Decentralised Clinical Trials: A Transformative Opportunity in Australia

Decentralised Clinical Trials (DCTs) are reshaping the clinical research landscape, offering a patient-centric approach that reduces barriers to participation while improving efficiency and data quality. In Australia, where vast geographic distances often hinder trial accessibility, the adoption of DCTs presents a compelling opportunity for innovation.

DCTs leverage technology to enable remote participation including:

• eScreening

• eRecruitment

• Direct to patient IP delivery

• eConsent

• Telehealth consultations

• Remote monitoring

• Use of ePRO, eCOA, eClinRO Technology

• Wearable devices for vitals in real time

For sponsors and sites, these tools help reduce operational burdens, streamline processes, and broaden access to diverse patient populations, including those in rural and remote areas.

Australia is well-positioned to embrace DCTs, with its robust healthcare infrastructure, tech-savvy population, and government commitment to advancing clinical research. Initiatives like the National Clinical Trials Governance Framework and continued investment in digital health create an environment conducive to integrating decentralised approaches.

However, implementing DCTs in Australia requires careful planning. Sponsors and sites must navigate regulatory requirements, data privacy concerns, and technology adoption challenges. Ensuring equitable access to DCT technologies is critical, as not all patients may have the necessary resources or digital literacy to participate remotely. Collaboration across stakeholders is essential to address these hurdles effectively.

For clinical trial sponsors, biotechs, and sites, transitioning to a decentralised model can:

• Accelerate patient recruitment

• Improve retention rates

• Improve operational efficiency

• Reduce costs and study burden

At our consultancy, we specialise in helping organisations navigate this shift. From protocol design to regulatory compliance and patient engagement strategies, we provide tailored solutions to ensure DCT success.

As the industry evolves, DCTs represent a paradigm shift toward more inclusive, efficient, and patient-friendly clinical research. By embracing decentralised approaches, Australia has the potential to solidify its position as a global leader in clinical trials, delivering innovative treatments to patients faster than ever before.