- Note the recent developments with, and future plans for, the UK MS Clinical Trials Network

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1 8 December 2010 Open BD.5.10.Q UK MS Clinical Trials Network Doug Brown Head of Biomedical Research Jayne Spink Director of Policy and Research The purpose of this paper is to update the Board on recent developments with the UK MS Clinical Trials Network. Established in 2007 the network was tasked with planning and conducting a clinical trial for progressive MS. The final planning stage of a five year trial has now been reached and it is proposed that, subject to funding, recruitment to the trial could commence in late 2011/early The Board of Trustees is recommended to: - Note the recent developments with, and future plans for, the UK MS Clinical Trials Network

2 In late 2007 the MS Society established the UK MS Clinical Trials Network (CTN) and tasked the Network with planning and conducting a large scale clinical trial for progressive MS. There are currently no disease modifying treatments (DMTs) available for progressive MS hence this is a significant unmet need. The MS Society is dedicated to supporting research in this important area and has been committed to this initiative from the beginning. The CTN currently comprises 27 clinicians, scientists, statisticians and people affected by MS and is led by the Society. The CTN has progressed significantly in the last two years and has now entered the final planning stages of the clinical trial; it is envisaged that the trial will be the largest type of its kind to be performed for progressive MS, globally. The developments and future plans are highlighted below. Recent developments: 1. The Society has commissioned five research projects that have helped underpin the activities of the Network: Project 1: systematic review of the published literature to identify drugs that may protect nerve fibres from damage in people with MS, ie a drug that would be potentially effective for progressive MS. Project 2: development of an effective and efficient clinical trial design for a large scale trial for progressive MS. Project 3: screening of molecules in the blood and other bodily fluids (biomarkers) in an attempt to identify a marker that can be used to measure whether a drug is working or not. Project 4: identification of an appropriate patient reported outcome measure for use in the clinical trial, ie a test that can be used to measure the actual benefits felt by trial participants. Project 5: laboratory model screening of several drugs to test whether they have the potential to protect nerve fibres from damage in people with MS. These projects have either completed or due to complete soon (by the end of 2010 latest). 2. In 2009, following Board approval (BD.5.08.L), the MS Society established

3 the CTN steering group which was tasked with expediting the planning phase of the initiative. The Society also appointed Dr Sue Pavitt as independent Chair of the steering group; Dr Pavitt is a director of the University of Leeds Clinical Trials Unit and has extensive experience in planning and running large scale clinical trials. The steering group comprises a subset of members of the wider CTN and two people affected by MS; it has met three times since its inception. 3. To ensure success of the trial it was advised that the CTN engages with a university-based Clinical Trials Unit (CTU); CTUs are expert in all areas of clinical trial design and execution and can assist with the logistical challenges of planning and running a clinical trial. In July 2010 the Society identified several CTUs in the UK that appeared to have the relevant skills and experience to assist with this particular trial and put out a call for expressions of interest. Two CTUs expressed an interest in partnering with the Society on this initiative. The steering group recommended that the Society partner with one of them. Subsequently the Edinburgh CTU accepted an invitation to join as a partner to this initiative. 4. A Chief Investigator (CI) for the trial has been appointed to lead the trial. Dr Jeremy Chataway, a consultant neurologist from the National Hospital in London, has extensive experience in leading trials for progressive MS and has been appointed to lead on this particular trial through the CTN. A structure of the Network and its subgroups/partners can be found in appendix 1 Future plans: 1. The trial organising committee, led by Dr Chataway and the Edinburgh CTU, are currently finalising details of the clinical trial and aim to have the final plan ready by spring Once the plan is finalised the CTN will apply to the Health Technology Assessment programme (HTA) for funding to support the trial. The MS Society is due to meet with the HTA at the end of November 2010 to discuss the trial and potential ways of collaborative working. 3. If funding for the trial is found then it is hoped that recruitment to the trial will begin at the end of 2011/beginning Other collaborative partners are being identified and negotiations are

4 ongoing. There has been a considerable amount of interest from other national MS Societies (e.g. from the US, Australia and Canada) and from neurologists worldwide in the CTN and potential participation/collaborative funding will be scoped once the trial detail is complete. 5. The trial itself is likely to be designed in such a way so that research projects can be bolted on. This will allow research to be conducted to further investigate and/or validate new measures that will be useful in showing whether a drug has worked or not (e.g. biomarkers, patient reported outcome measures, MRI). These projects will continue to be scoped. 6. Once the trial has begun the CTN will then focus on other aspects. It is likely to be established as a support Network for all types of clinical trial for MS (e.g. disease modifying treatment therapies for progressive and relapsing MS, symptom relief therapy trial and service development). It will also be used to help identify clinical research priorities that will help the MS Society and other organisations (e.g. the HTA) focus research programmes accordingly. Resource implications The studies commissioned to date have been funded fully by the MS Society at a total cost of almost 400,000. This cost has been offset by a restricted donation of 100,000. It is estimated that the trial could cost around 1m per year (for 5 years) to run therefore it is expected that the vast majority of trial costs will be covered by external sources. Talks are ongoing with relevant funding bodies. The MS Society will consider commissioning bolt-on studies to the trial with open competition for funding. In recognition of our rigorous peer review and monitoring processes the Society received National Institute for Health Research (NIHR) portfolio status for the entire research portfolio, including activities of the CTN. This will ultimately reduce the cost of clinical trials by providing access to Department of Health funded resources such as neurologists, trial nurses and statisticians This initiative, being led by the MS Society, has significant potential to raise funds either via warm or cold donors. A Direct Marketing appeal on the CTN has already been made during 2010 and the Research Team will continue to work with the Fundraising teams to support any future appeals.

5 Risk Implications The major risk is that the funding received from external sources is not sufficient to begin the clinical trial. This risk has been minimised through the establishment of a Steering Group agreement of terms of reference development of an operational plan completion of under-pinning commissioned research Altogether this formalises the CTN and its activities making the Network attractive to external investors. Communications The Society will publicise the Network and its activities through the website, via press releases where appropriate and via relevant MS Society literature. Appendix 1 Structure of the CTN and its subgroups/partners (see attached)

6 Structure of the CTN and its subgroups/partners BD.5.10.Q Appendix 1 CTN Steering Group Edinburgh Clinical Trials Unit (ECTU) CTN sub-groups: Trial organising Committee: led by Dr Chataway Drug selection Clinical trial design Biomarkers Patient reported Outcome measures = MS Society led = ECTU MS Society partnership = ECTU led Clinical Trials Network