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Clinical Research at Harrogate Foundation District Trust Medicine for Members 15th July Clinical Studies Study Initiation & Approval Patient Screening Taking Research Forward in the NHS – Dr Alison Layton Patient Screening in Cancer Research Nicky Thomas Consent Consent and Information Governance in Research – Kate Gunn Study Baseline Baseline Data in Dermatology Research – Margaret Broome Study Participation Patient Participation in the PHACS Cardiology Study – Carol Bagshaw & Malcolm Wood Study Outcomes What has research ever done for us? Maggie Peat Taking research forward in the NHS Dr Alison Layton Consultant Dermatologist, HDFT Clinical Director North East Yorkshire & North Lincolnshire CLRN AIMS – Share National Perspective • • • • Why we believe is research important How research is being supported Demonstrate the impact of research Public and Patient involvement – How could you help? Why do we need research in the NHS? Health Wealth Policy Delivers more R&D in the NHS Health Clinical Research Studies benefit the NHS because they: Improve patient care Establish innovation Stimulate recruitment and enrich jobs Wealth Clinical Research Studies benefit the NHS because: Importance of life sciences sector Employment determines health Additional income Policy context Office for Life Sciences NHS Life Sciences Innovation Delivery Board White Paper How is research being supported? Supports facilities for research (e.g. Biomedical Research Units) National Institute for Health Research The Clinical Research Network: Provides the practical support researchers need to run clinical studies in the NHS, so that more studies can happen, and more patients can take part Commissions and funds NHS and social care research Trains and develops researchers The Context NIHR Clinical Research Network Coordinating Centre (NIHR CRN CC, formerly UKCRN) 6 Topic Specific Clinical Research Network Coordinating Centres: • Diabetes (DRN) • Dementias and Neurodegenerative Diseases (DeNDRoN) • Cancer (NCRN) - 2001 • Medicines for Children (MCRN) • Mental Health (MHRN) • Stroke (SRN) Primary Care Research Network Comprehensive Clinical Research Network (PCRN) (CCRN) 25 Comprehensive Local Research Networks CLRNs NEYNL CLRN North East Yorkshire and North Lincolnshire Comprehensive research network (1 of 25) Population 1.7m Budget £6m (2011-12) NIHR Research Categories SPECIALTY GROUPS Age and ageing Anaesthetics Haematology Cardiovascular Clinical Genetics Critical Care Dermatology ENT Gastrointestinal Health Services Research Hepatology Infection Inflammatory and Immune Injuries and Accidents Metabolic and Endocrine Musculoskeletal *Neurological Ophthalmology Oral and Dental *Paediatrics Public Health Renal Reproductive Health Respiratory Surgery Urogenital + Palliative Care et al The importance of the networks... Help to improve treatments for patients Help medical professionals to offer patients research as part of treatment options Help the NHS to focus resources on “what works” Help NHS Trusts to deliver the quality and innovation agenda Enable NHS Trusts to benefit from income generated by research activity IT IS CORE BUSINESS – NHS constitution commits to promotion and conduct of research What does “practical support” mean? • Reducing the red-tape around setting up a study • Funding additional people (e.g. research nurses) and facilities needed to support research – “on the ground” so research activity does not use core NHS resources • Helping researchers to identify suitable NHS sites to identify and recruit patients • Advising researchers how to make their study “work” in the NHS environment The ultimate goals:• To support research and change the culture • embed research within every day practice • Provide evidence based medicine • Improve patient care and the NHS • Potential health and economic advantages How are we performing? • We recruited more than half a million patients into high quality clinical studies last year – Increased treatment options for those patients – Helped patients to participate in improving care for others in the future • At this point, we are helping researchers to recruit patients to more than 2,400 studies – Researchers more confident that they can complete their studies on time, and on patient target England NHS strategic health authority (SHA) recruitment analysis 01/04/10 - 31/03/11 160000 150535 140000 120000 100000 80000 78074 (blank) West Yorkshire CLRN 60000 50986 40000 49711 48710 South Yorkshire CLRN 45511 23617 20000 N&E Yorkshire & N Lincs CLRN 41035 32758 30019 20744 13010 13084 0 NHS London NHS North NHS South West West NHS Yorkshire and the Humber NHS South