Traditional Chinese medicine (TCM) has some unique advantages in the prevention and treatment of cancer. Due to different ideas and mechanism of between TCM and biomedicine in the prevention and treatment of cancer, the clinial effect evaluation approches of biomedicine could not be used as a beneficial method to scientifically evaluate the effects of TCM. From three angles, this article analyzes the key issues regardsing the evaluation methods of TCM as an adjuvant therapy of cancer. It draws lessons from the idea of quality-adjusted survival (QAS), proposes Two-in-One (TIO) method to evaluate the effects of TCM as adjuvant therapy of cancer, which reflects the combined value of the individual patient dynamic information and provides methodological support for the effect evaluation of TCM.
With the implementation of “Good Clinical Practice”, the quality of clinical trials in China has increased constantly and more importance has been attached to the protection of the subject. Large scale clinical trials are primarily featured by long-term intervention, large sample size, many participant organizations, different levels of investigators, long test periods, and lots of adverse events. Consequently, the protection of subject is full of extensive complexities and difficulties and currently there is little experience to refer to. Hence, the article introduces the subject’s protection method adopted in the National Program Subject of Secondary Prevention Clinical Trial about Effect of Qi Shen Tonifying Qi on Myocardial Infarction (MISPS-TCM).
To aim directly at the individualized character and tendency about clinical assessment of Traditional Chinese Medicine (TCM), we draw off a new pathway which is evidence-based goal attainment scale(EBGAS) in the text. i.e., we will develop clinical individualized assessment method of TCM on account of GAS by the approach of evidence based medicine.
Based on evidence-based medicine (EBM) and from the viewpoint of providing scientific evidence for clinical application, we found that Traditional Chinese Medicine (TCM) was short of adequate evidence to support its therapeutic effects due to lack of high quality clinical research. Data management plays a very important role in clinical research. Lack of adequate data management may lead to low quality clinical research. Thus, it is of great importance to establish a set of standards for data management so as to improve the quality of clinical research. Based on the real practice in Myocardial Infarction Secondary Prevention Study in TCM (MISPS-TCM), this article introduces methods on data audit in clinical trials of TCM.