Capacity building at an Australian regional clinical trials unit: determinants of growth and correlation with a capability framework

Expanding the capacity for clinical trials in regional/nonmetropolitan locations will increase accessibility for patients who live remotely, however there are limited studies on the growth of regional clinical trials units over time. This study aims to explore the status of the growth of a regional Australian clinical trial unit between 2011 and 2022, utilising a recently published clinical trial capability framework. An evaluation of a regional clinical trial unit in Victoria, Australia, between 2011 and 2022 was conducted to objectively describe growth, including the number of trials, number of patients and number of principal investigators (PIs). We used an objective capability framework published by Woollett et al. (2023). The framework uses a maturity model applied across several domains. Descriptive statistics are reported as totals and means. Scatter plots, pairwise correlations and Bland–Altman adjustments for trends were computed to show correlations and agreements between the framework average score and objective measures of the clinical trials between 2011 and 2022. The number of clinical trials active in 2011 and 2022 were n = 4 and n = 70, respectively. Across all domains, the Grampians Health Clinical Trials Unit was assessed as ‘established’ in 2011, whereas the trial unit was considered ‘high performing’ in 2022. The framework capability score correlated well with the number of PIs per year (r (10) = 0.9, p < 0.001), the number of open trials per year (r (10) = 0.9, p < 0.001), and the number of patients (r (10) = 0.8, p < 0.001). The key contributors to growth identified were organisational support and infrastructure. Growth was largely driven by oncology trials. Significant growth was observed for a regional clinical trial unit across a decade. The framework score strongly correlated with objective clinical trial data. Understanding the growth of clinical trial units in nonmetropolitan areas is essential for developing the capacity of clinical trials in regional and rural areas.