Decentralised clinical trials (DCTs) represent a paradigm shift in clinical research,1 offering flexibility and accessibility while ensuring regulatory compliance. The COVID-19 pandemic accelerated the rapid uptake of digital processes to maintain clinical trial activity, validating long-standing advocacy efforts. The Kinghorn Cancer Centre trials unit at St Vincent's Hospital Sydney adapted to function as a decentralised clinical trial (DCT) unit, and in the process, enhanced our ability to offer more equity in access to trials for rural, regional and remote populations. We will highlight the operational setup, challenges and successes associated with this experience.
DCT set up
To establish remote capabilities, we leverage digital technologies for trial start-up, document management, electronic signatures, remote consent processes and virtual visits. Collaboration with Health Research Ethics Committees (HRECs) and Regulatory and Governance Offices (RGOs) ensures compliance across regulatory landscapes.
DCT challenges
Challenges emerge from differing regulatory requirements and interpretations between states, local health districts and ethical and regulatory committees. Clear communication and alignment among all parties, including sponsors, contract research organisations, and regulatory bodies are crucial to navigate these complexities and support novel trial methodologies.
DCT successes
Despite challenges, our transition yielded substantial successes. Since 2019, the clinical trial unit not only sustained operations but also expanded significantly. We secured HREC approval as the lead site for 104 new trials, predominantly phase 1, and RGO approval for 249 new trials. Conducting regulatory processes entirely remotely facilitated efficient trial management and continued knowledge sharing.
Summary
While DCTs pose regulatory challenges, their implementation with digital innovations significantly enhances trial efficiency and patient-centricity. Continuous collaboration among stakeholders and ongoing dialogue with regulatory authorities are essential to overcome barriers and promote decentralised approaches in clinical research effectively. This experience underscores the transformative potential of DCTs in advancing equitable access to innovative therapies across diverse patient populations.