Évaluation des dépenses du circuit des produits de santé dans le cadre d’études institutionnelles – Étude de cas au CHU de Toulouse

Abstract

Clinical research faces complex and unpredictable budgetary challenges, despite its central role in the development of healthcare products. This retrospective study examines the estimated and actual costs of 13 trials managed by the Clinical Trials Coordinating Pharmacy at the University Hospital of Toulouse. It aims to assess the accuracy of estimates, identify trial-influencing events and identify budget adjustment variables. The results show that only two of the 13 studies stay within their initial estimates, with most exceeding their projected margins. Costs vary by area, with shipping and packaging in particular exceeding the initial budget, while distribution costs are more accurately estimated. Several factors influence costs, including study duration, centre locations, number of enrolments, product stability and protocol amendments. Extending the study duration leads to increased costs in all areas, while reducing the number of inclusions tends to be in line with the original budget. In conclusion, budget management in clinical trials is complex due to numerous influencing variables. Careful planning and consideration of the specifics of each trial are crucial for more accurate estimates and budget adherence. This study enhances the understanding of the financial challenges faced by institutional sponsors of clinical trials and contributes to the refinement of budgeting methods for future clinical trials.