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[AHA2012]随机对照试验管理及对学术会议的影响——斯坦福大学医学院Robert Harrington教授专访
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作者:R.Harrington 编辑:国际循环网 时间:2012/12/14 17:42:20 关键字:随机对照试验管理 RCT  PCI 

  International Circulation: How do you think RCTs are changing in terms of the way they are conducted? Is it harder to get a positive result now?
  《国际循环》:您认为RCT的管理是不是正在改变,现在得到阳性结果是不是越来越难了?
  Dr. Robert Harrington: Yes. Elliot Antman and I have a perspective piece that came out yesterday in JAMA on this topic called “Transforming Clinical Trials.” It was a viewpoint for JAMA’s special cardiovascular issue that came out this week. We addressed most of these points. We have essentially said that given the amount of money available in the US and globally spent on healthcare, understanding the value of each therapy is very important. The best way is through RCT, but the way RCTs have been conventionally done is not a sustainable model for many reasons. One of which as we improve in our treatment of CVDs to show incremental benefit is very difficult. That has meant that these studies have been large, they have been looking for modest effects, and they have been expensive. In the current economic environment, most of us believe that this is not sustainable. The return on investment is not there. If you go back into the history of cardiology, 15 or 25 years ago, these were all placebo-controlled trials. Today, they are directed against an active agent and it is difficult to demonstrate a benefit when something is already fairly good. Our belief is that the kind of trials we perform needs to change and the way we do trials needs to change.
  Robert Harrington:是的,Elliot Antman和我昨天在JAMA上就这个主题提出了一个观点,题目是“变化中的临床试验”,是JAMA心血管专刊的一个视点,在本周出版。我们文中阐述的主要就是这些问题。我们说,考虑到美国和全世界在医疗方面能够利用的经费,理解每一种治疗的价值是非常重要的,最好的方法是通过RCT。但是按照传统方式进行的RCT因为各种原因,并不是可持续的模式。原因之一就是我们改进心血管疾病治疗来取得增量获益很困难,这意味着研究规模很大,要去寻找相对较小的疗效,而且研究花费昂贵。在目前的经济环境中,我们大多认为这是不可持续的,没有投资回报率。如果你回顾心血管病学的历史,15或者25年前,进行的都是安慰剂对照试验。而目前的对照组都是正在使用的药物,因此,在现有治疗已经很好的情况下,再去证明更多的获益就很困难。我们相信我们需要改变试验的类型以及方式。
  International Circulation: What kind of trials are we talking about?
  《国际循环》:我们讨论是的哪种类型的试验?
  Dr. Harrington: The phrase commonly used in the US is comparative effectiveness. We are trying to understand, in an A vs. B world, what is the choice that is giving maximal health value. In order to perform those kinds of studies, which may be quite large by necessity, means that you have to think differently about large studies. Our view is that as information technology improves, we need to take advantage of that. For example, utilizing randomization built into the electronic health record as a way to perform clinical trials is starting to be explored by people. Is that something that will allow to perform trials more quickly and efficiently by embedding RCTs in the electronic health record?
  Robert Harrington:在美国,经常说的是比较疗效。我们试图了解,在一个A对比B的世界中,哪一种选择有最高的健康价值。为了实施这类研究——而且这些研究不可避免的可能规模很大——意味着必须对大型研究有不同的思考。我们的观点是信息技术在进步,我们需要利用好它。例如,将随机化植入电子健康档案系统来进行临床试验的方法,正在进行开发。通过这种方法,可以更快、效率更高的在电子健康档案中植入RCT。



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