Research and Development

Diabetes test

Lewisham and Greenwich NHS Trust is a research active Trust.

Clinical research drives better outcomes for patients, promotes innovation new knowledge needed to improve health outcomes and reduce inequalities and efficiency, making us committed to providing the best patient care.

With regards to the initiation, delivery and the time it takes to set up and approve studies, the Government wants to see dramatic and sustained improvement.  This is all part of the Government’s plan for growth to improve efficiency of research within the NHS and working towards transforming it, making the NHS and the UK a more attractive place to undertake clinical research working with commercial organisations.

Performance Indicator Data

The Government wishes to see a dramatic and sustained improvement in the performance of providers of NHS services in initiating and delivering clinical research with a particular aim to increase the number of patients having the opportunity to participate in research and to enhance the nation’s attractiveness as a host for research.

Performance in Initiating Clinical Research aims to assess the initial benchmark of 70 days or less from receipt of a valid research application, to first participant recruitment for the study. The Department of Health places a contractual obligation to providers of NHS services contracted through the National institute of Health research (NIHR) to submit data and publish outcomes against the 70 day benchmark and delivery to time and target for commercial Clinical trials.

PI - Performance in Initiating Clinical Research - every clinical trial for which NHS permission was given.

PD – Performance in Delivering Clinical Research – every commercial contract clinical trial hosted by the NHS provider closed to recruitment in the previous twelve months.

For further information please see

http://www.nihr.ac.uk/policy-and-standards/Performance-in-initiating-and-delivering-research.htm

View the latest Trust reports:

Q2 16.17 Performance In Delivering.pdf [pdf] 203KB

Q2 16.17 Performance Of Initiating.pdf [pdf] 197KB

Q1 16.17 Performance In Delivering.pdf [pdf] 200KB

Q1 16.17 Performance Of Initiating.pdf [pdf] 199KB

Quarter 4 201516 Performance in Initiating Clinical Research Report (PDF 123KB).pdf

Quarter 4 201516 Performance in Delivering Clinical Research Report (PDF 92KB).pdf

 

Starting clinical trials: the 70-day benchmark

 

There is a target that has been set out by the Government called the ’70-day benchmark’, which looks at the time NHS Trusts should take to process a valid research application and also when the first patient has been recruited into a clinical trial.

The Department of Health requires the publication on a quarterly basis of information. To see how we are doing against this measure, please click the link below.

70-day benchmark performance >>


Find out more

For more information, please email LH.RD@nhs.net


Why clinical research?

At Lewisham and Greenwich we are committed to taking part in high quality research as we believe…

  • it adds positively to the experience of our patients and their family members
  • ensures the best outcome for our patients and their families in the most cost-effective manner
  • will embed an innovative and vibrant research culture within the Trust, which will attract opportunities for our staff, patients and local community.

Please click on the links below for further information:


Our Research

Both hospital sites of Lewisham and Greenwich NHS Trust are actively engaged in research and we aim for all clinical areas to eventually participate in clinical research studies.

All research carried out within the Trust is governed by strict NHS regulations and in order to carry out a clinical research trial within any of our services areas a detailed assessment is carried out by the Trust Research and development Department as well as - for a majority of studies – the NHS National Institute for Health Research and its sub divisions such as the London (South) Comprehensive Local Research Network.

At our sites we currently have clinical trials taking place in the following service areas:

  • Hepatology
  • Gastroenterology
  • Cardiology
  • Diabetes
  • HIV
  • Women’s Health Services
  • MSK
  • Neurology
  • Dermatology
  • Intensive Care
  • Cancer Services
  • Paediatrics
  • Anaesthetics
  • Stroke
  • Age & Ageing
  • Epilepsy
  • Respiratory


Research Partnerships

We believe that success lies within collaboration and we work closely with a number of funders and partners to achieve this.

National Institute for Health Research (NIHR) Clinical Research Network

Lewisham and Greenwich NHS Trust have a close working relationship with the NIHR’s local Clinical Research Network.

NIHR Clinical Research Network: South London

The NIHR Clinical Research Network: South London is part of the larger Clinical Research Network (CRN) which is the clinical research delivery arm of the NHS.

The NIHR CRN operates nationally across England through a national coordinating centre and 15 local branches delivering research in the NHS across all disease areas.

The NIHR Clinical Research Network: South London is hosted by Guy’s and St Thomas’ NHS Foundation Trust. The host is responsible for ensuring the effective delivery of research in the Trusts, primary care organisations and other qualified NHS providers throughout the South London area.

