Clinical trials reform underway with first phase of consultation complete

Pharma News: Patients, researchers, industry representatives and sponsors will have improved access to clinical trials due to reforms to be introduced by the Australian Government following advocacy by Medicines Australia, AusBiotech, and Medical Technology Association of Australia (MTAA).

The ‘National One Stop Shop’ and the ‘National Clinical Trials Front Door’ reforms have just completed the first phase of consultation with the industry peak bodies via the R&D Taskforce. The co-chairs of the R&D Taskforce are David Wilks from Bristol Myers Squibb and Ana Svensson from NovoNordisk.

Medicines Australia CEO, Elizabeth de Somer, said these exciting reforms will significantly benefit patients and improve Australia’s international competitiveness in medical and scientific innovation.

“Clinical trials allow patients to gain early, no-cost access to innovative treatment across a broad range of diseases,” Ms de Somer said.

“They contribute to better healthcare outcomes and improvements in clinical practice. Currently, each state and territory have their own separate regulatory requirements, which create unnecessary duplication, complexity, and inconsistency. This dramatically slows down patient access to clinical trials and discourages international companies from engaging with Australia on innovation.

“The consultations on the National One Stop Shop and the National Clinical Trials Front Door are a real opportunity for change, and we welcome the completion of the first phase. It is great to see consensus across all jurisdictions for a single platform to harmonise the clinical trials landscape.”

Clinical trials create jobs and ensure medical breakthroughs are happening right here at home. In 2019, $1.4 billion was invested in clinical trials and at least 8,000 Australian jobs were supported by the clinical trials sector.

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To inform the development of the National One Stop Shop and the Front Door, the Australian Commission on Safety and Quality in Healthcare (ACSQH) is undertaking a two-phase consultation in partnership with all Australian jurisdictions.

To date, the consultations have revealed wide-spread support for the incorporation of single national ethics and site-specific approvals (SSA), linked to authorisation and notification systems of the Therapeutic Goods Administration and the Gene Technology Regulator and incorporation of an embedded and real-time national health-related human research registry. There is also widespread support for a next generation national health-related human research registry to be embedded into the approvals platform to underpin the cutting edge-website for the community. 

Many stakeholders expressed the view that an innovative and intuitive approvals platform combining the functionality and with jurisdictional governance arrangements would make the research process significantly easier and less burdensome in Australia.

As part of the second phase of consultations, the Commission is conducting consultations on the core elements of the national SSA. These consultations are being guided by an expert reference group, the Health and Medical Research Advisory Group and the Clinical Trials Project Reference Group. The aim of the single national SSA is to ensure a single process for local site risk assessment and authorisation for health-related human research. 

Ms de Somer said the first phase of the consultation has been comprehensive, engaging a broad range of stakeholders, and she looks forward to the next phase.

“Along with AusBiotech and MTAA, Medicines Australia congratulates the Government on the progress in the consultations which promise to be a much-needed win for Australian innovation. The R&D Taskforce will continue to engage with the consultations and other harmonisation initiatives that improve access for patients and boosts Australia’s international competitiveness in clinical trials once and for all,” Ms de Somer commented.

The Commission has developed a survey to gather feedback from the research community on the minimum core SSA requirements by 11 March 2022.