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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

作者:  R.Harrington   日期:2012/12/14 17:42:20

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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。


  International Circulation: What are your opinions of the SWEETHEART at TCT?
  《国际循环》:您对TCT大会的SWEETHEART有什么看法?
  Dr. Harrington: That is the TOAST trial, where they built randomization into their quality improvement registry and asked very simple question: does thrombectomy make a difference in acute MI? The most interesting thing is that they enrolled almost three-quarters of the eligible MI patients in Sweden. This is extraordinary. Duke has an interesting trial underway which has the same concepts. The underpinnings come from the stimulus funding. Along with John Rumsfeld in Colorado, Peterson at Duke, and the American College of Cardiology, we put in a grant to build a randomization platform off of the NCDR, the ACC’s national catheter database. After a couple years of assembling the technical pieces and now Mitch Krucoff and David Cohen 4:40 are performing a RCT embedded in the NCDR. They are randomizing woman to a cath approach of radial or femoral access. They have enrolled well over a 1000 patients. In this next year we will have results in the next year. This will be important on two fronts: the medical question and methodological question. Can we do this? Can we randomize people within a registry?
  Robert Harrington:这是TOAST试验,该试验将随机化植入质量改进注册研究中,并且询问很简单的问题:血栓切除术对急性心肌梗死有影响吗?最有趣的是,他们入选了瑞典近3/4的合适的心肌梗死患者。这非常了不起。Duke临床研究所目前进行的一个有趣的试验也有同样的概念。我们和Colorado的John Rumsfeld,Duke的Peterson以及美国心脏病学会(ACC)共同合作,提交基金,在ACC国家导管数据库,即NCDR(美国心血管数据注册)中建立随机平台。经过几年的技术整合,目前Mitch Krucoff和David Cohen正在实施一项基于NCDR的RCT。他们将女性随机至桡动脉或股动脉入路。已经入选了超过1000例患者。在下一年中将会有结果。这在两方面都很重要,即医学方面和方法论方面。我们能做到这个吗?我们能在注册研究中进行随机吗?
  International Circulation: What about costs?
  《国际循环》:花费方面怎么样?
  Dr. Harrington: This will be 30-50% cheaper than an RCT.
  Robert Harrington:比RCT便宜30-50%。
  International Circulation: Where is the money coming from for support of these registry studies? Is it from the government? Or from the NIH?
  《国际循环》:这些注册研究的资金来源于哪里?是来自政府还是NIH?
  Dr. Harrington: At meeting like the AHA, were we have 27 late-breaking clinical trials. A full third of them were funded by NHLBI. This represents the public investment in science and had some favorable results: stem cells, chelation therapy, bypass surgery vs. PCI. This is a good investment by the tax payer. You also see trials where there are partnerships of funding. For example, the American College of Cardiology or the AHA will partner with private and public money. We need to see more combinations of funding when a question is of importance to the public health. Those may or may not involve a medical product.
  Robert Harrington:在AHA大会上,我们有27个最新公布的临床试验,2/3由NHLBI(国家心肺和血液研究所)资助。这代表了在科学方面的公共投资,我们也取得了一些良好结果:干细胞,螯合疗法,搭桥和PCI的对比。对于纳税人来说,这是很好的投资。你也能够看到有些合作伙伴的资助。例如ACC或AHA会和私人或公共资金合作。当遇到对公共健康很重要的问题的时候,我们需要得到更多联合资助。这些研究可能和医疗产品有关,也可能无关。

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