Novel Design for Validation of Study Endpoints in TCM Clinical Trials |Biomedgrid

In recent years, the search for traditional Chinese medicines (TCM) for treating patients with critical and/or life-threatening diseases has attracted much attention in the pharmaceutical industry. However, the evaluation of safety and efficacy of a TCM under investigation has been criticized due to its subjectivity (i.e., experience based rather than scientific based). Thus, statistical validation of study endpoints (usually based on a quality of-life-like instrument) is essential to have an accurate and reliable clinical assessment of the performance of the TCM under study. Hsiao et al. [1] proposed some statistical methods for calibration/validation of Chinese study endpoints against Western clinical endpoints in terms of the performance characteristics of validity, reliability, and ruggedness under a valid study design. In this article, we proposed some innovative study designs for calibration/validation of Chinese study endpoints against Western clinical endpoints. under certain considerations of study design.