The NIHR Clinical Research Network: South London helps to increase the opportunities for patients to take part in clinical research, ensures that studies are carried out efficiently, and supports the Government’s Strategy for UK Life Sciences by improving the environment for commercial contract clinical research in the NHS in the South London area.

We are passionate about the contribution that clinical research can make to patient care, and work collaboratively with other NHS providers to translate that passion into the effective delivery of studies in the area.

We make sure that clinical research occupies the place it deserves to in the day-to-day work of the NHS across the South London area. This includes Trusts, primary care organisations and any other qualified providers of NHS services.

For a list of the Trusts and CCGs covered by this branch of the NIHR Clinical Research Network, click here.

For more information about the NIHR Clinical Research Network: South London visit: www.crn.nihr.ac.uk/slondon


Get Involved: Information for Patients & the Public

There are many opportunities for our patients and members of the public to participate in clinical trials and get involved with research at Lewisham and Greenwich NHS Trust and beyond.

Participating in a clinical Trial

As a patient, you may be asked to participate in a research project. Depending on the research this may involve simply filling in a questionnaire; it might involve having an extra blood test taken, or it could involve trying out a medicine that doctors believe will work as well or better than the medicine that you would normally receive.

Information about the research and what it would involve would be clearly explained to you before you make a decision about whether or not you would like to take part.

It is really important to remember that you do not have to take part in any research if you do not want to, and if you decide not to take part in a research project that you have been invited to participate in, your normal clinical care will not be affected in any way.

Research Governance sets standards to ensure that the safety, dignity, rights and welfare of research participants is protected. It also ensures that research carried out is of a high quality and is not wasteful of NHS resources. To ensure that this is the case, all research that happens within the NHS must be approved by an independent Research Ethics Committee, and must be approved by the R&D Department.

If you are interested in participating in research studies there are a number of ways in which you can get involved:

It’s Ok to Ask

If you are under the care of a consultant or GP for a particular health condition, speak to them initially about clinical trials that may be running at your hospital or surgery which may be suitable for you.

UK Clinical Trials Gateway

The website is full of information for those interested in taking part in clinical trials.

UK Clinical Research Network Study Portfolio

Here you can find a list of studies that are open to participants. This list includes contact details for the individual study.

Getting involved

Researchers are always looking for the patient perspective. As well as taking part in a clinical trials as a participant, there are also many opportunities for you to be involved in helping researchers design, plan and run future studies.

People in Research – Opportunities for public involvement in research

You can find out more about public involvement in research, including a database of current opportunities. The website also provides further information and explains public involvement in research. It also provides the views and experiences of those that have been involved.

Contact us

If you would like further details about how to possibly take part in a clinical trial or to be involved with research at Lewisham and Greenwich NHS Trust you can contact the Research & Development (R&D) Team on:

E: LH.RD@nhs.net
T: 020 3192 6361


Conducting Research at Lewisham and Greenwich NHS Trust

In order to conduct any research at Lewisham and Greenwich NHS Trust there are number of questions to be asked and steps to be taken. This section will take you through the steps and provide advice on how to access funding, secure a sponsor and obtain the relevant permissions required to undertake research in the Trust.

  • Is it Research?
  • Study Design & Research Funding
  • Identifying a sponsor
  • R&D approval

Is it Research?

Firstly when planning to undertake any research you need to ask is it research?

The NRES (National Research Ethics Service) and the NHS R&D Forum have issued guidance on the categorising of research, clinical audit and service evaluation. Whilst all three types of study require the approval of host Trusts, systems for approval for each type of study vary.

Only research requires Research Ethics Committee review.

  • Research - Is designed and conducted to generate new knowledge and should follow the systems for approval of NHS Research.
  • Audit - Is designed to answer the question "Does this service reach a predetermined standard?"
  • Service evaluation - Is designed to answer the question "What standard does this service achieve?"

Study Design & Funding

Research funding comes from a number of different sources mainly through research grants that are applied for to the NIHR, Charities, organisations or pharmaceutical industry.

In order to apply for funding you may need some advice on your study design.

The NIHR Research Design Service London (RDS London) has been set up to provide advice on all aspects of preparing grant applications, including:

  • Formulating research questions
  • Building an appropriate research team
  • Involving patients and the public
  • Designing a study
  • Appropriate methodologies
  • Regulatory and ethical issues
  • Advice on writing lay summaries
  • Identifying the resources required for a successful project.

