Australia-UK platform studies in areas of unmet clinical need

Specification

This call is for either Phase 2 or Phase 3 focused platforms, where there is a pipeline of technologies which justifies a platform approach. This call will not support funding for studies aiming to run platforms seamlessly from phase 2 into phase 3.

• Phase 2 platforms should focus on establishing the efficacy of multiple interventions in a defined patient group or circumstance (which may include sub-groups). The study must focus on interventions with convincing human clinical proof of concept which suggests they may be efficacious. By robustly evaluating efficacy, the study should have the potential to inform future Phase 3 (comparative and cost-effectiveness) trials.
• Phase 3 platforms should aim to efficiently generate high-quality evidence around the clinical and cost-effectiveness of multiple interventions in a defined patient group or circumstance. The focus must be on candidate therapies which have demonstrated some clinical efficacy but which require further testing in a multi-centre, pragmatic trial to compare against current best practice.

Interventions must have an appropriate level of supporting evidence for the phase of the platform, although it is recognised that there may be some variation in the amount of evidence for the interventions across a platform.

For this call, a platform is defined as a multi-arm study employing a master protocol and shared infrastructure to simultaneously evaluate multiple interventions. Arms may be terminated early, based on interim analyses, or added as new candidates are identified and mature. A platform should realise efficiencies in conduct and management, which may include statistical efficiencies due to a shared control group and early termination of arms which do not show any positive effect.

A platform approach may be justified where:

• There are multiple technologies requiring evaluation, with others likely to arise within the anticipated lifetime of the platform.
• Relevant outcomes/endpoints may be observed in the short- and medium-term, allowing the platform to adapt and focus on the most promising interventions.
• A collaborative, multi-disciplinary team and multi-centre recruitment plan can support the delivery of a platform.

It is envisaged that the project(s) awarded from this call will set up a platform to evaluate the current most promising candidates and will have the potential to adopt additional interventions at a later date through an adaptive protocol. 

For the purposes of this call, unmet medical need arises where individuals have a serious health condition where there are limited satisfactory options for prevention, diagnosis or treatment to support improved health outcomes. Applications are welcomed across all areas of health which meet these criteria. 

Areas of particular interest include, but are not limited to:

• Childhood, brain and prostate cancers
• Stroke and traumatic brain injuries
• Neurodegenerative diseases
• Cardiometabolic conditions, including obesity

These areas are identified on the basis of shared strategic interest; applicants are still required to provide justification for a platform approach.

Scope

Applications to this funding opportunity must describe a platform trial seeking to evaluate a number of specified technologies. Each technology must have sufficient clinical, human proof of concept to justify a definitive efficacy study.

Although applications must set out to evaluate predetermined interventions, applicants should describe an adaptive protocol, able to discontinue study arms as appropriate and incorporate additional interventions as candidates are identified. Applicants must demonstrate that there is a pipeline of interventions which justifies a platform approach. Specifically, that further candidates are in development and are likely to be evaluated for a ‘signal of efficacy’, such that they may be considered for evaluation through the platform. Phase 3 platform studies should aim to evaluate the clinical (and cost) effectiveness of multiple interventions, in a defined condition or area so evidence is aligned to the needs of clinicians and policy makers and will ultimately contribute to changes in practice and policy.

A clear process and Independent Scientific Advisory Group for the identification and prioritisation of future candidate interventions should be described. Applicants should consider the anticipated funding model for sustainability of the platform.

Existing platforms are not eligible to apply for further funding under this call, and should apply through other existing Medical Research Future Fund (MRFF), National Health and Medical Research Council (NHMRC)and NIHR funding schemes.

The proposed study must be multi-centre and collaborative. Recruitment must be split across both countries but needn’t be apportioned equally, with a minimum of 20% of the total number of participants being recruited in each country. Further international recruitment involving other countries may be proposed, where justified, however the MRFF, NHMRC and NIHR are not able to pay site and recruitment costs for these countries through this call.

