Real-World Evidence of Traditional Chinese Medicine (TCM) Treatment on Cancer: A Literature-Based Review.

While randomized controlled trials (RCTs) are the gold standard for evidence-based medicine, they do not always reflect the real condition of patients in the real-world setting, which limits their generalizability and external validity. Real-world evidence (RWE), generated during routine clinical practice, is increasingly important in determining external effectiveness of the tightly controlled conditions of RCTs and is well recognized as a valuable complement to RCTs by regulatory bodies currently. Since it could provide new ideas and methods for clinical efficacy and safety evaluation of traditional Chinese medicine (TCM) and high-quality evidence support, real-world study (RWS) has received great attention in the field of medicine, especially in the field of TCM. RWS has shown desirable adaptability in the clinical diagnosis and treatment practice of traditional Chinese medicine. Consequently, it is increasingly essential for physicians and researchers to understand how RWE can be used alongside clinical trial data on TCM. Here, we discuss what real-world study is and outline the benefits and limitations of real-world study. Furthermore, using examples from TCM treatment on cancer, including Chinese herbal medicine, acupuncture, moxibustion, integrated TCM and Western medicine treatment, and other treatments, we elaborate how RWE can be used to help inform treatment decisions when doctoring patients with cancer in the clinic.