Research Development AMMVIRTUAL MARKET Place Professor Shanaya Rathod

Research & Development AMM-VIRTUAL MARKET Place Professor Shanaya Rathod, Director of Research Dr Peter Phiri, Research & Development Manager 8 th September 2020

Our Mission Statement “Encourage and embed a culture of research in the organisation that enables every patient & clinician and public the opportunity to participate in research” "Research is a core part of the NHS. Research enables the NHS to improve the current and future health of the people it serves. ” (Handbook to the NHS Constitution, 2009)

Vision Be seen as a leader of research in Mental and Physical Health, Learning Disability and Community Care regionally, nationally and globally (develop capability and capacity) Attract national, international and regional research funding (maximise benefits) Develop the infrastructure to be able to participate in commercial trials in accordance with national agenda (develop infrastructure) Embed research and the use of evidence in every day clinical practice (improve standards) Ability to offer research and innovation in every clinical service (increase opportunity, participation and performance)

About us Southern Health NHS FT is a diverse organisation with a wellestablished small but growing R&D Department based at Moorgreen Hospital that undertakes a number of clinical trials and contribute to our overall recruitment target and a growth income and expenditure. The Clinical Trials Facility at Tom Rudd Unit has significantly grown over the last eight years due to a committed albeit small research team and dedicated clinicians to delivering first class clinical research to the organisation. We run both commercial and non-commercial research. We are and we have research department The Memory Assessment & Research Centre (MARC) runs clinical trials in Dementia. The majority of trials investigate how effective new drug treatments are; some explore aspects associated with Alzheimer's such as depression and sickness behaviour. One of the leading centres in Europe for Dementia research.

Research is an integral part of SHFT Clinical research is critical to Southern Health; to advancing our knowledge and to the development of health care generally. The public and patients benefit from a thriving and innovative research culture that is evident in real clinical gains. There is also some emerging evidence that patients do well simply by taking part in a clinical research study. The National Institute for Health Research (NIHR) recognises that there must be a strong commitment to clinical research in the UK, and the past few years have seen a significant investment and dramatic increase in research infrastructure both locally and nationally.

National Drivers Clinical research is the means by which evidence is generated to inform and change our clinical practices. There is evidence that research active organisations have better patient experience and outcomes. Research improves quality and culture of services and helps recruitment and retention (Plan for Growth, 2011; the NHS Constitution, 2009; The NHS Operation Framework, 2009; Sumit et al. , 2008). Mortality rates are lower in research active organisations. Therefore, nationally research remains a priority more important when resources are under pressure – it identifies new ways of preventing, diagnosing and treating disease. Moreover, it is essential if we are to increase the quality and productivity of the NHS and support growth in the economy (Equity and Excellence, July 2010). The Life Sciences Sector deal highlights the commitment to increase investment in R&D to 2. 4% GDP by 2027 (Bell, 2018).

Strategic aims 2020 -2025 1. To be seen as research leaders in Mental Health, Intellectual disability and Community care, regionally and nationally. 2. Increase commercial and non-commercial research portfolio in every service area provided by the trust. 3. Global Health Research.

Strategic aims 2020 -2025 4. Patient and Public Involvement and Engagement. 5. Collaboration with Academic institutions to increase scope of home grown research and develop a collaborative research career pathway for Early Career Academics (ECA). 6. Engagement of clinical staff across the organisation.

CQC Research Indicators These will focus on three areas, namely: How organisations promote research awareness for patients How organisations facilitate research How organisations show equity for access and improvement for research (across disease area and groups).

Research Governance • A key function of the R&D department is to ensure robust research governance, as set out in the UK Policy Framework for Health and Social Care Research (v 3. 2 2017). • All NHS organisations must comply with the UK Policy Framework for Health and Social Care Research. • This includes research finance governance. • Regulatory inspections: MHRA Inspection – 2012. • Ongoing Sponsor monitoring of Commercial trials. • Sponsorship for you to conduct your research as a SHFT employee.

