Research in Wales · patients in Wales and beyond. The Unit has built a strong reputation for...
Transcript of Research in Wales · patients in Wales and beyond. The Unit has built a strong reputation for...
Research in WalesOur offer to the life sciences sector
• World-Leading Research
• Streamlined Services
• Vibrant Research Culture
Health and Care Research Wales | healthandcareresearch.gov.wales2
3Health and Care Research Wales | healthandcareresearch.gov.wales
In support of this, Wales offers expertise across a full range of clinical specialties. Our universities are home to world-leading researchers, many of whom work collaboratively with the NHS and industry to create therapies and technologies that will bring life changing benefits to patients. In addition to this, through partnership working with our colleagues across the UK, a streamlined environment has also been created to ensure a proactive response to industry; ensuring studies
hrough Health and Care Research Wales, the Welsh Government has
established a vibrant research culture that recognises and supports fruitful collaboration with the life sciences sector. Through continued investment in NHS Wales, clinical research continues to gain strength as core activity, ensuring that patients are continually offered the opportunity to participate in clinical research and play a greater role in drug discovery programmes providing essential evidence for the future.
T
Professor Jon BissonDirector of Health and Care Research Wales
ForewordIn Wales, our vision is to be internationally recognised for our excellent health and social care
research that has a positive impact on the health, wellbeing and prosperity of the people in Wales.
We know that working together with the life sciences sector is key to achieving these goals.
are commenced in a timely manner. Whether you have an established working relationship or are looking to develop one with us, as Director of Health and Care Research Wales I am confident that through dedicated study management and commercial expertise, NHS Wales can play a significant role in the delivery of high quality research for worldwide patient benefit.
3
4
Our experienceoday Wales continues to demonstrate vast experience in delivering clinical research studies, leading multicentre, international research
and participating in research which has a major impact on the health of the nation, UK and globally. Health and Care Research Wales also has significant experience of working with industry, supported by long standing agreements with commercial partners and effectively delivering research studies across a wide range of clinical speciality areas.
T
Dr Frank AthertonChief Medical Officer for Wales
“Wales has a rich heritage of clinical research which includes pioneering work undertaken by the Medical Research Council Pneumoconiosis unit in Cardiff back in the 1940s. Led by Professor Archie Cochrane, this ground breaking research studied a possible causative relationship between tuberculosis and the development of simple pneumoconiosis into the much more serious condition of progressive massive fibrosis in over 20,000 coal miners from the Welsh Valleys by using high quality comparative studies.
This work has revolutionised the design of epidemiological studies ever since, prompting the value of randomised controlled trials and the importance of the systematic review. This rich tradition of research excellence continues today and forms the basis of evidence based medicine which has positively impacted the care of so many patients, not just in Wales but internationally.”
The NHS is recognised as a world-leading healthcare system
Health and Care Research Wales | healthandcareresearch.gov.wales 5
NHS Wales is home to world class clinicians, scientists and healthcare professionals
Integrated health and social care research development
A dedicated, skilled workforce supports health and social care research from phase one to four studies
Internationally recognised universities and academic expertise
Access to high quality clinical data
UK integrated and streamlined study set-up ensures fast and efficient start-up
Direct access to patient populations and NHS and social care services in Wales
What makes Wales a dynamic place to do research?
Health and Care Research Wales | healthandcareresearch.gov.wales6
The impact of commercial research
Patients enrolled to the study continued to receive treatment as long as they benefited from the study drug and did not suffer severe side effects. Singleton Hospital was one of eight sites in the UK and recruited six patients in total. Three patients continued to receive treatment and have had better treatment options because of the study. The health board is set to realise cost savings (£45K per patient per year) as a result of taking part and the patients will benefit from improved quality of life.
bertawe Bro Morgannwg University Health Board completed a phase
three study to compare the outcomes of treatment with bortezomib and low dose dexamethasone with or without the addition of an immunotherapy treatment pomalidomide in patients with relapsed or refractory multiple myeloma (a type of blood cancer).The study, which was sponsored by Celgene and coordinated by the National Institute for Health Research (NIHR) feasibility service, aimed to establish whether this combination of pomalidomide would benefit patients with more efficient treatment, prolonged survival and improved quality of life.
