Paediatric Rheumatology Clinical Studies Group

• Reactive and proactive: To support and develop a portfolio of clinical studies directed towards and including clinical trials in all areas of paediatric rheumatology across the UK
• Advisory: To advise the MCRN and Arthritis Research UK in defining research priorities in paediatric rheumatology for their support and subsequent adoption to run through the MCRN

• To be responsible for developing and overseeing a comprehensive portfolio/strategy for clinical trials and related studies covering the spectrum of major disease areas in paediatric rheumatology
• To propose and develop new trials and other well-designed studies, to consider trials proposed by others, and advise the MCRN and Arthritis Research UK
• To provide specific advice to investigators
• To ensure consumer involvement in all activities

Biologics for Children with Rheumatic Diseases – The Extended Biologics Study

The CSG’s JIA Topic Specific Group have been successful in being awarded a grant from Arthritis Research UK to support long term pharmacovigilance and efficacy data collection on children receiving biologics other than etanercept for rheumatic diseases. This Extended Biologics Study, which will run from the University of Manchester in parallel with the BSPAR Etanercept Cohort Study. Adopted onto the UK CRN and MCRN Portfolios, recruitment has already begun in June 2010.

Randomised Control Trial of the Clinical Effectiveness, Safety and Cost Effectiveness of Adalimumab for the Treatment of Juvenile Idiopathic Arthritis-associated Uveitis

Following a comprehensive consultation process, a trial of anti-TNF therapy in JIA-Uveitis was set as a key priority area for the UK MCRN/Arthritis Research UK Paediatric Rheumatology Clinical Studies Group’s (CSG) Clinical Research Strategy. Widespread discussions took place, meetings open to representatives of participating centres, and discussion at specialty meetings and symposia where the potential trial was highlighted. A team including representatives from rheumatology, ophthalmology, parents, health economist and clinical trials unit (CTU) submitted a preliminary application last summer. Final submission was made at the end of September 2009 to a joint HTA/Arthritis Research UK call in April 2009 for a trial of anti-TNF in the treatment of JIA-Uveitis. This has been successful, subject to successful response to the reviewers’ comments and approval of costings. Detailed longitudinal feasibility will be conducted through the MCRN CTU and the respective Research Networks before site selection is finalised. Supply of the Investigational Medicinal Product and placebo will be from Abbott in this Investigator-led trial. Trial Protocol is currently (June 2010) being finalised based on the detailed study proposal which has been approved and application for MHRA approval to conduct the trial, Ethical / R&D approval and UK CRN Network Portfolio adoption.

• The TSGs are principally disease-based, but each will address common themes and collaborate where appropriate.
• All those interested in participating in the activities of the TSGs and contributing to strategic development are warmly invited to engage with one or more of the TSGs. Those approaching the CSG with study ideas will be directed in the first place to these TSGs. This is to optimize the experience and expertise in given areas so that, in accordance with MCRN and Arthritis Research UK guidelines, the best possible trial or study of that condition may take place.
• Each TSG has a link-person from the CSG Scientific Membership to ensure integration into the whole CSG portfolio that will facilitate its activity. Please contact them directly if you are interested (or the CSG Chair). Clinical and multi-disciplinary participation is warmly encouraged. Lead investigator and collaborations for specific studies developed through the TSGs will be determined by those involved and actively contributing on scientific merit and responsibility.
• Minutes of meetings and teleconferences of the TSGs will be submitted regularly to the CSG Chair and summary updates published on the website. Costs for meetings/conferences must be agreed a priori with the CSG Chair / Administrator.

The following TSGs have been established:

• The CSG’s Strategy summarises this process and its development to date including a comprehensive open consultation process. It will receive International Peer Review comment. All comments on the Strategy should be sent directly to the CSG Chair and / or the respective TSG-link person.
• The CSG will undertake on-going review with evolution of this Strategy in a timely manner as well as its processes and procedures to ensure it is developed in an open and transparent manner. All stakeholders may contribute to this process.
• The published strategy will form the working basis of its current pro-active activity in 2009.
• The principle means of communicating all aspects of the Strategy is via the CSG’s MCRN, Arthritis Research UK and BSPAR websites. In addition, regular e-circulars continue to be sent to the entire BSPAR membership drawing their attention to the process. Anyone wanting specific notification who is not a member of BSPAR can contact the CSG Administrator with details.
• All those interested in participating in this strategic development are warmly invited to engage with one or more of the TSGs.

• Investigators should approach the CSG at their earliest opportunity, considering the very minimum of 3-4 months run-in for them to prepare a full application. The CSG will endeavour to act as speedily as possible to support initiatives, within limits of its Members' time and resources
• In response to Expressions of Interest, the CSGs will assess whether or not the expression of interest currently fits its Research Strategy
• Protocols at an earlier stage in development will be supported as possible, and be assessed on their own merits, in the light of the evolving Research Strategy. Key trials / related studies may be supported at an early stage in this process if central to the future research strategy.
• Where relevant, the CSG may give advice to investigators to support the best study going forward. They may also make investigators aware of funding options other than Arthritis Research UK that they could consider.
• For priority studies supported by the CSG, access to support from an Information Officer is available on request to the CSG Chair for a review of current evidence in the area of investigation (approximately a 6 week turnaround)
• Where and Expression of Interest does not match current priorities as outlined in its Research Strategy, the CSG will consider the importance of the topic and whether it needs including in subsequent updates of this process. However the published Strategy remains the working basis of supported activity.
• Investigators are strongly encouraged to involve consumer representatives (children, young people and parents / guardians) from the earliest stage of protocol development
• All proposals seeking specific Arthritis Research UK support will be processed in accordance with Arthritis Research UK's new Clinical Trials Initiative.
• For studies / trials already funded, they should be processed according to MCRN guidelines. Support from the CSG can be sought by contacting the CSG's administrator.
• Where several investigators are working in similar areas, the CSG will facilitate opportunities to consider collaboration, to bring together expertise and optimize the success of the study and funding applications. It remains the responsibility of the investigators to form constructive collaborations and for the scientific content of their proposals.

• All studies submitted to the CSG include consumer consideration and input
• Investigators are strongly encouraged to involve consumers from the outset in study development
• CSG and TSG-related meetings aim to include consumers fully in their activities and meetings. All meetings seek to be Chaired in accordance with the Consumer “Guidance for Chairs”, produced following an evaluation of PPI in the UK Clinical Research Collaboration
• Pilot models are being developed for consumer comment on the wider CSG agenda while groups related to specific TSGs have already taken place. The MCRN are developing a Database of Consumers/Shadow Consumer Panel in all disease areas including Paediatric Rheumatology

ERANET Program

• The CSG actively contributed to this process and encouraged the whole BSPAR membership to do so. Outcomes from this have been considered and included in the CSG’s Strategy document

Industry Liaison

• Important to the future work of the CSG, a panel of potential industrial partners interested in the future portfolio of the Paediatric Rheumatology CSG has been established and continues to develop. Any interested parties should approach the MCRN's Industry Team or alternatively the CSG Chair or one of the CSG Members

Websites

• Details of all activities, supported trials/studies and the proposed research strategy of the CSG will be made available through the MCRN Website with summary information and direct links to this website made available through the BSPAR and Arthritis Research UK websites.

Correspondence from CSG Chair or CSG to BSPAR Members

See BSPAR Website: http://www.bspar.org.uk/pages/paed_rheum_CSG.asp