Benefits for Patients

• Opportunity to receive new/innovative therapies/treatments/assessment
• Access to new medical information
• Feel they are giving something back-altruism

Benefits for the Health Economy

• Develop new ways of working
• Working at scale
• Building infrastructure
• Developing personality as a collaborative

Research Team – About us

Patients

Patient Introduction

What do I do If I am invited to take part in research?
If you have been sent a patient information sheet (PIS) by your practice, inviting you to consider taking part in research, you must have appeared eligible based on the criteria for the study.

The PIS is an invitation only. It is voluntary. If you have further questions that need to be answered after reading the PIS , there should be a study phone number and/or email address to contact to get in touch with the study team directly.

The PIS will display information on various aspects of the study, such as length of intervention time, screening visit locations, study contact information, to name a few. Alternatively, if participating in a questionnaire study, you will be provided with a link, either via text message or email. You are free to withdraw from a study at any time without your healthcare being affected.

Who is doing the research?
GP practices in Barnet have been inviting patients to get involved in research.

This is a new initiative and 48 practices have now formed part of the Barnet Federated GPs Research Network.

The research team helping with this are funded by public money from North Thames Clinical Research Network. You may receive an invitation to take part in research from your GP if you are eligible for any studies.

Can I refuse to take part in research?
You can refuse a study without having to give a reason and it will not affect your relationship with your GP.

If you agree to a study and later change your mind you can just withdraw from the study by letting the study team know.

What are the risks of taking part?
The risks of each study will be outlined in the information that you are sent in the PIS.

You can discuss this further with the study teams and their contact details should be in the information you have been sent.

Where will the research take place?
Depending on the study design, you may be asked to do one of the following:

• Attend a clinic visit at your GP surgery or a surgery in Barnet
• Complete a questionnaire at home
• Attend a research clinic at a hospital
• Be interviewed by a researcher at your surgery
• Attend a focus group at your GP surgery or a surgery in Barnet

What types of research studies are available?
The practices in Barnet are taking part in the following types of studies

• Drug trials
• Surveys
• Observational studies
• Evaluation of technologies

So far, the practices are doing research in the following main areas:

• Covid-19
• Respiratory Disease
• Diabetes
• Cancer
• Mental health
• Heart Disease

Research for GPs

Barnet Federated GPs Research Network

Barnet Federated GPs have acquired funding from The North Thames Clinical Research Network (CRN) to set up their own Research Network of GP practices within the Barnet borough. It operates with the support of the CRN, specifically Noclor.

The purpose of the Network is to help GP practices get involved in research. By doing this, patients registered at GP practices can be invited to take part in studies. Some patients can benefit directly by having extra assessments. Other patients like to do this to contribute to medical research. Usually patients are only invited to take part in research when they visit secondary care settings. However, we wanted to change that and increase the amount of research taking part in primary care.

It is very exciting to have so many practices in Barnet being involved in research and giving their patients something that they can be part of. We hope you stay with us on this journey as the network grows. If you have not signed up as of yet, please contact us and we can visit your practice and give a presentation (virtual or face-to-face).

Will my practice get paid?

Each research study is costed by the NIHR in terms of the time it takes individuals to perform study related tasks. You will know how much you will get paid for a study before you agree to take part.

The research network invoice quarterly for all research performed.

Do I need any research training?

Research that includes humans should follow the principles of Good Clinical Practice (GCP). This has been law since 2005. Training in GCP helps to learn the principles that should be followed.

Sometimes your practice is only referring patients to secondary care, to be enrolled in a study. On those occasions the sponsor/university usually do not ask a GP to complete their GCP certificate, as they are not directly conducting research on those patients.

We would like the Lead GP at your practice to complete the Good Clinical Practice to learn the principles so that they are ready to be involved in more advanced studies such as drug trials.

Also, when your Lead GPs completes the GCP course your practice will receive your final payment for joining the Research Network.