If you need advice, guidance or support, visit the RDS London website at: www.rdslondon.co.uk or contact the R&D Department

NIHR Funding Streams

The NIHR commissions and fund NHS, social care and public health research that is essential for delivering our responsibilities in public, health and personal social services.

This funding is managed by NIHR Central Commissioning Facility (CCF) or NIHR Evaluation, Trials and studies Coordinating centre (NETSCC).

Programmes covered by CCF are;

  • Invention for Innovation (I4i)
  • Research for Patient Benefit (RfPB)
  • Research Design Service
  • Funds biomedical research centres and units
  • Clinical research facilities for experimental medicine
  • Patient & Public Involvement (PPI)

NIHR Evaluation, Trials and studies Coordinating centre (NETSCC) manages funding on behalf of the NIHR and covers the following:

  • Health Technology Assessment (HTA)
  • Efficacy and Mechanism Evaluation (EME)
  • Health Services and Delivery Research (HS&DR)
  • Trainee Coordinating Centre (TCC)
  • Public Health Research (PHR)
  • Programme Grants for Applied Research (PGfAR)

For further details on NIHR Funding visit: http://www.nihr.ac.uk/research/Pages/default.aspx

Other Funding Streams

Medical Research Council (MRC) Funding

The MRC is a public funded organisation dedicated to improving human health

It supports research across spectrum of medical sciences, universities and hospitals.

The MRC Funds research through grants, call, highlights notices, studentship and fellowship.

Visit the MRC website for further details and open calls and opportunities at www.mrc.ac.uk

Charity Research Funding

Charities offer different types of grants and can also joint fund with NIHR funding schemes. The types of grants generally offered are:

  • Clinical trial grants
  • Feasibility/pilot studies
  • Programme grants

Industry Funders

Pharmaceutical industry funds research via their research and development departments.

Some of this research can be adopted onto the NIHR portfolio which allows access to additional delivery of research support from the NIHR Clinical Research Networks.

Clinical Research Organisation (CRO)

CROs such as Quintiles, Icon, Parexel, support and run pharmaceutical, biotechnology and medical device studies. They are not funders or sponsors but are out sourced to run studies for the expertise in the area.

Identifying a sponsor

All research conducted within the NHS is required to have a research sponsor. This is the organisation which takes responsibility for the quality and conduct of the research and is not the same as a funder.

Researchers should identify a sponsor at an early stage in the research planning process as the sponsor may have requirements related to the protocol to assure themselves of the quality of the study. Sponsors are also responsible for the scientific review of the study.

The sponsor of a research project should be identified before all the necessary approvals (e.g. Research Ethics Committee, MHRA, R&D) are sought.

In the NHS, before a research project can commence, it is essential that permission to do so has been obtained from:

  • A Research Ethics Committee (REC)
  • Each NHS organisation in which the research is taking place in through the R&D/RD&I department

Approval may also be required from:

  • The Medicines and Healthcare Products Regulatory Agency (MHRA) – for studies that involve medicines or devices
  • National Information Governance Board for Health and Social Care (NIGB) – for research that will involve accessing participant identifiable information without obtaining consent
  • Gene Therapy Advisory Committee (GTAC) – for clinical trials involving gene or stem cell therapies
  • Administration of Radioactive Substances Advisory Committee (ARSAC)

The Integrated Research Application System (IRAS) is an electronic form that is used to apply for approval from all the different bodies that need to give permission in order for research to go ahead in the NHS.

The IRAS form is available at www.myresearchproject.org.uk.

If you would like help with the IRAS form, please do not hesitate to get in contact with the R&D Department.

R&D Approval

If you would like Lewisham & Greenwich NHS Trust to be involved as a site in a research project, you must seek R&D approval.  We require the following documentation:

All documents must be submitted electronically, and we will require that the relevant sections of the IRAS form be submitted as an .xml and .pdf file.

