Conducting clinical trials in China

Ming Wang, MD, PhD 

Founding president, Tennessee Chinese Chamber of Commerce (www.tccc.us)

Clinical associate professor of ophthalmology, University of Tennessee 
Director, Wang Vision Cataract and LASIK Center, Nashville, TN, USA

drwang@wangvisioninstitute.com, www.WangCataractLASIK.com 

- China is the country with the fastest growth, in clinical trials, from 2005 to 2008, the increase is 75%, in 3 years.

- There are nearly 2,000 registered trials in China today.

- China represents the second largest pool of venture capital investment for start-up life sciences organizations, trailing only the U.S..

- Among all countries, China has shown the largest improvement in its medical technology innovative capacity and is expected to outpace other countries and reach near parity with the developed countries of Europe by 2020.

- Global figures for clinical trial recruitment highlights a dramatic shift away from the U.S. and towards Asia. In 2002, 53% of the patients recruited globally were in North America; in 2008, that figure was down to 32%. Today, Asia represents 11%, while Europe represents 17%.

- An increasingly popular route, for product approval is: run a study in China, submit to U.S.' FDA, and China's SFDA (State Food and Drug Administration).

- The cost of running a trial in China is 40-50% less, than that of U.S.

- The duration is a 12-14 month process.

- Hiring a contract research organization (CRO) is one of the ways to go about it.

- At U.S. FDA: in 2008, 8% of the FDA approval relies exclusively on foreign data; 80% involves data from at least one foreign country. Most remarkably, at U.S. FDA, for all clinical studies approved, 78% of all human subjects were enrolled at foreign sites including locations in China.

- Finding qualified investigator and investigative sites (there are only about 300 in China) is the key.

- There are non-uniformities, in trial experience, standard, oversight, ethics committee standard, etc. etc.  

Overall, China is rising rapidly as a more attractive clinical trial site, than even the U.S., outpacing in terms of growth speed, among all nations. Government is working hard to shrink the trial time and do it right (while here in the U.S., FDA is working hard towards procrastinating forever!)