Basel Institute for Clinical Epidemiology and Biostatistics, Department of Clinical Research, University of Basel and University Hospital Basel, Basel, Switzerland.
Clinical Trial Unit, Department of Clinical Research, University of Basel and University Hospital Basel, Basel, Switzerland.
J Clin Epidemiol. 2018 Apr;96:73-83. doi: 10.1016/j.jclinepi.2017.12.022. Epub 2017 Dec 30.
Randomized clinical trials (RCTs) are costly and published information on resource requirements for their conduct is limited. To identify key factors for making RCTs more sustainable, empirical data on resource use and associated costs are needed. We aimed to retrospectively assess resource use and detailed costs of two academic, investigator-initiated RCTs using a comprehensive list of cost items.
The resource use of two investigator-initiated RCTs (Prednisone-Trial [NCT00973154] and Oxantel-Trial [ISRCTN54577342]) was empirically assessed in a standardized manner through semistructured interviews and a systematically developed cost item list. Using information about yearly salaries, resource use was translated into costs. In addition, we collected all "other costs" including fixed priced items. Overall costs as well as cost of different study phases were calculated.
The personnel time used in the Prednisone-Trial trial was approximately 2,897 working days and the overall costs were calculated to be USD 2.3 million, which was USD 700,000 more than planned. In the Oxantel-Trial 798 working days were spent and the overall costs were as originally planned USD 100,000. Cost drivers were similar between the two RCTs with recruitment delays explaining the additional costs in the Prednisone-Trial.
This case study provides an example of how to transparently assess resources and costs of RCTs and presents detailed empirical data on type and magnitude of expenses. In the future, this model approach may serve others to plan, assess, or monitor resource use and costs of RCTs.
随机对照试验（RCT）成本高昂，有关其实施资源需求的已发表信息有限。为了确定使 RCT 更具可持续性的关键因素，需要有关于资源使用和相关成本的经验数据。我们旨在使用全面的成本项目清单，回顾性评估两项学术性、研究者发起的 RCT 的资源使用情况和详细成本。
通过半结构化访谈和系统开发的成本项目清单，以标准化方式对两项研究者发起的 RCT（泼尼松试验[ISRCTN54577342]和奥硝唑试验）的资源使用情况进行了实证评估。利用有关年薪的信息，将资源使用转化为成本。此外，我们收集了所有“其他成本”，包括固定价格项目。计算了总体成本以及不同研究阶段的成本。
泼尼松试验中使用的人员时间约为 2897 个工作日，总费用计算为 230 万美元，比计划多出 70 万美元。奥硝唑试验中花费了 798 个工作日，总费用与原计划的 10 万美元相符。两项 RCT 之间的成本驱动因素相似，招募延迟解释了泼尼松试验中额外成本的原因。
本案例研究提供了一个如何透明地评估 RCT 资源和成本的示例，并提供了有关费用类型和规模的详细经验数据。未来，这种模型方法可能有助于其他人规划、评估或监测 RCT 的资源使用和成本。
