MRFF 2026 Clinical Trials Activity Grant - Now Open
A priority-driven investment in translational research to transform health outcomes, strengthen Australia's life sciences sector and contribute to a more sustainable health system
The Australian Government has officially opened the Medical Research Future Fund (MRFF) 2026 Clinical Trials Activity Grant Opportunity (GO8645), offering funding of up to $5 million per project to support innovative clinical trials addressing critical gaps in healthcare, rare diseases, unmet medical needs and disease prevention.
Opening on 30 September 2026, this highly competitive funding opportunity represents a significant investment in Australia's clinical research ecosystem, supporting the development, evaluation and translation of new treatments, medical interventions and evidence-based models of care.
The Medical Research Future Fund (MRFF) Clinical Trials Activity Initiative aims to:
improve the evidence base supporting clinical care
help patients access trials relevant to their health circumstances
enable researchers to bring international trials to Australian patients.
About the 2026 Clinical Trials Activity Grant
The grant opportunity aims to fund research in two priority areas identified in the Medical Research Future Fund 10-year Investment Plan:
- Rare cancers, rare diseases and unmet need
- Effective health interventions
Priority 1: Rare cancers, rare diseases and unmet need
Rare cancers are a broad and diverse group of cancers with a range of incidence and survival outcomes. In Australia, it is estimated that more than 42,000 Australians are diagnosed with a rare or less common form of cancer every year1. While one in three cancer diagnoses in Australia are rare or less common, they contribute to over half of all cancer deaths2. There is a lack of evidence-based information to inform treatment options for many patients diagnosed with a rare cancer.
Rare diseases are life-threatening or chronically debilitating disorders or conditions uncommon in the general population. To date, more than 10,000 rare diseases have been identified, and approximately 8 per cent of Australians live with a rare disease3. Rare diseases typically exhibit a high level of symptom complexity leading to diagnostic delays and require frequent, ongoing multidisciplinary care and treatment4.
Unmet medical need arises where individuals are living with a serious health condition, where there are limited satisfactory options for prevention, diagnosis or treatment to support improved health outcomes.
Priority 2: Effective health interventions
The purpose of this research is to assist consumers, clinicians, purchasers, and policy makers to make informed decisions that will improve health care at both the individual and population levels.
The objectives and intended outcomes of this grant opportunity are aligned with the following Australian Medical Research and Innovation Priorities 2024-2026:
- Effective and High Value Care
- Preventive and Public Health Research
- Health and Medical Researcher Capacity and Capability
- Priority Populations.
Consistent with the MRFF Act, the objective of this grant opportunity is to provide grants of financial assistance to support medical research and medical innovation projects that:
Stream 1 (Incubator): conduct a pilot study to assess the feasibility of a new clinical trial for one or more treatments and/or management strategies for a rare cancer, rare disease and/or unmet need. Stream 1 is intended to support early stage, small scale research projects that seek to assess the potential and feasibility of novel strategies to address critical or intractable health issues.
Stream 2 (Targeted Call for Research): conduct a clinical trial of one or more treatments and/or management-based interventions for rare cancers, rare diseases and/or unmet need.
Stream 3 (Targeted Call for Research): conduct a clinical trial that supports the delivery of effective and high value care by targeting evidence gaps of value to health technology assessment processes in Australia.
Stream 4 (Targeted Call for Research): conduct a prevention clinical trial aimed at reducing the risk, onset or progression of disease through early intervention strategies.
Streams 2-4 are intended to support projects that progress research that addresses a specific health need.
For the purposes of this grant opportunity, a clinical trial can include methodologies based on master protocols (including basket trials, umbrella trials, and platform trials). Applications that utilise novel and innovative clinical trial methodologies, including ‘n of 1’ trials and/or utilise the capabilities of established clinical quality registries are encouraged.
Rare disease is defined as a life-threatening or chronically debilitating health condition that affects fewer than 1 in 2,000 people in the population5. Rare cancer is defined as a type of cancer that has fewer than 6 incidences per year per 100,000 population6.
Additional information for Stream 1
Applications to Stream 1 are required to address a rare cancer, rare disease and/or an unmet need. Applications should clearly demonstrate that the condition being studied is rare cancer, rare disease and/or unmet need through one or multiple aspects including disease burden, patient population size, and/or limited satisfactory options for prevention, detection, diagnosis, or treatment to support improved health outcomes. Applicants should propose research that tests the feasibility of an intervention and generates pilot data that could be leveraged to support larger/more definitive trials. Applications that propose to assess interventions for which a commercial return may be unlikely (e.g. re-purposing or extending the use of medicines) are particularly encouraged.
Phase 1 trials are considered out of scope for this Stream.