A
Health and Care Research Wales | healthandcareresearch.gov.wales 7
Wales provides a dedicated industry service linked to an integrated research community
Complete study management ensuring recruitment to time and target and rapid study closure
UK wide coordinated feasibility process with our study set-up processes streamlined across the UK
Standard contracts and costings templates are consistent across the UK
Speed... Quality... Reliability...
Access to high calibre staff and networked groups of research active clinicians
Strong collaborative working facilitated within our small agile country
Delivering the highest quality health data
Coordinated and managed delivery from feasibility to study closure
Wales has clear performance metrics and transparent measurement and reporting of performance
National approach ensures capacity to deal with performance issues as they arise and resolve efficiently
Our teams have direct access to NHS patients and participants across health and social care
Our offer to the commercial sector
Health and Care Research Wales | healthandcareresearch.gov.wales
Support and Delivery ServiceHealth and Care Research Wales’ support and delivery service offers complete support and oversight for individual company’s needs
Welsh Government reforms have ensured streamlining and UK compatibility for all our services in order to reduce start-up times, standardise costs and drive quality improvement. Our processes are fully integrated with the UK regulatory pathway.
Our services span primary, secondary and social care
Our seamless service ensures a rapid and responsive experience throughout the life cycle of a research study.
Ten NHS organisations in Wales and access toover 100 primary care practices which areresearch ready and supported through Healthand Care Research Wales investment andincentives. HealthWise Wales is national research study
collecting information on the health andlifestyle of people living in Wales. The datacollected is linked to NHS health records andis not available from routinely available healthand social datasets. It includes informationabout sociodemographic characteristics andprovides a wealth of information readilyavailable to researchers for bespoke researchstudies. The study is a step change in Wales’ability to understand how to prevent andimprove outcomes for the future.
8
9
We are part of the UK wide feasibility service
One conversation for access to our nationwide resources through a dedicated industry team in our national support centre
Fast turnaround for site identification
Rapid feedback and expressions of interest from NHS Wales clinical specialties and organisations
Bespoke advice for your study support requirements
Our national research training programme supports high quality research services and skilled research ready teams
Nationwide access to Good Clinical Practice training
Access to expertise and resources to ensure public involvement in research
Direct engagement with interested investigators and on site teams in primary and secondary care
Comprehensive site level feasibility assessments include local targets and capabilities
Standard UK contracts and costings templates
National oversight supports consistent study wide set-up
Direct access to patient populations and NHS and social care services in Wales
Dedicated on site research delivery staff support study management and delivery
Capacity to resolve challenges as they occur
NHS Wales research delivery is driven by clear Welsh Government commercial research performance metrics
Our national research data system supports proactive performance management
National oversight ensures delivery of study wide targets and timelines
Early engagement & national feasibility
Training
Involving patients & the public
Site selection & set-up Delivery & performance management
Health and Care Research Wales | healthandcareresearch.gov.wales10
Health and Care Research Wales
Aims to be a world class research centre, addressing internationally important questions in ageing and dementia.
Centre lead: Professor Vanessa Burholt Website: cadr.cymru
Aims to improve health and wellbeing through undertaking high quality research in primary and emergency care.
Centre lead: Professor Adrian Edwards Website: primecentre.wales
Focuses on mental illness, neurodevelopmental disorders and learning disability conditions at all stages and in all areas of life.
Centre lead: Professor Ian JonesWebsite: ncmh.info
Focuses on population health science and the promotion and maintenance of health.
Centre lead: Professor Ronan Lyons Website:ncphwr.publichealthnetwork.cymru
Built upon a track record in research excellence, the centres and units, listed below, support integrated health and social care research to address areas of public need.
