Retrospective assessment of resource use and costs in two investigator-initiated randomized trials exemplified a comprehensive cost item list.
Retrospective assessment of resource use and costs in two investigator-initiated randomized trials exemplified a comprehensive cost item list.
复制标题
在两项研究者发起的随机试验中对资源使用和成本的回顾性评估例证了全面的成本项目清单。
DOI：
10.1016/j.jclinepi.2017.12.022
复制
发表时间：
2017
影响因子：
7.2
通讯作者：
M. Briel
中科院分区：
文献类型：
--
作者：
B. Speich;Belinda von Niederhäusern;C. Blum;J. Keiser;N. Schur;Thomas Fürst;B. Kasenda;M. Christ;L. Hemkens;C. Pauli;M. Schwenkglenks;M. Briel
目的随机临床试验（RCT）是昂贵的，其进行的资源需求的公开信息是有限的。为了确定使随机对照试验更具可持续性的关键因素，需要关于资源使用和相关成本的经验数据。我们的目的是回顾性评估资源的使用和详细的成本，两个学术，制药商发起的随机对照试验，使用一个全面的列表costites.Study设计和SettingThe资源使用的两个制药商发起的随机对照试验（泼尼松试验[NCT 00973154]和Oxantel试验[ISRCTN 54577342]）进行了经验性评估，在一个标准化的方式，通过半结构化的访谈和系统开发的成本项目列表。利用关于年薪的信息，将资源使用转化为成本。此外，我们收集了所有“其他成本”，包括固定价格的项目。总体成本以及不同研究阶段的成本进行了计算。ResultsThe人员时间用于泼尼松试验试验约为2,897个工作日，总成本计算为230万美元，这是70万美元以上的计划。在Oxantel试验中，花费了798个工作日，总费用按原计划为100，000美元。两个随机对照试验与招聘延迟解释额外的费用Prednisone-Trial.ConclusionThis案例研究提供了一个例子，如何透明地评估资源和成本的随机对照试验，并提出了详细的经验数据的类型和规模的费用。在未来，这种模式的方法可能会服务于其他人计划，评估，或监测资源使用和成本的随机对照试验。
ObjectivesRandomized 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.Study Design and SettingThe 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.ResultsThe 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.ConclusionThis 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.