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Clinical trials in China: the potential and pitfalls

Mar. 31, 2017

Clinical trials are a global industry, but many companies are reconsidering where they will conduct their work in the future. One of the most promising locations is China. The potential for clinical trials in China is great, but not without significant challenges.

The industry is in a state of flux. At present, the bulk of clinical trials occur in the West. Statistics from SCORR Marketing’s recent China Clinical Trials, Survey Report (2015) suggested that 62% of companies conduct clinical trials in North America, with Europe trailing close behind with 57%. Companies who say they conduct clinical trials in Russia, India, China, and the rest of East Asia are 47%, 45%, 41% and 40%, respectively. These numbers, however, are forecast to change.

Regions such as Latin America (presently 33%) and North Africa/the Middle East (presently 29%) are expected to see increases, but the country predicted to see the largest rise in clinical trials is China. Why China? There are a number of factors.

The risk and rewards of Chinese clinical trials

The growth potential for clinical trials in China makes perfect sense when considering the country’s size and economy. With a population of 1.38 billion in late 2016, China presents clinical trial companies with countless potential recruits. Moreover, China has the world’s second-largest pharmaceutical market, with a projected 9.1% annual growth. This means that the $108 billion pharmaceutical market of China in 2015 will swell to $167 billion by the year 2020.

The Chinese market comes with a number of risks, as well. The language barrier is one of the largest challenges, as is the increasing shortage of fully trained and certified experts in the clinical trials field. Then there is the issue of quality control: China’s Food and Drug Administration recently concluded that up to 80% of clinical trials conducted in the country may contain tainted or otherwise falsified data. Add the rising costs associated with doing business in the country, and the challenges of clinical trials in China are brought into stark relief.

China: the way forward

One of the most common practices for companies entering the Chinese market is to partner with a domestic provider. With over 300 companies specializing in clinical trials in China, these domestic partners provide local English-speaking staff and help navigate Chinese bureaucracy.

China offers a tantalizing array of possibilities for clinical trials, but not without significant risks. Its population and rapidly expanding domestic markets offer the promise of growth. However, problems such as tainted data, an expertise gap and the language barrier present real concerns for anyone considering entering the market. To be successful in the China, companies will need to address the country’s risks in order to reap the rewards. Finding the right local partners and the right local talent will play a major role in that success.

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