Capability evaluation of a large regional clinical trials unit to assess growth over time.
Authors: Bell Lisa Ann , Pitman Ethan , Goss Carmel , Clarke Ashleigh , Gurnett Rebecca , Murphy Virginia , Chong Geoffrey , Faisal Wasek 
Published: June 2023

e13671 Background: Participation in clinical trials is associated with better health outcomes, however prevalence of clinical trial participation among regional and rural patients are low, while simultaneously experiencing poorer health outcomes. Expanding capacity for clinical trials in regional locations increases accessibility for patients who live more remotely. The aim of this study is to describe the growth of a regional Australian clinical trials unit between 2014 and 2022, as part of a validation study of a recently published capability framework. Methods: Survey of Grampians Health Ballarat Clinical Trials unit across 2014 - 2022 was evaluated using a capability framework by Woollett et al. (2023) The framework uses a maturity model which allows a clinical trials unit capacity to be assessed by assigning a score (0-4) across several domains including trial infrastructure, leadership and culture, technology, skilled people, professional networks and collaborations and organisational support. A survey of the Grampians Health Ballarat Clinical Trials Unit was conducted to assign a score for each domain, and the average sum of scores used for an overall assessment; formative (0), developing (1), established (2), high performing (3), leading (4). The number of Principal Investigators (PI), opened trials and new participants recruited annually between 2014 – 2022 was obtained. Scatter plots, pairwise correlation and Bland Altman adjusted for trend were computed to show correlation and agreement between framework and number of PI and new trials opened per year. Results: Across all domains, Grampians Health Ballarat Clinical Trials unit was assessed as ‘established’ (average score 2.6) in 2014, compared to 2022 where the trials unit was considered ‘high performing’ (average score 3.4). Between 2014 and 2022 there was a tenfold increase in new patients recruited annually, n=8 and n=81, respectively. The only trial open in 2014 was investigator initiated, whereas in 2022 67% of trials were industry-sponsored trials. Oncology trials made up 82% of trials conducted, followed by gastroenterology (7%), cardiology (5%), infectious diseases (4%) and neurology (1%). investigators. There was one PI in 2014 compared to 18 in 2022. The framework correlated well with number of PI’s each year (r(7)=0.9 p=0.002) and number of trials opened each year (r(7)=0.8 p=0.015). Bland Altman adjusted for trend found 22% (2/9) outside limits of agreement for overall framework score and number of PI per year and 0% outside limits of agreement for overall framework score and new trials opened per year. Conclusions: This research is among the first to use a framework for outer metropolitan and rural areas to assess clinical trials unit capacity. The framework score correlated well with objective clinical trials data. Understanding the growth of a regional site may provide insight for developing clinical trials capacity in regional and rural areas.