Central NHS West NHS East of Midlands England NHS East Midlands NHS North NHS South East East Coast Baseline Patient Recruitment - Comparison by year 14000 13084 12960 12000 10000 8812 8000 7680 6000 4000 2000 0 Apr May Jun Jul 2008/2009 Aug 2009/2010 Sep Oct 2010/2011 Nov Dec 2010/2011 Target Jan Feb Mar How are we performing • Increasing the involvement of the industry in NHS research, which helps to bring new and better treatments to our patients earlier – 639 “industry” studies currently supported – Renewed confidence in the UK as a research locality from companies such as Novartis What has been achieved: Helped researchers to prove that a new vaccine provided better protection for children against pneumococcal disease. The vaccination programme for all children in England has changed as a result. Results Helped researchers to show that radiotherapy before rectal cancer surgery lowered the chances of cancer returning. 40% of surgeons now follow this. How could you help? • Participation – Active involvement – Identifying research questions – Helping with research protocols • Increase awareness – Appointment letters – Posters – Newsletters • Consent register – Dementia and Neurodegenerative disease We need your help and ideas! How to find out more • Visit the website: www.crncc.nihr.ac.uk • Sign up to our quarterly e-newsletter to find out more about our research activity (from the website home page) Screening in Research Nicky Thomas Cancer Research Nurse Multi-Disciplinary Team Consultants Nurse specialists Histopathologist Radiologist Surgical team/ medical team Oncologists Video-link / York or Leeds Research Nurse Match Each Patient to a Clinical Trial Personalising cancer treatment Why Screen? Screening provides Quality Assurance to the results We need reliable, valid and consistent results From research that was performed under the same conditions Eligibility Inclusion/Exclusion Criteria Patient Information Meeting & discussion with patient is very important Written information about trial is given to patient Time is given to the patient to consider all their options and to discuss with their family/friends RESEARCH IS VOLUNTARY Driving up the Quality of Care for Our Patients Choices of treatment Empowering the patient Equality and excellence Information Governance and Consent within Research Kate Gunn Research Administrator Why are Information Governance Checks Necessary? To safe guard participant’s data To ensure participant’s are fully aware of how their data will be used To ensure the participant’s consent will cover all usage of their data To ensure that studies demonstrate data protection policies that match the Trust’s policies To ensure that studies are staying within the Data Protection Act Keeping to High Standards of Information Governance By keeping to high standards of information governance we: Safe guard participants taking part in research studies Protect researchers/investigators Enhance ethical and scientific quality Minimise risk Promote good information governance practice Information Governance – Consent Form Consent within Research Today patients have a choice, but it was not always the case 1900 Prussian Regulations Nuremburg Code Helsinki Declaration ICH-GCP Legislation was developed to protect patients taking part in clinical trials So What is Informed Consent? How Long Does a Patient Have to Make a Decision? What about Consenting Minors? CONCLUSION By Gaining “Informed Consent” We: Ensure that we are following the International regulations governing clinical research Ensure that participants understand the full extent of their commitment Help to ensure that excellent data can be collected and analysed Help to ensure that any research studies we are involved in at Harrogate are conducted to the highest possible standards Baseline Data Margaret Broome Wound Care Research Nurse Baseline data - What is it ? Information gathered from a patient prior to any study intervention that defines the status of the patient at that time Information is collected once the patient has been matched & found to be eligible for the study Written consent should have been given by the patient prior to any data collection How is it collected and who collects it? Patient interviews Questionnaires Physical examinations Laboratory tests Imaging Observation General/ Medical study specific staff Research nurses/staff VenUS IV Study As a Research Nurse with a background in wound management, I tend to be involved wounds studies Currently involved in VenUS IV study which requires both general and specific baseline data Baseline Assessment for VenUS IV Study Baseline Assessment for VenUS IV study Baseline Assessment for VenUS IV Study