F. Collecting Cost Data in Clinical Studies. F.收集临床研究成本数据

The validity of a cost-related study depends on the sources of the data for costs and outcomes. 成本相关研究的有效度取决于成本和成果数据的来源。Increased attention is being given to collection of cost data in more rigorous, prospective studies. 更严格的前瞻性研究越来越关注收集成本数据。The closer integration of economic and clinical studies raises important methodological issues. 经济和临床研究的紧密结合提出了重要的方法问题。In order to promote more informed resource allocation for new technologies, it would be desirable to generate reliable cost and outcomes data during the early part of a technology's lifecycle, such as during RCTs required for seeking regulatory approval for marketing. 为了促进新技术的资源分配，在技术生命周期的早期阶段，产生可靠的成本和成果数据是值得的，例如在寻求监管批准上市的RCT期间。Although an RCT would be expected to yield the most reliable data concerning efficacy of an intervention, the care given in an RCT and the costs of providing it may be atypical compared to more general settings. 尽管RCT预期可以产生最可靠的关于干预效力的数据，但RCT中给予的护理和成本与普通的场景相比可能是非典型的。For example, RCTs may involve more extensive and frequent laboratory tests and other patient monitoring, and may occur more often in academic medical centers whose costs tend to be higher than in community health care institutions. 例如，RCT可能涉及更贵和更频繁的实验室检查和其他监测，并且学术医疗中心的成本往往高于社区医疗机构。Other aspects of trial design, sample size, choice of outcome measures, identification and tabulation of costs, burden on investigators of data collection and related matters affect the usefulness of clinical trial data for meaningful economic studies (Briggs 2003; Drummond 2005; Graves 2002; Poe 1995). The prevalence of multinational clinical trials of drugs and other technologies can complicate estimating country-specific treatment effects and cost-effectiveness, given differences in epidemiological factors, health care delivery models, resource use, and other factors (Willke 1998).