Lifting Clinical Trials and Registries Capacity – Grant Program

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Investment

The Australian Government will invest $13 million to stimulate clinical trial and registry activity to improve patient outcomes, health system efficiency and drive innovation.

Key elements

This competitive grant program will target public good clinical trials and Clinical Quality Registries (CQRs) that address areas of health burden and unmet need. Novel and innovative methodologies will be encouraged, such as the application of precision medicine.

Rationale

  • Clinical trials benefit patients, improve health outcomes, advance medical knowledge and are a significant contributor to the innovation economy.
  • CQRs are an increasing feature of complex clinical investigations – they allow deep data analysis, trend identification, drive improvements in clinical practice, and illuminate new areas for research.
  • Clinical trial public investment is roughly proportionate to the burden of disease; however some conditions can benefit from further investment and investigation.
  • Public good trials activity increases opportunities for patient therapy, strengthens the operational systems that support trials, and grows workforce capacity.
  • The Australian Medical Research Advisory Board acknowledges in their Strategy that the MRFF has a role to play in facilitating non-commercial clinical trials of potential significance.

Desired outcomes

  • New opportunities for clinical trial participation and associated benefits from accessing the latest research.
  • Attention given to under researched health priorities and conditions.
  • Deployment of innovative trial designs and recruitment strategies.
  • Purposeful health service engagement to improve the translation of research into practice and improve outcomes for patients.
  • New health treatments, drugs and devices to improve health and wellbeing.
  • Reinforcement of Australia’s position as a preferred destination for clinical trials.

Key facts

  • Clinical trials are research investigations that evaluate whether a medical strategy, treatment, drug or device is safe and effective for humans.
  • Clinical trials provide the evidence to inform best practice. They also offer participants opportunities to benefit from the latest medical research and provide legitimate alternative therapy options.
  • Clinical trials are estimated to be worth around $1 billion to the Australian economy each year.
  • Registries in general are data-rich repositories that enable responsive trial design built around patient needs.
  • CQRs capture clinical data to allow for the identification of benchmarks and variations in patient outcomes. They provide a feedback loop to clinicians and researchers about the efficacy of clinical interventions – what is and isn’t working.
  • Recent estimates indicate that national CQRs could provide a return of up to $7.00 for every dollar invested.
  • Innovative clinical trial design methods can overcome barriers to recruitment (including for regional Australians), and explore comparative effective and adaptive platforms with agile treatment protocols.
  • Precision medicine holds the potential to transform medicine – it changes the paradigm from a medicine focussed on organs (heart, liver) to a medicine that targets cells, molecules and genes.
  • This investment strategically builds on the Government’s 2016 Encouraging more clinical trials in Australia initiative that seeks to streamline trial operations to improve start-up and recruitment efforts.

Implementation

  • This grant program will be administered in partnership between the Department of Health and the National Health and Medical Research Council.
  • Clinical trials and CQRs will be selected based on peer review and ability to address unmet need and deploy innovative approaches, where appropriate.
  • Program guidelines will be developed shortly and a call for proposals will occur in early 2017-18.

Medical Research Future Fund

The Medical Research Future Fund (MRFF) demonstrates the Government’s strong commitment to research and innovation. The MRFF provides a long term sustainable source of funding for endeavours that aim to improve health outcomes, quality of life and health system sustainability.

The MRFF will double direct Australian Government funding for health and medical research.

The MRFF is a dedicated vehicle for priority investment in health and medical research.

The MRFF, established under the Medical Research Future Fund Act 2015, provides grants of financial assistance to support health and medical research and innovation in improving the health and wellbeing of Australians. It operates as an endowment fund with the capital preserved in perpetuity. At maturity, the MRFF will reach $20 billion.

The first disbursements from the MRFF focus on translating research into real health benefits, breakthrough investments in new technologies and challenges, and enhancing Australia’s reputation for research excellence and leadership.

Over $65 million will be injected into a range of programs that cut across the research pipeline – fuelling new discoveries and the translation and commercialisation of great Australian ideas.

Advisory Board

The Australian Medical Research Advisory Board, established in accordance with the MRFF Act, is responsible for consulting on and developing a five-yearly Strategy that sets out the vision, aims and objectives for the MRFF and an accompanying two-yearly list of Priorities. The Government must consider the Strategy and Priorities in making MRFF investment decisions.

Strategy 2016-2021

Vision: A health system fully informed by quality health and medical research.

Identifies key strategic investment platforms that set to position Australia to meet future healthcare challenges:
  • Strategic and international horizons
  • Data and infrastructure
  • Health services and systems research
  • Capacity and collaboration
  • Trials and translation
  • Commercialisation

Priorities 2016-2018

The first MRFF disbursements address identified Priorities under each strategic platform, are a mix of strategic investments, and use a range of administrative mechanisms to maximise impact. More disbursements will occur in 2017-18.

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