Healthy Skepticism Library item: 850

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Publication type: news

Hirschler B.
Drug Companies Export Trials to China, New Markets
Reuters 2005 Mar 9

Full text:

Western drugmakers are shifting more clinical trials to emerging markets in a bid to save money, speed research and educate a new generation of local doctors about their products.

Just how far the trend has gone was highlighted on Wednesday when Sanofi-Aventis SA, Bristol-Myers Squibb Co and AstraZeneca Plc announced results from a 46,000-patient trial of two drugs in China.

The study on blood thinner Plavix and beta blocker Toprol XL, presented at the American College of Cardiology in Orlando, was the largest ever undertaken in China and the second biggest heart attack study anywhere in the world.

Yet it cost just $3 million.

“If we had done this study in the United States it would have cost at least 10 to 20 times more,” Dr Zhengming Chen, reader in epidemiology at Oxford University and the principal investigator of the so-called COMMIT study, told Reuters. Companies typically pay doctors or hospitals for each patient studied, so it makes sense to shift big trials to countries where costs are lower.

In addition to China hot favorites among the new destinations for testing experimental drugs include India and Poland.

For Chen’s trial the cost per patient was just $12, though collaborating doctors also had their travel costs covered for attending investigators’ meetings.

FEWER INTERACTIONS

Cost is not the only factor, however.

At a time when patient recruitment has become more difficult in the United States, western Europe and Japan, other parts of the world can offer better and faster access to patients.

It is often a lot quicker to find enough patients to take part in a clinical trial in an emerging market because rival drugmakers are not competing so fiercely for subjects.

Furthermore, patients in such countries are less likely to be taking other medicines that could interact with the drug being studied. Such “treatment-naive” subjects are increasingly hard to come by in wealthy nations.

“The kind of questions you can address in China are sometimes difficult in other settings because of the kinds of treatment being used,” Chen said.

So, it is no surprise that more and more companies are looking east.

Britain’s GlaxoSmithKline Plc, the world’s second largest drugmaker, announced in October it was looking to move 30 percent of its clinical trials to low-cost countries over the next two years.

Other companies are doing the same, often using independent contract research organizations to recruit patients worldwide.

India, in particular, has seen a wave of western pharmaceutical manufacturers investing in local research operations in the past year, with firms encouraged by the country’s adoption of new patent laws.

GOOD BUSINESS

There is also a sound business case for taking trials to emerging markets, since it alerts local opinion leaders to the medical potential of modern drugs, according to Iain Clark of Edinburgh-based consultancy Wood Mackenzie.

“Growth over the next 10-15 years is going to be very subdued in the traditional major markets — so countries like China are really seen as an opportunity for companies to get out of a very low growth track,” he said.

Chen said the success of the COMMIT trial had proved that hospitals there could manage clinical trial data efficiently.

“We only completed this study on Feb. 9, yet we only have one entry form and three discharge forms missing out of 46,000, which is a remarkable achievement,” he said.

“There is still some prejudice and lack of understanding about the Chinese research community, but it offers fantastic opportunities for high quality research at very low cost.”

In the past there have been questions as to whether results from Asia are applicable to other populations. But Chen said there was no evidence that the nature of heart attacks was materially different in China from elsewhere.