Office for Clinical Research Infrastructure. NIHR Clinical Research Infrastructure Collaborations Engaging with Medical Research Charities

Transcription

1 Office for Clinical Research Infrastructure NIHR Clinical Research Infrastructure Collaborations Engaging with Medical Research Charities

2 Contents 3 Foreword 4 Introduction 5 NIHR Clinical Research Infrastructure 6 Medical Research Charities can Engage With the NIHR-supported Clinical Research Infrastructure 7 Examples of Charity & NIHR Clinical Research Infrastructure Interactions Biomedical Research Units & Centres 8 British Tinnitus Association & NIHR Nottingham Hearing Biomedical Research Unit Evidence-based Research Set to Shape the Future of Tinnitus Research 10 Ataxia UK & NIHR University College London Hospitals Biomedical Research Centre Patients Help Develop Research into Rare Neurodegenerative Disease 12 DIPEx & NIHR Oxford Biomedical Research Centre Exploring People s Experiences of Participation in Research Experimental Cancer Medicine Centres 14 Myeloma UK & NIHR/Cancer Research UK Experimental Cancer Medicine Centres Establishing a New Clinical Trials Network for Myeloma NIHR Healthcare Technology Cooperatives 16 Whizz-kidz & NIHR Healthcare Technology Cooperative Developing a New Wheelchair for Children NIHR Clinical Research Network 18 Arthritis Research UK & NIHR Comprehensive Clinical Research Network Establishing Clinical Study Groups to Support Arthritis Trials 20 Kidney Research UK & NIHR Comprehensive Clinical Research Network Establishing a UK Kidney Research Consortium NIHR Collaboration for Leadership in Applied Health Research and Care 22 SpeakwithIT & NIHR Collaboration for Leadership in Applied Health Research and Care for South Yorkshire Developing a Self-Managed Computerised Speech Therapy Tool 24 Further Information and Contact Details

3 Foreword The research funding landscape in the UK is diverse with a broad range of public sector, charity and industry organisations funding clinical research for the benefit of patients and the public. The Government has a strong commitment to supporting life science research and has reinforced its commitment to the principle that research and innovation should be central to an efficient and effective National Health Service (NHS). One of the ways this can be realised is through partnerships between all the organisations responsible for funding, organising and delivering health research. The medical research charity sector is particularly strong and well organised in this country, which complements the nation s reputation and attractiveness to deliver world-class health research. Charities provide funding that supports research taking place in universities and the NHS. They are also increasingly developing stronger collaborations with the National Institute for Health Research (NIHR) clinical research infrastructure to ensure that our joint aims are delivered. These collaborations can be to fund projects in strategically important areas, or to develop patient-related activities that improve health research. By working together, the NIHR and medical research charities are supporting world-class health research that will really make a difference to patients lives. The following examples of collaborative working provide some potential models to achieving that aim. Funded by patients, their families and carers, medical research charities have an important role in helping to ensure that life science research in the UK leads to new knowledge about medical conditions and treatments. In this way, patients have a voice in the way health research is carried out. Sharmila Nebhrajani Chief Executive Officer Association of Medical Research Charities Professor Dame Sally C. Davies Chief Medical Officer and Chief Scientific Adviser Department of Health 3

4 Introduction Medical research charities make a significant contribution to the research funding landscape in the UK. In 2010/11, the 124 members of the Association of Medical Research Charities (AMRC) contributed over 1.1 billion to medical research in the UK aimed at tackling major diseases such as cancer, diabetes and heart disease, as well as rarer conditions like cystic fibrosis and motor neurone disease. The investment in health research by charities focuses not only on direct support for research projects and programmes, but also helps to create an environment and infrastructure where health research can be carried out in the most efficient and effective way. This means that maximum benefit can reach patients and the public in the shortest possible time. The National Institute for Health Research (NIHR) Since its establishment in 2006 the NIHR has made major investment in the infrastructure required in the NHS to support high quality health research for the benefit of patients and the public. This infrastructure brings together a wide range of individuals with the expertise to design, carry out and support research studies and clinical trials to answer important questions about the treatment of diseases that affect people today. The NIHR clinical research infrastructure ranges from expert researchers working in world-class facilities embedded within the country s leading universities/nhs partnerships using some of the most advanced technologies available, through to nationwide coverage provided via clinical research networks. The infrastructure has been built up to provide an optimal environment to support clinical research funded by the NIHR itself as well as other key partners including public, charity and industry research funders. The broad range of research infrastructure that the NIHR has established across the country provides an important opportunity for partnership working with medical research charities, helping to maximise the potential outcomes of their research funding. NIHR Office for Clinical Research Infrastructure (NOCRI) NOCRI has been established to help research partners, including charities, navigate their way through the research environment in this country and establish mutually beneficial partnerships with the NIHR clinical research infrastructure. 4