Centre for Ageing and Dementia Research
Wales Centre for Primary and Emergency Care Research (PRIME)
National Centre for Mental Health
National Centre for Population Health and Wellbeing Research
Welsh Government has significantly invested in a sustainable research infrastructure to support and increase capacity in research and development. This package of support ensures that Wales builds on research strengths where it excels and includes vital collaborations with the life sciences industry for the universal benefit of patients.
Health and Care Research Wales works in collaboration with UK partners on the development and delivery of multicentre research involving leading researchers across the UK and globally.
Health and Care Research Wales | healthandcareresearch.gov.wales 11
Active in areas of basic, clinical, epidemiological, social care and health services research, focusing on research which includes diabetic retinopathy, immunity and type 1 diabetes.
Centre lead: Professor Steve BainWebsite: diabeteswales.org.uk
Tests existing clinical approaches to underpin discovery, design and pre-clinical development of prototype diagnostics and therapies for kidneydisease. Centre lead: Professor Donald FraserWebsite: kidneyresearchunit.wales
Delivers research into cutting-edge treatments, evidence-based palliative care and cancer-based social care, cancer prevention and earlier cancer diagnosis.
Centre lead: Professor John ChesterWebsite:walescancerpartnership.com/wcrc
Delivers novel cell, drug and growth factor therapies to patients with neurological and neurodegenerative diseases.
Centre lead: Professor William Gray Website: brain.wales
Diabetes Research Unit Cymru Wales Kidney Research Unit
Wales Cancer Research Centre
The Infrastructure Support Groups in data linkage, genetics and genomics and health economics provide expertise, opportunities for collaboration and support to the research community in Wales.
Clinical Trials Units provide expertise in clinical trials and other well-designed studies. Located across Wales, all three Clinical Trials Units are UK Clinical Research Collaboration (UKCRC)-registered.
Brain Repair and Intracranial Neurotherapeutics (BRAIN)
Health and Care Research Wales | healthandcareresearch.gov.wales12
Exceptional Facilities
The Clinical Research Facility based within Cardiff & Vale University Health Board supports a broad range of research from phase one to four in haematology, rheumatology, endocrinology, renal, cardiac, genetics, neurosurgery and ophthalmology. More recently research collaborations have supported high risk early phase work in haemophilia, respiratory, infectious diseases, endoscopy and solid tumour cancers. Partnerships with the life science sector are an important part of the work and established relationships with the pharmaceutical industry account for 40% of the research undertaken.
For more information, email:[email protected]
Established in 2013, Wales’ dedicated early phase unit at Velindre Cancer Centre has provided a significant extension of services available to patients in Wales and beyond. The Unit has built a strong reputation for successful delivery of studies to patients, having led worldwide recruitment in ARADES and achieved the highest recruitment rate for the Genmab trial in 2016.
Specialising in solid tumour oncology, the Unit is one of the two trial treatment units for Cardiff Experimental Cancer Medicines Centre, with a commitment to a balanced portfolio of trials offered to patients by a highly skilled workforce. The team are currently expanding work in to trial drug/radiotherapy combinations, developing solid haematological trial delivery and taking a significant lead in the development of translational research, working in partnership with academia and industry.
For more information, email: [email protected]
Clinical Research Facilities
(Cardiff)
Clinical Research Facilities
(Newport)Early Phase Unit
(Velindre Cancer Centre, Cardiff)
The Clinical Research and Innovation Centre based within Aneurin Bevan University Health Board provides a facility where patients can take part in high quality commercial and non-commercial research. Established in 2015, the Centre is the focal point for research and development within the health board enabling patients, researchers and staff to come together within a designated research space.