Within each jurisdiction, applications are encouraged which include recruitment from geographic populations with high disease burden which have been historically underserved by research activity. The involvement of consumers including patients and the public must be embedded throughout the research lifecycle from informing the research priorities and needs, the design of clinical trial plans and during the conduct of the clinical trial and dissemination of research findings. Applications are expected to evidence strong patient and public involvement and engagement in the development of the clinical study protocol particularly around the acceptability of the proposed treatment strategies and, the feasibility of recruitment. Applicants should clearly define and justify their inclusion/exclusion criteria, study design and outcome measures, and explain how the research fits within the scope of the call. 

Applicants must ensure they meet eligibility requirements specified by their respective governmental funding bodies. Australian applicants must follow the MRFF and NHMRC Grant Opportunity Guidelines for this grant opportunity. These are available on GrantConnect.

Research team

Applications must be jointly led, with an Australian Lead and United Kingdom Lead. For practical purposes (e.g. application portals, regulators, ethics) there must be one named ‘Lead Applicant’ (UK Lead) and one named lead collaborator (Australian Lead) listed on the NIHR UK application as a co-applicant. 

The successful platforms are expected to contribute to the building of experience and capacity for research in their area. Applications should demonstrate how the study will support capacity building amongst Early and Mid-Career Researchers (EMCRs), through experience and training in the conduct and leadership of clinical trials. EMCRs will also become members of the NIHR Academy, with access to career development support such as leadership training and mentorship. Consideration should also be given to the potential of exchange visits between UK and Australian based EMCRs to facilitate knowledge and skills exchange.

Additionally, consideration must be given to a strategy that allows collaborators to join and exit the platform as appropriate, a publications plan that enables recognition of collaborators’ contribution, and the development of a succession plan to allow the leadership of the platform to change over time if sustained.

Duration and costs

The total funding available through this funding opportunity is in the region of $30 million AUD/ £15.5 million GBP with contributions from each funder.

• for the Australian-based component the maximum grant amount that can be requested is up to $5 million AUD over 7 years, with a total contribution of up to $15m AUD.
• for the NIHR UK-based component, there is approximately £2.6m per award over 7 years, with a total contribution of up to £7.8 million GBP.   

MRFF, NHMRC and NIHR are aiming to fund 1 to 3 platforms for up to 7 Years. NHMRC and MRFF will fund the Australian research component and the NIHR will fund the UK research component of successful applications. Each national funder will support selected individual awards and there will be no shared or split funding arrangements between funders.

There is no set upper limit for the cost of applications for UK based components however, value for money will be a key consideration. The Australian-based components have a maximum amount of $5 million.

Studies are expected to incorporate predefined stop/go decision points, with measurable criteria to enable assessment of the successful completion of the stage. A reporting schedule agreed as part of the contracting process will assess completion of these critical contractual milestones during the lifetime of the award. Funders reserve the right to close studies not achieving critical milestones.

The successful platform(s) will be commissioned for up to 7 years, to evaluate the interventions set out at application. Due to the adaptive nature of platforms, it is anticipated that additional funding to support per-intervention costing may be required at a later date, to continue the platform. Applicants are encouraged to consider the sustainability of the platform beyond the initially funded work, where relevant, and how additional costs would be funded.

Applicants must separately detail the funding requested for research activities undertaken in Australia and funding requested for research activities undertaken in the UK. Costs for trials’ coordination activity may be included within costs for the country leading this activity. 

The NIHR, MRFF and NHMRC wish to encourage and grow collaborations under this call. Costs relating to the exchange of personnel between international sites may be considered, where this is linked to a specific research activity, of clear benefit to the study and of a short duration.

A small proportion (up to 10%) of costs may relate to research services to be undertaken by co-applicants or collaborators in other countries, if teams can justify that suitable facilities are not available in Australia or the UK.

For more information, please refer to the funding opportunity guidance notes. Australian applicants must also review and follow the MRFF and NHMRC Grant Opportunity Guidelines to ensure that what they're requesting funding for is eligible and the requests adhere to specific MRFF and NHMRC requirements (e.g. salaries funded through Personnel Support Packages). These are available on GrantConnect.

