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[TCT2012]注册研究与随机临床试验的结合——Stefan James专访
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 编辑:国际循环网 时间:2012/11/1 14:30:10    加入收藏
 关键字:心肌梗死 介入手术治疗 软件开发 

  International Circulation: Could you please discuss the concept of doing prospective, randomized clinical trials through the registry, such as the SCARR trial?
  Dr. James: Since we are filling out all the of the baseline characteristics and the procedural variables in the registry, we have all of the data we usually enter in CRF. We have performed many retrospective studies, but those are always limited by selection basis so you cannot compare treatment alternatives. We wanted to design a system where we directly randomized within the registry. All of the CRF, all of the paperwork is done by the registry automatically. Then we just randomized. When a patient comes with an MI and if you say you are going to undergo a primary PCI, do you want to randomize? And you can click yes. The system presents the inclusive and exclusive criteria and the consent form. You read it to the patients and the patient agrees, you click “randomize” and the system randomizes.
  《国际循环》:能否请您谈谈通过注册数据实施前瞻性随机化临床试验的概念?比如SCARR试验。
  Dr. Stefan James: 当我们在注册数据库中填写了所有基线特征和治疗参数时,就获得了我们通常在病例报告表格(CRF)中需要输入的所有数据。我们已经做了大量的回顾性研究,但由于选择性偏倚的限制,无法比较不同治疗方式的优劣。因此我们试图设计一种在注册数据库内进行直接随机化的系统。所有的CRF和文书工作均由注册数据库自动完成,我们只需进行随机化。当1名MI患者前来,而你将施行直接PCI治疗,你是否需要进行随机化?你可以点击“是”。该系统将提供纳入和排除标准以及知情同意书,你向患者宣读并征得其同意后,点击“随机化”,系统便执行随机化操作。
 



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