- 2017年06月15日11:12 来源：互联网
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Clinical trials——Testing, testing
The nation is losing its grip on a valuable industry
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.
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.
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.
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.
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.
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.
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.