Development of general considerations for clinical research and assessment index for cancer clinical trials on traditional Korean medicine

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With the tremendous expansion in the use of Traditional Korean Medicine(TKM) worldwide, safety and efficacy as well as quality control have become important issues. Researchers and pharmaceutical manufacturers were increasingly requesting KFDA to provide standards and information on these concerns. This guidelines were carefully developed through the various experts' opinions, guidelines of KFDA, WHO, EMEA, FDA, NCI, TGA and ICH related to clinical study. The contents of the "General considerations for clinical research on TKM" are definition, general concerns, methodologies for research and evaluation of TKM products. The methodologies are composed of basic principles, sample size, study design, selection of patients, control groups, randomization and blind assessment, study outcome measure and safety and efficacy assessment, interaction between drugs, evaluation of quality of life, traditional medicinal diagnosis and other issues related to clinical trials. The "Assessment index for cancer clinical trials on TKM" suggest that syndrome improvement is mainly evaluated by Zubrod and Karnofsky(%) methods. Questionnaire on physical, emotional, cognitive, social and role subjects availability, three more syndromes (Fatigue, Pain and Nausea/Vomit), quality of life(QOL) will be evaluated by GLM statistics. The assessment endpoints for efficacy to reduce side effects induced by chemotherapy and radiotherapy, the data of image scanning and hemato-urinalysis can be usefully applied on immune response, weight loss, indigestion, hematopoietic damage and injury of liver and kidney. However, it is still necessary to determine the ratio between scientific analytical method and traditional medicine differentiation method as well as confirm the traditional medicine assessment endpoints by clinical trial. These guidelines could be contributed to improving of the quality and value of clinical research in TKM and developing of TKM.