Ready for Research

1. Ready for Research Information for GP Practices NIHR Cumbria and Lancashire Comprehensive Local Research Network

2. Why Research in Primary Care Research is vital in providing new knowledge needed to improve health outcomes and reduce inequalities Practice in primary care is based on evidence gathered in secondary care but different approaches to both care and research may be required in primary care NIHR Cumbria and Lancashire Comprehensive Local Research Network

3. Vast majority of patient contacts within NHS take place in primary care setting Some conditions/diseases are only seen in primary care Primary care offers the opportunity to conduct research spanning: Preventative medicine Early diagnosis Acute and chronic disease management Service delivery NIHR Cumbria and Lancashire Comprehensive Local Research Network

4. Observational Studies Medicinal products are prescribed in usual manner No experimental drug administered No additional diagnostic or medical procedures Laboratory values and response to treatment observed during course of normal medical management NIHR Cumbria and Lancashire Comprehensive Local Research Network

5. Interventional Studies Medication Vaccines Devices Treatments Behaviour change Processes of care change Service delivery Can be Industry or Academic Led NIHR Cumbria and Lancashire Comprehensive Local Research Network

6. Snapshot Primary Care Studies DUTYDiagnosis Urinary Tract Infection in Young Children Observational study factors associated with urinary tract infection in children under 5 presenting with acute illness in primary care DARE Diabetes Alliance for Research in England Observational study for collection of genetic and clinical information to provide a platform for further studies into the causes, complications and treatment of diabetes Control patients also being recruited CPSSChild Parent Screening Study for Familial Hypercholesterolaemia Diagnosis/screening study performed at 1 year routine vaccination clinic NIHR Cumbria and Lancashire Comprehensive Local Research Network

7. GARFIELD International Registry of patients newly diagnosed with Atrial Fibrillation Observational Study Routine Clinical Practice observed 4 monthly for 2 years from diagnosis ‘Unpacking the Home’Family carers’ reflections on dying at home Qualitative study PIC sites only NIHR Cumbria and Lancashire Comprehensive Local Research Network

8. Industry Studies Several Lead Research Sites have been involved in Commercial Clinical Trials in Diabetes, Benign Prostatic Hyperplasia, Asthma, COPD, IBS NIHR Cumbria and Lancashire Comprehensive Local Research Network

9. Advantages of participating in research Contribution to new knowledge Improve understanding of health and healthcare Offer patients access to new treatments at no cost to practice - even patients in control arm tend to do better than others who have not been involved Practices involved in research are more likely to embrace new ways of thinking and look at new ways to improve their way of working Advance own professional development NIHR Cumbria and Lancashire Comprehensive Local Research Network

10. Practice Involvement Participant Identification Centre (PIC): involves searching patient lists to identify eligible patients and referring them to an active research site where all study related procedures are conducted Research Site: conducting whole study in practice with own patients and/or those referred in from a PIC site NIHR Cumbria and Lancashire Comprehensive Local Research Network

11. How to make the Practice Research Ready RCGP Research Ready - on-line self accreditation tool covering the minimum requirements of the Research Governance Framework for undertaking research in primary care Make patients aware practice research active Involve whole practice team GP Colleagues Practice Nurses Reception staff Admin staff NIHR Cumbria and Lancashire Comprehensive Local Research Network

12. Regulatory context of research The Law and governance arrangements that apply to research are complex and vary depending on type of research and the participants involved NIHR Cumbria and Lancashire Comprehensive Local Research Network

13. All research conducted within the NHS must comply with the Research Governance Framework for Health and Social Care 2005 A Sponsor must be identified Approval must be obtained from an Ethics Committee and relevant NHS R&D departments NIHR Cumbria and Lancashire Comprehensive Local Research Network

14. In addition Clinical Trials of Investigational Medicinal Products (CTIMPs) Must register on European Clinical Trials Database (EudraCT) Must receive Clinical Trials Authorisation Must adhere to the Medicines for Human Use (Clinical Trials) regulations 2004 and it’s subsequent amendments. NIHR Cumbria and Lancashire Comprehensive Local Research Network

15. Other guidelines to be followed depending on specific research studies Protection of Children Act (1999) Mental Capacity Act (2005) Human Tissue Act (2004) Equality and Diversity Legislation Freedom of Information Act (2000) Local Trust Policies NIHR Cumbria and Lancashire Comprehensive Local Research Network

16. GP’s role in research GP usually Principal Investigator for site Takes responsibility for initiation and conduct of study at site, can delegate duties to other members of practice team but remains responsible for them Qualities Organised Well respected/team player Committed NIHR Cumbria and Lancashire Comprehensive Local Research Network

