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

NIHR Cumbria and Lancashire Comprehensive Local Research Network

Ready for Research

Information for GP Practices


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


• 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


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


Interventional Studies– Medication– Vaccines– Devices– Treatments– Behaviour change– Processes of care change– Service delivery

Can be Industry or Academic Led


Snapshot Primary Care Studies• DUTY Diagnosis 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

• CPSS Child Parent Screening Study for Familial Hypercholesterolaemia

– Diagnosis/screening study performed at 1 year routine vaccination clinic


• 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


Industry Studies

Several Lead Research Sites have been involved in Commercial Clinical Trials in Diabetes, Benign Prostatic Hyperplasia, Asthma, COPD, IBS


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


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


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


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


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


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.


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


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

QualitiesOrganisedWell respected/team playerCommitted


Responsibilities placed on practice

• 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


• 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


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


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


• Pre site selection visit

• Chosen as site

• Regulatory approvals completed-assistance CLRN

This can all take several months to complete!!!


• Site initiation visit– Training

– Protocol– Study related procedures– Study equipment– Labs- Local or central– CRF– ECRF– Discuss recruitment strategies– Drug storage– Safety reporting


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


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


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


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


Financial considerations


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


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!!!

Abnormal Blood Results-More work!!


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


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


Contact Details

Lesley Miller

[email protected]

O1772 52 4964

mailto:[email protected]


Thank You

Any Questions?

Documents

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