5 NIHR Clinical Research Infrastructure As well as funding clinical research studies and trials through programme and grant funding, the NIHR also funds a broad range of clinical research infrastructure that spans the innovation pathway. This ranges from research centres that sit at the interface between the laboratory and the clinic, to facilities that specialise in early-phase and first-in-man / first-in-patient studies. In addition, clinical research networks support the efficient delivery of larger, multicentre clinical studies and collaborations. NIHR Biomedical Research Centres and Units NIHR Biomedical Research Centres (BRCs) and Units (BRUs) are based within the most outstanding NHS and University partnerships in the country and are leaders in scientific translation across a wide range of disease and therapeutic areas. They bring together the country s leading investigators and clinicians with the expertise to translate fundamental biomedical research into new and improved therapeutic approaches. Many charities fund studies that are carried out by investigators based in these BRCs and BRUs and there is a clear opportunity for more strategic relationships to be built with benefit to both parties. NIHR Clinical Research Facilities NIHR-supported Clinical Research Facilities for Experimental Medicine (CRFs) and Experimental Cancer Medicine Centres (ECMCs) provide dedicated research facilities for early-phase volunteer and patient studies. They can provide assistance throughout the research process, from trial design through to data collection and study management. Working in partnership with medical research charities, CRFs and ECMCs are playing leading roles in speeding up the development of a variety of drugs and supporting experimental medicine. NIHR Healthcare Technology Cooperatives Healthcare Technology Cooperatives (HTCs) accelerate the development and adoption of technologies, treatments and services to help people with debilitating conditions deal with daily challenges. They enable patients and carers, healthcare staff, academics and inventors, to collaborate with health technology companies to develop practical and innovative products, to address areas of unmet patient and clinical need. Currently there are two pilot HTCs working in two areas of assistive technologies urinary incontinence and renal technologies, and bowel function. In 2012, the NIHR launched a new competition to establish new infrastructure HTCs, to enable NHS organisations to act as centres of expertise, focusing in clinical areas or themes of high morbidity and unmet need for NHS patients. The successful NIHR HTCs, to be announced by the end of 2012, will work collaboratively with industry to develop new medical devices, healthcare technologies or technologydependent interventions which improve treatment and quality of life for patients. 5

6 NIHR Clinical Research Infrastructure (continued) NIHR Clinical Research Network The NIHR Clinical Research Network supports the delivery of later-phase and multi-centre clinical studies. It provides a single point of national access for this type of research in the NHS. The NIHR Clinical Research Network offers expert support for: study and protocol feasibility assessment; access to systems to speed clinical trial set up processes, including costing, contracting and permissions; and staff and resources to ensure efficient patient recruitment and study delivery. NIHR Collaborations for Leadership in Applied Health Research and Care NIHR Collaborations for Leadership in Applied Health Research and Care (CLAHRCs) undertake research focused on the needs of patients and supports the translation of research evidence into practice in the NHS. They are collaborative partnerships between a university and the surrounding NHS organisations, focused on improving patient outcomes through the conduct and application of applied health research. Medical research charities are already developing strategic relationships with the Network as illustrated in the Arthritis UK and Kidney Research UK case studies. This helps to ensure that the most important research questions for their patient communities are answered. How Medical Research Charities can Engage With the NIHR-Supported Clinical Research Infrastructure NOCRI is a unique resource for medical research charities and other funders of health research including the global life sciences industry. Through a managed process, NOCRI provides simple, efficient access to expert investigators and cutting edge technologies within the UK s clinical research infrastructure. This NIHR clinical research infrastructure, as described in this section, includes world-leading clinical academics, working in world-class research facilities, with access to well characterised patient cohorts within the 60 million people who use the NHS in the UK. This booklet highlights just some of the numerous successful collaborations between the NIHR clinical research infrastructure and UK-based medical research charities. 6

