临床实验

　　Testing, testing

　　测试，测试

　　The nation is losing its grip on a valuable industry

　　我国正失去一项重要行业的优势。

　　THE British have long been experimenting on each other: in 1747 a Scottish doctor first fed oranges to a group of scurvy-ridden sailors. But clinical trials have been moving overseas for years. The number of trials approved in Britain dropped by 14% between 2005 and 2013; at the same time, the country's share of the global market fell. This is a big problem—but one with a solution.

　　不列颠人对自己人进行实验由来已久：1747年，一名苏格兰医生首次让一群饱受坏血病折磨的水手进食橘子。不过临床试验搬移海外已有数年之久。在2005年至2013年间，在不列颠进行的实验数量已经下降14%；与此同时，我国医药领域在全球市场的份额下降。这是个大问题——好在还有挽救的余地。

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　　The process of testing new treatments is unusually slow in Britain. It is held up at every stage—from getting formal approval to finding the right hospital. But the biggest challenge is the time it takes to round up subjects. At present trial designers often recruit by phoning doctors they know, who will try and remember to mention the trial to their patients. It is “all quite ad hoc,” says Shaun Treweek, a researcher at Dundee University. Indeed, recruitment has not moved on much since the tuberculosis trials of the 1940s, where ten to 20 subjects were thought sufficient, and could be gathered locally and at random.

　　在不列颠推进新治疗方案的过程异常缓慢。在所有阶段都会有阻碍—从获得正式许可到找到合适的医院。不过最大的问题在于招募被试时费时过长。目前实验设计者常通过打电话给他们熟知的医生进行招募。这些医生会试着在记起来的情况下向他们的病人提及此事。此乃“便宜之举，”Dundee大学的研究员Shaun Treweek道。实际上，招募自从上世纪40年代的肺结核实验之后便无改观。彼时认为10至20名被试足矣，而且可以在当地就近随机选取。

　　For drugs companies the delays that result are costly. The life of a patent starts as soon as a drug is discovered, and a single day's delay getting it to market costs up to $10m. Trials have been moving to eastern Europe and China, where hurdles are fewer. Britain is thus losing its grasp on a valuable industry: the global clinical trials industry is worth ￡30 billion ($51 billion) a year. It is also in danger of losing research and development investment. Trials are the habitat of R&D's most valuable workers: skilled researchers and clinicians.

　　对医药公司而言，结果的耽搁意味着代价高昂。药物专利的时限在发现之日起就开始计算，而每多一日的延迟将使药物投放市场的成本上升1000万美元。目前实验已经迁至东欧和中国，那些地区阻碍较少。自此不列颠正对这一有价值产业的影响正在下降：每年全世界临床实验产业价值300亿英镑。在研发领域的投资也存在上述危险。实验是研发产业最有价值职工—熟练研究者和临床医生的聚集地。

　　And as trials move away from Britain, more subtle damage is being done. Martin Landray, a researcher at Oxford University, points out that clinical standards go up when doctors are involved in research, as their hospital keeps pace with evolving knowledge. And, as in many other industries, innovation happens in clusters.

　　而且，随着实验从不列颠迁走，小损失产生不断。牛津大学的研究员Martin Landray指出，临床标准会随着医生研究的进行而提高，同时他们所在的医院也会随着知识的演进紧随步伐。而这如同许多其他产业一样，在聚集中产生创新。

　　Yet in recent years some of the biggest and most smoothly-conducted trials have taken place in Britain. One is UK Biobank, which, with half a million subjects, has become one of the largest ever studies into the importance of nature versus nurture. Then there is the vast REVEAL heart disease trial, which recruited 19,000 Britons in record time.

　　当然最近这些年，一些大型和进展顺利的实验还是在不列颠进行了，其中一个是联合王国生物银行计划，大约有50万被试参与其中。这项计划已经成为天性与教养孰轻孰重的研究中规模最大的一个。然后还有规模庞大的“揭示”心脏病发病机制的实验，这项计划创纪录地招募了19000名不列颠人。

　　These studies have something in common: researchers were able to trawl NHS data to find appropriate subjects and contact them directly. Data-protection laws usually make this tricky, but they were granted an exemption by the confidentiality advisory group. Unfortunately, such exemptions are rare, and are now under threat from a proposed EU directive. Mr Landray, who helped arrange the REVEAL study, reckons the bar is set too high. “We wrote to a third of a million people. 19,000 took part; 30 complained,” he says.

　　这些研究具有一些共性：研究者得以查阅英伦国民健康档案，并依此寻找合适的被试，直接与之联系。信息保护法经常让事情变得棘手，不过这些研究者获得保密咨询小组的保证得以豁免。不幸的是，这种豁免少之又少，而现在又面临一项欧盟指令的威胁。Landray,曾帮助筹备安排“揭示”计划。他认为门槛设得太高了。“我们曾写给30万人请求加入计划。19000人加入；30人投诉。”他说。

　　Allowing more studies to recruit patients in this way would give Britain a unique advantage. After all, it is the only country with a centralised patient data system. And there are ways to protect patients from abuses—Ben Goldacre, a doctor and science writer, has suggested making the penalties for breaching medical privacy stiffer. Minimise the risks, and Britain could lead the world in clinical testing. Politicians panicked when it looked as though Pfizer, an American drugs company, might end up buying AstraZeneca, a British one, and shred the country's research base. They should consider Britain's hidden strengths.

　　允诺更多实验以此途径招募被试将给不列颠带来独特优势。不管怎么说，我国是世界上仅有的具有一个集中病例系统的国家。并且，避免病人受到虐待也方法颇多—医生与科学作家Ben Goldacre已经建议立法者对违反医疗隐私法例的人处以更严厉的惩罚。以最大的努力降低这些风险，不列颠可以引领世界临床测试。政客们面对辉瑞公司时惊慌失措。这个美国公司最终将购买不列颠的AstraZeneca公司。他们认为这将毁掉我国的研究根基。政客们应该注意到不列颠隐藏的能量。