Key cost drivers of pharmaceutical clinical trials in the United States
Key cost drivers of pharmaceutical clinical trials in the United States
复制标题
DOI：
10.1177/1740774515625964
复制
发表时间：
2016-04-01
期刊：
影响因子：
2.7
通讯作者：
Beleche, Trinidad
中科院分区：
文献类型：
--
作者：
Sertkaya, Aylin;Wong, Hui-Hsing;Beleche, Trinidad
背景资料：临床研究成本的增加对公共卫生产生了重大影响，因为它影响了制药公司进行临床试验的意愿，这反过来又限制了患者获得新的治疗方法。因此，更好地了解美国临床研究的主要成本驱动因素是很重要的。目的：这项研究是基于东方研究集团公司编写的一份报告，为美国卫生与公众服务部，检查不同的因素，如治疗领域，病人招募，行政人员，和临床程序的开支，以及他们的贡献，在美国的药物临床试验成本的临床试验phase.Methods：该研究使用的汇总数据从三个专有数据库的临床试验成本提供的Medidata解决方案。我们通过汇总详细的（每个患者和每个站点）成本信息来评估各个治疗领域的每个研究成本。我们还比较了使用加权平均值和标准差statistics.Results：治疗领域的成本驱动因素的平均支出是一个重要的决定因素，临床试验成本的阶段。在美国研究中心进行的I期研究的平均成本范围为140万美元（疼痛和麻醉）至660万美元（免疫调节），包括估计的研究中心管理费用和申办组织的监查费用。2期研究的平均成本从700万美元（心血管）到1960万美元（血液学），而3期研究的平均成本从1150万美元（皮肤科）到5290万美元（疼痛和麻醉）。在所有研究阶段，不包括估计的研究中心管理费用和申办者监查研究的费用，临床试验支出的前三大成本驱动因素是临床程序成本（占总数的15%-22%），行政人员费用（占总数的11%-29%），以及现场监测费用（占总数的9%-14%）。局限性：数据来自2004年至2012年，未根据通货膨胀进行调整。此外，所使用的数据库代表了一种方便，即非概率抽样，无法对成本动因进行统计上有效的估计。最后，这些数据仅来自全球制药和生物技术行业资助的试验。因此，我们的研究结果仅限于该segment.Conclusion：正在研究的治疗领域以及所涉及的临床程序的数量和类型是1期至3期研究中直接成本的关键驱动因素。研究表明，存在降低其中一些主要直接成本组成部分的价格的战略。因此，为了提高临床试验效率并降低成本，更好地了解关键的直接成本驱动因素是重要的一步。
Background: The increasing cost of clinical research has significant implications for public health, as it affects drug companies' willingness to undertake clinical trials, which in turn limits patient access to novel treatments. Thus, gaining a better understanding of the key cost drivers of clinical research in the United States is important.Purpose: The study which is based on a report prepared by Eastern Research Group, Inc., for the US Department of Health and Human Services, examined different factors, such as therapeutic area, patient recruitment, administrative staff, and clinical procedure expenditures, and their contribution to pharmaceutical clinical trial costs in the United States by clinical trial phase.Methods: The study used aggregate data from three proprietary databases on clinical trial costs provided by Medidata Solutions. We evaluated per-study costs across therapeutic areas by aggregating detailed (per patient and per site) cost information. We also compared average expenditures on cost drivers with the use of weighted mean and standard deviation statistics.Results: Therapeutic area was an important determinant of clinical trial costs by phase. The average cost of a Phase 1 study conducted at a US site ranged from US$1.4million (pain and anesthesia) to US$6.6million (immunomodulation), including estimated site overhead and monitoring costs of the sponsoring organization. A Phase 2 study cost from US$7.0million (cardiovascular) to US$19.6million (hematology), whereas a Phase 3 study cost ranged from US$11.5million (dermatology) to US$52.9 (pain and anesthesia) on average. Across all study phases and excluding estimated site overhead costs and costs for sponsors to monitor the study, the top three cost drivers of clinical trial expenditures were clinical procedure costs (15%-22% of total), administrative staff costs (11%-29% of total), and site monitoring costs (9%-14% of total).Limitations: The data were from 2004 through 2012 and were not adjusted for inflation. Additionally, the databases used represented a convenience, that is, non-probability, sample and did not allow for statistically valid estimates of cost drivers. Finally, the data were from trials funded by the global pharmaceutical and biotechnology industry only. Hence, our study findings are limited to that segment.Conclusion: Therapeutic area being studied as well as number and types of clinical procedures involved were the key drivers of direct costs in Phase 1 through Phase 3 studies. Research shows that strategies exist for reducing the price tag of some of these major direct cost components. Therefore, to increase clinical trial efficiency and reduce costs, gaining a better understanding of the key direct cost drivers is an important step.