7 Examples of Charity & NIHR Clinical Research Infrastructure Interactions The NIHR and the AMRC are working together to help research charities interact and collaborate with NIHR clinical research infrastructure and its expert researchers and have identified a range of potential models for joint working to suit different sizes of organisation and resources available. Patient and public involvement where patient involvement is integrated into the overarching strategy of an NIHR infrastructure organisation, guided and supported by a charity. See case studies: DIPEx, Arthritis UK, Ataxia UK Funding plus where charities have an additional added-value interaction with a part of the infrastructure as a consequence of, or linked to, funding of a particular research study. See case study: Arthritis UK Strategic interactions where coordinated work with the NIHR infrastructure becomes a core part of a charity s research strategy, for example through the support for clinical study groups within clinical research networks. See case studies: Ataxia UK, Kidney Research UK, Myeloma UK Research workshops charities and investigators from NIHR infrastructure in a thematic area, with patients and service users, to improve the development of research questions, study protocols and ultimately support better study outcomes. See case study: Whizzkidz, British Tinnitus Association Dissemination of research and movement of research outputs into practice where charities have the established routes to support this process. See case study: British Tinnitus Association, SpeakwithIT A number of these models of joint working are illustrated in the examples on the following pages. 7

8 Evidence-based Research Set to Shape Future of Tinnitus Studies A Fully Supported Medical Research Partnership The British Tinnitus Association (BTA), in partnership with the NIHR Nottingham Hearing Biomedical Research Unit (BRU) has embarked on a project to answer key questions about tinnitus treatment from patient and clinical perspectives and generate evidence-based research to direct future research funding strategies. I ve had Tinnitus for 27 years and I still get told It s just buzzing in your ears. What are you complaining about?, But people don t realise how bad this can be. I m looking forward to taking part in this research and hopefully helping to find a cure so future generations do not have to suffer. Tinnitus patient, Theresa. 8 Details of the project: British Tinnitus Association: NIHR Nottingham Hearing Biomedical Research Unit:

9 Tinnitus: Research Challenges Tinnitus is a debilitating condition in which people experience a ringing or buzzing in their head. In the UK, approximately five million people suffer from tinnitus, which can be extremely difficult to treat due to the huge variation in symptoms and severity between individual patients. While there is currently no cure for the condition, this project, focusing on considerable patient and public involvement, seeks to address the uncertainties surrounding the current assessment procedures and treatments being provided. The Nottingham Hearing BRU is collaborating with the BTA, the James Lind Alliance Priority Setting Partnership and the Judi Meadows Memorial Fund, to work with patients and NIHR-funded clinicians to identify and prioritise unanswered questions about tinnitus treatment. This research aims to help people cope with the distress that tinnitus causes and to help improve their quality of life. The BTA is committed to use these research outcomes to drive the charity s future research funding. Targeted Research Partnership Patient and public involvement is a key element of this research project. In 2011, at the request of the NIHR Nottingham Hearing BRU, the BTA and supported by the Judi Meadows Memorial Fund, the James Lind Alliance commenced a Priority Setting Partnership project with various organisations and individuals interested in tinnitus research. The project received over 2,500 questions regarding the assessment and treatment uncertainties from 800 respondents. As tinnitus underlying causes are poorly understood, the intended outcomes of this research include identifying and prioritising research targets that patients and clinicians agree are the most important, making the research results available to commissioning bodies to help structure funding. Impact This collaboration between the NIHR, research charities and patients has succeeded in not only raising awareness about tinnitus within the hearing-related healthcare profession and the general public, but has brought together professional bodies, develop the future strategy of tinnitus research. The BTA aims to formulate areas of research that patients and clinicians consider most relevant. Professor Deborah Hall, Director, NIHR Hearing BRU commented: The NIHR Nottingham Hearing Biomedical Research Unit is happy to be co-leading this national project with the James Lind Alliance, thereby helping to shape the future of tinnitus research in the UK. The James Lind Alliance was approached to collaborate on this project as its work is highly respected across the medical field for being extremely systematic and transparent, while ensuring that patients and clinicians have equal voices and that real treatment uncertainties are considered and prioritised. David Stockdale, Chief Executive, BTA said: The British Tinnitus Association is very excited about what this project will mean for the future of tinnitus research. Whilst the BTA will not lose focus on the search for a cure, the Tinnitus Priority Setting Partnership will allow us to also focus on areas that patients and clinicians tell us are important. We hope that this will lead to increased number of professionals and students taking an interest in tinnitus research and hopefully more investment in tinnitus research from some of the leading medical research funders. 9

