BMS report says government action the key on trials

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A report commissioned by Bristol Myers Squibb says the federal government could use its research funding bodies to take further action on harmonising clinical trial approvals in Australia. 

The report, 'Pathways to deliver harmonisation of clinical trial approvals in Australia', was developed by economic consultancy Evaluate.

The report says over 1,000 new clinical trials are commenced in Australia each year with $1.1 billion in direct expenditure since 2015. Of this, around one-quarter originates from commercial entities like biopharmaceutical companies, the majority emanating from outside Australia.

Australia is one of the six top countries for investment by Bristol Myers Squibb in clinical trials globally. In 2017, Australia attracted $33 million of the company's investment in clinical trials.

Yet the report says further action is required to maintain and even enhance Australia's attractiveness as a location for clinical trials, particularly in relation to the harmonisation of approvals, with the opportunity to become a medical research hub in the Asia-Pacific.

"Clinical trials in Australia are subject to a variety of ethics guidelines and codes of conduct, including our National Statement on Ethical Conduct in Human Research and the Australian Code for Responsible Conduct of Research," says the report.

"Numerous Commonwealth, state and territory laws are also relevant and compliance with the National Statement is a prerequisite for receipt of NHMRC [National Health and Medical Research Council] funding and of the other two signatory bodies – the Australian Research Council and Universities Australia."

The report says there has been some progress toward the harmonisation of trial approvals. 

"Further action is required however as multiple state-based online information systems and portals still exist meaning that investigators and sponsors need to provide different data and forms across different jurisdictions.

"Further, the portals into which this information is lodged do not communicate with each other while site-specific requirements for applications also differ depending on their criteria. This again adds to the complexity for those trying to establish new clinical trials."

The report says further harmonisation could be delivered by standardising the Human Research Ethics Committee (HREC) and clinical governance requirements.

It identifies three opportunities to achieve this standardisation, including the adoption of a common dataset and set of questions for trial approvals, a single software system and mutual recognition of approvals granted by recognised HRECs so that only a single application would be required.

The Evaluate report says the economic benefit of adopting these changes would be almost $6 for every additional $1 invested in trials.

It recommends the extension of existing compliance requirements under which the NHMRC, the Australian Research Council (ARC) and Australian Universities all require compliance with the National Statement on Ethical Conduct in Human Research as a prerequisite to receive their funding.

"In light of this, there seems little reason why this could not be extended to require those individuals and organisations in receipt of these funds to utilise a single platform for scientific and ethical review and for SSAs [Site Specific Assessment].

"This could be achieved via changes to the NHMRC Funding Agreement and would provide significant incentive to move forward to a more streamlined and efficient application process for all involved. Similar arrangements could then be mirrored in relation to MRFF, ARC and other federally funded research grants."