General guidance

Governance and regulation

Applicants are asked to consult the following documents and follow them as appropriate:

• Medical Research Council’s Good Research Practice guidelines - to be used when planning how studies, particularly RCTs, will be supervised
• UK Policy Framework for Health and Social Care Research 
• The Clinical Trials Toolkit

Note that trials or studies involving medicinal products must comply with The Medicines for Human Use (Clinical Trials) Regulations 2006 and the amendment to the regulations. In these cases, the DHSC expects the employing institution of the chief investigator to be nominated as the sponsor. Other institutions may wish to take on this responsibility or agree co-sponsorship with the employing institution. The DHSC is prepared to accept the nomination of multiple sponsors. Applicants who are asked to submit a stage 2 proposal will need to obtain confirmation of a sponsor(s) to complete their application. The DHSC reserves the right to withdraw from funding the project if they are not satisfied with the arrangements put in place to conduct the trial. The MHRA can provide guidance as to whether your trial would be covered by the regulations. To request this, please email: info@mhra.gsi.gov.uk.

For Australian applicants

Australian personnel must comply with all relevant Australian laws and regulations in undertaking the project. Australian personnel must also comply with any specific legislation/policies/industry standards within the grant agreement, such as:

• the MRFF Act
• the NHMRC Act
• working with Vulnerable People registration
• state/territory legislation in relation to working with children
• ethics and research practices

All personnel contributing to the research activity must familiarise themselves with the Australian Code for the Responsible Conduct of Research, the National Statement of the Ethical Conduct of Human Research, the Australian Code for the Care and Use of Animals for Scientific Purposes and other relevant NHMRC policies concerning the conduct of research, and agree to conduct themselves in accordance with those policies.

Application support

Please carefully review the following call documents before applying:

• Stage 1 2025 Australia-UK Platform studies guidance notes
• Stage 1 supporting information
• MRFF and NHMRC Grant Opportunity Guidelines

Research Support Service

Got a research idea and not sure how to turn it into a funding application? The free NIHR Research Support Service (RSS) supports researchers in England to apply for funding, and to develop and deliver clinical and applied health, social care and public health research post award. Find out how the RSS can help you.

Download application form template

You can download a template of the application form below. Please use this template as a guide to help you prepare your application. This Word document of the Stage 1 application form is to be used as a guide only. It is designed to help you complete the online application form only. For example, to see how many characters are accepted in each section and to see how information in the form is laid out. Please do not try to use this as an application form. You must submit your application in our online Awards Management System which you can access by clicking on the 'Apply now' links when a funding opportunity is open.

Criteria for assessment of proposals

• how well the proposal matches the call specification
• scientific rigour:
  • the study design would answer the research question proposed
  • the proposed study would be feasible and deliverable
• value for money:
  • the proposed costs of the research are reasonable and commensurate with the proposed work involved
  • the costs to health and care services in supporting the research are reasonable in relation to the likely benefits of the research to decision-makers, patients and the public
• demonstration of experience in the team of delivering multi-centre interventional studies in the UK/Australia. Experience of innovative adaptive designs, particularly platform studies, is likely to be particularly relevant.
• demonstration within the proposal, and/or prior track record, of working with members of the public, and people who draw on services and are in locations of greatest need, and how these needs, priorities, views and values have informed the research plans and will continue to be embedded across the planned research lifecycle.
• inclusive research approaches that target underserved populations and demonstrate how outcomes will benefit these populations and contribute to their improved health outcomes  
• evidenced plans to work closely in partnership, both with local healthcare organisations and across the international collaboration
• ability to establish and coordinate data input from all proposed sites
• ability to work effectively with industrial partners and deliver robust, independent and industrially relevant research

How to apply

Applications to this funding opportunity will follow a two-stage application process.

Committee representatives from both Australia and the UK will assess applications against the criteria at both stages. For details about the criteria, see the 'Application support' section of this funding opportunity.

The deadline for Stage 1 applications will be 23 July 2025 10:00 UK (UTC+1) / 19:00 AEST ( UTC+10). Shortlisted applications will be provided with feedback and invited to submit a Stage 2 (full) application for consideration.

When you are ready, you will need to log in to our application system to apply.

If you have any questions which have not been covered in this funding opportunity, please contact us at internationalapplications@nihr.ac.uk