10 Patients Help Ensure Research into Rare Neurodegenerative Disease is Effective Clinicians supported by the NIHR University College London Hospitals Biomedical Research Centre (UCLH BRC) are partnering with patients and a specialist charity to develop a holistic approach to ataxia care and research. By working closely with patients, clinical researchers supported by infrastructure funding from the UCLH BRC have been able to design more effective research studies and recruit large numbers of patients to participate in clinical trials. I believe strongly that the partnership between researchers, patients and patient support groups helped develop a stronger support framework in the guise of the Ataxia Centre and that is extremely valued by patients and is at the forefront of translational research at an international level. Dr Paola Giunti, Patient and Public Involvement Lead for the NIHR UCLH BRC and UCLH Consultant Neurologist and researcher. 10 More information: NIHR University College London Hospitals Biomedical Research Centre:

11 Ataxia Ataxia is a group of neurodegenerative conditions caused by brain damage as a result of disease or faulty genes. More than 100 different disorders can lead to ataxia which, in many cases, is progressive and is as yet incurable. People affected by ataxia lose their physical coordination and balance, often develop tremors, uncontrollable muscle spasms, as well as vision and speech defects. Some forms of ataxia also affect the heart and increase the likelihood of other serious complications such as diabetes, blindness or curvature of the spine. Progressive ataxia is relatively rare affecting an estimated 10,000 adults in the UK plus an unknown number of children. The Ataxia Centre In 2005 a specialist centre for ataxia was set up at the National Hospital for Neurology and Neurosurgery (NHNN) which is part of the University College London Hospitals NHS Foundation Trust. The specialist centre was the first in the UK and the first centre to be accredited by the patient support organisation Ataxia UK. Based on this model, other centres of excellence were created. The NIHR UCLH BRC has worked closely with the Ataxia Centre at NHNN to coordinate services combining diagnosis, treatment, support and research. UCLH Consultant Neurologist and researcher Dr Paola Giunti, the Patient and Public Involvement Lead for the UCLH BRC, pioneered the successful holistic approach offered by working closely with Ataxia UK and the success of this approach is largely due to close working with Ataxia UK and involving the involvement of patients and carers in the development of the service. The clinic at the NHNN receives numerous referrals from across the UK, which has enabled the research team to build up a large number of patients and a rich source of data on the condition. But most importantly, patients at the clinic and Ataxia UK have been consulted and involved at all stages during the development of the research, from helping develop protocols and design of the trials, through to writing patient information leaflets, to making sure information is relevant, understandable by everyone involved. Nigel Kilvington was one of the patients who helped design protocols and patient information for a study to evaluate Patient Reported Outcomes after withdrawal from Treatment with Idebenone (PROTI) study. Nigel s input is generally thought to have helped secure ethics approval for the study. Nigel commented that in one trial they wanted to look at the impact of a drug after a couple of weeks. I said you need to see more and look at it after a couple of months. The Ataxia Centre, in collaboration with researchers at the UCLH BRC, has also been involved in a study aimed at understanding balance disruptions in ataxia patients. The data generated from this project, supported by Ataxia UK, was used to design a pilot trial testing a physiotherapy intervention in a small group of spinocerebellar ataxia patients. Patients played a key role in helping design the trial, by attending focus groups to recommend changes, such as shorter testing periods to avoid fatigue, and testing at patient s homes. 11

12 Exploring People s Experiences of Research Participation A Novel Infrastructure-supported Fellowship The NIHR Oxford Biomedical Research Centre (BRC) is working with Healthtalkonline and the Health Experiences Research Group, to improve how research studies are communicated and organised. The Oxford BRC funded a Fellowship at the University of Oxford, to conduct a survey of patients taking part in different types of research. Between 2009/11, 55 patients were interviewed, with the information gathered used to improve the efficient use of NHS time. Healthtalkonline collects people s personal stories of health and illness and shares them with patients, families and healthcare professionals This enables them to benefit from the experiences of others and gain an insight into what it is really like to take part in health research. My role allows us to bring the philosophy of Healthtalkonline to the NIHR Oxford Biomedical Research Centre and give patients a chance to express their views about being involved in research and to make a real difference to how things are done. Dr Louise Locock, Research Fellow University of Oxford. 12 More information: Details of the NIHR project: and:

