/. 

We closely appraise the progress of funded clinical research.

For their specific areas the national CSGs consider and produce a portfolio of clinical research priorities and proposed study questions which include some, or all, of:

• Pilot and feasibility studies for recruitment, biomarkers and outcome assessments
• Formal randomised clinical trials
• Other well designed clinical studies

Production of each of the Groups’ portfolios involves extensive and continuing collaboration and involvement of all relevant stakeholders.

The CSGs remit is to support research aiming to answer the questions that have been identified as needing answering by whichever route, not necessarily via Arthritis Research UK funding and as such they support applications to various funders, notably the NIHR. 

Applications can be made in open competition by individuals/groups to conduct specific studies relating to these identified priorities.

Although the CSGs are committed to developing strategic priorities based on consensus following consultation they are also keen to receive, at any time, suggestions for research in novel areas of therapeutics.

Ownership of the strategy is the group’s but ownership of individual studies is determined to maximise the scientific benefits to those who submit the ideas and provide the most inputs.

The groups and their leaders are listed below.

The Prioritisation Strategy for each CSG and the approaches adopted by each group to develop it can be found by clicking on the relevant group.

* The Paediatric Group exists as a partnership with the NIHR Topic Specific Clinical Research Network: the Medicines for Children Research Network (MCRN).

The MCRN/Arthritis Research UK Paediatric Rheumatology Clinical Studies Group functions within the existing structures of the MCRN and Arthritis Research UK CSGs. The strategy document is in a different format to the other Arthritis Research UK CSGs as it fits in with requirements of the MCRN.

Each CSG Lead has recruited an advisory group which includes a patient representative.

The groups also have both ad hoc and standing subgroups depending on the area of interest (e.g. by disease area, disease stage or approach to therapy).

Initial ideas and strategy development come from and are informed by a combination of:

• Specially convened meetings
• Direct contact with the Group Chair
• Ongoing ad hoc receipt of non-solicited proposals from the musculoskeletal community
• Onwards transmission to Group Chair of non-solicited relevant proposals received by Arthritis Research UK
• Contacts with industry identifying new products or new indications for existing products
• Literature reviews including Cochrane and the Database of Uncertainties about the Effects of Treatments (DUETS)
• Contacts with NICE on influencing their ‘Research Use only’ decisions and their stated research agendas in their issued appraisals
• Discussions with HTA, MRC and other bodies

The CSGs seek ongoing input and participation from the wider musculoskeletal community on the strategies and other matters and welcome any approach at any time.

There is an 'Expression of interest’ form which can be submitted to help this interaction.

To manage the interests and ideas submission, in addition to the open and continual receipt of suggestions and proposals, some CSGs do issue deadlines or ‘calls’ for Expressions of Interest to be received by certain dates such that the Groups may manage their activity efficiently.

To assist in considering whether to support to a given proposal the CSG will seek initial international peer commentary.

Role of individual investigators

The role of individual investigators in ensuring the success of funded studies is well recognised.

Participation in strategic development: group leaders ensure that all proposals from any potential investigator are considered as part of any final agreed strategy. In that sense, this is considered a part of the peer review process in terms of agreement of the value of the proposal.

Ownership of the agreed proposal: Each Group is responsible for allocating leadership of the projects it supports. Generally those who are responsible for suggesting a study are likely to be in the strongest position (should they wish) to lead on it. However the opportunity for collaborative research and amalgamation of two or more similarly focussed objectives is one of the CSG functions.

Role of CSG members

The role of the CSG advisory group in ensuring the success of the prioritisation initiative and the success of funded studies is key.

Our CSGs are made up of dedicated experts from relevant disciplines who meet regularly via face-to-face meetings and teleconferences. Their remit requires input to:

• Strategy development: responsible for developing and overseeing a comprehensive portfolio/strategy for clinical trials and related studies.
• Study development: all proposals from potential investigators are considered with regard to the identified priorities. In that sense, this is considered a part of the peer review process in terms of agreement of the value of the proposal. Responsible for advising investigators, allocating leadership of the projects, encouraging collaboration amongst investigators and ensuring consumer involvement.
• Portfolio oversight: each funded project requires CSG representation on the Trial Steering Committee to provide independent advice regarding ongoing conduct and progress and thereby linking back to the underlying CSG activity.

The NIHRCRN Portfolio is used to manage the allocation of NHS infrastructure funding.

In England, the Department of Health has determined that studies that are funded by NIHR non-commercial Partners are automatically eligible to be included in the Portfolio.

We are an NIHR non-commercial Partner and as such in England funding can be obtained for identified activities from NIHR CRN via the Comprehensive Clinical Research Network (CCRN) and via comparable routes in the devolved nations.

For further information please see applying for a grant.

Patients recruited for studies in any disease area could usefully provide the base material for such data collection. We encourage Groups to capitalise on supported clinical studies to develop such resources for the wider research benefit of the community in that area. Such resources must be embedded within hypothesis led, strategically directed clinical studies aiming for patient benefit, only in exceptional circumstances would a CSG consider putting forward a proposal for a bank in the absence of any directly linked study.

If your query is regarding whether your proposal should be submitted via a CSG please generate and forward a brief summary of the proposed objectives and methods.