Governance and Quality Assurance Any activity involved in the running of Clinical Trials here Archiving SOPs Statistics Adverse Event reporting Contracts Data Management Drug Management Trial reporting Project Management Training Laboratory Randomisation Computer Systems Regulatory approvals Study Monitoring Trial Files

Opportunities for Trainees Drive this success The Wessex Clinical Fellowship programme SHFT and Univ of Southampton Research Apprenticeship scheme -RCF Use of Sp. R time for research activity Health Education England Wessex and NIHR run an Integrated Clinical Academic (ICA) Programme Funded time by Research Department Different levels of engagement and support

Research opportunities using real live data Clinical Record Interactive Search (CRIS) unlocks and transforms clinical data held in Trust systems to provide a rich and de-identified data resource. http: //www. southernhealth. nhs. uk/research/cris/

What is the catch? Increases efficiency Faster delivery of results from research initiatives leads to earlier improvements in patient care. Supports strategic and service quality reviews to improve business planning. Efficient studies protect the reputation of both the Trust and the NHS. Reduces costs Quicker and more efficient identification of viable studies ensures better targeting of Research and Development funding. Reduces researcher time spent on study feasibility. Reduces the number of days spent on inappropriate sites and incomplete studies.

Leaflet

Performance Recruitment figures into NIHR Portfolio studies by fiscal year

Key Achievements ➢ SHFT first Investigator led CTMIP – LOSE Weight, recruiting 32 participants with a target of 60 by end of October 2019. ➢ Digi. Meds Trial: a co-production with SHFT and Commercial Sponsor. Recruited to Time/Target [n = 12] ➢ Co. ACTi. ON CRN Wessex Led portfolio study that was open to 24 NHS sites nationally and contributed over 2400 participants. ➢ MARC: Site Appreciation Award nominated by Syneos Health. ➢ Primary Care Research the Willow Group delivered to its first Primary care CTIMP: ARTIC + trial. Trial recruited well at SHFT. ➢ SHFT recognised for their contribution to Diabetes research at Diabetes UK Conference. ➢ Achieving 2019/20 Recruitment target 1879 ➢ Staff investment: Three Ph. Ds and MSc students. ➢ MARC- Dementia Research Champion appointed. ➢ Finance: CRN Wessex site monitoring visit went well. ➢ CRIS 1 st publication ➢ 2019 CRN AWARD nominations x 4 from SHFT and Dr Price winning award

Research Impact

Current Research studies you can be involved in.

Current Research studies you can be involved in. CLIMB – How do you think your health data should be shared and used? Online survey run by the University of Cambridge. Follow this link: www. climbproject. org. uk GLAD – People with Depression and Anxiety. Online survey that if eligible may require a mouth swab. Follow this link: www. gladstudy. org. uk Both studies will require you to select Southern Health in the drop down menu.

Psychological impact of the Coronavirus (COVID 19) pandemic and experience: An international survey An online survey, open to everybody over the age of 16, aiming to investigate the psychological impact the Coronavirus and lockdown has had on behaviour and wellbeing. Recruitment is being undertaken in both the UK and Internationally. We have successfully recruited over 29, 000 participants in the UK! The first round of recruitment in the UK has ended but round two will be opening in the coming months. For more information contact: Ashlea. Brooks@southernhealth. nhs. uk

Current Research studies you can be involved in. Preference for Art Therapies – Online questionnaire for people with mental health problems – Contact Ashlea. Brooks@southernhealth. nhs. uk to take part. Hearing Nasty Voices – Telephone questionnaire for people who hear negative and threatening voices – Contact Ayaat-Al. Sudani@southernhealth. nhs. uk to take part.

Quality of Life Injectable. This study considers the effect of injectable therapies on health status, quality of life and treatment satisfaction in patients with type 2 diabetes. The study involves three contacts with the research team over a period of six months which may be conducted either be over the phone or face to face. Visits will involve obtaining a medical history, asking about diabetes medications you may take, filling out paper questionnaires about your quality of life and treatment satisfaction and recording your height and weight. Patients with type 2 diabetes treated with diet or oral medications only, who are planning to start a new oral diabetes medication or injectable diabetes treatments to improve their diabetes control, are invited to take part in this research study. Therefore to be eligible you must: • • • Be aged 18+ Have a diagnosis of type 2 diabetes. Not currently on an injectable diabetes treatment. If you would like to take part or want more information please contact the study lead: Liz Houghton Email: elizabeth. houghton 2@nhs. net Tel: 023 8047 5258

Screening of Target Genes (Asthma study) *COVID-19 UPDATE: This study is currently paused. * This study aims to look for specific genes that individuals with asthma may have. These genes may alter how certain treatments work in different individuals, and may also contribute to disease severity. Participants in the study would be required to attend a 20 - 30 minute appointment which will include: • Conducting a peak flow test, and a breathing test known as spirometry • Collecting a blood sample • Asking you a few questions about your asthma and medications you take To be eligible to take part you must meet the following criteria: • • Have asthma for more than one year Be prescribed asthma medication Aged 16 to 60 Of European descent If you would like to take part or want more information please contact the study lead: Qi Zheng Email: Qi. Zheng@nhs. net Tel: 023 8047 5258

