China's Clinical Trials

The emergence of China as a market for clinical trials offers sponsors an attractive alternative. But is China's regulatory regime sufficienty robust?

Treatment populations for clinical trials in Western countries are shrinking, and sponsor manufacturers are therefore looking closely at "emerging markets" for the solution. One of these emerging markets is China.

China's offering for clinical trial sponsors looking to explore farther afield includes the following:  

• An ageing population, reflective of the advances in healthcare and nutrition, and the now historical one child policy 
• A densely populated pool of patients, meaning lower costs 
• Government support, following a decade long focus by the Chinese government on the development of new drugs  
• An upgraded regulatory infrastructure, with the introduction of new anti-corruption disciplinary rules and recent regulations to promote good clinical practices  

The updated infrastructure has the potential to improve the quality of clinical trials undertaken in China. Indeed, Astra Zeneca has reportedly "expressed confidence" in its Phase III trial programme in China, specifically for prospective immuno-oncology treatments, and will "expand its activities in pursuit of a strong regulatory submission there".  

However, reports in late 2016 questioned whether the new regulations have been enforced effectively. China's regulator, the CFDA (Chinese Food & Drug Administration), undertook an investigation into 1,622 clinical trials for new pharmaceutical drugs that were awaiting approval, finding that more than 80% of the data failed to meet the analysis requirements (some including potentially fraudulent activity).  

We can expect to see further regulatory enforcement in the coming years as part of China's ambition to achieve a gold standard clinical trial practice, as well as efforts to improve the infamously slow approval process (already seen in recently announced policy changes to allow drugs to get into the clinic faster). International sponsors should be both cautious and encouraged.  

Sponsors thinking of running clinical trials in China should consider:  

• Planning for a lengthy application process at the outset 
• Recruiting nationals or Chinese speakers to assist on the ground 
• Investing in specialists to guide them through the regulations 
• Liaising closely with the CFDA