1. Vicki Saul and Sarah Evans
Health and Care Research Wales

2. Health and Care Research Wales @NHS R&D
Research and development (R&D) is a core function of NHS Wales.
There are seven Health Boards and three all-Wales Trusts
All organisations have a R&D team lead by a R&D Director to provide a range of services including:
Delivering the research strategy for the organisation, in collaboration with university colleagues
Providing support to researchers through the research pathway, from grant application to dissemination of results
Ensuring the organisation fulfils its legal, regulatory and financial responsibilities relating to research it hosts or sponsors, and managing risks relating to these responsibilities
Ensuring information about research is available to patients and clinicians
Ensuring staff and other resources are in place so that studies can be delivered

3. BCUHB Workforce Support
43 WTE staff = 53 head count
Covers all BCUHB
Secondary care
Community Mental Health Team
Primary care - 53 GP practices
Supporting 288 studies in this region
(370 active in BCUHB )
449 agreements for study support in place
80% currently delivering to target
1187 participants recruited to studies 2015/16
Create a co-ordinated and dynamic research environment to attract researchers, non-commercial funders and life sciences industry
Maximise the efficiency and effectiveness of research support and delivery at national level through centrally organised functions, to reduce duplication and single decision making when appropriate
Provide a framework for more informed, joined up decision making on resources, and seamless integration of activities through ensuring national and local partners remits are aligned, complementary and mutually supportive
Provide greater shared responsibility for meeting objectives and metrics to move away from silo working
Increase the effectiveness of the deployment of resources to ensure that studies can be opened quickly and organised efficiently to recruit participants across Wales
Provide services to researchers/public as consistent as possible regardless of topic or location

4. Study delivery
Support NIHR Clinical Research Portfolio research studies
Support the planning, set up and co-ordination of studies – costing and feasibility
Identify eligible participants including database searches and notes screening
Support and obtain patient and service user consent for participation
Ensure compliance with research management and governance legislation, ethical and GCP requirements
Recruit patients, service users and collaborators
Collect data for studies and follow up
Record and report recruitment and performance manage studies
Support and mentor local study teams
Support inspections by MHRA and authorising bodies
Safety reporting
Quality assurance of delivery
Our Research Networks offer researchers a wide range of support depending on the needs of the study and of each local investigator
Support can include: database searches/ note screening; giving information about studies to potential participants; recruitment of participants and support with approval processes.
Our research staff are integrated within multi-disciplinary teams, working alongside doctors, nurses and health and social care professionals, prioritising patient well being and safety. We provide research participants with a high standard of support, information and care throughout their involvement in research.

5. Primary Care Support BCUHB Primary Care Facilitator
Led by Health and Care Research Wales Support Centre
PiCRIS
BCUHB Primary Care Facilitator
Health and Care Research Wales Workforce support
Specific challenges in Primary Care
Culture
Engagement and access at GP practice level
Communication processes within Primary Care
Limitations on time
Limited space
Primary Care skills and knowledge
IT and systems knowledge
Model of working
Sustainability
Support Centre leads on the development of infrastructure for Primary Care
Primary Care Research Incentive Scheme – PiCRIS
Incentivises participation in research, provides mentorship and supports infrastructure development
Current PiCRIS information:
Practices in North Wales
Nationally
Relationship to SAIL
Research Ready
BCUHB development
Primary Care Facilitator role

6. Cardiology Portfolio Commercial Non- commercial
Sanofi, Covance, Merck Sharpe and Dohme
Non- commercial
European Cardiovascular Research Institute, Oxford University Clinical Trials Service Unit
Observational studies, CTIMPS and RCTs
Recent areas of focus include:
Use of cholesterol reducing medications alongside highest tolerable dose of statin
Anticoagulant regimes post cardiac stent
Efficacy and long term patient outcomes of current AF patient care pathways
Our Research Networks offer researchers a wide range of support depending on the needs of the study and of each local investigator
Support can include: database searches/ note screening; giving information about studies to potential participants; recruitment of participants and support with approval processes.
Our research staff are integrated within multi-disciplinary teams, working alongside doctors, nurses and health and social care professionals, prioritising patient well being and safety. We provide research participants with a high standard of support, information and care throughout their involvement in research.

7. REVEAL – Oxford University (Merck Sharpe Dohme sponsor)
Trial of daily atorvastatin plus anacetrapib (a cholesterol ester transfer protein) or placebo
Aim to reduce risk of further cardiac events by massively increasing HCL (up to approx 140%)
30,000 + participants recruited worldwide
UK lead site and recruiter
Supported setup, recruitment and follow-up
354 patients screened
153 patients recruited
Seen in research nurse-led clinic every 6mths for 5 years
2 year follow-on trial beginning shortly

8. ODYSSEY Outcomes - Sanofi
Multinational, commercial, RCT, CTIMP of monoclonal antibody or placebo alongside 80mg atorvastatin
Aim to improve the action of statins in persistent hypercholesterolemia with recent history of acute cardiac event
Approx 18,000 patient recruited worldwide and took fortnightly, self administered, sub-cut injection of drug or placebo
Supported setup, recruitment and follow-up
23 patients screened
12 patients recruited
Seen in clinic every 6mths for 5 years
Complete final visits in November
Set up for 10 yr follow on study

9. StatinWISE – Clinical Trials Unit, London School of Hygiene and Tropical Medicine
Two GP surgeries chosen to be selection sites in North Wales
Supported setup, support recruitment and follow-up
Trial medication supplied by trial direct to patients
Remote follow-up done by patient with Research Nurse support
GPs support initial screening of patients and baseline data
Aim to determine whether statins cause muscle symptoms
Blinded randomisation to take 20mg atorvastatin or placebo daily for 12 mths
Looking for 200 patients across UK in Primary Care who have
stopped statins due to muscle symptoms
or considering stopping due to muscle symptoms
Recruited from GP surgeries with Research Network support using review of database searches

10. Primary Care Research Support
Caroline Mulvaney Jones – Primary Care Clinical Studies Officer
Arwel Lloyd - Primary Care Research Nurse
Angela Evans – Primary Care Clinical Studies Officer
Wendy Scrase – Primary Care Research and Development Facilitator

11. www.healthandcareresearch.gov.wales @ResearchWales