Are you looking for the right site for your next clinical trial? China may not have been on your radar, but with recent developments leading to a dramatic improvement in what it has to offer, it really should be. There are good reasons why more and more healthcare companies are choosing to work with Chinese CROs. Here are five you ought to know about.
Easy access to suitable volunteers
One of the biggest challenges in any clinical trial is finding the right volunteers within a suitable period of time. China offers big advantages in terms of its patient population. With a population of almost 1.4bn and 15 megacities whose populations are over 10 million, it offers a lot of prospective volunteers, and even more so – as far as most research is concerned – when you factor in the fact that its population is ageing. Soon, it will have more people aged over 80 than any other country in the world. This means higher than average rates of chronic disease and disability, and many people ready to participate in trials of pharmaceuticals and medical devices. China is particularly notable for its high rates of cardiovascular disease, lung cancer, gastric and oesophageal cancers, and musculoskeletal disorders.
Where regulation in China was once cumbersome, the last few years have seen it transform and become much more accessible to foreign companies. In particular, it has sought to reduce start-up time for trials, with the NMPA adopting a priority review process in an attempt to streamline trials of promising new drugs. Today, drug registration in China has been restructured to make it easy to run trials in parallel inside and outside the country, ideal if you want speedy access to data on any variation related to ethnicity. The NMPA has also introduced guidelines on the management of clinical trials, and it has made moves to strengthen intellectual property protection so you can be confident about remaining in control of the product you’ve invested in developing.
Highly competitive prices
Persistently favourable exchange rates, economies of scale and extensive government support for the biotech sector mean that in China, clinical trials cost significantly less than they do in Europe or North America, and in fact, they’re among the cheapest in Asia. You can easily end up paying less than half what it would cost you to run an equivalent trial in the UK, in part because faster patient recruitment removes many of the costs associated with delays. This also makes prices more predictable, making it easier for you to budget efficiently. In the past, the costs associated with waiting for NMPA approval weighed against these factors, but now that the regulatory process has been streamlined – with further improvements expected in the next few years – the situation is very appealing.
Highly skilled workers
Historically, China has suffered from a shortage of skilled workers, but that is now changing rapidly due to government efforts to enhance the potential of the developing biotech and pharmaceutical industries. The Ministry of Education’s 985 Innovative Platforms for Key Disciplines Project has included the development of centres such as the China Pharmaceutical University in Nanjing as part of a dedicated effort to bridge the skills gap, while a programme of international academic exchanges has also taken place, with the result that in China, clinical trial quality is improving rapidly. China’s commitment to developing a reputation for excellence in the sector means it’s likely to improve still further. You can now be confident that the data produced is as robust as it would be in the UK.
Access to the Chinese market
The China clinical research market is showing a lot of promise to those who want to sell pharmaceuticals or medical devices in the country. Its large, ageing population, 70% of which is expected to be middle-class by the end of the decade, makes this a very attractive proposition. It also has a high proportion of treatment-naive people with chronic illness. In 2017, it was the second-largest market in the world for pharmaceuticals and demand is rapidly growing, partly due to increasing awareness by patients that effective treatments for their conditions may be available. The Chinese government has made it a priority to ensure that all the country’s citizens can access affordable basic healthcare insurance by the end of this year. Overall, healthcare expenditure amounts to around 7% of GDP, which means that this is a large market that still has significant growth potential.
With all these things going for it, China is now a great place to consider conducting your clinical trials. It’s easier than ever to visit, so why not do so and check out the way it works for yourself? You might be pleasantly surprised.