1. What is UKCRN The
UK Clinical Research Network was established in February 2005 to
provide a world-class health service infrastructure to support clinical
resaerch in the NHS, under the umbrella of the UK Clinical Research
Collaboration and as part of the National Institute for Health Research
(NIHR) in England. Department of Health funding in England has been
provided to facilitate the conduct of randomised prospective trials and
other well-designed studies across the NHS. This will involve the
appointment of research nurses, data managers and other support staff
across England.
Close collaboration is being established with Clinical Research Networks in all of the four administrations of the UK.
Clinical Research Networks supporting activity in Dementias and
Neurodegenerative Diseases, Diabetes, Medicines for Children, Primary
Care and Stroke have been established as part of UKCRN. The previously
established Research Networks in Cancer (National Cancer Research
Network) and Mental Health (Mental Health Research Network) are also
part of UKCRN.
Through an open competitive process each new
Topic Specific Clinical Research Network (TCRN) and the Primary Care
Research Network have identified a number of Local Research Networks
(LRNs) that receive TCRN funding to support clinical research
activities. Maps showing the location of the Local Research Networks
within each TCRN are available here.
The UKCRN Coordinating Centre is working with key partners in Northern
Ireland, Scotland and Wales to aid the transformation of the clinical
research environment and develop clinical research infrastructure
across the whole of the UK. Networks are being established in each
country that will work closely with the Topic Specific Networks in
England.
The Joint Directors of UKCRN are Professors Janet
Darbyshire and Peter Selby. A Coordinating Centre, mainly based in
Leeds but with offices in London, oversees UKCRN and leads for each
area of work, together with external, advisory Associate Directors have
been appointed.
3. What is the aim of the Research Networks? The
Research Networks will support the set-up of clinical research studies,
patient identification, recruitment and follow-up and the collection of
research data. They will also work to raise the profile of research and
seek ways of establishing new and more streamlined working practices
and relationships with NHS clinical staff. The ultimate goal is to
improve patient care by improving the speed and coordination of high
quality clinical research in the UK.
The Network model has
been shown to be highly successful by the National Cancer Research
Network (NCRN) and later by the Mental Health Research Network (MHRN).
Since its creation in 2001, NCRN has helped to more than triple the
number of cancer patients entering into clinical research studies. The
MHRN has also had a significant impact on the NHS research environment,
working to engage research naive clinicians and encouraging additional
sites to support research in mental health.
4. When will the Comprehensive Research Network in England be set up and what is its role? From
April 2007, as described in the NHS R&D Strategy, "Best Research
for Best Health" (published January 2006), Comprehensive Local Research
Networks will begin to be established across England to provide
infrastructure support for all diseases areas, enabling research to be
conducted across the full spectrum of disease and clinical need. The
Comprehensive Research Network will work together with the Topic
Specific Clinical Research Networks and the Primary Care Research
Network to support clinical research in the NHS and provide the
infrastructure for clinical research.
The aims of the Comprehensive Research Network are:
To
ensure that patients and healthcare professionals from all parts of the
country and from all areas of healthcare are able to participate in and
benefit from clinical research
To improve the quality, speed and coordination of clinical research by removing the barriers to research in the NHS
To
streamline and performance manage NHS support for clinical studies to
ensure that the NHS Service Support Costs of research are met in a
timely and efficient manner
To unify and streamline administrative procedures associated with regulation, governance, reporting and approvals
To strenghten research collaboration with industry and ensure that the NHS can meet the health resaerch needs of industry
To further integrate health research and patient care.
The Comprehensive Research Network will also help to streamline and deliver research management.
Comprehensive Local Research Networks (CLRNs) will be established as
operational entities designed to support clinical research and will be
managed locally for that purpose. CLRNs will be established across all
England within the boundaries of Strategic Health Authorities. The
location of 18 CLRNs has already been agreed within 7 SHA areas. Three
remaining SHA areas are in discussions with UKCRN to finalise the CLRN
areas. A call for host applications for the agreed CLRNs has been
released. Further information is available here.
5. What is the role of the Primary Care Research Network in England?
The roles of the Primary Care Research Network are to:
Provide a world-class health service infrastructure to support studies originating from a range of sources
Facilitate
the conduct of clinical trials and other well-designed studies in
primary care and at the interface with secondary/tertiary care
Create
a unified structure that will safeguard and build on the quality and
breadth of ongoing activities in primary care research
Facilitate
and increase the participation of practices and practitioners to foster
participant recruitment, retention and the collection of high quality
data
Facilitate the set up, process and successful
completion of a comprehensive and high quality national portfolio of
primary care studies, including both non-commercial and industry
studies
Continue to build capacity to support these activities by working with others.
6. What is the role of the Clinical Studies Groups Each
Topic Specific Clinical Research Network has established
multi-disciplinary UK-wide Clinical Studies Groups that will have a
remit to oversee the development of a national portfolio of high
quality studies in the specific area of research relevant to that
Group. It is hoped that the studies developed by the Clinical Studies
Groups that receive funding will be supported by the Research Networks.
