<Oncology Frontier>: When applied to clinical practice， results of clinical trials should be carefully interpreted to avoid misunderstanding. Is there any general principle to follow?

　　《肿瘤瞭望》：将临床研究结果进行解读并应用于临床实践中时，需要注意哪些方面，以免产生误读？

　　Dr. Murphy: The currency of science and certainly medical science revolves around the peer-reviewed published paper. Everything we do in science must withstand peer scrutiny in the hope that only the truth will be advanced. That is the scientific method. Governments have the responsibility in China as exercised by the Chinese FDA， to regulate the appropriate prescription and usage of drugs and various devices based on science. So how do we get from a great idea or a compound that looks like it is going to be helpful in a cancer patient， to an approved therapy and registered drug? It has to go through rigorous clinical trials according to the requirements of their respective regulatory authorities， the US FDA，China’s CFDA and the European EMA， for example. They oversee the trials and then approve or disapprove drugs that have gone through the rigorous and statutory clinical trials. That is the way it has to be. What can be made better and is in the process of taking place， is that， although they are three different regulatory agencies， their communication facilitates harmony. The harmonizing of the regulations between those three jurisdictions of China， the US and Europe is underway so that clinical trials conducted in China may be useful in Europe and conversely， drugs that have been clinically approved in Europe may be more readily reviewed and more quickly approved by China. That is something that is taking place. It is not entirely there， but it is happening. A very good example is a targeted drug for a specific subtype of lung cancer which was developed and approved in less than four years in the United States (which would be considered a very rapid development and progression) because it worked so well. That drug was then explored in China with the approval of the CFDA to undergo clinical trials. It was approved in eleven months. For cancer drugs， on average， it has been up to ten years， sometimes longer， to gain approval. Because of this drugs specific target effectiveness as documented in clinical trials， it roared through approval by the US FDA in less than four years and that established data was utilized by the CFDA to identify required additional clinical trials in China with Chinese patients that could be conducted rapidly， such that Chinese patients with that specific lung cancer were receiving effective therapy in just eleven months. That is progress. It shows that the CFDA， just like the US FDA and the EMA， really have their heart in the right place. It is a great credit to all of the world’s regulatory agencies for having achieved that.

　　Murphy博士：科学和医学科学的交流围绕着各地的已发表的同行评议论文。我们在科学上所做的一切都必须经得起同行推敲，希望只有真理才能前进。这就是科学的方法。各国政府有责任在科学的基础上调节适当的处方以及药物和各种设备的使用，在中国则由中国FDA来行使。那么，我们如何得到一个伟大的想法或一堆想法，它看起来对癌症患者、对治疗方法的批准以及药物注册的获取是有帮助的呢？它必须根据各自监管部门的要求，例如美国的FDA，中国的CFDA和欧洲的EMA，经过严格的临床试验。监管部门负责监督试验，然后批准或否决已经通过了严格的和法定的临床试验的药物。这是一个必须执行的过程。

　　在这个过程中有什么可以做得更好的呢，那就是，虽然他们是三个不同的监管机构，但他们之间的沟通有利于促进和谐发展。中国、美国和欧洲这三个司法管辖区之间的规定协调正在进行，所以在中国进行的临床试验可能在欧洲有用，相反，对已被欧洲批准的临床药物在中国可以更容易地评审，并更迅速地被批准。这就是正在发生的事情，虽然它不完全存在，但它正在发生。一个很好的例子，是针对肺癌的靶向药物。这种药物的研制和批准在美国用了不到四年的时间，这将被认为是一个非常快速的发展和进步，因为它的效果很好。然后在中国，该药物被研发并获CFDA批准进行临床试验。它已被批准了11个月。对于抗癌药物获得批准平均需要十年，甚至更长时间。由于这种药物的特定靶向效果在临床试验中被记录，它通过美国FDA的批准不到四年的时间，而建立的数据已被CFDA应用并通过在中国患者中进行更多的临床试验来验证，这样可以进行很快，使得中国肺癌患者在仅仅11个月的时间内接受有效的治疗，这就是进步。这表明了CFDA正在正确的位置发挥着他们的核心作用。这是世界上所有的监管机构已实现的一个伟大的成就。