Evaluation of Traditional Chinese Medicine Herbs in Oncology Clinical Trials.

Despite wide empirical use and demand for traditional Chinese medicine (TCM) herbs worldwide, high-quality clinical trials of TCM herbs in oncology are limited. We developed recommendations for rigorous clinical trials to evaluate their safety and efficacy for oncology patients. To accomplish this goal, the TCM & Cancer Research Committee of the Chinese Pharmaceutical Association convened a working group of oncologists, TCM experts, clinical researchers, biostatisticians, and industry/government representatives to develop principles and approaches for TCM cancer drug clinical trials. They identified 2 categories of herbal drugs based on therapeutic intent: survival improvement and symptom management. The working group also emphasized the need to adopt international standards when appropriate for TCM herbal drug approval and to develop methodology to standardize diagnostic criteria, treatment approaches, and outcome measures according to defining TCM characteristics. These recommendations aim to improve study design and methods to inform rigorous investigation of TCM herbs in patients with cancer.