ABSTRACT

As indicated earlier, most Western medicines contain single active ingredients for treating patients with the specific disease (e.g., cancer) under study. Statistical methods for clinical evaluation of the active ingredient in terms of some well-defined study endpoints (e.g., response rate, time to disease progression, and median survival time) are well established. Unlike Western medicines, most traditional Chinese medicines (TCMs) often consist of multiple components (active and inactive). Thus, standard methods for clinical evaluation of Western medicines cannot be applied directly to evaluate the safety and efficacy of TCMs. In practice, TCMs can be viewed as combinational drug products with known or unknown ratio of combination of the multiple components. In practice, it is difficult to evaluate the safety and efficacy of traditional Chinese medicine due the following reasons that (1) there is a large number of components (e.g., say up to 12-15), (2) some individual components cannot be characterized, (3) it is not clear which components are active and which components are inactive, (4) the relationships among these components are unknown, and (5) the ratio of the combination is often unknown.