Decentralised Clinical Trials SOPs

Cancer Decentralised Clinical Trial (DCT) Methodology

Clinical trials are essential to improving outcomes for patients with cancer. Opportunities for participation in clinical trials across Aotearoa New Zealand are inequitable, particularly for whānau living outside of major centres and for Māori and Pasifika. The implementation of decentralised clinical trials aims to increase access to clinical trials for people with cancer living across Aotearoa New Zealand. In the decentralised clinical trial model the primary trial site(s) work collaboratively with sites in smaller centres and rural areas (satellite sites) to enrol, consent and treat patients for the trial. Decentralised clinical trials essentially aim to increase access to clinical trials by decentralising the processes of a clinical trial. This can include consent, randomisation, delivery of investigational products, trial activity, data entry and potentially trial monitoring. Decentralised clinical trials give patients and whānau the opportunity to participate in clinical trials without the requirement for travel, which comes at a financial cost to both patients and the healthcare system. It also allows patients to continue to receive care locally (which can be in person), without removing them from their whānau and support systems. This makes trials more inclusive, accessible and whānau-centred.