<International circulation>:  With many databases， large cardiovascular registries ， and large scale clinical studies， can more meaningful information be data mined if the relationship between those studies are established?

　　《国际循环》：在有多个数据库、大型心血管登记注册及大型临床研究的情况下，如果确立了这些研究之间的关系，还可以从数据中挖掘出更有意义的信息吗？
　　Dr Rumsfeld  :  I think that is a really great question.  It speaks to the gap that there has been between so called efficacy trials， for clinical trials that are often done to test a new drug or a new device to get it on the market say in the United States or Internationally.  And in a different way we have these large clinical registries like we do through the American College of Cardiology and American Heart Association.  Those tend to be measures of what is going on in clinical practice and the two have not been well linked but I think there is a new movement afoot， at least in the United States， of trying to link those two efforts.  Number 1， the US Food and Drug Administration is increasingly interested in having clinical registries serve as the post market surveillance studies once a new drug.  So at least you have the clinical study that got the drug or device approved and at least you would have follow up studies in the registries to look at their real world benefit and safety.  Second of all， the American College of Cardiology in collaboration with Duke and founded by the National Institutes of Health in the United States， we are putting together what we call a National Clinical Research Infrastructure and what we are trying to do is to do exactly what this question asks.  That is we are trying to marry the clinical registries that are out there trying to measure current practice and do clinical trials over that infrastructure and what I mean by that is that we are going to take the sites that are contributing the clinical registries and have them participate in randomized trials.  The randomized trials will come up and get done and then you have the built in follow up in the registry and that truly will marry that data， otherwise it can be quite difficult to take a randomized trial database and somehow compare it to a registry database.

　　Rumsfeld博士：我认为这真是一个很棒的问题。它谈到了一直存在的所谓的疗效试验间的差距，在美国或国际上在新药物或新设备上市前常常做临床试验，测试新药和新仪器。并以不同的方式进行大型临床登记，像我们通过美国心脏病学院和美国心脏学会做的登记。这些往往是衡量临床实践的措施，但这两者衔接不是很好，我认为有一个新的变革正在进行中，至少在美国正在试图连结这两个努力。第一，美国食品和药物管理局对临床登记越来越有兴趣，将其作为市场后新药物监测研究服务。所以，至少该药物或设备的临床研究得到了批准，或者你会在登记处跟进研究，以了解他们在现实世界的的疗效和安全性。第二是，美国心脏病学院和杜克大学合作，由美国国立卫生研究院资助，正致力于我们所说的国家临床研究基础设施，我们正在试图做的正是这个问题问的。就是我们正在努力结合临床注册，我们正试图衡量目前的做法，做了这些基础设施的临床试验。我的意思是，我们将要采取行动帮助临床登记处，让他们参加随机试验。提出并完成随机试验，然后在登记注册处随访，才能真正结合这些数据，否则随机挑选试验数据库并与注册表数据库比较会很困难。

上一页  [1]  [2]  [3]  下一页