Background/Aims: Populations in regional, rural, and socially disadvantaged areas continue to face persistent barriers to clinical trial participation. Decentralised Clinical Trials (DCTs) offer critical, flexible delivery approaches that reduce participant burden and improve recruitment and retention among diverse groups. However, in lieu of consolidated guidance from global regulators for routinely integrating DCT elements into standard practice, practical implementation has been hindered. To address this gap, a commercial sponsor sought to proactively integrate local DCT solutions into their own studies.
Methods: To operationalise this, the sponsor developed and embedded a dedicated DCT statement directly into a Phase 1, FDA and EMA approved commercial study protocol (ClinicalTrials.gov: NCT06188702). Recognising the value of this approach, the Clinical Oncology Society of Australia (COSA) facilitated extensive consultations with commercial sponsors, trial sites, researchers, and patients. Through these discussions, COSA evaluated the sponsor's statement as a standardised approach to integrate DCT methodologies across clinical trial protocols.
Results: Consequently, COSA adopted the sponsor-embedded DCT statement as their position statement. This inclusion provides clear, ready-to-use wording that sets expectations for embedding DCT components into study designs. The adopted statement retains necessary flexibility regarding the level of uptake and application, accommodating variations in specific trial designs, site capabilities, operational expertise, and compliance with local laws. This integration directly reinforces COSA’s foundational principle of equitable and inclusive engagement for all individuals, regardless of geography or background.
Conclusions: Embedding a standardised DCT statement as a COSA position statement is a practical and critical step toward addressing participation inequities and improving cancer outcomes. By leveraging a sponsor-initiated solution, this approach bypasses the lack of global regulatory guidance, supporting broader access and accelerating progress toward inclusive, patient-centred research. Importantly, the inclusion of this statement via the national template applies regardless of whether the protocol is commercially or academically driven.