Beyond the protocol: navigating ethics and governance in the multicentre implementation trials - the QASC Australasia...

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.

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).

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.

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.