13 Showcasing Experiences Healthtalkonline is an award-winning website run by the DIPEx Charity, which allows individuals to share in other people s experiences of health and illness. It has developed a new section on its website to provide an insight into people s experiences of taking part in clinical research. This features video and audio interviews with 42 people from a wide range of backgrounds talking about why they took part in a research study, what information they needed and what it was like for them. Research Fellowship Building on the work of Healthtalkonline, the Oxford BRC funded a Fellowship at the University of Oxford, held by Dr Louise Locock, to conduct interviews with patients taking part in different types of medical research. These interviews featured patients assessing a new local screening programme for heart valve disease, a cohort study on transient ischaemic attack and stroke prevention, and biobank studies where people donate blood, tissue or other samples for future research. The interviews were designed to provide information for patients taking part in these types of research studies and to be available through the Healthtalkonline website. The outcomes of the interviews are now used to give research staff an insight into what patients feel about research participation. A series of short films, highlighting these experiences and showing staff explaining their research, are available on the Oxford BRC website. Results The findings showed there is considerable support for medical research amongst those who took part, and that study participants particularly value having a sense of equal partnership with that of the research teams. Study participants often enquire into the results of research they have contributed to, with some seeking a more active and longer term involvement. Impact of Patient Involvement The information generated from these interviews has already had a direct impact on current research studies. This includes improving information provided to the patients about the research studies, the way results are fed back to the patient and the scheduling of research appointments. Ongoing Research The Oxford BRC s subsequent collaboration with Healthtalkonline will gather experiences of people who become involved as lay representatives in research design and governance. The collaborative project will investigate what motivates people to join clinical studies, how they hear about the trial opportunities and what training and information needs they have. This study will feed directly into the BRC s wider strategy for patient and public involvement and contribute to training for lay research participants and research staff. 13

14 A New National Clinical Trials Network for Myeloma: A Novel Collaborative Approach Myeloma UK has established a new national clinical trials network to transform the way drugs for myeloma are tested and accessed in the UK. The creation of the Myeloma UK Early Phase Clinical Trial Network represents a significant investment for the charity, forming an important part of its strategic decision to implement a new research model for myeloma in the UK. Working with and building on the expertise provided by the network of NIHR / CRUK Experimental Cancer Medicine Centres (ECMCs) across the country is a key component of Myeloma UK s bench-to-bedside strategic plan. 14 More information: Information on myeloma and myeloma research: Experimental Cancer Medicine Centres:

15 Network Structure and Benefits Myeloma UK developed its Early Phase Clinical Trial Network to ensure that the NHS becomes a world leader in myeloma research and that patients in this country can access new and innovative treatments. This Network consists of eight established centres around the UK that carry out a prioritised portfolio of trials. All eight of the Myeloma UK network centres conduct experimental medicine research working with the Experimental Medicine Centre and Cancer Research UK. Impact of ECMC Support ECMCs provide support for clinical researchers and experts in cancer biology to progress the safe, rapid and rational evaluation of new cancer treatments. ECMCs also drive the discovery, development, testing and application of new biomarkers to identify promising new treatments and facilitate the evolution of personalised medicine. By bringing together some of the UK s best cancer researchers and doctors, ECMCs are moving discoveries from the lab bench to the patient s bedside more effectively and improving access to the very latest drugs. Fostering a culture of collaboration between ECMCs and industry is a key goal of the Myeloma UK Clinical Trial Network, which will be further developed in the future. The Myeloma UK Early Phase Clinical Trial Network is already showing success, with the first study Myeloma UK one, investigating the best combination of treatments for patients with relapsed or refractory myeloma, opening in record time. The study opened for recruitment at the end of January 2011, only 12 months from protocol design, compared to the two years average time it takes to launch a clinical study of this type. Strategic Drivers The decision to establish the Myeloma UK Early Phase Clinical Trial Network was driven by Myeloma UK s recognition that the development and access to new drugs for myeloma, a debilitating cancer of the bone marrow, can be a frustratingly slow and inefficient process. The network therefore brings together clinical specialists and researchers, the pharmaceutical industry and NHS regulatory bodies to conceive, design and conduct a portfolio of early phase trials of novel myeloma drugs. The aim is to develop a more structured approach to myeloma clinical trials in this country and improve the speed and effectiveness of set-up and delivery. Eric Low, Chief Executive, Myeloma UK said: The Myeloma Experimental Clinical Trial Network aims to rapidly move new treatments developed in the laboratory to the clinic, where they constitute useful treatments for myeloma patients. The first step of this approach is to test the safety and effectiveness of these therapies. When this is completed, they will be made more generally available for widespread late phase testing. It intends to support the wider efforts of the Government and research community to champion innovation, improve the competitiveness of the UK as a site for clinical research, and encourage the speedy introduction of new drugs into NHS practice. We are delighted that through our collaboration and efforts, we have successfully set the first study up in record time. This is an important milestone for the Network and an amazing achievement. 15

