New report exposes critical gaps in clinical research and funding

Medical: The Department of Health and Aged Care has unveiled the long-awaited report detailing the evaluation of the Medical Research Future Fund’s (MRFF) Clinical Trials Activity Initiative. The report’s primary aim was to scrutinise the initiative’s advancement in fulfilling the objectives set forth in the MRFF’s 10-year Investment Plan, and to offer insights to shape future investments in clinical trials.

Nadia Levin, CEO and Managing Director of Research Australia, expressed optimism for the report’s initial findings. She welcomed the revelation that MRFF’s clinical trials exhibited a higher standard of design and quality compared to those funded by other sources. However, she acknowledged that only a limited number of MRFF trials have reached completion and as such assessing their dissemination and impact remains a challenge.

“Importantly, health and medical research is a long game, and we need to be patient but persistent in making sure our investments in research deliver results for our community. And this includes better supporting the implementation and adoption of new interventions that are proven effective in clinical trials.

“This report highlights why the National Health and Medical Research Strategy has a critical role to play in better coordinating the whole of our research sector and funding bodies to deliver safer, better, higher quality healthcare,” Ms Levin emphasised.

One particularly commendable aspect highlighted in the report was MRFF’s emphasis on inclusivity. The MRFF’s guidelines and processes actively encouraged researchers to incorporate diverse communities and consumers in their trials. While over 20% of these trials featured consumers or patients as chief investigators, some stakeholders voiced concerns about the clarity of MRFF’s priority-setting process and the limited timeframes available for extensive consumer input.

Consumer involvement in grant guidelines, assessment, and panel composition was generally well-received, although stakeholders identified opportunities for greater community engagement. Some suggested including community members as full panel members on Grant Assessment Committees.

Rare Voices Australia (RVA) urged the Department of Health to involve RVA and its Scientific and Medical Advisory Committee in future evaluations of rare disease research funding.

Nicole Millis, CEO of Rare Voices Australia, pointed out the persistent scarcity of rare disease research studies selected for MRFF funding, despite the fund’s intentions.

“The barriers and enablers to clinical trials identified in the Evaluation Report are relevant to rare diseases, including the duration of grant funding, workforce limitations, site governance and approval processes and patient recruitment. However, there are several barriers to clinical trials that are compounded in rare disease, including expectations around more conventional trial designs due to inherently small and geographically spread patient cohorts, and the expectation that verified Standardised Outcome Sets for rare diseases exist,” Ms Millis noted.

The report also highlighted certain barriers in conducting clinical trials, with site governance and study site approvals posing challenges for over 50% of the trials. These findings underscored the pressing need for clinical trials reform in Australia, with AusBiotech and pharmaceutical companies such as BMS endorsing the proposed National One Stop Shop as a solution to streamline clinical trials.

Leah Goodman, Managing Director of BMS Australia and New Zealand said recently “Australia has so much advantage when it comes to the quality of our R&D. Our clinical trial capability is immense and it is saddening to see the barriers and disincentives currently in the Australian system lessening Australia’s attractiveness to global choices in country investment. Access to clinical trials improves the economy as well as patient lives. We need stronger Government-Industry partnership to turn this around so the global prisonisation of Australia for investment can be improved.”

“AusBiotech is supportive of the proposed platform, and encourages funding in MYEFO, in order to retain Australia’s global competitive advantage and ensure greater patient access to clinical trials,” the organisation added.

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