CLINICAL OPERATIONS AND OUTSOURCING
The great wall: why overseas sponsors are yet to fully tap into China’s clinical trial resources
China is an attractive study destination, yet the country’s clinical trial industry is still insular, according to a data-driven analysis by our sister publication Clinical Trials Arena. Reynald Castañeda and Andrew Hillman man the barricades.
C
hina’s increasing footprint in the clinical trials industry is hard to ignore. There are two sides to the story: how
the local industry is fortifying its foundations to serve local sponsors, and overseas sponsors looking to expand their clinical trial presence into the country. But, according to an investigation by Clinical
Trials Arena, based on exclusive data analysis and interviews with experts, there is still a great wall that overseas-based sponsors need to overcome in order to establish local clinical trial connections. There are cultural and structural nuances that sponsors need to take heed of, and local experts, while plenty, may need more training in running certain aspects of clinical trials. Clinical research in China is still relatively
insular, with only one in four commercial clinical trials in China sponsored by an overseas company. On single-country commercial trials in China, just 18% include any foreign commercial companies. By comparison, in South Korea the proportion is 21%, in India it’s 30%, and in Japan 45%. Multi-country trials are much more likely to include foreign involvement. Since the start of 2020, half of all multi-country trials with sites in China have included Western commercial sponsors. This is roughly in line with other non-Western countries – with Japan at 52%, South Korea at 56%, and India 64%. But multi-country trials are scarce in China, representing just 9% of all commercial trials, and this rate is 42% in South Korea and Japan. But there are many reasons for overseas sponsors to persist. China is an attractive clinical trial destination due to its large pool of patients,
and there is investment in improving local expertise and infrastructure in supporting clinical trials. Concerns about data integrity coming from the country are also being addressed.
Cisema, puts it, the decision to open a drug or medical device clinical trial in China is simple: it is a mostly mandatory requirement to sell a product locally. And as a business strategy, China would be a tough one to skip over.
China has opportunities for further growth in trials run in China has grown gradually, from around 100 trials a year in 2010 to around 350 in 2021, according to our analysis using the GlobalData Clinical Trials Database. (GlobalData is the parent company of Clinical Trials Arena and Outsourcing Clinical Trials Handbook.) In addition, two in every 10 single-country China trials with a Western commercial sponsor are Phase III studies, compared with 12% for trials occurring in the West. Nonetheless, while Western companies are slowly creeping into China, growth in commercial trial activity in the country is still driven by local companies. Between 2017 and 2021, 8% of single-
country trials in China with Western commercial involvement were for immuno-oncology, compared with 3% of single-country trials in Western countries. Other therapy types that make up a greater proportion of Western trials in China than trials in the West include autologous therapy (5% Clinical investigation of certain therapy classes in China is rare, except when a Western
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