As the fight against cancer continues, early-phase clinical trials are crucial frontiers in advancing treatment and therapy. Australia has emerged as a global leader in early-phase oncology trials, offering a unique combination of scientific expertise, regulatory efficiency, high-quality research infrastructure, and cost-effective opportunities. If you plan to conduct phase 1/2 cancer trials in Australia, here are some essential considerations and practical tips for success.

Leverage Australia's regulatory framework

Australia's regulatory environment provides distinct advantages for early-phase trials. The Clinical Trial Notification (CTN) scheme, administered by the Therapeutic Goods Administration (TGA), enables a streamlined regulatory process that can accelerate study startup compared to other regions. Key advantages include:

• Almost all clinical trials require a simple notification to the TGA which takes less than 10 days to process
• A full IND (Investigational New Drug) style application is rarely required
• The responsibility for scientific and ethical review of a clinical trial sits with a Human Research Ethics Committee (HREC)
• There is mutual recognition in place across many jurisdictions so that 1-2 submissions to individual HRECs may be required for a multi-site trial
• There is acceptance of Good Manufacturing Practice (GMP) ‘like’ products  for first in human trials

Engaging early with a lead site for submission to a Human Research Ethics Committee (HREC) is crucial to maximise these benefits. Focus on thoroughly preparing core trial documents of protocol, investigators’ brochure, participant information and consent forms at this stage.

Know your infrastructure and personnel requirements

When selecting a site for early-phase cancer trials in Australia, it's important to recognize that infrastructure and personnel are inseparable. Sites are not just physical locations—they come with dedicated, highly skilled medical professionals essential for trial success. Key factors to consider, include:

• Modern facilities in public and private hospital settings: There are many purpose-built oncology clinics around Australia with access to the emergency facilities necessary for first-in-human dosing and pharmacokinetic (PK) sampling. In addition, there are purpose-built phase 1 clinical trial units some of which conduct phase 1 cancer trials.
• Integrated research teams: Select oncologists experienced in clinical trial implementation and supported by dedicated study coordinators. Specialized nursing staff and pharmacists familiar with complex dosing protocols are critical to ensuring smooth trial execution and patient safety.

Choosing a site with the right infrastructure and a multidisciplinary team will ensure your trial is set up for success from day one.

Optimize your trial design

To ensure your early-phase cancer trial in Australia is both scientifically rigorous and operationally feasible, your protocol must be designed to answer the key questions and recruit and retain the required number of patients in a timely manner. Here are some key considerations:

• Incorporate adaptive trial designs: Design your protocol with adaptive elements that allow real-time modifications based on accumulating data. This can help minimize patient exposure to subtherapeutic doses and accelerate the identification of optimal dosing regimens. Ensure these designs include robust safety monitoring frameworks and clearly defined decision-making criteria to align with Australia's regulatory expectations.
• Plan for geographic dispersal: Factor in Australia’s vast geography by integrating flexible visit schedules and telehealth options to accommodate patients from regional areas. Satellite sites, home nursing and local lab sample collection can facilitate the inclusion and retention of cancer patients in long-term clinical trials from their homes.
• Define clear operational processes: Establish cohort management and decision-making strategies, stopping rules, and adverse event reporting protocols to maintain patient safety and data integrity. A comprehensive data management strategy will maximize the efficiency of Australia’s clinical trial infrastructure.

Implement strategic patient recruitment practices

The success of your early-phase cancer trials in Australia relies on sophisticated recruitment and retention strategies that leverage the country's established healthcare networks. For example, major cancer centers provide a robust referral framework, while partnerships with patient advocacy groups and clinical trial registries enable precise patient matching and enhanced trial visibility. You can also integrate genetic and molecular screening programs to further streamline the identification of suitable candidates, creating an efficient pathway from identification to enrollment.

Maximize your trial budget

Financial planning for early-phase cancer trials in Australia requires careful consideration of various factors that can impact overall trial costs. When comparing costs with other regions, sponsors often find that Australia's per-patient costs are competitive, particularly when considering the high quality of data generated, the efficiency of trial execution and the R&D tax incentive program on offer.

Partnerships with local CROs can provide access to additional resources and expert knowledge of the Australian clinical trial landscape. Their established relationships with sites often translate to more competitive pricing and streamlined processes. At the same time, their deep understanding of local clinical trial costs will help you develop realistic budgets that account for Australia-specific factors and avoid costly delays and amendments down the line.

Conducting early-phase cancer trials in Australia offers unique advantages that can significantly enhance the probability of trial success. The combination of regulatory efficiency, high-quality infrastructure and skilled personnel makes Australia an attractive destination for early-phase oncology research. By carefully considering these elements and leveraging local expertise and resources, you can optimize your trial execution while maintaining the highest standard of patient care and scientific excellence.

If you want to learn more about working within the Australian clinical landscape with a research team who are professional, dedicated and committed to safe and scientifically sound studies, get in touch with us today.

Southern Star Research is a full-service Australian Contract Research Organization. We help sponsors run safe and efficient trials that meet regulatory requirements, ensure scientific excellence, and demonstrate the commercial viability of your product. If you're looking for an agile and dedicated team to help you run a successful trial, contact us today.