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Why you should consider Australia for clinical trials
A
ustralia is recognised globally as a leader in clinical trials for its streamlined, cost-effective processes and
its commitment to high-quality standards. With efficient regulatory systems, supportive government incentives, and compliance with internationally accepted data governance, Australia is the ideal choice for companies looking to accelerate their clinical development.
Fast and flexible regulatory system Australia’s regulatory framework is internationally praised for its efficiency. Australia does not require an Investigational New Drug (IND) application that can delay trial initiation, and routinely utilizes a local ethics-based approval process. This often enables the first participant to be recruited within 12 weeks, compared to the six to nine months typically needed in other significant markets.
Competitive costs and financial incentives The Research and Development (R&D) Tax Incentive offers generous rebates of up to 43.5% on eligible clinical trial expenses and lower overall operational costs than many Western markets, allowing sponsors to conduct trials on a more modest budget without compromising quality.
Globally recognised data standards Clinical trials in Australia adhere to the International Council for Harmonisation Good Clinical Practice (ICH-GCP) standards, ensuring that the data collected is accepted by regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Australia’s strong intellectual property laws also provide robust protection for sponsors’ innovations and investments.
The Australian Teletrial Model Only 12% of clinical trial sites are in non- metropolitan areas, but the Australasian Teletrial Model (ICH-GCP approved) promotes diversity in recruitment by connecting regional sites with clinical trial primary sites in urban and city areas
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through Regional Clinical Trial Coordinating Centres (RCCCs) in the Northern Territory, Queensland, South Australia, Western Australia and Tasmania. Over 1,000 participants have already accessed
treatments via a Teletrial, with 85% living in rural or remote areas that have never run clinical trials before. The model has moved outside of oncology, with nearly 50% of teletrials running in other medical speciality areas. The National Teletrials Compendium, endorsed
by all Australian states, provides a unified framework for these initiatives. It ensures that teletrials meet the same rigorous standards as traditional models, instilling confidence in sponsors regarding the quality and reliability of the data generated.
Rural Clinical Trial Program The Rural, Regional, and Remote Clinical Trial Enabling Program funded by the Australian Government Medical Research Future Fund is strengthening infrastructure across New South Wales (NSW) health services and leveraging local healthcare providers to ensure equitable trial access for rural populations. This approach works for trials related to chronic and rare diseases, where recruitment can be challenging due to dispersed patient populations. Three Clinical Trial Support Units were established in the Northern, Western and Southern areas of NSW and the ACT. Already 20 new clinical trials are underway and have recruited 168 clinical trial participants.
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