The impact of clinical trials on clinical practice.
The impact of clinical trials on clinical practice.
复制标题
临床试验对临床实践的影响。
DOI：
10.1007/978-3-642-74615-4_12
复制
发表时间：
1989
期刊：
影响因子：
--
通讯作者：
C. Furberg
中科院分区：
文献类型：
--
作者：
C. Furberg
在决定是否资助临床试验的过程中，赞助商会权衡投入的资金、精力和时间与试验可能产生的信息。不同的目标反映在试验设计中。例如，一种新药经历了几个开发阶段，从剂量反应研究到大型随机临床试验。由行业赞助的大规模试验主要是为了记录预期的有益效果，而联邦机构或基金会可能更感兴趣的是确定干预效果是有益的、无关紧要的，甚至是有害的。在分析临床试验对医疗实践的影响时，区分这些目标是很重要的。此外，应该认识到，临床实践本身不能直接衡量。通过临床诊断的病人就诊次数以及药物处方或销售量等间接衡量标准可以表明临床试验的影响。医生访谈可以在知识、处方习惯、感知的有效性和安全性方面提供更多信息。然而，这种方法也有缺点，包括成本。
In the process of deciding whether to fund a clinical trial, the sponsor weighs the investment of dollars, effort, and time against the information the trial is likely to generate. Varying objectives are reflected in the trial design. For example, a new drug goes through several phases of development, from dose-response studies to large, randomized clinical trials. Industry-sponsored, large-scale trials are primarily designed to document an anticipated beneficial effect, while federal agencies or foundations may have a broader interest in determining whether an intervention effect is beneficial, indifferent, or even harmful. It is important to distinguish between these goals in any analysis of the impact of clinical trials on medical practice. Moreover, it should be recognized that clinical practice itself cannot be measured directly. Indirect measures such as number of patient visits by clinical diagnosis as well as drug prescriptions or sales can indicate the impact of clinical trials. Physician interviews can provide additional information in terms of knowledge, prescription habits, perceived effectiveness, and safety. However, this approach has drawbacks, including cost.