Lessons learned: Infrastructure development and financial management for large, publicly funded, international trials.
Lessons learned: Infrastructure development and financial management for large, publicly funded, international trials.
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DOI：
10.1177/1740774515625974
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发表时间：
2016-04
期刊：
影响因子：
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通讯作者：
INSIGHT Group
中科院分区：
文献类型：
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作者：
Larson GS;Carey C;Grarup J;Hudson F;Sachi K;Vjecha MJ;Gordin F;INSIGHT Group
随机临床试验被广泛认为是解决全球临床和公共卫生研究问题的关键。然而，在许多情况下，其规模和持续时间可能超过现有的公共和私人资源。为了在国际研究环境中保持竞争力，临床试验的倡导者和从业者必须实施降低成本的做法。我们确定了大型公共资助的国际试验的方法和实践，这些方法和实践在不影响数据完整性的情况下降低了成本，并推荐了一种允许临床试验比较的成本报告方法。我们描述了INSIGHT的组织和财务特征，INSIGHT是一个传染病研究网络，进行多个，大型，长期的国际试验，并研究与简单和精简的治理以及基于绩效，透明度和问责制的基础设施和财务管理模式相关的挑战。可以降低受试者随访的成本，而不会影响临床试验的质量或完整性。INSIGHT网络成功地完成了四项大型艾滋病毒试验，采用了具有成本效益的做法，这些做法没有对研究者的热情、增加率、失访、遵守方案和完成数据收集产生不利影响。这一经验对于在其他疾病领域开展大型的、由医疗机构资助的试验，特别是依赖于国际合作的试验，具有相关意义。新的方法，或对传统临床试验基础设施和财务管理工具的创造性调整，可以通过强调结构简单性，使大型国际临床试验更具成本效益;最小的前期成本;按绩效付费;统一的算法和服务费，而不受地点的影响。然而，挑战依然存在。它们包括对金融变革的机构阻力，日益增长的试验复杂性，以及缺乏稳定研究工作的网络基础设施难以维持。还需要更多的中央监测，改进和统一法规，以及广泛应用的衡量和比较临床试验成本效益的指标。建议将ClinicalTrials.gov作为公开提供标准化审判费用信息的网址。
Randomized clinical trials are widely recognized as essential to address world-wide clinical and public health research questions. However, for many conditions, their size and duration can overwhelm available public and private resources. To remain competitive in international research settings, advocates and practitioners of clinical trials must implement practices that reduce their cost. We identify approaches and practices for large, publicly-funded, international trials that reduce cost without compromising data integrity, and recommend an approach to cost reporting that permits comparison of clinical trials. We describe the organizational and financial characteristics of INSIGHT, an infectious disease research network that conducts multiple, large, long-term, international trials, and examine challenges associated with simple and streamlined governance and an infrastructure and financial management model that is based on performance, transparency, and accountability. It is possible to reduce costs of participant follow-up and not compromise clinical trial quality or integrity. The INSIGHT network has successfully completed four large HIV trials using cost-efficient practices that have not adversely affected investigator enthusiasm, accrual rates, loss-to-follow-up, adherence to the protocol, and completion of data collection. This experience is relevant to the conduct of large, publically funded trials in other disease areas, particularly trials dependent on international collaborations. New approaches, or creative adaption of traditional clinical trial infrastructure and financial management tools, can render large, international clinical trials more cost-efficient by emphasizing structural simplicity; minimal up-front costs; payments for performance; and uniform algorithms and fees-for-service, irrespective of location. However, challenges remain. They include institutional resistance to financial change, growing trial complexity, and the difficulty of sustaining network infrastructure absent stable research work. There is also a need for more central monitoring, improved and harmonized regulations, and a widely-applied metric for measuring and comparing cost efficiency in clinical trials. ClinicalTrials.gov is recommended as a location where standardized trial cost information could be made publicly accessible.