Offshore Clinical Trials Raising Ethical Concerns

When several AIDS patients died after a clinical trial at a Beijing hospital five years ago, Viral Generics, a California biotech, was criticized for failing to explain adequately to patients they were taking part in a study rather than receiving a proven drug. There were also questions why some patients were given the experimental compound and others a placebo, The Financial Times writes.

The trial complied with current international standards and a Chinese investigation concluded that there was “no serious violation of ethical principles.” Even so, the paper cites this as an illustration of both the rapid growth in clinical trials in the developing world and what it calls the tensions caused by this latest form of globalization. Irene Schipper from Somo, a Dutch research group, tells the Times that existing guidance from the International Commission on Harmonisation – which governs best clinical practice among regulators in the US, Europe and Japan – “leaves all the options open and gives research efficiency priority over ethical considerations.”

Meanwhile, overseas trials continue unabated. Clinicaltrials.gov shows nearly 50,000 trials under way, and 10 per cent are outside North America, western Europe and Japan. The proportion of principal investigators registered with the FDA, but based outside the US and western Europe, rose from 5 per cent in 1997 to 29 per cent last year, the Times writes. The fastest growth in the past five years has come from India, China, Russia and Argentina. “We’re doubling in size every year and expect to keep doing so in each of the next few years,” Mark Engel of Excel PharmaStudies, a clinical research organization that runs trials in China for big pharma, tells the paper.

In populous countries such as China, a single specialist may see dozens each day, allowing recruitment into trials far more quickly from just a few sites. That can speed up testing by several months, offering the chance to win regulatory approval more rapidly – and the prospect of an extended period of sales before patents expire. “Time is money,” says Ole Molskov from Novo Nordisk, the Danish company that was among the first to establish a research center in Beijing. “They have big hospitals here treating thousands of patients, for whom there is much less competition with other trials.”

But Ken Getz, senior research fellow at the Tufts Center for the Study of Drug Development, believes overseas trials may be slowed by the growing focus on biologics and the shift towards more stratified treatments targeted at smaller sub-groups of patients with a particular genetic make-up. “That might reverse the globalization of trials,” he tells the Times.

To read the rest of the story, please look here. The charts, by the way, ran with the story and were based on data from the Tufts Center.