International Circulation: What are the barriers for getting combinations of funding between private and public money?
　　《国际循环》:私人资金和公共资金联合的主要障碍是什么？
　　Dr. Harrington: The NIH is actually encouraging this. When you submit a trial proposal to the NHLBI， it is common to state that， in addition to grant money， we are also bringing money in from the private sector. NIH has been supportive. The trial has to be conducted under the rules of the NHLBI. Leverage public money， leverage private money， perform the trial under the umbrella of the NHLBI， and stick to the rules. At other times， when a company is trying to get a therapy or technology approved in a regulatory way， that is obviously much more directed to private industry， but even those trials， we ought do more efficiently and effectively.
　　Robert Harrington：事实上，NIH也鼓励这样。当你向NHLBI申请试验时，经常会声明除了拨付资金之外，我们还从私人投资获得了资助。NIH也支持这样做。试验需要按照NHLBI的规定进行运作。平衡公共资金和私人资金，在NHLBI的监督保护下进行试验，并坚持遵守规则。其他情况下，当公司希望根据规定来通过一项治疗或者技术的时候，那么显然资金就更直接来源于私人企业，但即使是是这些试验，我们也应当更高效，更有效的完成。
　　International Circulation: What do you mean by more efficiently and effectively? Is this in terms of funding?
　　《国际循环》:你说的更高效，更有效是什么意思，是在资金方面吗？
　　Dr. Harrington: This is in terms of funding. Some of these large trials will costs hundreds of millions of to conduct， why is that? There is much built in from a regulatory perspective or a perception of the regulatory process that makes people very conservative about how they do things， i.e. monitoring the data. If you look at the typical large cardiovascular trial， and you take the budget as one dollar， about 50? is reimbursement to the sites for their work. The only way to decrease this is to ask them to do less work， so we can accept the 50?. What about the other half? 25? is for data monitoring. These are people who fly out to the centers and source document verify the data. I think this is a colossal misuse of funds， particularly as we move towards a model of electronic health records where we ought to be able to monitor that data in a more statistically robust manner without requiring the human-human interface of going to the center.
　　Robert Harrington：是资金方面。有些大型试验会花费许多亿资金来实施，为什么呢？因为管理方面的观点让人们对做事方式非常保守。例如监察数据。如果你看看典型的大型心血管试验，每投资1美元，大约有50美分是为中心支付的劳务费。减少这个支出的唯一办法是让他们减少工作，因此我们能接受这50美分的开支。剩下的一半呢？25美分是数据监察，供监察人员飞往各中心，寻找原始文件，并核实数据。我认为这是对资金的巨大浪费，尤其是我们目前在向电子健康档案模型过渡，应当有能力用统计学上更可靠的方法来进行数据检查，而不需要去各个中心进行人对人的核查。

上一页  [1]  [2]  [3]  [4]  [5]  下一页