Oncology Frontier: “Clinical value” was one of the keywords of the 50th ASCO annual meeting held a month ago. It was suggested that we should raise the bar for clinical trials by defining clinically meaningful outcomes. Why should we specially emphasize clinical values now? After all， isn’t the aim of a clinical trial to prove whether a drug or a technique can benefit patients’ outcomes?

 

　　《肿瘤瞭望》：“临床价值”是一个月前刚刚结束的第50届ASCO的关键词之一。而且有人认为应该用有临床意义的终点来提高对临床试验的要求。临床试验的目的不就是要证明对患者结局是否获益吗，为什么现在对这个问题格外关注呢？

 

　　Dr Kerr: I think value is important. I work in the National Health Service in the UK which is a socialized health system and where cost effectiveness is important. Too many drugs and certainly many modern expensive anticancer drugs have very marginal benefits. I think there should be a move towards selecting drugs which are more clinically impactful. These trials would not just have to meet their statistical endpoint but also the important endpoint of clinical benefit. If we can link that to cost effectiveness and value， then even better. This is a movement we would applaud and in the UK we have the National Institute for Clinical Excellence and all new drugs， before they are accepted by our peer system， the NHS， would undergo a cost effective evaluation. For some expensive anticancer drugs which are marginally effective， we don’t use them in the NHS. They are considered to not provide enough value to the health care system as a whole. I think that is a very reasonable way to go about the rational rationing of drugs.

 

　　Kerr教授:我认为临床价值是非常重要的。我在英国国民医疗保健体系工作，这是一个社会性的健康体系，并且非常重视成本效益。太多的药物以及许多现代昂贵的抗肿瘤药物都有边际效益。我认为现在应该有一个选择有临床影响力药物的趋势。这些临床试验将不仅仅是为了满足统计学终末事件，也是为了那些有临床益处的重要终末事件。如果我们能够将之与成本效益和价值联系起来，将会更好。这是我们乐见的行动，并且在英国我们有国家卫生与临床优化研究所（NICE），所有的新药，在他们被英国国民健康服务（NHS）接受之前，将接受成本有效性评价。对于一些昂贵的疗效不明显的抗肿瘤药物，被认为在总体上来看并不能对医疗系统提供足够价值的药物，我们并不会在NHS使用这些药物。我认为这是着手进行常规的药物定量配给的合理方式。