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.
摘要：
临床研究面临复杂和不可预测的预算挑战，尽管它在医疗保健产品的开发中起着核心作用。这项回顾性研究调查了图卢兹大学医院临床试验协调药房管理的13项试验的估计和实际成本。它旨在评估估计的准确性，确定影响试验的事件并确定预算调整变量。结果表明，13项研究中只有两项保持在最初的估计范围内，大部分超出了他们的预计利润率。成本因地区而异，特别是运输和包装超出了最初的预算，而分销成本的估计更准确。影响成本的几个因素，包括研究持续时间，中心位置,报名人数,产品稳定性和协议修订。延长研究时间会导致所有领域的成本增加，而减少夹杂物的数量往往与原始预算相符。总之,由于影响变量众多，临床试验中的预算管理非常复杂。仔细计划和考虑每个试验的细节对于更准确的估计和预算遵守至关重要。这项研究增强了对临床试验机构赞助者面临的财务挑战的理解，并有助于完善未来临床试验的预算方法。
