Outsourcing
Beyond these financial considerations, meanwhile, demography helps explain Asia’s rising popularity in other ways. For one thing, Ali notes that many across the region are “treatment-naïve” – meaning they’ve never undergone treatment for a particular illness before. That offers obvious advantages for trial conveners looking for unadulterated subjects to investigate, especially given that a lack of medical opportunities often makes for enthusiastic volunteers. At the same time, the region is increasingly witnessing a proliferation of illnesses traditionally associated with Western societies. From diabetes in India (77 million sufferers) to cardiovascular disease in China, it’s no wonder the region has seen research here explode, a fact that’ll mean trials across APAC are worth nearly $12bn by 2025.
China improves If you visit Wulumuqi Road, a few miles west of central Shanghai, you’ll find the nondescript business centre, wrapped in glass and metal sheeting. It looks like one of the countless industrial facilities that now dominate Chinese cities – but go inside and the facility may surprise you. Owned by laboratory giant Labcorp, the revamped space offers a range of clinical gadgets. That’s true everywhere from the cell culture laboratories through to the disease-model testing for hepatitis and fibrosis. Nor is the Shanghai centre unique. On the contrary, the clear investment in the site, which now boasts over 85,000ft² of space, speaks vividly to the intensive investment the region is enjoying more broadly. That’s clear enough if you examine the biggest industry players. In July, for instance, Merck announced $100,000 prizes for promising local research across Asia. Roche, for its part, is working with the Chinese authorities to develop and test new anti-pneumonia medications. As Elegant hints, investment is helping countries in the region move towards the high standards set by their neighbours, albeit unevenly. “Singapore is fantastic,” she says of the facilities there. “Hong Kong is fantastic. It depends – even within a country. Some of the facilities in India are fantastic and some are not. It varies where you go.”
As this last comment implies, both Elegant and Ali emphasise that even with investment, it’s vital for trial conveners to understand exactly what they’re getting into before they organise research in the APAC region. To explain what she means, Elegant offers the example of biomarkers in oncology, noting that not all countries yet have the capacity to carry out such tests. The important point, at any rate, is to carry out robust feasibility studies – or else partner with a CRO provider that knows the lay of the land. Ali agrees. “A site visit is the first step in the clinical trial,” is how he puts it.
Clinical Trials Insight /
www.worldpharmaceuticals.net
“The researchers must first go there, see the sponsors and the doctors, and provide awareness and training.”
Political trials With so much activity, the experts seem understandably buoyant about the future of clinical trials across Asia. If nothing else, Elegant argues that is down to the rising globalisation of the medical profession at large. “A lot of physicians have trained in the US, Australia or Europe, and then come back to countries in the region,” she explains. “So, I think there’s a lot more confidence in the ability [of these countries] to conduct clinical trials.” That’s just as well: according to the WHO, much of Asia has only one doctor per 1,000 people, even if medical schools in places like China are pumping out hundreds of thousands of new physicians each year.
A large but also ageing population in China offers numerous opportunities to conduct clinical trials on diseases.
“A lot of physicians have trained in the US, Australia or Europe, and then come back to countries in the region. So, I think there’s a lot more confidence in the ability [of these countries] to conduct clinical trials.”
And if Ali is reasonably optimistic too – he already considers Taiwan and South Korea as “excellent” places to conduct trials – he also strikes a note of caution. We happen to be speaking on the day that ex-Prime Minister of Pakistan, Imran Khan, faced an assassination attempt. Though Khan escaped with a bullet to the leg, Ali uses the incident to note the intrinsic difficulties of organising trials in the country. Despite boasting a huge population, as well as a number of unusual diseases, Ali stresses that the prevalence of clinical trials here is “extremely” low. “The reason,” he adds, “is political instability.” It goes without saying that, even in the region that produced the Ben Cao Tu Jing, that’s an ailment without a simple cure. ●
30%
Dispensing with on- site monitoring can cut overall trial costs by this much.
Clinical Leader 39
testing/
Shutterstock.com
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