Good Clinical Practice principles

1. Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s).

2. Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks.

3. The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.

4 The available nonclinical and clinical information on an investigational product should be adequate to support the proposed clinical trial.

5. Clinical trials should be scientifically sound, and described in a clear, detailed protocol.

6. A trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC) approval/favourable opinion.

7. The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist.

8. Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).

9. Freely given informed consent should be obtained from every subject prior to clinical trial participation.

10. All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification.

11. The confidentiality of records that could identify subjects should be protected, respecting the privacy and confidentiality rules in accordance with the applicable regulatory requirement(s).

12. Investigational products should be manufactured, handled, and stored in accordance with applicable good manufacturing practice (GMP). They should be used in accordance with the approved protocol.

13. Systems with procedures that assure the quality of every aspect of the trial should be implemented.
Amended by S.I. 2006 No. 1928. The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 5 Commission Directive 2005/28/EC 7

What about GDPR?

The BFG research network is funded with public money and so their legal basis for processing patient data is “task in the public interest”.

The research staff are aware of the responsibilities with Data Protection legislation. Processing of data is performed in accordance with written Standard Operating Procedures.

By now you should have edited your Privacy Statement to make patients aware that they may be contacted for purposes of research. If you have trouble with the wording of your Privacy Statement, we can advise you and point you in the right direction if you have more complex questions.

What does a Research Cluster Lead do?

You may have heard of Research Cluster Leads in the Barnet Federation. The GP practices in Barnet have been grouped into 4 clusters to help with engagement and relationship building.

A Research Cluster lead helps practices to engage with research at a local level.

You can ask them questions about research and any queries you may have about particular studies.

The research cluster leads attend meetings with Universities and Sponsors to develop relationships that will help the network grow and to bring in more research studies.

They meet monthly with senior primary care staff, research coordinators and Clinical Lead, Joanna Yong, to help evaluate the progress of the network.

How are the studies chosen?

We try to choose studies that will not impact too much on your practice, unless you have extra capacity to cope with the workload.

We are looking to support a variety of studies in different subject areas, focusing on national health priorities and those of the CCG.

All research studies come through Noclor from various Sponsors and Universities and we distribute them to your practice to see if you would like to take part in them.

Noclor chooses studies that are on the Clinical Research Network Portfolio which is a group of studies that the CRN promote. The NIHR Clinical Research Network Portfolio is part of the UK Clinical Research Network Portfolio of studies, which comprises the network Portfolios for England, Northern Ireland, Scotland and Wales. These four Portfolios are held on a single information system: the Central Portfolio Management System (CPMS).

Portfolio studies are considered worthwhile by the CRN as they meet the eligibility criteria of a research study, have full research funding and have appropriate ethical approval and Health Research Authority (HRA) approval where required.

We may send you summaries of commercial studies that are in the process of getting ethical approval, as the pharmaceutical company will need to tell the ethics committee where the research will take place. You may have minimal information to make an informed decision at that point but you can change your mind once you have read the protocol and assessed whether the renumeration will be worth practice time and capacity. Reimbursement for commercial studies is usually well above that of portfolio studies.

Research Approvals Process

Before research can start (i.e the recruitment of the first patient) it must be approved by an Ethics Committee who weighs up the risk and benefits.

The benefits must outweigh the risks.

The ethics committee will review the application that has been sent via the IRAS website (Integrated Research Application System).

The Health Research Authority also gives approval as part of the IRAS application process. The HRA looks at research governance, legal compliance, capacity and capability.

