Process of development of decentralised clinical trial methodology for cancer clinical trials in Aotearoa New Zealand.

Abstract

Aim: To develop processes for the development of decentralised clinical trial methodology for Aotearoa New Zealand, focussing on equity of access to cancer clinical trials for Māori, Pacific people, vulnerable communities and those in rural settings.

Methods: A national steering committee supported by Te Aho o Te Kahu - Cancer Control Agency was formed to: guide the adaptation and implementation of overseas decentralised clinical trial models to suit the needs of Aotearoa New Zealand with an equity focus; provide high-level oversight and expertise for direction and development of policies, procedures and infrastructure compliant with ICH GCP R2; and implement a national strategy.

Results: Twelve standard operating procedures were developed, as well as a supervision plan and a glossary. These were made freely available on the New Zealand Association of Clinical Research website.

Conclusion: Decentralised clinical trials offer a novel method of trial conduct that is patient- and whānau-centred. The model allows patients to remain in their local area with whānau and support networks, and their local treating team, increasing clinical trial accessibility and quality of care. This methodology has the potential to support improvement in research capabilities nationally and be utilised beyond oncology. It would benefit from significant investment in national clinical trial infrastructure.