Current studies GAIN Based on research demonstrating a potential link between bacteria associated with gum disease and Alzheimer’s disease. This clinical trial aims to evaluate whether an investigational oral drug is safe and effective in stopping the progression of Alzheimer’s disease by reducing the damage caused by bacteria in the brain. JULIUS A clinical trial aiming to assess the effects of a new drug on biomarkers including tau for people with mild cognitive impairment or Alzheimer’s disease.

Current studies CLARITY An infusion drug trial for people with Alzheimer’s Disease or Mild Cognitive Impairment. The drug aims to remove targeted amyloid plaques and improve cognition. AVANIR A drug trial aiming to target symptoms of agitation in people with Alzheimer’s Disease. This is a rare study aiming to alleviate some of the more challenging and distressing symptoms of Alzheimer’s Disease.

Current studies RESIST An observational study aiming to establish if Tumour Necrosis Factor inhibitors reduce the rate of cognitive decline in Rheumatoid Arthritis (RA) patients with amnesic mild cognitive impairment (a. MCI) compared to RA patients with a. MCI who are being treated with synthetic Disease Modifying Drugs.

The Journey continues Be part of our success! Research is integral to our clinical services

Finally! “Research is even more important when resources are under pressure- it identifies new ways of preventing, diagnosing and treating disease. It is essential if we are increase the quality and productivity of the NHS and support growth in the economy” (Equity and Excellence, July 2010, p. 24)

Thank you for your attention

Thank You Dr Peter Phiri, Ph. D R&D Manager peter. phiri@nhs. net Contact us: research@southernhealth. nhs. uk http: //www. southernhealth. nhs. uk/research Twitter: @SHFT_Research

Additional Resources

Audit Designed and conducted to produce information to inform delivery of best care Designed to measure against a standard and whether the service reaches that standard. No allocation to intervention or randomisation.

Service Evaluation Designed and conducted solely to define or judge current care. Could answer what standard does this service achieve? Involves the intervention in use only. No allocation to intervention or randomisation.

Clinical Research “The attempt to derive generalisable or transferable new knowledge to answer questions with scientifically sound methods. This excludes audits of practice and service evaluations. ” UK Policy Framework for Health & Social Care Research, HRA October 2017

Systematic Review A review of the relevant existing scientific literature Purpose: – To exclude the possibility that the research question has already been answered and provide up to date view of current knowledge – To inform the design of your project TOP TIP: Make friends with your librarian!

APPROVALS: UK Research Ethics Service (REC) Reviews applications and assesses the proposed participant involvement and whether the research is ethical Health Research Authority (HRA) Introduced 31 March 2016 to bring together the assessment of governance and legal compliance Applies to research in NHS organisations and independent contractor primary care services Local R&D Approvals

Approvals: UK Research Ethics Approval required: – Interventional studies: where you may be using an investigational medication or procedure or comparing interventions in clinical practice – Where you are interviewing or using. questionnaires that could potentially be intrusive – Where you are taking human tissue samples and data or data only.

If you are using NHS staff chosen because of their profession or healthy volunteers (such as students) HRA only All research being conducted in the NHS will need to be approved by the local R&D office

Applying for Approvals – what documents do I need? IRAS application form : https: //www. myresearchproject. org. uk/help/hlphraapproval. aspx Protocol Participant Information and Consent sheets. Template Organisational Information Document. Template Schedule of Events. Templates available: https: //www. hra. nhs. uk/planningand-improving-research/research-planning/prepare-study -documentation/

NHS R&D approval The NHS R&D department will consider: ØParticipant patient group required. ØAny service implications your protocol my have. ØStaffing resources required. ØFinancial implications. Confirmation of capacity and capability email and return of signed Organisational Information Document.

Good Clinical Practice (GCP) GCP is an international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects. All staff working on clinical research should be appropriately trained and qualified for their activities within the research study.

How do I start planning my research? Protocol – Templates available: https: //www. hra. nhs. uk/planning-and-improvingresearch/research-planning/protocol/ Review by University supervisors and R&D team Then start completing ERGOII and IRAS forms

R&D Policy https: //www. southernhealth. nhs. uk/_resources/assets/attachment/full/0/ 34577. pdf