Applicants should consider parameters for evaluation of the intervention such as:
• standard deviation of the outcome measure
• willingness of participants to be randomised
• willingness/capacity of clinicians to recruit participants
• number of eligible patients
• design or refinement of a suitable outcome measure
• rate at which participants are lost to follow-up
• response rates to questionnaires
• adherence/compliance rates7.
Additional information for Stream 2
Applications to Stream 2 are required to address a rare cancer, rare disease and/or an unmet need. Applications should clearly demonstrate that the condition being studied is rare cancer, rare disease and/or unmet need through one or multiple aspects including disease burden, patient population size, and/or limited satisfactory options for prevention, detection, diagnosis, or treatment to support improved health outcomes. Applications that propose to assess interventions for which a commercial return may be unlikely (e.g. re-purposing or extending the use of medicines) are particularly encouraged.
Additional information for Stream 3
Applications to Stream 3 are required to address the Effective health interventions priority.
For the purposes of Stream 3 of this grant opportunity, clinical trials that support the delivery of effective and high value care address critical evidence gaps relevant to health technology assessment and consider the clinical effectiveness, cost-effectiveness and comparative effectiveness (e.g. a specific standard of care as comparator) of the intervention/s.
Expected trial outcomes should be reflective of real-world practice to support their implementation and uptake into routine clinical practice. Applications to Stream 3 are not required to address a rare cancer, rare disease or an unmet need.
Additional information for Stream 4
Applications to Stream 4 are required to address the Effective health interventions priority.
For the purposes of Stream 4 of this grant opportunity, prevention clinical trials involve the study of interventions that prevent primary or secondary disease (i.e., the risk or progression of disease, respectively). Applications that investigate treatments for a disease are out of scope.
Applications must clearly define the need for the disease prevention in Australia (e.g. disease burden and/or impact on an MRFF Priority Population such as Aboriginal and/or Torres Strait Islander people or people in remote and rural communities). Applications are not required to address a rare cancer, rare disease or an unmet need.
This grant opportunity has allocated increased funding to these Streams when compared to previous, similar grant opportunities by utilising funding available to the Clinical Trials Activity Initiative under the MRFF 10-Year Investment Plan. As a result, a similar grant opportunity will not be offered in 2027, with the next such grant opportunity expected to open in 2028. This approach supports the earlier disbursement of MRFF funding to clinical trials, while reducing the administrative burden for the sector associated with preparing and submitting applications.
To be competitive for funding, applicants must propose to conduct research that delivers against the above objectives and those of the Clinical Trials Activity Initiative. Applicants are encouraged to propose novel and/or innovative research and describe how the outcomes of the research will be translated into health benefits for Australians.
Applications to this grant opportunity must propose research that addresses one of the four Streams of research. An application may only be submitted to one of the above four Streams. Applicants must specify the Stream to which they are applying in their application.
The intended outcome of the research funded by this grant opportunity is to improve the health and wellbeing of Australians by investing in new clinical trials that support increased access to high-quality, evidence-based and effective health care.
Key Grant Dates
Applications opened: 30 September 2026
Minimum Data deadline: 10 March 2027, 5:00 pm ACT local time
Full application deadline: 7 April 2027, 5:00 pm ACT local time
Importantly, the Minimum Data deadline is a critical application milestone. Prospective applicants should commence project planning, eligibility assessment, consortium development and submission preparation well in advance.
Who Can Apply?
Applications must be submitted by an approved MRFF Eligible Organisation.
Research institutions, universities, healthcare organisations and industry participants should establish the eligibility of the proposed lead organisation and relevant investigators before commencing a submission.
Collaborative applications can provide opportunities for biotechnology and medical technology companies to participate alongside eligible administering organisations, clinical investigators and research partners.
Grants Available
The Australian Government has announced a total of $750 million for the Clinical Trials Activity Initiative. For this grant opportunity, up to $136 million of funding is available over 5 years from 2027-28 for the four Streams listed
The amounts available for a single grant in each Stream are as follows:
Stream 1: There is no minimum grant amount and the maximum amount available for a single grant is $1.0 million.
Stream 2: There is no minimum grant amount and the maximum amount available for a single grant is $5.0 million.
Stream 3: There is no minimum grant amount and the maximum amount available for a single grant is $5.0 million.
Stream 4: There is no minimum grant amount and the maximum amount available for a single grant is $5.0 million.
What Makes a Competitive MRFF Clinical Trials Application?
Securing MRFF funding requires considerably more than a promising clinical innovation.
Competitive applications must demonstrate a compelling unmet clinical need, a robust scientific and clinical rationale, a credible trial methodology and a clearly articulated pathway to measurable patient and healthcare system benefits.
