Critical Care International Endorsement Policy
INTERNATIONAL CRITICAL CARE TRIALS AND STUDIES UNDERTAKEN IN THE UNITED KINGDOM:
National Institute for Health Research (NIHR) Critical Care National Specialty Group and UK Critical Care Research Group (UKCCRG) International Endorsement Policy.
• The volume of research undertaken by the UK critical care community has increased substantially during recent years
• The UK critical care NIHR research portfolio comprises a wide range of research designs, single and multi-centre studies, and commercial/non-commercial trials
• There are an increasing number of large trials funded by prestigious funders either as commissioned or investigator-initiated proposals. These trials have the potential to ‘compete’ for similar study populations, especially in the areas of sepsis, mechanical ventilation, and general ‘process of care’ studies.
• More than 80% of UK ICUs participate in research. Infrastructure is provided through mixed models, but is underpinned by research staff funded through the NIHR networks/Local Clinical Research Networks (LCRNs)
• Co-enrolment guidance and agreements can mitigate, in part, the risk to recruitment from ‘competing’ studies, but this is not always possible and for many RCTs in specific patient groups co-enrolment is not appropriate.
The UK research funding model differs from other healthcare systems, because there are three distinct elements funded through different routes:
1. Direct research costs (funded by grant-giving body)
2. Excess treatment costs (funded by the NHS or through individual study arrangements (e.g. commercial partners))
3. NHS Support costs (funded through the NIHR through LCRNs and R&D budgets)
For critical care studies, the embedded NHS Support Costs provide substantial embedded resource for screening and consent, and some other elements of study conduct, for studies adopted onto the NIHR portfolio.
In order to access network support, and especially NHS support costs, studies must be included in the NIHR CRN Portfolio.
Many critical care trials led from other countries and funded by overseas charities or government organizations are also able to apply for inclusion in the NIHR CRN Portfolio and if deemed eligible are able to access support from the UK critical care research network.
A significant number of important international trials have been undertaken in the UK through this route. Typically, the approach to the UK is through an individual clinician/researcher who applies for CRN Support and aims to acquire UK sites.
As part of the Extended Review Process that studies funded by an overseas charity or government have to undergo, NIHR CRN ask relevant clinical experts (usually from NIHR’s National Specialty Group in Critical Care) to comment on whether the study is: 1) of value to the NHS, social care or public health and 2) meet the needs, priorities and realities of the NHS, social care or public health. These questions provide the opportunity for the National Specialty Group to influence what international critical care studies are included in the CRN Portfolio.
This consultation is limited, and there is currently no formal process for internationally funded studies that provides a transparent wider network consideration of the following:
• Does the UK network have capacity to support the project?
• Are there UK led projects that may be compromised by ‘competition’ from the project?
• Is there interest and support from the UK critical care community in the research question being addressed in the study?
• Is the study design relevant to UK critical care practice, and will the results potentially change practice and/or result in improved clinical outcomes and value for money?
• Will the effort invested by the UK critical care community, and the funding invested by the NIHR network be recognized in the research outputs?
NIHR policy and priorities
Clear eligibility criteria for NIHR Clinical Research Network support have been updated.
The Department of Health and Social Care recognizes that resources needed to support research, both NIHR CRN support and the availability of suitable/appropriate individuals, are finite. To enable the Government to meet its commitment to provide the necessary NHS Support (or equivalent in a non-NHS setting) or its own and its Partners' research, whilst also allowing other important research to be undertaken within the NIHR CRN, there is a need to prioritize eligible studies. When resources are stretched it is important that NIHR CRN effort on studies with the highest priority is not diminished. Studies with a lower priority can still receive NIHR CRN support but patient recruitment may take a little longer.
NIHR High Priority Studies
i. Funded by the NIHR, other areas of central Government or an NIHR non-commercial Partner; or
ii. Commercial contract research.
NIHR Medium Priority Studies
i. Funded by overseas governments; or
ii. Investigator-initiated commercial collaborative studies.
NIHR Low Priority Studies
i. Funded by overseas charities; or
ii. Funded by any source of funding not mentioned above, but which meet eligibility criteria.
Joint NIHR Critical Care National Specialty Group and UKCCRG agreed processes for UK international endorsement of clinical studies and trials:
1. All critical care research trials originating outside the UK, where the trial management team seek to establish UK participating centres and access to CRN Support, should approach the NIHR Critical Care National Specialty Group and/or the UKCCRG oversight committee. This process will be promoted by direct communication with the major international trial groups, through UK investigators interacting with international groups, and through websites.
2. The approach can come direct from the Chief Investigator, a member of the Trial Management team, or from a proposed UK Lead/Principle investigator.
3. The trial team should provide the protocol, the proposed number of sites and/or recruitment, and likely duration of recruitment for consideration.
4. The trial team should provide details of the funding available to UK sites from the grant for recruitment or other aspects of the study.
5. The trial team should explain how the addition of patients from the UK contributes to the estimated global sample size and what secondary analyses are planned to help understand trial outcomes for UK practice.
6. The trial team should demonstrate their willingness to comply with UK guidance on co-enrolment in critical care studies (available on request).
7. The trial team should indicate how the UK community will be acknowledged in publications, either through authorship for UK lead investigators/contributors and/or by acknowledging the support of the UKCCRG and NIHR Clinical Research Network
8. The NIHR Critical Care National Specialty Group will lead on assessing whether the study:
a) Will compete with current or imminent studies originating in the UK and whether UK critical care has the capacity to contribute to the trial or study without compromising UK-led and/or funded research studies
b) Will have potential sites interested in participating
c) Provides an appropriate level of funding for recruitment in the NIHR/NHS
9. The UKCCRG will lead on assessing whether the study has support from the UK critical care community. This will be coordinated by the oversight committee, and may involve:
a) Consultation with UK leads in the area of study
b) Potentially surveying opinions through networks (ICS, UKCCRG, NIHR)
c) Inviting presentation to the UKCCRF meeting (or other UK meeting) or access to details of the research through other means
d) Assessing whether the proposed acknowledgement of the UK Critical Care community is acceptable and proportionate to the contribution requested
10. The NIHR National Specialty Group and UKCCRG committees will coordinate communication of the review by the UK community to the individual trial/study groups.
11. The outcome of successful review will be formal study endorsement by the NIHR Critical Care National Specialty Group/UKCCRG. The Chairs of the groups will formally communicate with the trial team/Chief Investigator. Following this the trial will be ‘endorsed by the NIHR Critical Care National Specialty Group and UK Critical Care Research Group membership’ and provides the Specialty consultation outcome feeding into NIHR CRN Portfolio study eligibility assessment.
Professor Paul Dark
NIHR National Specialty Lead (Critical Care)
Professor Natalie Pattison
UK Critical Care Research Group Chair