Frequently Asked Questions
1. What is UKCRN
2. What research areas do the Topics cover?
3. What is the aim of the Research Networks?
4. When will the Comprehensive Research Network in England be set up and what is its role?
5. What is the role of the Primary Care Research Network in England?
6. What is the role of the Clinical Studies Groups?
7. Who do I need to speak to if I am making contact with a Network for the first time?
8. What are the criteria used for accepting a study into the portfolio?
9. How will funders know which studies have been adopted by the Network?
10. What does inclusion of a study in the UKCRN portfolio mean?
11. What will be the mechanism for reporting progress on studies adopted by the Network?
12. What would be the cost implications for a study funded by funding bodies involving UKCRN infrastructure?
13. How do we ensure studies are not being double funded?
14. What liabilities/responsibilities do I incur as a funder by having a study accepted into the portfolio?
15. How do we know that a recently funded study will be prioritised?
16. What if a study we fund is not adopted by the Network?
17. During the peer review process do we need to liaise with the Network before taking funding decisions or should it be the PI talking to the Networks?
18. Are there any implications for the way that funding bodies conduct peer review?
19. What should we do if a Local Research Network does not cover all the proposed sites in a study we are funding?
20. If funders fund a study not in a Topic Specific Research Network how will the trial be supported?
21. Does one have to be part of a Network to undertake a clinical trial?
22. What about trials versus other well designed studies?
23. What is the capacity of trials in a 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?
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.
2. What research areas do the Topics cover?
Topic Specific Clinical Research Networks (TCRNs) support activity in the following areas:
In addition, a Primary Care Research Network
(PCRN) has been set up.
In time, the Comprehensive Research Network will provide support to all areas of disease and clinical need (further details under question 4).
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:
The contact for the Comprehensive Research Network is Ms Nancy Lester, Tel 0113 392 4463, Email
n.lester@ukcrn.org.uk 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.
For definitions of research costs, infrastructure costs (Service Support Costs) and treatment costs see the Department of Health document
"Attributing Revenue Costs of Externally-Funded Non-Commercial Research in the NHS (ARCO)". 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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