We are inviting one consortium application for the evaluation of treatments for brain tumours. Across a network of trials, aligned along a pathway of care and with shared infrastructure and systems, the consortium will efficiently undertake studies seeking to evaluate potential treatments. The consortium will also aim to build research capacity and capability, address disparities in research participation for people with brain tumours, and take a coordinated approach to collaborating with industry.
This opportunity has a broad scope encompassing all types of brain tumours, including adult and paediatric brain cancers, metastatic and recurrent disease, low-grade or ‘benign’ and high-grade tumours, and the evaluation of all relevant technology types.
The work initially funded under this opportunity will focus on the most important current research opportunities around treatment efficacy and effectiveness. However, it is envisaged that the consortium will be adaptive and may evolve over time, to enable the timely evaluation of new technologies and research questions as these arise.
We are inviting expressions of interest to:
- identify those who wish to nominate themselves as the Lead Applicant for the Consortium. There will be a maximum of two joint Lead Applicants. (Please note, applicants who do not nominate themselves as Lead or who are unsuccessful may still be a co-applicant, and the lead CI of a trial within the consortium.)
- attend a workshop to inform and begin the development of this application. It is expected that attendees will include existing brain tumour researchers, those from other fields who may be able to contribute expertise, and industry.
To express an interest in leading the application, please submit our National consortium to evaluate treatments for brain tumours - Expression of Interest for lead form and send to crossprogramme@nihr.ac.uk, by 1pm, 11 October. You do not need to apply to attend the workshop separately.
To apply to attend the workshop and collaborate on the application, please complete our National consortium to evaluate treatments for brain tumours - Expression of Interest to attend workshop form and send to crossprogramme@nihr.ac.uk, by 1pm, 11 October.
Expressions of interest will be assessed based on relevant individual and institutional expertise, experience and ability to contribute to the leadership and/or work packages of the consortium.
The Lead Applicant(s) will be selected and informed, allowing them to contribute to the design of the Convening Workshop.
The Convening Workshop will be held face-to-face in London and will involve successful EOIs and any additional attendees identified by the NIHR and Tessa Jowell Brain Cancer Mission (TJBCM) to provide guidance and expertise. This workshop will define the aims of the consortium and begin to shape the work packages of the application. A provisional date of 13 December has been set, although arrangements and invites will be confirmed following consideration of EOIs.
Those in attendance at the workshop may or may not form part of the eventual application team, and the consortium team may be further expanded during the application process and lifetime of the award, particularly given that work packages are expected to evolve over time.
Applicants should note that we are looking to support a range of brain tumour research outside of this opportunity . This includes a parallel Health Technology Assessment (HTA) and Health and Social Care Delivery Research (HSDR) Programmes funding opportunity for high quality studies on brain tumour care, support, and rehabilitation.
To delineate between the scope of these calls, evaluative research into the following interventions is considered to be within scope of this national consortium funding opportunity:
- surgical interventions
- radiotherapy and proton beam therapy
- chemotherapy
- targeted therapy and immunotherapy
- any other therapeutic agents or interventions to treat brain tumours
Research into the following interventions is considered to be within scope of the HTA and HSDR ‘Care, Support, and Rehabilitation for Patients with Brain Tumours’ call:
- interventions and technology for brain tumour diagnosis and post-treatment follow-up
- prehabilitation, rehabilitation, and other support interventions for patients, family, carers, and the healthcare workforce
- treatment interventions to manage side effects and late effects
Background
Brain tumours are the ninth most common cancer in the UK and kill more children and adults under the age of 40 than any other cancer, with only 12% of those diagnosed with a brain tumour surviving beyond five years . Research into new treatments has been recognised as an area of unmet need and the government has set out the ambition to increase both the level and impact of research, to advance the field.
Since May 2018, £40 million has been committed by the government to brain cancer/tumour research, to be invested through the NIHR . However, to date, it has not been possible to meet this target through single-study awards, owing to challenges around capacity and the pipeline of earlier research. It is therefore proposed that a single, large-scale and collaborative award is needed, to address blockages and to coordinate and undertake research which will drive the translation of novel and repurposed interventions.
The aim of this funding opportunity is to bring the brain tumour community together and accelerate the translation and evaluation of treatment options through clinical research, thereby ensuring the most promising opportunities are made available to patients as widely as possible.
In the longer term, it is envisaged that the successful consortium will produce a step-change in the research landscape, by building investigator capacity and an adaptive trial network, which will underpin the evaluation of novel technologies as these mature.
Call specification
Starting with the Convening Workshop, the applicants will need to determine the following:
- the key barriers, current research opportunities and uncertainties to be addressed as aims of the consortium
- the work packages and key objectives, deliverables, and milestones for each
- who will lead which aspects of the application and how they will be delivered
- how the work packages will be coordinated
The application must describe a cohesive collection of work packages, which address all aspects of the call. The exact work packages will be informed by the Application Team, but will include:
- one or more interventional clinical trials, each constituting its own work package. Applicants will consider and justify the scope of each trial, for example whether separate adult and paediatric trials are required. Each trial should use the most appropriate methodology to realise efficiencies, both within the study and across the consortium’s network of trials, which may include multi-arm or ‘platform’ designs
- capacity and capability building activity, which will grow the research community. This is likely to include developing clinical trial expertise and involving researchers from adjacent fields in brain tumour trials. Depending on the aims of the consortium, this may be embedded within trial work packages, constitute its own work package, and/or be delivered through the NIHR Biomedical Research Centres (BRCs)
- strategic engagement, partnering and planning work. This will ensure the consortium complements the wider landscape and is positioned to efficiently evaluate novel therapeutics as these are developed. It is envisaged that industry engagement and international alignment will be key components. This activity must explicitly support the identification of new research questions, promising interventions and technologies arising within the area of any adaptive platform trials.
