Beyond the protocol: navigating ethics and governance in the multicentre implementation trials – the QASC Australasia and T3 Trials

OBJECTIVE: To describe and compare ethics and governance approval timelines for the Quality in Acute Stroke Care (QASC) Australasia Trial (2021-present) and Triage, Treatment, and Transfer of Patients with Stroke in Emergency Departments (T3) Trial (2012-2014), benchmarking against national and international targets. METHODS: Retrospective, descriptive analysis of approval timelines for ethics, Site-Specific Assessment (SSA), Clinical Trials Research Agreements (CTRA), and Public Health Act (PHA) application (Queensland hospitals). RESULTS: The QASC Australasia Trial involved 52 Australian and 8 New Zealand hospitals. In Australia, lead ethics approval took 30 days. SSA approvals took a median of 91 days (interquartile range (IQR) 52-144). CTRA execution required a median of 56 days (IQR 38-105). PHA approval was required at 10 sites, with a median of 34 days (IQR 29-52). In New Zealand, ethics approval took 53 days. SSA approvals and CTRA execution took medians of 121 days (IQR 73-152) and 133 days (IQR 84-146), respectively. The T3 Trial involved 26 Australian hospitals. Lead ethics approval took 76 days. SSA approvals (n = 22) took a median of 132 days (IQR 106-175). Since the T3 Trial, Australian lead ethics approval times decreased by 61% and SSA approvals decreased by 31%. Only 33% of Australian QASC Australasia Trial and 5% of T3 Trial SSA approvals met the 60-day national benchmark. CONCLUSIONS: Multicentre trial governance processes remain lengthy, particularly for New Zealand. CTRA and jurisdiction requirements delayed SSA approval. Streamlined processes are needed to optimise resources and accelerate evidence translation.