Federal Members and patients tackle clinical trial reforms at BMS Summit

Pharma News: It is recognised that Australia’s medical research sector makes a significant contribution to the economy. For every $1 invested in medical research in Australia, $3.90 is returned to the broader economy. In addition, the sector employs more than 32,000 people directly, with a further 78,000 in the downstream medical technologies and pharmaceuticals sector.

Despite the significant health and economic benefits of Australian-based clinical trials, the local clinical trials environment is not internationally competitive. Australia is less competitive than emerging and established markets on clinical trial measures of timely and efficient trial start-up, cost and the capacity to recruit trial participants.

The Australian Commission on Safety and Quality in Healthcare, in partnership with the Clinical Trial Project Reference Group (CTPRG) submitted The National One Stop Shop Report recently – a full report and proof-of-concept web platform to the Australian Government as a possible solution to the issue of the current fragmented clinical trials approach. The goal of the platform is to simplify the processes for patients, researchers, industry and sponsors to find, conduct, participate and invest in high-quality, ethical research in Australia.

“There is an opportunity for Australia to build on its existing strengths in medical research and appeal as a destination for clinical trials by ensuring national harmonisation of key processes across states and territories,” said James McAdam, Associate Director, Government Affairs Policy and Advocacy, BMS Australia.

In support of the recent submission and in recognition of the invaluable role of patient experiences in informing policies and enhancing clinical trial delivery and governance, BMSA joined forces with the Parliamentary Friends of Medicines and Australian Health Research Alliance (AHRA) to host the Patient and Parliament Summit in Canberra from 6 – 7 November.

Co-chairs of the Parliamentary Friends of Medicines, Dr Mike Freelander MP and The Hon Dr David Gillespie MP hosted the lunch component of the Patient and Parliament Summit. Other attendees included Medicines Australia, Sharon Claydon MP – Deputy Speaker, Chair of Joint Select Committee on Parliamentary Standards, Dr Gordon Reid MP, Member for Robertson, Dr Anne Webster MP, Deputy Chair of Joint Standing Committee on Migration and Professor Chris Levi, immediate past chair of AHRA.

Ingrid Cook, Head of Clinical Operations, BMS ANZ, said “BMSA is committed to ensuring Australia continues to be a key destination for clinical trials. BMSA has a significant clinical trial footprint in Australia with more than 120 active clinical trials being conducted, and approximately 2,500 patients currently participating in clinical trials. With this comes a responsibility to ensure our federal policy environment and trial infrastructure stays innovative and optimises efficiencies.”

“If sponsors like BMSA run multi-site trials across more than one jurisdiction and/or between public and private institutions, the clinical teams are confronted with multiple and duplicative requirements for ethics approval, clinical governance approvals and site-specific authorisations which can lead to delays in access for patients. Efficiencies and harmonisation are what is needed to ensure we stay competitive as a country and remain a world class destination for clinical trials. BMSA fully endorses the ‘proof of concept’ platform designed by the Australian Commission on Safety and Quality in Healthcare.

“It is critical that the proposed changes outlined by the commission be implemented, and funding provided in the May 2023 Federal Budget to implement a single platform and mandate its use by states and territories to effectively harmonise the multiple portals currently in use,” said James McAdam.

The R&D Taskforce (RDTF), convened by Medicines Australia, AusBiotech and the Medical Technology Association of Australia (MTAA) also strongly supports the focus and investment in a One Stop Shop and National Clinical Trials Front Door as a significant step forward in making the necessary improvements to increase Australia’s global competitiveness in clinical trials.

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