16 Developing a New Wheelchair Dragon s Den Style Workshop Gives Children the Opportunity to Influence the Design In this pioneering project to design a new wheelchair for children, collaboration between clinicians, product designers and engineers was greatly enhanced through the running of a workshop for children, their parents and their carers. Through engagement with the charity Whizz-Kidz, Devices for Dignity, one of the NIHR Pilot Healthcare Technology Cooperatives, was able to develop a project which directly improves the lives of disabled children. People don t usually ask us what we want and need but by working together we can ensure children in the future get better wheelchairs than the ones I had when I was growing up. One wheelchair user at the workshop was clear about the value of this approach. 16 More information: NIHR pilot Healthcare Technology Cooperative: Whizz-Kidz charity:

17 Designing a New Wheelchair Devices for Dignity, one of the NIHR Pilot Healthcare Technology Cooperatives, partnered with Frazer-Nash Consultancy, a multi-disciplinary engineering consultancy, to design a wheelchair specifically for children. The new design was aimed at allowing children with long term conditions to leave a hospital environment with confidence and for them and their families be able to get out and about safely and with more independence. The team worked closely with paediatric consultants from Great Ormond Street Hospital and Sheffield Children s Hospital, occupational therapists, engineers and clinical scientists to design a new wheelchair that could cater for the children s everyday needs. Involving Children and Parents As the design of these new wheelchairs is important to the children who use them, a key part of the design and development process for the new wheelchairs was the involvement of children, parents and their carers. Devices for Dignity worked with the charity Whizz-Kidz to carry out a series of online surveys and a Dragon s Den style workshop to find out exactly what children needed from their wheelchairs and how it could be incorporated into the new designs. Whizz-Kidz hosted this workshop to provide a national platform for input. As part of the workshop, children and parents used paper images of key features of the possible wheelchair designs to create a collage of their ideal wheelchairs. These collages and feedback from the workshops were used alongside data from clinicians to produce a final design scheme. Whizz-Kidz was ideally placed to partner with on this project, as it is a charity that provides children with disabilities, with essential wheelchairs and other mobility equipment they need to lead fun and active lives. Whizz-Kidz currently estimates that there are approximately 70,000 children and young people with disabilities in the UK, waiting for a wheelchair that fits their lifestyle. One of the project team said: The priority needs to be that children have a well fitting chair that supports their posture and development and once they grow are not left for months/years in ill fitting chairs which are contributing to deterioration of posture and body shape. One workshop participant commented: Since I have grown out of my high low outdoor base I have actually become more disabled. My quality of life has decreased dramatically, so please, please make a height-adjustable wheelchair so I can touch the floor and feel the sand at the beach with my bare feet! Jack, a 16 year old boy who cannot self-propel a manual wheelchair said: My powered wheelchair allows me to go where I want to go, meaning at school I can get around by myself, which is really important to me because I don t like having others push me around where they want to go. 17

18 Clinical Study Groups: A New Approach to Funding Clinical Trials in Arthritis Arthritis Research UK is committed to increasing its support for clinical research by developing a new approach to funding. The charity has established clinical study groups to work with the NIHR Comprehensive Clinical Research Network and help drive forward the testing of new treatments for arthritis. One of the key activities that Arthritis UK supports is evaluating the best treatments with those that are newly available. This means undertaking clinical trials comparing treatments in different groups of patients. These are fundamentally important studies. The results identify which treatments are best given to which patients. The Clinical Studies Groups we have established, each with a broad range of stakeholders and experiences, are important to help us understand the questions that should be priorities in these areas. Professor Alan Silman, Medical Director, Arthritis Research UK. 18 More information: Information on arthritis and arthritis research: Information on NIHR Comprehensive Clinical Research Network:

