Advancing equity in clinical trials through decentralized methodology: A national position statement.

Abstract

e23022 Background: Regional/Rural and socially disadvantaged populations continue to face persistent barriers to clinical trial participation. For research to truly improve health outcomes, equity must be central to the strategy. Decentralised Clinical Trials (DCTs) offer a critical solution by providing flexible delivery approaches that reduce participant burden, thereby improving recruitment and retention among diverse populations. However, a significant gap remains: while international agencies such as the FDA and EMA explicitly support these approaches, consolidated recommendations for routinely integrating DCT elements into study protocols, as a standard approach, are non-existent. Bridging this gap is essential to operationalise equity in research and healthcare. Methods: The Clinical Oncology Society of Australia (COSA), a peak national body representing multidisciplinary cancer care professionals, conducted extensive consultations with commercial sponsors, trial sites, researchers, and patients. These discussions informed of a national approach to integrate DCT methodology into all clinical trial protocols. COSA subsequently developed a position statement mandating inclusion of DCT options in trial design. Results: The position statement provides clear guidance and sets expectations for embedding components of a DCT in protocols. A set of wording that could be inserted into the protocol was also provided which was adapted from a phase 1, FDA and EMA approved commercial sponsor study ( ClinicalTrials.gov ID NCT06188702 ). The statement considers the need for flexibility in the level of uptake and application, based on the trial design, site capability, operational expertise, and compliance with local laws. It reinforces COSA’s foundational principle of equitable and inclusive engagement for all individuals, regardless of geography or background. Conclusions: Embedding DCT methodology into clinical trial protocols is critical to addressing participation inequities and improving cancer outcomes. COSA’s position statement establishes a national framework aligned with international best practice, supporting broader access and accelerating progress toward inclusive, patient-centered research. Importantly, the statement applies regardless of whether the protocol is commercially or academically driven.