Updated on 13 April 2012
In China, most people are not fluent nor proficient in English. Currently, all documentation must be submitted in Mandarin Chinese, the official language of China (850 million speakers). Other main languages spoken in China include Wu (90 million speakers), Min (70 million speakers), and Cantonese (70 million speakers). The extent and complexity of these secondary languages are important factors for getting accurate results from clinical trials. Medical practices such as acupuncture and herbal medicine, as well as cultural differences that affect medical practice are also paramount factors in China.
With rapid growth in the research arena there is currently a shortage of qualified staff and the number of trained staff to conduct the increasing number of trials compared to the amount of work coming to China is increasing. This aspect is probably going to be the biggest challenge in coming years and more efforts and better ways of training people involved in clinical trials in China is urgently required.
China offers tremendous opportunities such as low cost, increase in potential revenue and the availability of large pool of patients, many of which are treatment nave, but the hurdles for conducting research in China are more daunting, but the benefits can be large. Even smaller companies with very limited resources can benefit from conducting their trials in China provided it is borne in mind that strategies and regulatory procedures employed in other countries will not always work when doing business in China. There are also significant challenges within the Chinese pharmaceutical market, including hospital sector problems, procurement policies and intellectual property infringement. Any company looking to conduct clinical research in China is strongly advised to work with an established partner or a contract research organization that has knowledge of the local regulations, testing facilities, etiquette and culture. This will not only smooth things and help absorb some of the frustrations, but will also make research work in China more interesting and rewarding.
The author Mr James Thorburn, director, Clinical Trial Concepts Limited, Hong Kong, has experience in both early and late stage pharmaceutical studies. He has worked on clinical trials in Europe, the UK and Hong Kong, where he managed all aspects of clinical research. He was responsible for the recruitment and training of investigators, preparation of ethics committee submissions, writing study protocols, designing case report forms and informed consent documentation, study monitoring, and training of in-house clinical research associates.