Summary Describes study group Influence of certain characteristics Promotes reliability and validity Shows a balanced study Can assist in further studies Study Participation Pharmacogenetics of Acute Coronary Syndrome (PHACS) Carol Bagshaw, Cardiac Research Nurse & Mr. Malcolm Wood PHACS patient Carol Bagshaw 07/07/2011 Pharmacogenetics Is the study of how your genes affect the way your body responds to a medicine Acute Coronary Syndrome (ACS) Heart Attack (myocardial infarction) Medications ACE Inhibitor Beta Blocker Aspirin Clopidogrel Statin Angina Patient Journey Diagnosis Approach, information Visit 1 Consent, samples and patient diary Visit 2 samples and questionnaires Visit 3 samples and questionnaires Visit 4 case note review Study Outcome Future Treatment Benefits Better understanding of the side effects Personalised Prescriptions Eventually it is hoped that each patient’s treatment for ACS will be tailored to their genetic profile Study Outcomes What has Research Ever Done for Us? Maggie Peat Senior Research Nurse It’s Not Just About New Treatments Out of 115 studies recruiting patients at the Trust less than 10% involve ‘new’ treatments some are old treatments in new situations some are old treatments which have been used alongside each other for some time some are observational studies some are registries and so on…… What has Research Ever Done for Us? Improves patient care It saves time It saves public money It can make care safer It finds new uses for old treatments It can give patients more treatment options It saves time… CLOTS 1 study ‘Common sense’ approach Anti-embolism stockings standard after stroke Trial – 2518pts (75 from Harrogate), randomised to stockings or no stockings Stockings did not reduce risk of DVT & increased skin lesions (blisters, skin breaks, ulcers) Estimated saving of 320,000 hrs of nurse time The Lancet, Volume 373, Issue 9679, Pages 1958 - 1965, 6 June 2009 It saves public money… CLOTS 1 Estimated saving of: £4 million annually It can make care safer… Corticosteroids for severe head injury ‘Common sense’ approach CRASH study (2007) Trial – 20,000 patients, 239 ICUs, 49 countries allocated to methylprednisolone or placebo No positive long term effect for steroid group Trial stopped after 10,008 recruited as significant increase in death within 2 weeks (steroid 21.1%; placebo 17.9%) www.thelancet.com Vol 364 October 9, 2004 1321-1328 It finds new uses for old treatments ISIS 2 - reported 1988 17,187 patients, 417 hospitals in 16 countries Aspirin has a significant impact on mortality after acute myocardial infarction So beneficial & side effects so minimal in comparison - virtually anyone suspected of having a heart attack should be given it Randomised trial of intravenous streptokinase, oral aspirin, both, or neither among 17,187 cases of suspected acute myocardial infarction: ISIS-2. ISIS-2 (Second International Study of Infarct Survival) Collaborative Group. Lancet 1988;2:349-60 Aspirin - wonder drug Subsequent MI, stroke or vascular death reduced by 25% Deaths from any cause reduced by one fifth 1000 patients – 40 deaths, MIs or strokes prevented in 1st month, 40 more over next 2 years The prompt treatment of suspected MI patients with aspirin will save the life of 1 in 40 patients It finds new uses for ‘bad’ drugs Thalidomide can be used to treat: Leprosy – licensed in 1998 (found to be effective in mid 1960s) Multiple myeloma HIV related mouth & throat ulcers & Kaposi’s sarcoma Inflammatory diseases such as arthritis Stopping growth of cancers Kaposi’s sarcoma So it’s worth doing… ……even if or especially when it shows that something doesn’t work! Department of Health has recognised this and boosted funding for research ‘research and innovation (by academia, charities, businesses and the NHS) are vital to the continuous improvement of quality in the NHS’ Government response to ‘NHS Future Forum’ 20th June 2011 http://www.nihr.ac.uk/about/Pages/Government_response_to_NHS_Future_Forum.aspx And it has worked! Here at HDFT: 115 studies 2108 patients recruited April to April 2010/11 78 research clinicians, research nurses & staff Patient Recruitment 2500 2106 2000 Apr 08-09: 167 patients 1500 Apr 09-10: 622 patients 1000 500 Apr 10-11: 2106 patients 622 167 0 April 08-09 April 09-10 April 10-11 Patient recruitment Patient recruitment per 10,000 population served by Acute NHS Trusts 100 90 91 80 70 60 50 40 39 39 34 30 30 27 20 10 0 Harrogate And York Teaching District NHS Hospital NHS Foundation Trust Foundation Trust Hull and East Yorkshire Hospitals NHS Trust Northern Lincolnshire and Goole Hospitals NHS Trust Scarborough and Humber NHS North East Foundation Trust Yorkshire Health Care NHS Trust