Current statistical requirements for pharmaceutical clinical trials in China

During the past several years, China has issued a number of drug regulations and guidelines. Based primarily on international guidance such as ICH guidance and FDA regulations, these draft and final guidelines greatly improve the approval process of pharmaceutical products in China. Understanding these guidelines is useful to international companies interested in conducting clinical trials in China and entering the Chinese pharmaceutical market. The purpose of this article is to describe the development and contents of the Chinese version of Guidelines on Statistical Principles (GSP) for Clinical Trials, issued in March 2005. We discuss some successes as well as challenges in implementing the Chinese GSP, and what can be anticipated for future clinical trials in China.