On Traditional Chinese Medicine Clinical Trials
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STAT 1ST I (5
On Traditional Chinese Medicine Clinical Trials
Shein-Chung Chow Duke University School of Medicine, Durham, NorthCarolina, USA E' . ISm
395
Annpey Pong Medical Research Inc., Ridgefield Park, NewJersey, USA
Yu-Wel Chang Carol Electronics Co., Ltd, Research and Development Division, Taichung, Taiwan, ROC
In recent years, theWesternization of traditional Chinese medicine (TCM) has attracted much attention inpharmaceutical research anddevelopment. One of thekey issues in Westernization of rCM is how to conduct a scientifically valid clinical trial to evaluate safety andeffectiveness of the rCM under investigation. A typical approach is to conduct a clinical trial theWestern way by ignoring the fact that there are fundamental differences between a rCM anda Western 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 ofthebody versus local site ofaction); (2) techniques for diagnosis (ie. subjec-
tive 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, theuse of matching placebo, and sample size calculation when conducting a rCM clinical trial are discussed. We also discuss strategy for statistical quality control (QC) for raw materials, inprocess materials or final product in terms of testing forconsistency, stability analysis for estimation of drug expiration dating period, and regulatory requirements for future rCM research anddevelopment.
Key Wards Global balance/harmony; Calibration; Validation; Test for consistency; Multiple components; Flexible dose Correspondente Address Yu- Wei Chang, Carol Electronics Co., Ltd., Research and Development Division. No. 202, TungKuang Road, Taichung, Taiwan, ROC (e-mail: [email protected]).
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INTRODUCTION In recent years, as more and more innovator drug products are going off patent, the search for new medicines that treat critical or lifethreatening diseases has become the center of attention of many pharmaceutical companies. As indicated by Chow and Liu (1), pharmaceutical research and development is a lengthy and costly process. On average, it may take more than 12 years to bring a promising compound to the market. The probability of success, however, is usually very low. In the past decade, tremendous effort was put on drug research and development, yet only a handful of new drug products were approved by the regulatory agencies. As a result, an alternative approach for drug discovery is necessary. This leads to the study of the potential use of promising traditional Chinese medicines (TCMs), especially for those intended for treating critical or Ii fethreatening diseases. ATCM is defined as a Chinese herbal medicine developed for treating patients with
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