19 Clinical Study Groups In order to understand the most urgent questions around the treatment of arthritis, the charity Arthritis Research UK has established eight clinical study groups focusing on different areas of arthritis research. Membership of each Arthritis Clinical Study Group comprises the key stakeholders in that research area which includes clinicians, surgeons, nurses, physiotherapists and patients. Each group is tasked with identifying national research priorities for that area and articulating them as a research strategy. The remit of the Clinical Study Groups is not only to support research to answer these prioritised questions, but to involve at least one patient representative to ensure that the research priorities include the patient s views as well as those of clinicians. Benefits of Collaboration Working in this way has enabled Arthritis Research UK to take full advantage of the services and support offered by the NIHR Comprehensive Clinical Research Network which includes access to the support and additional resources required to complete clinical trials in a efficient and effective way. Any investigator with a new idea for an arthritis treatment or intervention is encouraged to work with the relevant Clinical Study Group to help shape the research idea to fit in with the nationally agreed priorities. Any funding applications must be submitted with Clinical Study Group support. Research funding may not necessarily be sourced solely through Arthritis Research UK. It may involve other funders, such as the NIHR. One such example is where Arthritis Research UK is co-funding a trial of anti-tumour necrosis factor (anti-tnf, a class of drugs used to treat and reduce inflammation and disease progression) with the NIHR Health Technology Assessment Programme, to treat sight threatening uveitis, inflammation of the middle layer of the eye, in children with juvenile arthritis. 19

20 Establishing a UK Kidney Research Consortium: Enhancing Links With NIHR Clinical Research Networks The UK Kidney Research Consortium was established by Kidney Research UK and the Renal Association to stimulate clinical research and trials in kidney disease. Since being set up in 2007, one of the consortium s major strategic aims has been to ensure that best use is made of the NIHR clinical research infrastructure, specifically the NIHR Comprehensive Clinical Research Network, in order to drive forward renal research for the benefit of kidney patients in this country. We recognised early on that the NIHR Comprehensive Clinical Research Network and some of the Topic-Specific Networks could provide a major boost to clinical research in kidney disease if the renal research community was able to work in a coordinated and strategic way. Establishing the consortium was the catalyst for this to happen and, ultimately the benefit to people with kidney disease has been greatly enhanced. Charles Kernahan, Chief Executive Officer, Kidney Research UK. 20 More information: UK Renal Research Consortium: Kidney Research UK:

21 Need for a Coordinated Approach Research into kidney disease in the UK has been relatively under-supported compared to the burden of disease. Consequently, kidney disease has not developed the profile needed to stimulate the level of research required by patients and clinicians alike. A clear need was therefore identified to bring together the clinical and academic research communities to focus on the major research questions in kidney disease and to begin to plan the studies required to answer them. Establishing the Consortium Kidney Research UK, as the major charity funding research into renal disease, and the Renal Association, the professional body for renal physicians and scientists in the UK, were ideally positioned to begin this coordinated approach. Together they established the UK Kidney Research Consortium to support the development of clinical research in kidney diseases in the UK by advising on research needs and encouraging the development of new trials. The consortium immediately began building working relationships with NIHR clinical research infrastructure across the country, and this has since led to huge improvements in the coordination of renal research. The consortium s impact can be illustrated by an approximate two-fold increase in studies on the NIHR Comprehensive Clinical Research Network s Renal Portfolio since mid-2008, which currently number around 90. Patient Impact A recent example of a Kidney Research Consortium initiative supported by the NIHR Comprehensive Clinical Research Network is a project which aims to improve the variability in managing chronic kidney disease (CKD) using a quality improvement intervention called a Care Bundle (a set of evidence-based activities grouped together and carried out at the same time). The bundle comprises three clinical interventions, plus one self-management intervention developed and delivered by a Patient Advisory Group. Twenty six GP practices received training in the self-management intervention, with over 500 patients utilising the self-management packages. The NIHR Comprehensive Clinical Research Network has been particularly useful in addressing financial considerations for practices wishing to participate in research, which has enabled the charity to engage with a broader range of practices. Working With NIHR Comprehensive Clinical Research Network The NIHR Comprehensive Clinical Research Network has a number of national specialty groups designed to capture the expertise and enthusiasm of researchers working in specific areas of health and disease. The Kidney Research Consortium works closely with the Renal Specialty Group which is important strategically, as a major remit of the Renal Specialty Group is to review potential studies, particularly from industry, for inclusion on the The NIHR Comprehensive Clinical Research Network Portfolio. 21