It is not mandatory for all studies funded by an NIHR partner to be
developed by a Clinical Studies Group, although ideally studies will at
least considered by the relevant Clinical Studies Group prior to the
grant application. Studies can either be developed solely by members of
the Groups, or by members of the Groups in collaboration with other
investigators, or they can be developed by non-members and circulated
to the relevant Group for discussion and consideration for inclusion in
the Clinical Studies Groups portfolio, if funded.
Clinical Studies Groups have following generic objectives:
To be responsible for developing and overseeing a portfolio of studies in their specific topics
To identify gaps in the research porfolio for their specific area
To propose and develop new trials and other well-designed studies, and submit applications for funding
To consider and contribute to the development of studies proposed by others
To consider international studies for inclusion in the portfolio
To undergo independent international peer review of their activities every three years
To ensure patient and public involvement in activities.
Clinical Studies Groups will meet two or three times per year, with email communication between meetings where necessary.
7. Who do I need to speak to if I am making contact with a Network for the first time? Each
Topic Specific Clinical Research Network has a Director (part time) and
an Assistant Director (full time). Either of these should be the first
point of contact for queries. Details are as follows:
8. What are the criteria used for accepting a study into the portfolio? The
Department of Health has produced guidelines on inclusion criteria for
the studies in the NIHR portfolio. Broadly, NIHR partners that award
research funds as a result of open competition across England with peer
review can place such research within the portfolio, providing it fits
with the remit of the relevant Topic Specific Clinical Research
Network. Multi-centre and single-centre studies can be including in the
portfolio. Further details are available here.
Studies that are eligible for inclusion in the UKCRN portfolio must be
asking a specific researchg question and have clearly defined
endpoints, and require fully informed consent. Under some
circumstances, Topic Specific Coordinating Centres may wish to include
pieces of research in which explicit informed consent is not required.
However, surveys, tissue banking exercises that do not have planned
analyses and studies that are more accurately described as 'audit'
studies are not eligible for inclusion in the UKCRN portfolio.
It should be noted that exclusion does not negate the quality or
importance of such research, but such studies not within the UKCRN's
remit. Eligible studies must have a clear and detailed protocol
including a formal study design.
9. How will funders know which studies have been adopted by the Network? Details of all UKCRN studies and associated accrual data are stored in the UKCRN portfolio database which is accessible here on the UKCRN website.
It is hoped that the UKCRN and/or Topic Specific Clinical Research
Network Coordinating Centres will develop close links with the relevant
UKCRC partners so that the Coordinating Centres are informed of newly
funded/approved studies that fit the remit of the UKCRN and the
specific Topic Specific Network. Once studies have been funded they
will be added to the portfolio to alert the Local Research Networks
that they will be opening shortly. This will facilitate early
participation of Local Research Networks in new studies.
Studies should be added to the Topic Specific portfolios before they
are opened to recruitment. Initially, however, it is necessary to
include ongoing studies funded by a UKCRC partner in order to establish
the Topic Specific portfolios. This will be carried out by the Topic
Specific Coordinating Centres who will contact relevant Chief
Investigators or clinical trials units of ongoing studies once
identified to discuss the implications of this with them.
10. What does inclusion of a study in the UKCRN portfolio mean?
A study that is in the UKCRN portfolio can be supported by
Network-funded staff. This can range from publicity of the study to
R&D approval applications to identification and recruitment of
patients to collection of data, etc. depending on the available
resource within individual sites in the Local Research Network.
It is not mandatory for each Local Research Network and participating
investigator within a Local Research Network to recruit patients to
every study in the UKCRN portfolio, although there is a strong
preference for Local Research Networks to fully commit to portfolio
studies. Each Local Research Network will be able to determine its own
local portfolio from the relevant Topic Network portfolio in
consultation with the relevant Coordinating Centre. Local Research
Networks should consider which studies they can make a contribution to,
taking account of the Local Research Network's priorities and those
areas where there clinical investigators and the distribution of their
infrastructure allow them to contribute effectively with efficient use
of resources.
The activity of each Local Research Network
within the UKCRN topics will be reviewed on a result basis to ensure
that UKCRN studies are actively supported across the Topic Networks.
There is an expection that Local Research Networks will be involved in
the majority of appropriate national studies within the relevant Topic
portfolio.
Centres outwith the Local Research Network may also participate in UKCRN studies if appropriate and feasible.
11. What will be the mechanism for reporting progress on studies adopted by the Network? Progress on studies will continue to be reported to funders via the Chief Investigator and their study management team.
As one of the key performance measures for UKCRN is the percentage of
studies completing on time, the Topic Specific Network Coordinating
Centres and the Local Research Networks will also be monitoring
progress with individual sites to ensure timely delivery of studies in
their portfolio. Reports within the UKCRN portfolio database will
support the management of study delivery and progress.
12. What would be the cost implications for a study funded by funding bodies involving UKCRN infrastructure? There should be no additional infrastructure costs for funded studies to be included in the UKCRN portfolio.
In some cases, the costs requested in the grant application may be less
than previously, as the study (if funded and if it fits within the
UKCRN remit) will have access to the UKCRN infrastructure. It should be
noted however that UKCRN infrastructure will not replace research costs
and studies will still need to request funding for research staff.
