As clinical trials become more globalised, Western pharmaceutical companies are assessing the pros and cons of conducting them in emerging markets. Julie Danvers speaks to Juan Mendoza, director of clinical supplies at Sanofi, about the challenges and strategies pharmaceutical companies must adopt as they enter new geographical locations.
In 2003, a rural farmer named Zhen Suxia exposed the challenges of globalisation in an industry that deals with life and death. Zhen, like many in his village, had been infected with AIDS after a mishap with traders that were buying his blood. Unable to afford the antiretroviral drugs necessary to prolong his life, and seeing fellow villagers dying around him, Zhen signed up to a medical trial at Ditan hospital in Beijing.
The three-month trial involved a drug called VGV-1, developed by Viral Genetics, a Californian biotechnology company. It was a textbook case of globalisation – a Western drug company using an emerging market to trial its new ideas. Costs were low, and with an HIV epidemic gripping the country, the possibility of a massive market was on the horizon.
It seemed like a win-win scenario, but for Zhen and 18 others, things quickly went downhill. Soon after receiving their first dose of VGV-1, the villagers started reporting rashes and high fevers. Shortly after leaving the hospital, two passed away.
The trial, it turned out, had been conducted without the approval of China’s Food and Drug Administration. The patients, to the shame of everyone involved, were never fully informed about what they were signing themselves up for, and the health consequences of the trial were hidden from them. When they did finally ask to see the documentation, they were told they had to pay.
Driver of progress
This is, without doubt, an extreme example of what happens when things go wrong – a consequence, perhaps, of how quickly globalisation took place in the industry. "Such practices highlight both the rapid growth in clinical trials in the developing world and the tensions caused by this latest form of globalisation," said Andrew Jack in the Financial Times.
Of course, turning away was never an option for the industry. Globalisation quickly becomes central to the business model of pharmaceutical companies under pressure to produce innovative drugs and find fresh markets into which to bring these new products.
"During my 19 years of experience working in clinical supplies, I have seen a massive increase in different regions," says Juan Mendoza, director of clinical supplies at Sanofi, a pharmaceutical company headquartered in France.
"I’ve had the opportunity to travel around the world, interacting with people in local countries and I can see how enthusiastic they are to be a part of this adventure and be part of the globalisation of the industry, making sure they are contributors to improving the health of patients in local countries."
One of the main reasons driving globalisation has been the need for unimpeded patient recruitment. After scandals like Vioxx, an anti-inflammatory pill marketed by Bristol-Myers, found to cause serious harm in patients, approving new drugs has become more difficult than ever. To satisfy the new requirements of the US Food and Drug Administration (FDA), trials are required to involve more patients over much longer periods of time.
Of course, doing this in Western counties isn’t easy – the number of willing patients is limited, and the costs of finding and paying them can be prohibitively high, particularly for trials that involve rare diseases. That’s where emerging markets come into play.
"In Asia in particular, there is a large population and a wide availability of patients with different illnesses that require treatment, who are willing to undertake clinical trials," Mendoza says.
"That means the cost involved in the clinical trials in emerging markets is far lower compared with trials in regular markets like the US and EU. Then you have the benefit of brand exposure outside established markets. I know some organisations that are hoping a big part of their revenue will come once the product is available commercially in these different areas."
It is not, however, just about reducing costs and increasing brand exposure. Sanofi’s approach to R&D puts the patient first.
"Our patient-centric approach to clinical trials provides novel treatments," adds Mendoza. "Our aim is to find solutions to unmet health issues in different regions around the world."
Know the locals
There are, of course, numerous challenges involved in conducting trials from abroad. Some, like Zhen’s story, involve patients unjustly coerced in the trial process. Others involve the pharmaceutical companies themselves.
It may be easy to categorise emerging markets as one monolithic block, but the reality is a maze of different cultural, ethical, scientific and regulatory differences.
"You need to be able to deal with the differences in each region," Mendoza says. "Having local representatives that act on behalf of the country, that know the culture, the language and the regulations, is crucial. Just look at how regulations in these different countries are constantly changing. Some recent changes include the labelling requirements in India, or the changes to Israel’s import process. If you’re not prepared for these changes and differences, you will not be in a good condition to conduct your trials and achieve the outcomes that you are expecting.
"To avoid the most difficult challenges, proper due diligence, the right preparation and research in advance – contacting local authorities and trying to be as proactive as possible – will contribute to the success of a clinical trial in new markets."
While the majority of trials still take place in developed countries, as work in emerging markets continues to grow, these questions of strategy and ethics will only become more important. The opportunities emerging markets present for the industry are significant. But without planning, local knowledge and respect for local populations, the full benefits will not be realised.