What is the issue:
Clinical trials are an essential step in the global efforts to discover and develop the new breakthrough medicines, vaccines and biotherapeutics. Despite having significant benefits for Australia, clinical trials are difficult to set up in Australia due to long start-up times, high costs, and fragmented systems between States and Territories.
Why is it important:
Clinical trials drive better healthcare outcomes for Australian patients, makes a significant contribution to the Australian economy and has benefits the broader healthcare system and medical research industry. The Federal and State Governments are currently working to improve Australia’s clinical trials environment by creating a nationally harmonised system known as the National One Stop Shop and National Clinical Trials Front Door.
Recommendations:
- The Federal, State and Territory Governments need to work with industry and clinical trial stakeholders to implement the One Stop Shop and Front Door recommendations with haste.
- The agreement to expand National Mutual Acceptance (NMA) for clinical trial ethics review and approvals to include private institutions and not only public institutions should be finalised.
- The following recommendations from the House of Representative ‘Inquiry into approval processes for new drugs and novel medical technologies in Australia’ should be implemented:
- Recommendation 23: All levels of government should provide funding for a national clinical trials register
- Recommendation 24: The Australian Government should develop policies that encourage modernising digital technologies and practices to position Australia as the premier destination for international clinical trials
- Recommendation 25: The Australian Government should develop a national standard approach to strengthen the capacity to conduct clinical tele-trials in rural, regional and remote areas
- The Federal Government should work with industry and clinical trial stakeholders to develop and implement a mutually agreed and coordinated National 10-year Plan will allow Australia to become a global hub for clinical trials into the future.
Background
Despite the significant health and economic benefits of Australian-based clinical trials, the clinical trials environment in Australia 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. Delivering a multi-centre trial in Australia across state and territory borders continues to involve significant duplication of effort, complexity and inconsistency in approach with variable and unreliable return on contracted participant numbers.
If successfully implemented, the One Stop Shop and the Front Door will address these barriers through a national, interconnected, streamlined approvals platform will include a cross-jurisdictional ethics and governance approvals platform that incorporates key application, notification, and approval systems.
Additional References
HOR Inquiry into Access to new drugs and novel medical technologies 2021 report: https://www.aph.gov.au/ Parliamentary_Business/Committees/House/Health_Aged_Care_and_Sport/Newdrugs/Report