Interestingly, after posting the blog that stated that India is the next hot destination for clinical trials, read another article which stated China to be the next hot place for global clinical trials.
Here is an excerpt from the same...
The numbers being bandied about suggest $2 billion in Chinese pharmaceutical research and development in 2008. That's expected to surge to $10 billion by 2010. The Chinese government just committed $1 billion toward jump-starting its biotech industry. So there is no doubt the potential for research in China is massive.
Difficulties:
....there's also a big issue around the start-up time for trials. Formal approval from the SFDA is required before conducting a trial; it can take between six months and a year to obtain. The good news is that an approval is valid for three years, allowing sponsors and CROs to plan ahead. Folks hoping to get started right away will be sorely disappointed.
As in any emerging clinical trial market, informed consent is an issue in China. Garrett observes that, ten years ago, when her CRO was setting up shop in Shanghai, she hired linguistics experts to translate its documents into Mandarin Chinese. The company was startled to learn the language had no equivalent terms for “to inform” or “to consent.” That lead to problems, she recalls. Now, patients considering a clinical trial must go through classes to ensure that they understand elementary issues related to consent...
Staffing: As in India, it will get worse before it gets better. Jenny Zhang, senior director of business development for the CRO Tigermed Consulting, pointed out that though the clinical trial market may be growing by 40 percent per year, the number of qualified workers in the field is only growing by about 20 percent.
China joined the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) in March of 2008. Before that, the country had its own version of Good Clinical Practice (GCP) guidelines, which closely resembled ICH GCP, says Zhang. Those guidelines required that all sites participating in a trial be China GCP-certified. Since that was enacted six years ago, 325 institutions have gotten the permit. That's only a fraction of China's 18,000 hospitals and 1.9 million doctors.
Postapproval Boom
Phase I studies, as in India, remain off limits unless the tested compound was originally developed in China. Phase II and III remain a virtually untapped market. So the lion's share of the projects to date have been in Phase IV.
As a result, most research in China need not comply with GCP. Chinese regulations do not allow drugs to be sold there unless they have already been approved elsewhere. But drugs must be tested in a Phase IV trial in China to reach its market. So most of the trials in China haven't been global research projects but needed to gain access the Chinese market.
Adding it all up, China's population of 1.3 billion virtually guarantees it will be a major research hub in the future. But the country still has work to do before a global clinical trials industry can flourish there.