Studies

Current Studies

• Accellacare Study Summary
  An intermediary organisation that recruit participants for clinical trials that are run out of Mount Vernon Hospital
• APPLE-Tree Study Summary
• Assessment of a wellbeing intervention on reducing cognitive decline in people with memory problems
• ATTACK – Study Summary Low-dose aspirin for the primary prevention of cardiovascular disease in people with chronic kidney disease
• BRIGhTMIND Study Summary
  Effects of two different types of Transcranial Magnetic Stimulation in treatment resistant depression to severe major depressive disorder
• INTERACT RCT Study Summary
  Integrated CBT to reduce depressive symptoms and improve quality of life
• GLAD Study summary
  Genetic Links to Anxiety and Depression
• LQD Study Summary
  Lithium versus Quetiapine augmentation therapy in treatment-resistant depression
• PAM Study Summary
  Supporting adherence to hypertensive medication using a brief smartphone app intervention
• PRINCIPLE Study Summary
  Platform trial investigating the use of various clinical interventions for epidemic and pandemic illnesses
• Treat2Target in Gout Study Summary
  Effects of an allopurinal-based treat-to-target urate lowering treatment on gout flares
• TriOptimize Study Summary
  Effects of a Trimbow inhaler on reducing COPD exacerbations
• Vacc on Track Study Summary
  Catch-up childhood vaccinations for migrant and BAME individuals; signpost for Covid-19 vaccinations
• YouScreen
  Self-screening for individuals overdue for cervical screening

Closed studies

GLOOCOSE:
A randomised controlled trial of the sulfonylurea Gliclazide and the DPP$ inhibitor Linagliptin on the frequency of hypoglycaemia among patients with Type 2 Diabetes and Chronic Kidney disease stage 3b and 4.

Design: Randomised controlled trial

Sponsor: Imperial college London

Chief investigator: Dr Andrew Frankel

Main Objectives: Hypoglycaemia is a common and potentially life-threatening side effect of the sulphonylurea class of drugs used to treat type 2 diabetes. Subjects with type 2 diabetes and kidney disease are particularly prone to hypoglycaemia and this is often unrecognised.

The aim of this study is to access if the diabetic drug Linagliptin (a non-sulphonylurea) is associated with fewer episodes of hypoglycaemia that the UK’s most commonly used diabetic drug of type 2 diabetic kidney disease (Gliclazide, a sulphonylurea)

Factoid
Design: A feasibility study of acceptance and commitment therapy for older people with treatment-resistant generalised anxiety disorder (FACTOID)

Sponsor: University college London

Chief investigator: Dr Rebecca Gould

Main Objectives: The primary objective of the study is to develop and refine a manualised intervention based on
acceptance and commitment therapy (ACT) for treatment-resistant generalised anxiety disorder (GAD) in older people in accordance with MRC guidelines for developing and evaluating complex interventions (MRC, 2008). The secondary objectives are to i) assess the feasibility and acceptability of the intervention via an open uncontrolled feasibility study in order to inform a future substantive trial of clinical and cost-effectiveness; and ii) clarify key study design parameters for a future substantive trial

NEON
Personal experience as a recovery resource in psychosis: Narrative experiences online (NEON) programme

Design: Interview study

Sponsor: Nottinghamshire Healthcare NHS Foundation trust

Chief: Professor Mike Slade

Main Objectives: An interview study to learn about narratives of recovery from mental health difficulties, as presented by four under-researched groups: People with recent experience of psychosis, but who are not active service users; People currently using mental health services, but non-majority populations; People who are under-served by mental health services, and Peer support workers, or others working in roles for which lived experience of mental health difficulties is a requirement.

Trainings & Events

Good Clinical Practice

Good Clinical Practice is a set of scientific and ethical principles which we are required by law to follow when conducting research with human subjects.

You can learn more about this doing a GCP course online at London School of Hygiene and Tropical Medicine which you can find here: https://open.lshtm.ac.uk/enrol/index.php?id=6

Training in Research Skills

Training in research skills such as design, critical appraisal and literature reviewing can be achieved via Noclor.

Go to https://www.noclor.nhs.uk/training-resources for more information

The Royal College of GPs

GP courses and Events can be found here at

http://www.rcgp.org.uk/learning/courses-and-events.aspx