For more information, email:ABB.R&[email protected]
Health and Care Research Wales | healthandcareresearch.gov.wales 13
The Facility provides expertise in phase two to three studies and has a robust portfolio of research addressing many of the current health challenges including diabetes, heart disease and multiple sclerosis. Highly skilled research nurses are trained in research methods and work across a diverse portfolio of studies. The majority of clinical research is undertaken in two dedicated facilities based within Abertawe Bro Morgannwg University Health Board. The Facility has well established alliances with a number of blue chip pharmaceutical companies and clinical research organisations, with a wealth of experience in the assessment of new medicines and devices.
For more information, email:[email protected]
The Welsh Wound Innovation Centre is the first national wound healing centre worldwide and is the flagship facility for clinical innovation in Wales. Established to tackle the challenges associated with acute, traumatic and chronic, non-healing wounds and their treatment and prevention, the Centre has a vital role in Wales’ economic development, helping to accelerate growth by stimulating and supporting business-led innovation in wound care.
For more information, go to: wwic.wales
By connecting, inspiring, and accelerating businesses, the Life Sciences Hub Wales is the ‘nerve centre’ for the life sciences eco-system in Wales. From research and entrepreneurs through to healthcare professionals and multinational corporations, the Hub provides a commercially-driven resource for the sector.
For more information, go to:lifescienceshubwales.com
Joint Clinical Research Facility
(Swansea)
Welsh Wound Innovation Centre Life Sciences Hub Wales
Health and Care Research Wales | healthandcareresearch.gov.wales14
Excellence in therapeutic areas
Wales will become the destination of the first proton beam therapy system to treat cancer in the UK. This £17 million technology means that UK patients no longer need to go abroad for proton beam treatment.
The Wales Research and Diagnostic Positron Emission Tomography Imaging Centre (PETIC) provides researchers and doctors with greater ability to detect malignant tissue and track the effects of drugs in incredible detail.
The Cardiff University Brain Research Imaging Centre (CUBRIC) offers world-leading expertise in brain mapping alongside the very latest in brain imaging and brain stimulation, enabled by cutting-edge MR technology. The £44 million Centre has a pivotal role in the global effort to better understand the causes of neurological conditions such as dementia, schizophrenia and multiple sclerosis.
The Brain Repair and Intracranial Neurotherapeutics (BRAIN) Unit works to develop new therapies for brain diseases, bringing together academic experts, clinicians, patients, and colleagues in NHS Wales and industry to benefit people with diseases such as epilepsy, Huntington’s disease, Parkinson’s disease and multiple sclerosis. Setting up this strong infrastructure has enabled BRAIN to secure funding to collaborate with industry and undertake a ground breaking trial assessing the impact of neural transplantation in people with Huntington’s disease. The Unit’s success in establishing strong partnerships with industry enables the team to fulfil an unmet need for pioneering therapies in Wales which includes the first ever robot-assisted epilepsy procedure to accurately identify and reduce the burden of seizures.
For more information, contact Professor William Gray, Cardiff University; email:[email protected]
Neuroscience, cancer, imaging The BRAIN Unit
Health and Care Research Wales | healthandcareresearch.gov.wales 15
Nearly half a million people in Wales suffer from kidney disease and more than 1 in 10 people admitted to hospital suffer a sudden loss of kidneyfunction as part of their illness. Those with kidney damage stay twice as long in hospital and have double the risk of dying during their hospitaladmission. In the Unit, researchers work together with clinicians and patients to understand and improve the identification, prevention, treatment and social context of kidney disease. A very important part of this is working in collaboration with the life sciences industry, which includes a platform of research in infection, diagnostics and kidney disease.
The Wales Kidney Research Unit
A mission of the Unit has been to allow more senior specialists to increase their participation in clinical trials, and recently this has led to leadership of a UK trial in kidney transplantation for those especially challenging to transplant. These initiatives have led to an increasing number of clinical trials run by pharmaceutical companies coming to Wales, giving access for patients to the newest treatments, and benefitting the NHS through savings on costs of treatment.