Key considerations include:
Clinical significance: Clearly defining the unmet medical need and demonstrating why the proposed trial is necessary.
Scientific excellence: Establishing a rigorous trial design with clinically meaningful endpoints and appropriate statistical justification.
Clinical and commercial translation: Demonstrating how trial outcomes could inform clinical practice, treatment decisions, regulatory development or healthcare delivery.
Strategic partnerships: Assembling a consortium with the clinical, scientific, operational and institutional capabilities required for successful delivery.
Consumer involvement: Demonstrating meaningful engagement with patients, consumers and relevant communities throughout the research lifecycle.
Implementation readiness: Presenting credible recruitment strategies, clinical trial governance, budgets, milestones and risk management arrangements.
For biotech and medical technology companies, alignment between the clinical development program, research objectives, regulatory strategy and longer-term commercialisation pathway can provide important strategic advantages.
The strongest submissions do not simply demonstrate that a clinical trial can be conducted. They establish why the trial matters, why the proposed consortium is best positioned to deliver it and how its outcomes will generate meaningful benefits for Australian patients and the healthcare system.
Encouraging Partnerships
Applicants are encouraged to seek strategic partnerships involving organisations whose decisions and actions affect Australians’ health, health policy and health care delivery in ways that improve the health of Australians. Organisations that are capable of implementing policy and service delivery and would normally not be able to access funding through the MRFF are highly valued as partners.
Partnerships and co-investment are encouraged in order to maximise impact of investment, provide opportunities for more mature sites/agencies to build the capacity of emerging sites/agencies, reduce duplication of activities, and reduce potential respondent administrative burden on participating communities. Partnerships are also encouraged to ensure the proposed research is of relevance to consumers and delivery of services, and to support translation of research outcomes into practice.
Partner organisations may include:
- medical research institutes, i.e. organisations that conduct medical research as a primary purpose, and are also registered with the Australian Charities and Not-for-Profits Commission
- universities
- corporate Commonwealth entities, i.e. Commonwealth entities that are bodies corporate
- corporations, i.e. Australian public companies, Australian private companies and other incorporated entities
- those working in federal, state, territory or local government in the health portfolio or in other areas affecting health, such as economic policy, urban planning, education or transport
- those working in the private sector such as employers, private health insurance providers or private hospitals
- those commercial entities with an interest in this area, for example pharmaceutical companies and biotechnology companies
- non-government organisations and charities
- education institutions
- state education departments
- community organisations such as consumer groups
- health care providers
- professional groups.
In some instances, a body of a type listed above may be eligible to apply for MRFF funding in its own right, for example in the case of commercial entities or non-government organisations that are corporations. The above list recognises the desirability of entering into partnerships as a means of advancing the outcomes of the MRFF and is not intended to imply that the types of bodies listed are ineligible to seek MRFF funding.
How HAINES Can Help
At HAINES Consulting Group, we specialise in securing competitive, non-dilutive government funding for innovative Australian businesses, including biotechnology, medical technology and life sciences organisations.
Our end-to-end MRFF advisory services encompass funding eligibility and competitiveness assessments, grant strategy, clinical research project positioning, consortium development, application preparation, research translation and commercialisation strategy.
We work collaboratively with biotechnology companies, clinical investigators, universities, medical research institutes and industry partners to develop compelling, evidence-led funding applications aligned with government priorities and assessment requirements.
Considering an Application?
The MRFF 2026 Clinical Trials Activity Grant Opportunity presents a significant opportunity to accelerate clinical innovation, strengthen Australia's research capabilities and improve healthcare outcomes.
If your organisation is developing a clinical trial targeting rare diseases, unmet medical needs, health technology assessment evidence gaps or disease prevention, now is the time to assess your funding strategy.
Haines Consulting Group is Australia’s leading specialist in securing major non-dilutive funding for Australia’s most ambitious and high-growth ventures. We work with some of the country’s most innovative companies and universities to navigate and win competitive government grants. If you need any assistance with a grant submission, please contact us now for a confidential conversation.
2 Rare Cancers Australia - What is a rare cancer?
3 Elliott EJ and Zurynski YA. Rare diseases are a ‘common’ problem for clinicians. AFP. 2015;44:9
4 Anderson M, Elliott EJ, Zurynski YA. Australian families living with rare disease: Experiences of diagnosis, health services use and needs for psychosocial support. Orphanet J Rare Dis. 2013;8:22
7 Arain, M, Campbell, MJ, Cooper, CL et al. What is a pilot or feasibility study? A review of current practice and editorial policy. BMC Med Res Methodol 10, 67 (2010). https://doi.org/10.1186/1471-2288-10-67
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