Poster Presentation Clinical Oncology Society of Australia Annual Scientific Meeting 2026

Quantifying pharmacy service resource requirements in clinical trials: Pilot study of a novel complexity model (145885)

Geetha Mathew 1 , William Chong 1 , Amy Prawira 2 , Ian Fong 1 , Jessica van Schreven 1 , Declan Gibney 1
  1. Pharmacy Department, Prince of Wales Hospital & Royal Hospital for Women, SESLHD, NSW Health, Randwick, NSW, Australia
  2. Cancer Trials and Research Unit , SESLHD, NSW Health, Randwick, NSW, Australia

Background:
Advances in novel therapeutics have increased clinical trials’ complexity1 and pharmaceutical handling requirements, placing growing operational demands on resource-constrained public hospitals. This highlights the need to adequately quantify clinical trials pharmacy resource requirements, to ensure service sustainability.
Aim:
To implement a novel clinical trial complexity model and assess its feasibility in an Australian public hospital clinical trial pharmacy service by evaluating (1) inter-rater reliability of complexity scoring, and (2) the model's ability to differentiate trial complexity.
Methods:
A Pharmacy Clinical Trial Complexity Model was developed by integrating protocol-specific variables into a standardized scoring system2,3. To assess its feasibility, a structured tool on Microsoft Excel was developed to assess 25 parameters across four primary domains: Study Design, Investigational Product, Storage & Supply, and Dispensing. Each parameter was scored on a 0–3 scale. 25 trials were independently rated by two clinical trials pharmacists, and an average score was used to categorize trial complexity. Inter-rater reliability was evaluated using intraclass correlation coefficient (ICC)4.
Results:
The model demonstrated excellent inter-rater reliability for both consistency and absolute agreement ICC(3,1)=0.955 (95% CI [0.901, 0.980], p<0.001), and classified trials into three complexity categories based on total complexity score: low (≤15), moderate (>15 to <30), and high (≥30). Oncology trials (n=16) exhibited a substantially wider range of complexity scores than other therapeutic areas, spanning both the lowest and highest scores observed in the dataset (4.0–57.5 versus 4.5–35.5), reflecting the diverse operational demands of oncology trials.
Conclusion:
This model demonstrated excellent inter-rater reliability and was feasible to implement in a public hospital clinical trial pharmacy service in our pilot study. Further internal and external validation with larger sample sizes is needed to determine whether the model correlates with pharmacy workload, resource utilization, and trial costing, and can help standardize clinical trials workforce and costing metrics within the Australian healthcare system.

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  2. Calvin-Lamas M, Pita-Fernandez S, Pertega-Diaz S, Rabunal-Alvarez MT, Martín-Herranz I. A complexity scale for clinical trials from the perspective of a pharmacy service. Eur J Hosp Pharm. 2018 Sep;25(5):251-256.
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