For more information, contact Donald Fraser, Cardiff University; email: [email protected]
16
Health and Care Research Wales | healthandcareresearch.gov.wales 17
“Amgen is pleased to work with Health and Care Research Wales to bring high quality commercial research opportunities to patients in Wales. Amgen has engaged with Health and Care Research Wales and feel that working alongside the industry team has been beneficial in the area of site selection and in helping us to resolve issues as they arise at sites.”
“Boehringer Ingelheim is pleased to work with NHS Wales to bring high quality research opportunities and new medicines to the Welsh population in disease areas such as oncology, respiratory, diabetes, haematology and cardiovascular. Working with the Support Centre and utilising the feasibility service has allowed us to better identify research sites and engage with potential investigators via one point of access. We look forward to building upon the relationship already in place and continuing to bring high quality research studies to patients in Wales.”
“PPD has worked with Health and Care Research Wales for more than four years to bring high quality commercial research opportunities to patients in Wales. Using the all Wales feasibility service has enhanced our feasibility and site selection activities, and has made local knowledge of care pathways and potential investigators easier to obtain, which have helped PPD maximise the number of feasibility studies routed to NHS hospitals in Wales. Those studies have included haematology, oncology, cardiovascular, neuroscience, infectious disease and general medicine. The Health and Care Research Wales industry team has been extremely responsive by providing invaluable assistance in seeking ways to overcome obstacles related to study start-up activities.”
“The integrated Welsh NHS provides an excellent basis for research and development, which continues to be fully supported through significant funding by Welsh Government. As part of the treatment options offered to patients, we recognise that high quality clinical research plays a vital role in the clinical care pathway of patients, offering early access to treatment with the highest standards of medical care. Over the past few years, we have established a reputation as a location with the capability to lead a variety of research across a range of disciplines. We have continued to work alongside our colleagues across the other UK nations to collaborate on an approach that benefits life sciences companies to choose the UK as a destination for research.”
“There has been great progress in developing core services to industry, designed to facilitate the successful delivery of commercial research in NHS Wales. Speaking as a Principal Investigator for several large pharmaceutical company sponsored studies which are recruiting in Wales, I am acutely aware of the massive advantage that government support can give to Welsh trial centres. In the increasingly competitive and global market that exists today, such support cannot be underestimated.”
“GSK has a long track record of working with NHS sites in Wales with numerous active studies running across primary and secondary care. GSK has always been impressed with the level of expertise and commitment demonstrated by staff working in NHS Wales and are excited about building on these collaborative relationships in the future.”
Sarah Durston
Graham Oakley
Hugh Devine
Robyn Miles
Professor Steve Bain
Carys Thomas
Senior Manager, Development Operations, Amgen
Clinical Operations Manager, Boehringer Ingelheim
Senior Director, Clinical Management, PPD
Government Relations Manager, GSK
Clinical Lead, Diabetes Research Network, Wales
Head of NHS R&D Strategy, Welsh Government
Health and Care Research Wales | healthandcareresearch.gov.wales18
Betsi Cadwaladr University Health Board
Our trusts, Public Health Wales and Welsh Ambulance
Services NHS Trust cover the whole of Wales. Velindre
NHS Trust provides specialist cancer and blood services
across South and Mid Wales.
Hywel Dda University Health Board
Powys Teaching Health Board
Aneurin Bevan University Health Board
Cardiff and Vale University Health Board
Abertawe Bro MorgannwgUniversity Health Board
Cwm Taf University Health Board
694,000
384,000
132,600
580,400
481,900
523,100296,000
NHS Wales is part of the world’s top performing healthcare system
Source: Demography 2016, Public Health Wales Observatory.Wales total: 3,092,000
Here’s a breakdown of each health board and its population.
Health and Care Research Wales | healthandcareresearch.gov.wales 19
w: healthandcareresearch.gov.wales
t: +44 (0) 2920 230 457
Today’s Research; Tomorrow’s Care.