17. Ensure safety, dignity and wellbeing of participants Conduct study according to GCP Must follow latest version of Protocol Respect participants right to confidentiality and ensure data collected stored securely Maintain clear, accurate and legible records Maintain good study documentation-Site File Responsibilities placed on practice NIHR Cumbria and Lancashire Comprehensive Local Research Network

18. Staff suitably qualified Capacity of workforce Regular updates GCP training- covers ethical and scientific standards in clinical research Clinic room space Room space/time monitoring visits Access medical records for SDV Other studies practice participating in NIHR Cumbria and Lancashire Comprehensive Local Research Network

19. Flow of a research study Expressions of Interest form sent by Sponsor to Network Co-ordinating Centre To Industry or Topic Network Manager To site Sign confidentiality agreement NIHR Cumbria and Lancashire Comprehensive Local Research Network

20. Flow of a research study Complete feasibility form openly, honestly and realistically Consider potential issues Think do you have Trained staff Eligible patients-consider recruitment strategies Facilities Time NIHR Cumbria and Lancashire Comprehensive Local Research Network

21. Pre site selection visit Chosen as site Regulatory approvals completed-assistance CLRN This can all take several months to complete!!! NIHR Cumbria and Lancashire Comprehensive Local Research Network

22. Site initiation visit Training Protocol Study related procedures Study equipment Labs- Local or central CRF ECRF Discuss recruitment strategies Drug storage Safety reporting NIHR Cumbria and Lancashire Comprehensive Local Research Network

23. Recruitment of participants Thorough review of medical records to check inclusion/exclusion criteria Invite patient-telephone/post patient information leaflet provided Arrange appointment to discuss study Recruit to study if eligible and willing Protect vulnerable adults – Learning disabilities /mental health issues NIHR Cumbria and Lancashire Comprehensive Local Research Network

24. Consent Seeking participant consent is fundamental Must be informed of right to decline to take part or withdraw at any time without affecting relationship with health carer or treatment received Guidance applies when conducting research involving people who cannot consent for themselves Avoid conflict of interest NIHR Cumbria and Lancashire Comprehensive Local Research Network

25. Follow-up and close down Organise follow up visits of participants Ongoing monitoring Reporting of adverse events and serious adverse events Close down of study Archiving study documentation NIHR Cumbria and Lancashire Comprehensive Local Research Network

26. Promotion of research within practice Posters advertising research active practice Study specific posters Posters photographs research staff Involve all staff and keep informed of all research studies at practice at meetings NIHR Cumbria and Lancashire Comprehensive Local Research Network

27. Financial considerations NIHR Cumbria and Lancashire Comprehensive Local Research Network

31. Advantages to patients Benign Prostatic Hypertrophy Study: TRUS as part of study work up Consultant at this point strongly recommended patient to have a follow up due to a suspicious nodule detected in right lobe of prostate. Patient continued in study until biopsy result identified mild invasive prostatic adenocarcinoma-Patient withdrawn from study referred to Urology DARE Study: Control patient identified as having diabetes determined by high HbA1c on routine screening NIHR Cumbria and Lancashire Comprehensive Local Research Network

32. Disadvantages to Site Can’t predict when an adverse event or Serious Adverse Event (SAE) will occur A study participant fell and fractured femur requiring hospital admission, any hospital admission is classed as an SAE and must be reported to the Sponsor immediately using forms and process specified in the protocol. This caused considerable disruption to an organised day!!! NIHR Cumbria and Lancashire Comprehensive Local Research Network

33. Abnormal Blood Results-More work!!

34. Summary Opportunities to be involved in important research across wide range of specialities and interests Support with planning and practical measures prior to study commencing Access Clinical Research Network funded staff to support studies conducted in practice Free research training for practice staff working on NIHR Portfolio studies Opportunity to be involved in commercial life-sciences contract work which provides an additional funding stream NIHR Cumbria and Lancashire Comprehensive Local Research Network

35. Good Practice in research and consent to research Document brings together all GMC’s advice to doctors involved in research. http://www.gmc-uk.org/Research_guidance_FINAL.pdf_31379258.pdf NIHR Cumbria and Lancashire Comprehensive Local Research Network

36. Contact Details Lesley Miller Lesley.miller@lthtr.nhs.uk O1772 52 4964 NIHR Cumbria and Lancashire Comprehensive Local Research Network

37. Thank YouAny Questions? NIHR Cumbria and Lancashire Comprehensive Local Research Network