Faiz Kermani

China is generating huge interest as a destination for outsourced clinical trials, particularly since the US consulting firm AT Kearney ranked it above India in 2007 as the most attractive, low-cost location to run clinical trials outside the US.¹Other independent assessments have also ranked China highly.²In March 2006, the UK Trade and Investment department examined clinical trial trends in China from both a sponsor's and an outsourcing partner's perspective. Discussions with representatives of government departments, and local and foreign companies showed that the clinical trial market was maturing and was not simply based on 'hype'.³

A prime attraction for companies seeking to conduct clinical trials in China remains the country's large population, which offers a huge pool of patients. As China represents an estimated fifth of the world's population, it is likely that major diseases found elsewhere in the world will affect a sizeable number of people. An additional consideration is the rapid rate of urbanization, which has important healthcare implications. By 2050, 600 million Chinese people are expected to move from rural areas to urban districts. At present, China has more than 660 cities and 19000 towns. By 2050, 80% of towns will have grown into small- or medium-sized cities.⁴

Rapid urbanization can transform the environment as people compete for limited natural resources and space, leading to overcrowding and poor hygiene, as well as a change in social attitudes. The growing number of trials being run in the infectious disease therapeutic area reflects this trend in urbanization; for example, approximately 25% of the patients enrolled in Novartis's ongoing chronic hepatitis B Phase III clinical trial, the GLOBE study, are from Chinese centres.⁵

Apart from patient numbers, there are other attractions for conducting clinical trials in China, including positive patient attitudes and low costs. As the majority of the population is very poor, they have extremely limited access to healthcare. For such patients, clinical trials are seen as a means to receive free medical treatment and care.

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Another area that is becoming clearer to assess because of greater foreign company involvement is operational costs. Current thinking suggests that, in terms of general running costs, clinical trials can be conducted in China for approximately 10% of the equivalent cost in a Western country. More specific domestic estimates suggest that Phase I clinical trials in China are 15% of the price in the West, while Phase II trials cost 20% of the price in the West.³These estimates are in-line with comments from the former CEO of AstraZeneca, Sir Tom McKillop, who was cited in a 2006 edition of the Wall Street Journal as stating that a major postmarketing clinical trial for two cardiovascular drugs (involving 46000 patients in 1250 hospitals in China) cost US$3 million (€1.9 million).⁶Such a trial would be impossible to run in the West or Japan at the same low cost.

Regulations

When companies are interested in conducting a clinical trial, they first approach the Chinese State Food and Drug Administration (SFDA), after which they may choose one of the accredited hospitals from an official list for their study. In China, only medical institutes officially certified as 'National Institutes of Pharmaceutical Clinical Trials' by the SFDA may conduct clinical trials. At present, affiliated hospitals of medical universities, some large public hospitals and specialist hospitals can obtain certification, and Chinese hospitals have also become interested in competing for clinical trials. Each major hospital has a science and education department whose task is to document their involvement in clinical research. Physicians in charge of such departments have at least 10 years' experience and undergo continuous medical education training.