13. How do funders ensure studies are not being double funded? Applicants
of project grants need to clarify in their application whether support
(i.e. research nurses, other research support staff etc.) is required
in addition to the UKCRN resources available across the Local Research
Networks. Funding bodies will need to decide if additional funding is
justified.
14. What liabilities/responsibilities do funders incur by having a study accepted into the portfolio? There are no additional or different liabilities or responsibilities for funders if their study is in the UKCRN portfolio.
15. How do funders know that a recently funded study will be prioritised? Currently,
there is no prioritisation of studies in the UKCRN portfolio. However
in time, a weighting system may be applied to encourage Local Research
Networks to participate in certain types of studies, for example
studies deemed by funders, Dep[artment of Health or the NHS as being a
high priority, or studies that are more complex to deliver. Such a
weighting matrix is currently being developed by the National Cancer
Research Network and its use and impact will be reviewed and, if
successful, will be considered by UKCRN.
Individual Topic
Specific Research Networks may wish to flag a study as high priority in
the meantime, if deemed high priority by funders, Department of Health
or the NHS and to encourage Local Research Networks to support it.
16. What if a study funders fund is not adopted by the Network? Studies
funded by NIHR partners that award research funds as a result of open
competition across England with peer review will automatically become
part of the UKCRN portfolio, providing the study fits within the remit
of UKCRN (see 8 for further details). It will not be possible for Topic
Specific Research Networks not to adopt an eligible study.
17.
During the peer review process do funders need to liaise with the
Network before taking funding decisions or should it be the PI talking
to the Networks? Ideally, all studies funded by an NIHR
partner will have been developed or considered by a Clinical Studies
Group or an equivalent national collaborative group. It is preferable
that studies submitted for funding have been subject to consideration
by the Local Research Networks to ascertain levels of interest and
study feasibility. The Topic Specific Research Network Coordinating
Centres can facilitate such feasibility assessment.
However, to
facilitate links with Network infrastructure, it is recommended that
funding bodies including a question on their grant application form
that asks whether the relevant Topic Specific Network has been asked to
provide feasibility information and whether there is support from the
Networks for that study.
Funding bodies may also wish to ask
the relevant Clinical Studies Group whether or not the proposed study
has been developed by/in discussion with the Group (see 6 for further
information).
18. Are there any implications for the way that funding bodies conduct peer review? Full
independent scientific peer review is required before any study can be
adopted into the UKCRN portfolio. It has been agreed within the UKCRN
and supported by the Department of Health that the definition of proper
peer review for the purposes of the UKCRN portfolio must include more
than one reviewer and independence of the reviewer from the host
institution.
19. What should funders do if a Local
Research Network does not cover all the proposed sites in a
study they are funding?
From April 2007, the Comprehensive Research Network will be established
and will cover the whole of England to support clinical research in the
NHS and provide infrastructure for clinical research. Prior to the
Comprehensive Research Network being established, sites outwith Local
Research Networks will either require infrastructure support through
the project grant or they will need to access local sources of funding
to support patient recruitment in their centres.
20. If funders fund a study not in a Topic Specific Research Network how will the trial be supported? From
April 2007, the Comprehensive Research Network will be established and
will cover the whole of England to support clinical research in the NHS
and provide infrastructure for clinical research. Prior to the
Comprehensive Research Network being established, sites outwith Local
Research Networks will either require infrastructure support through
the project grant or they will need to access local sources of funding
to support patient recruitment in their centres.
21. Does one have to be part of a Network to undertake a clinical trial? No,
although the UKCRN resources have been allocated to provide additional
trained staff, and support systems to facilitate the set-up and
delivery of clinical research studies in a timely manner. From April
2007, the Comprehensive Research Network will begin to be established
and will cover the whole of England to support clinical research in the
NHS and provide infrastructure for all areas of clinical research. It
is hoped that this infrastructure support will be utilised to support
all relevant studies funded by UKCRC partners.
22. What about trials versus other well designed studies? UKCRN supports the conduct and delivery of both randomised controlled trials and other well designed studies.
23. What is the capacity of trials in a Network? Each
Local Research Network has been allocated funding that will enable the
recruitment of staff to support the set-up and delivery of clinical
research studies. It is difficult to quantify the capacity of trials,
as studies will vary in terms of complexity and duration. However, it
is estimated that with the current level of resources, the UKCRN will
be able to deliver the recruitment of approximately 60,000 patients per
year within the Topic Specific Networks and a further 40-50,000
patients per year through the Comprehensive Research Network.
24.
Is it a requirement that patients and carers have to be included in the
planning stage and on Trial Steering Committees in order for the
Network to adopt a study?
It is not mandatory to include
patients and carers in the planning or management of UKCRN studies
although this is strongly encouraged as patient and public involvement
is a fundamental principle in UKCRN.
The UKCRC has a patient
and public involvement project group which is carrying out several
projects, one of which will explore the criteria that funders use to
judge patient and public involvement when assessing research
applications and will then begin to develop a range of standard
criteria for assessment, with the aim of promoting the patient and
public involvement principles in funding initiatives.
Further questions will be added on a regular basis.
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