On Traditional Chinese Medicine Clinical Trials

In recentyears, the Westernization of traditional Chinese medicine (TCM) has attracted much attention in pharmaceutical research and development. One of the key issues in Westernization of TCM is how to conduct a scientifically valid clinical trial to evaluate safety and effectiveness of the TCM under investigation. A typical approach is to conduct a clinical trial the Western way by ignoring the fact that there are fundamental differences between a TCM and a West-em medicine intended for the same indication. These fundamental differences include (1) medical theory/mechanism and practice (ie, the concept of global dynamic balance/harmony among organs of the body versus local site of action); (2) techniques for diagnosis (ie, subjective diagnosis of inspection, auscultation and olfaction, interrogation, pulse taking and palpation versus objectively clinical evaluation); and (3) treatment (ie, personalized flexible dose of multiple components versus fixed dose). In this article, some practical issues, including validation of a quantitative instrument, the use of matching placebo, and sample size calculation when conducting a TCM clinical trial are discussed. We also discuss strategy for statistical quality control (QC) for raw materials, in-process materials or final product in terms of testing for consistency, stability analysis for estimation of drug expiration dating period, and regulatory requirements for future TCM research and development.