R&D Documentation:

 

Notes

Please provide NIHR CRN

Portfolio ID number where applicable

IRAS R&D Form

Mandatory

Please supply copies with appropriate signatures (eg Sponsor, Chief Investigator)

Site Specific Information (SSI) form

Mandatory

Must name a UHL employee as Principal Investigator (PI)

Please supply copies with appropriate signatures (where necessary this will include pharmacy, radiology, or any other relevant department involved in the project)

Research proposal / protocol

Mandatory

Please include version number

REC favourable opinion lette

Mandatory

(This must be submitted before R&D approval is given, however need not be submitted in the first instance if not available)

MHRA approval

Where necessary

GCP Certificate

For all research team members

Research Governance Sponsorship / Site / Clinical Trial agreement

(if required)

Please supply copies with appropriate signatures

Patient Information Sheet

Must include:

  -  Relevant local information

  -  Version numbers and dates

Consent form

 Must include:

  -  Relevant local information

  -  Version numbers and dates

CV

Short CV (no longer than 2 sides) P1 and any other key research collaborators who will be involved in research at this site

Research passport

Where required

Details of funding

Mandatory

for any studies that are not on the NIHR CRN portfolio

 Completing a site specific information form

A local Principal Investigator or Key Collaborator must be identified.

Key things to check:

1. The named Principal Investigator should be a Trust Employee

This is because we require the person who takes responsibility for the study at the site to have accountability to this Trust and be easily contactable.

2. The form is fully completed with no sections missed out

The information requested within the form is all necessary in order for finances to be calculated and governance checks to take place

3. All necessary authorisers have been named

The signatures to be added in section A23 of the SSI form depend on the nature of the research.

All research projects should include the signature of a relevant local manager to ensure that managers are aware of the research that will be taking place within their area.

Any research projects involving pharmacy, pathology or radiology should include the names and authorising signatures from the key research contacts within these departments to ensure that the department is aware of any workload that may be generated by research.

4. The SSI form has a submission code in the bottom right hand corner of each page

This shows that the form submitted is a final version and not a draft.  In order to generate the submission code, you will need to log in to the IRAS system, select your SSI form, go in to the “submission” tab and then click on “proceed to submission”.

Participant Identification Centres (PIC)

Documentation to be provided to the R&D Department for PIC studies:

  • R&D Form
  • Protocol
  • Ethics approval letter

NB Site Specific Information (SSI) form not always required.

Student Projects

Generally we are unable to host student research that is being carried out by students that are not employed by the Trust.

For students that are employed by the Trust, those anticipating conducting research in the NHS should consider building in a lag time of at least three months before they will be able to collect data as it is necessary to obtain Research Ethics Committee and R&D approval before commencing the research.

Often these time frames can be compromising for students wishing to complete projects for their dissertation. In addition, the time and effort necessary to gain approval for a study may seem disproportionate to the size and aims of the study.

We therefore advise that those conducting a study as part of an undergraduate or taught Masters programme consider whether the requirements for their qualification could be met as satisfactorily by conducting a clinical audit or service evaluation study.

Both these types of study can employ standard research methodologies and, whilst still requiring Trust approval, the processes for gaining this are more easily attainable within the timeframe of such studies.


Useful links

Medical Research Council
For MRC Funding opportunities and proposal calls
http://www.mrc.ac.uk/index.htm

NIHR Funding Information
For details on funding offer via the NIHR
http://www.nihr.ac.uk/research/Pages/default.aspx

NIHR Research Design Service – London
For assistance, advice and guidance with grant applications for NIHR funding
www.rdslondon.co.uk

The Integrated Research Application System (IRAS) form
Online form with which to apply for permission for research to go ahead from relevant bodies
www.myresearchproject.org.uk

The London (South) Comprehensive Local Research Network (CLRN)
Website for the local CLRN
http://slondon.crncc.nihr.ac.uk/

South East London Cancer Research Network (SELCRN)
Website for the local cancer research network
www.selcrn.nhs.uk

Stroke Research Network
Website for the national Stroke Research Network including local network information.
http://southeast.uksrn.ac.uk/

UK Clinical Trials Gateway
The UK Clinical Trials Gateway provides easy to understand information about clinical research trials running in the UK, and gives you and others access to a large range of information about these trials.
www.ukctg.nihr.ac.uk

UK Clinical Research Network Study Portfolio
Database of all NIHR Portfolio adopted research projects being carried out in England which are currently open to participants. This list includes contact details for the individual study.
http://public.ukcrn.org.uk/Search/Portfolio.aspx

INVOLVE
INVOLVE is a national advisory group that supports greater public involvement in NHS, public health and social care research. INVOLVE is funded by and part of the National Institute of Health Research (NIHR).
www.invo.org.uk

People in Research – Opportunities for public involvement in research
Provides further information and explains public involvement in research. It also provides the views and experiences of those that have been involved.
www.peopleinresearch.org


Contact us

If you have any queries or require further information please contact the Lewisham and Greenwich NHS Trust Research & Development (R&D) Team on:

E: LH.RD@nhs.net
T: 020 3192 6361

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