Pediatric Clinical Research Center, Queen Silvia Children's Hospital, Sahlgrenska University Hospital, Gothenburg, Sweden.
Department of Pediatric Oncology, Sahlgrenska University Hospital, Gothenburg, Sweden.
Acta Paediatr. 2023 Sep;112(9):1982-1985. doi: 10.1111/apa.16808. Epub 2023 May 10.
Clinical trials and the need for new treatments were recently listed among the most important factors for child health. The aim of the present study was to describe some of our experiences with budget preparations in paediatric clinical trials.
We selected 10 trials sponsored by the pharmaceutical industry at the Pediatric Clinical Research Center at Sahlgrenska University Hospital in Gothenburg, Sweden. We compared the sponsor's initial budget (budget proposal from the sponsor), with the final budget (negotiated and agreed between sponsor and site) and identified areas where discrepancies may arise.
The mean difference in total budget amount between the initial budget and the final budget was +60% (mean 59%, range 31%-139%). The costs for preparation of the clinical trial, time spent for study activities and costs for examinations were identified as key budget items for these differences.
Our findings indicate that a substantial part of the trial-related costs would not be covered by the sponsor, had the initial budget been accepted. A thorough review and budget negotiation, as well as to have a dedicated team member for this task, are essential to ensure equitable responsibility for the study-related costs and to avoid discontinuation of trials.
临床试验和新疗法的需求最近被列为儿童健康最重要的因素之一。本研究旨在描述我们在儿科临床试验预算编制方面的一些经验。
我们选择了瑞典哥德堡萨尔格伦斯卡大学医院儿科临床研究中心由制药业赞助的 10 项试验。我们比较了赞助商的初始预算（赞助商的预算提案）与最终预算（赞助商和研究点之间协商和商定），并确定了可能出现差异的领域。
初始预算和最终预算之间的总预算金额差异平均值为+60%（平均 59%，范围 31%-139%）。临床试验准备、研究活动所花费的时间以及检查费用被确定为这些差异的关键预算项目。
我们的研究结果表明，如果接受初始预算，试验相关费用的很大一部分将不会由赞助商承担。彻底的审查和预算谈判，以及专门为此任务的团队成员，对于确保研究相关费用的公平责任和避免试验中止至关重要。
