Clinical Trial Enabling Infrastructure

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Up to $7 million for development and implementation of adaptive platform or registry-based clinical trials, facilitating world-class health research in areas of unmet medical need.

What is the Clinical Trial Enabling Infrastructure?

The 2024 Clinical Trial Enabling Infrastructure (CTEI) Grant Opportunity is an Australian Government initiative under the Medical Research Future Fund (MRFF) that aims to strengthen clinical trial capabilities and support innovative research infrastructure. This opportunity provides targeted financial support for projects that focus on more effective and efficient clinical trials – including adaptive platform trials and registry-based randomised controlled trials – to address critical areas of unmet medical need and improve health outcomes.

Clinical Trial Enabling Infrastructure level of support

Minimum and maximum amount of funding:

  • Stream 1, Topic A (Incubator): No minimum, up to $300,000
  • Stream 1, Topic B (Targeted Call): No minimum, up to $5,000,000
  • Stream 1, Topic C (Targeted Call): No minimum, up to $3,000,000
  • Stream 2 (Targeted Call): No minimum, up to $1,500,000
  • Stream 3 (Targeted Call): No minimum, up to $7,000,000

Co-contribution requirement:

  • No co-contribution is required. The grant can cover up to 100% of eligible project costs. If you choose to bring in additional cash or in-kind support from partners, this can strengthen your proposal, but it is not mandatory.

Clinical Trial Enabling Infrastructure important dates

  • Closing date: 17 July 2025 at 5:00 pm (AEST)
  • Project duration Stream 1, Topic A: up to 1 year
  • Project duration Stream 1, Topic B & C; Stream 2; Stream 3: up to 7 years
  • Register your interest with GrantHelper

Clinical Trial Enabling Infrastructure objectives

The main objectives of this grant are to:

  • Enhance Australian research infrastructure to enable more effective and efficient clinical trials.
  • Foster innovations such as adaptive platform trials and registry-based randomised controlled trials in areas of unmet medical need.
  • Establish and extend clinical trial practice networks that promote sector capability, collaboration, and the embedding of evidence-based care across Australia.
  • Improve health outcomes through systematic evaluation of pharmacological and non-pharmacological interventions.
  • Encourage partnerships across academia, industry, state/territory agencies, and consumer organisations to strengthen trial capabilities and translational impact.

Projects and expenditure eligible for Clinical Trial Enabling Infrastructure support

To be eligible, your project must focus on at least one of the following areas:

  • Establishing or expanding adaptive platform trials (Stream 1).
  • Embedding a registry-based randomised controlled trial into a pre-existing clinical registry (Stream 2).
  • Establishing a new clinical trial practice network or extending an existing one (Stream 3).
  • Building the evidence base, capacity, or data infrastructure critical to the success of national-scale clinical trials.

Ineligible expenditure includes, but is not limited to:

  • Major capital works and building maintenance/upgrades.
  • Retrospective costs for activities undertaken prior to the grant agreement.
  • Costs already supported through other Commonwealth, state, or territory programs.
  • Financing costs (e.g. interest on loans), standard hospitality/entertainment, personal memberships, and other items outside the scope of direct project activities.

Other Clinical Trial Enabling Infrastructure important details that you will need to know

You must:

  • Have an Australian Business Number (ABN).
  • Be incorporated in Australia.
  • Be one of the following:
    1. A medical research institute
    2. A university
    3. A corporate Commonwealth entity
    4. A corporation (business or not-for-profit).

 

Ineligible applicants include individuals, unincorporated associations, trusts without an incorporated trustee, and non-corporate Commonwealth entities.

See the guidelines for full details of organisational requirements.

Eligible applications are assessed by an independent committee of experts. The assessment criteria include:

1. Project Impact (40% weighting)

  • How well the project addresses an unmet medical need and leads to meaningful advances in health outcomes, practice, or policy.
  • The degree of consumer/community/partner involvement in shaping and translating the research.

 

2. Project Methodology (30% weighting)

  • The rigour and feasibility of your research design, including clarity of objectives, milestones, and data management.
  • The extent to which your study builds on existing knowledge rather than duplicating past work.

 

3. Capacity, Capability and Resources (30% weighting)

  • Suitability of the research team’s expertise, leadership, and resources to achieve successful outcomes.
  • Diversity of disciplines, genders, and career stages among Chief Investigators and partners.

 

4. Overall Value and Risk (non-weighted)

  • How well the proposed outcomes align with the CTEI Grant Opportunity and the broader MRFF goals.
  • The appropriateness of the budget and a robust plan for identifying and managing risks.

 

A strong application must meet at least an acceptable standard for each of the first three weighted criteria and be rated “Good” or “Excellent” for Overall Value and Risk.

Check your eligibility: Ensure you’re an eligible organisation and that your project fits the program objectives and requirements.

Develop your project scope: Confirm costs, gather quotes, and identify any required approvals.

Compile your supporting documentation: Examples include a work plan and a detailed project budget.

  • Project Plan: Outline your research question, milestones, timelines, feasibility, and methods of data collection.
  • Budget & Evidence of Support: Provide a detailed, itemised project budget, plus a letter of endorsement from your board/CEO/equivalent.
  • Risk Management: Prepare a plan detailing how you will monitor, manage, and report on potential risks.
  • Early to Mid-Career Researchers: Confirm that at least 20% of your Chief Investigators meet this requirement.
  • Ethics & Standards: Align your proposal with relevant ethics guidelines and regulations.

 

See the guidelines for full details of information requirements.

Submit your application via the online portal on business.gov.au.

Register your interest with GrantHelper to explore your alignment with this grant and how we can assist you to increase your chances of success.

Clinical Trial Enabling Infrastructure resources

Is Your Business Eligible for This Government Grant?

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