評論
打印
Clinical trials
臨床實驗
Testing, testing
測試，測試
The nation is losing its grip on a valuable industry
我國正失去一項重要行業的優勢。
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.
不列顛人對自己人進行實驗由來已久：1747年，一名蘇格蘭醫生首次讓一群飽受壞血病折磨的水手進食橘子。不過臨床試驗搬移海外已有數年之久。在2005年至2013年間，在不列顛進行的實驗數量已經下降14%；與此同時，我國醫藥領域在全球市場的份額下降。這是個大問題——好在還有挽救的余地。
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.
在不列顛推進新治療方案的過程異常緩慢。在所有階段都會有阻礙—從獲得正式許可到找到合適的醫院。不過最大的問題在于招募被試時費時過長。目前實驗設計者常通過打電話給他們熟知的醫生進行招募。這些醫生會試著在記起來的情況下向他們的病人提及此事。此乃“便宜之舉，”Dundee大學的研究員Shaun Treweek道。實際上，招募自從上世紀40年代的肺結核實驗之后便無改觀。彼時認為10至20名被試足矣，而且可以在當地就近隨機選取。
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.
對醫藥公司而言，結果的耽擱意味著代價高昂。藥物專利的時限在發現之日起就開始計算，而每多一日的延遲將使藥物投放市場的成本上升1000萬美元。目前實驗已經遷至東歐和中國，那些地區阻礙較少。自此不列顛正對這一有價值產業的影響正在下降：每年全世界臨床實驗產業價值300億英鎊。在研發領域的投資也存在上述危險。實驗是研發產業最有價值職工—熟練研究者和臨床醫生的聚集地。
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，隨著實驗從不列顛遷走，小損失產生不斷。牛津大學的研究員Martin Landray指出，臨床標準會隨著醫生研究的進行而提高，同時他們所在的醫院也會隨著知識的演進緊隨步伐。而這如同許多其他產業一樣，在聚集中產生創新。
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.
當然最近這些年，一些大型和進展順利的實驗還是在不列顛進行了，其中一個是聯合王國生物銀行計劃，大約有50萬被試參與其中。這項計劃已經成為天性與教養孰輕孰重的研究中規模最大的一個。然后還有規模龐大的“揭示”心臟病發病機制的實驗，這項計劃創紀錄地招募了19000名不列顛人。
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.
這些研究具有一些共性：研究者得以查閱英倫國民健康檔案，并依此尋找合適的被試，直接與之聯系。信息保護法經常讓事情變得棘手，不過這些研究者獲得保密咨詢小組的保證得以豁免。不幸的是，這種豁免少之又少，而現在又面臨一項歐盟指令的威脅。Landray,曾幫助籌備安排“揭示”計劃。他認為門檻設得太高了。“我們曾寫給30萬人請求加入計劃。19000人加入；30人投訴。”他說。
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.
允諾更多實驗以此途徑招募被試將給不列顛帶來獨特優勢。不管怎么說，我國是世界上僅有的具有一個集中病例系統的國家。并且，避免病人受到虐待也方法頗多—醫生與科學作家Ben Goldacre已經建議立法者對違反醫療隱私法例的人處以更嚴厲的懲罰。以最大的努力降低這些風險，不列顛可以引領世界臨床測試。政客們面對輝瑞公司時驚慌失措。這個美國公司最終將購買不列顛的AstraZeneca公司。他們認為這將毀掉我國的研究根基。政客們應該注意到不列顛隱藏的能量。