22 Self-managed Computer Speech Therapy With Volunteer Support The NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC) for South Yorkshire, in collaboration with a number of partner organisations, designed and conducted the Computer Aphasia Treatment versus Usual Stimulation (CACTUS) project to evaluate the feasibility of delivering long term intervention using a model of self-managed computer therapy to support sufferers of aphasia. The StepByStep approach was developed using best practice within a small clinical setting and it has been thrilling to see the results in the CACTUS trial on a much larger scale, and also to see how well a charity like SpeakWithIT can offer long term support. Dr Jane Mortley, Steps Consulting Ltd. 22 More information: CLAHRC CACTUS trial: Steps Consulting Ltd. (Yorkshire): Speak With IT:

23 Aphasia: Difficult to Explain About a third of people who have had a stroke have aphasia, an acquired communication disorder, which makes it difficult to speak, understand speech, read and write. According to Speakability, a leading aphasia charity, approximately 250,000 people in the UK suffer from aphasia, with 20,000 new cases occurring each year. Long term speech and language difficulties can lead to depression, family breakdown, unemployment and social isolation. There is evidence that people with aphasia can continue to improve their language ability for several years after their stroke. However, aphasia treatment is most effective if it is offered intensively but speech and language therapy resources are limited, which means that this intensive therapy is not always available to patients. StepbyStep Improvement Steps Consulting Ltd is a company which has developed a computer-based software aphasia therapy programme called StepbyStep used by aphasia patients for independent speech practice. Funding, Patient Recruitment and Staff Training A Collaborative Effort Members of the CLAHRC for South Yorkshire received an NIHR Research for Patient Benefit Programme award to evaluate the StepbyStep approach for people with aphasia. With additional support from the Trent NIHR Stroke Research Network, thirty four patients with longstanding aphasia were recruited to the CACTUS project. Impact Although study patients had suffered from aphasia between one and 29 years (average six years), those who used the computer software treatment, learned to say almost 20% more words than those who did not received the treatment. The project findings indicated that independent use of this computer-based treatment with support has the potential to be a feasible and cost effective method of providing speech and language therapy for individuals with aphasia in the long term, post-stroke. A full randomised controlled trial needs to be conducted to provide robust evidence of this effect. Many South Yorkshire patients who took part in the CACTUS project continue to use the computer treatment independently. To extend this opportunity to more people with aphasia, the CLAHRC for South Yorkshire team is planning to work with local speech and language therapy departments and voluntary services to integrate the methodology into long term combined service provision. People with aphasia and their carers from the charity Speakability who were involved in identifying participants for the CACTUS project were so enthused with the StepbyStep method, that they formed their own registered charity SpeakwithIT. They now train and support volunteers, raising money for computers and software for aphasia patients. The CLAHRC for South Yorkshire provides assistance with training packages for the volunteers. The National Stroke Improvement Programme disseminated results of the CACTUS project throughout England. Consequently, more than 20 speech and language therapy departments contacted the CLAHRC for South Yorkshire, showing interest in the technology and in participating in further research. The qualitative impact for the patients is best described using their own words: My partner now has a name, I can say many of my friends names. I can even say my own name, which was impossible a year ago. I am looking forward to improving even more. 23

24 Further Information and Contact Details This booklet highlights a number of collaborative partnerships between medical research charities and the NIHR clinical research infrastructure. The examples show how the NIHR clinical research infrastructure can work with charities to develop and deliver benefits for patients, their carers and the NHS from working together to engage patients in the design of new technologies to longer-term strategic partnerships. NOCRI and the AMRC can help facilitate this process of engagement by helping charities to navigate the research environment, providing introductions where required, and helping to set up partnerships and collaborations. If you would like information or help please contact us at: NIHR Office for Clinical Research Infrastructure nocri@nihr.ac.uk National Institute for Health Research NIHR Clinical Research Network crncc.info@nihr.ac.uk Association of Medical Research Charities 24

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26 Notes 26

27 NIHR Office for Clinical Research Infrastructure (NOCRI) A305, Richmond House 79 Whitehall London SW1A 2NS Association of Medical Research Charities (AMRC) Charles Darwin House 12 Roger Street London WC1N 2JU Tel: +44 (020) The information in this booklet is correct at time of printing. November 2012.