The consortium must focus on interventions at or approaching an appropriate stage of development for evaluation in a clinical study which focuses on treatment benefit. Interventions and technologies may include surgical procedures, approaches to radiotherapy and novel or repurposed drug therapies, as well as the evaluation of companion diagnostics.
Technologies must have already generated experimental data in humans to support the case for a robust evaluation and to illustrate safety and technical feasibility. Specifically, there should be a signal and supporting evidence that the technology or intervention may be of benefit to relevant outcomes. Trials with embedded pilot or feasibility phases which focus on trial delivery may be included, with appropriate stop/go milestones. Late-phase studies into the comparative effectiveness of existing interventions, and optimising treatment strategies, are also within scope.
While the trials will initially focus on the current most promising technologies and interventions, an adaptive platform approach may be justified where there are multiple technologies requiring evaluation within the same protocol, with others likely to arise within the anticipated lifetime of the platform. Where new interventions or research questions arise which do not fit within existing work packages, the consortium will be able to adopt additional trials.
Across all trials, the consortium must aim for an approach to recruitment that is inclusive and which takes account of populations which have been historically underserved by research activity. Consideration must be given to coordination of recruitment across the network of trials.
Where relevant, work packages should take account of, complement, and actively seek collaboration with existing national infrastructure and NIHR investment.
Out of scope
The following are not included under this opportunity:
- any research involving animals or animal tissues
- basic research or pre-clinical development of interventions
- first-in-human studies seeking to establish the safety and feasibility of an intervention or technology
Application details, cost and duration
There is no set upper limit for the cost of the overall application. While value for money will be a key consideration, the NIHR wishes to encourage an application that is ambitious and transformative in scale.
Depending on the aims of the consortium established at the workshop, the NIHR will provide further guidance around any capacity building work package to be delivered by the NIHR BRCs.
The consortium will be able to request funding for between 5-10 years initially, based on the work packages proposed.
The application must define work packages individually and will detail separate costs and durations for trials, such that these can be contracted and separately monitored within the consortium.
The consortium will be adaptive in nature, with the potential to incorporate new trials or expand upon existing adaptive platform work packages. It is therefore anticipated that additional funding may be required at a later date.
Unless otherwise invited, applications to the NIHR for additional funding to add arms to existing trials within the consortium will be considered as requests for a ‘Variation to Contract’. Substantial requests will be considered by an NIHR Funding Committee.
Applications for new trials to join the consortium will remain an area of interest after this call and may be submitted at a later date as a standard application to the most appropriate of the MRC-NIHR Efficacy and Mechanism Evaluation (EME) Programme or Health Technology Assessment (HTA) Programme ‘Researcher-Led’ funding opportunities. Such applications must detail how the trial will integrate into the consortium, if funded.
The Application Team
The application will require a ‘Lead Applicant’, or a maximum of two Co-Leads, who will be appointed through the EOI process.
The team must have demonstrable expertise and experience in all areas relevant to delivering the proposed work packages, as well as the coordination of the consortium.
Each trial within the consortium will have its own Chief Investigator and the teams leading them will have responsibility for their work package. Other non-trial work packages may also take this approach, where appropriate. The consortium is expected to contribute to the building of research capacity; each trial should therefore have both a Senior Lead and a Junior Lead.
Early engagement with a UK Clinical Research Collaboration (UKCRC) registered clinical trials unit (CTU) is required and consideration should be given to where a common CTU across trials may be beneficial.
Patient and public involvement and engagement must be included within the application and the study design of trials.
The application must be UK-led and nationally collaborative. International collaborations may contribute to individual trials where this is justified, however, alternative sources of funding are required for recruitment outside of the UK. For more information, please view our international funding guidance.
Industry collaborators may also be involved. Their role or contribution to the work package or trial(s) must be clearly described.
This initial team may be expanded to include additional collaborators during the lifetime of the award, to support the evolution of activity and addition of new work packages or trials.
Governance, monitoring and reporting
The consortium will be commissioned using a standard Department of Health and Social Care research contract. However, for this opportunity, responsibility for the delivery of individual work packages will be through the chief investigator of the work package. There may be different sponsors for the different work packages. Similarly, any capacity building to be delivered by NIHR Biomedical Research Centres (BRCs) may be managed via the existing BRC contracts. As such, the contractor for the consortium award will have responsibility for work packages excluding the BRC and trial (sub)contracts.
Questions regarding the research contract can be asked of the NIHR secretariat using the contact details below.
We will establish an Engagement Board to provide input on the direction of the consortium, identification and prioritisation of future activity submitted to the NIHR.
Each work package will have individually defined outputs with measurable or evidenced criteria. Stop/go milestones may be included where necessary, to structure the progression of high-risk or phased work packages.
The application must include a publication plan, set out by a work package, which will ensure timely dissemination of key findings during the lifetime of the award and a full account of the award upon completion. The publication strategy should enable members of the consortium to receive recognition for their contribution and leadership within trials and other work packages. This will follow the approach set out in the NIHR Threaded Publication Model.
Process for assessment
We are working in partnership with the TJBCM to convene the research community and coordinate the submission of a single application.
The main application document should define the aims of the consortium, set out the work packages, and detail cross-cutting activity such as coordination. An appendix may be included for each trial, to provide a full rationale, research plan and supporting information.
This call will follow a single-stage (straight to Stage 2) assessment process. The deadline for the Stage 2 application is 1pm, 30 April 2025.