Wednesday, August 19, 2009

Everything You Always Wanted to Know About Clinical Research in China, But Were Afraid to Ask

After scandals involving tainted toothpaste, poisonous pet food, adulterated milk, contaminated heparin, and counterfeit medicines, and a thriving trade in organs, one shudders to imagine how well human subjects are protected in drug studies performed in China. Apart from an occasional report in the medical literature, there is little easily accessible information about Chinese human protections: the regulations and laws, compliance and enforcement, and professional standards. This information would be interesting in its own right; however, it is all the more essential given trends towards trans-national trials.

A recent report issued the Medical Research Council (UK) provides some indication of China's system of human protections, and how researchers in countries like UK might proceed when locating trials in China. The executive summary finds that Chinese regulations substantially parallel those of the International Committee on Harmonization (ICH). Informed consent and independent ethics review is required for any study. However, the UK and China "differ greatly in their approaches to enforcing guidelines for the conduct of research at the national level. In China, although there is some scrutiny of clinical trials, there is comparatively little inspection or review of compliance." Other intriguing mentions are concerns about undue inducement in China: "the high costs of healthcare and medicines, and the dependence on local providers means that particular attention [for UK researchers pursuing studies in China] must be given to potential inducements to participate in research. Collaboration with China may offer attractive opportunities for large-scale recruitment, but potential UK collaborators must be alert to the risk that unethical inducements may be offered to potential participants. ... given the high cost of accessing health care in China, a ‘free health check’ may be a relatively greater inducement than it would be deemed to be in the UK."

A perusal of the Chinese regulations- at least the ones provided in this report- indicate the following:

• China places heavy emphasis on procedure (e.g. IRB review) and informed consent, rather than substance (e.g. prohibitions on certain practices; definitions of minimal risk; categories of patients)

• China seems to take a very permissive stand (like ICH) on the use of placebos. Indeed, there is no mention of studies involving placebo.

• There is no mention of justice considerations- for example, post-trial access or responsiveness.

(photo credit: 2 dogs, 07/03/25 12:32:09 Shanghai, 2007)

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