Master protocol is a great transformation of clinical trials with complete research network, reasonable design and innovative statistical analysis methods. It is a highly efficient new model of clinical trials which could obtain more medical information with less clinical resources. Clinical researches in the field of oncology using master protocol have already made delightful achievements. This paper introduces the design of clinical trials on angina pectoris of coronary heart disease, myocardial infarction and heart failure for instance and discusses the application of master protocol to clinical researches of Traditional Chinese Medicine combined with the differentiation of syndromes and treatments. We expect to provide new ideas and methods for the design of master protocol on diseases with similary syndrome pattern series of Traditional Chinese Medicine.
Core outcome set (COS) is an agreed and minimal set of outcomes that should be measured and reported in all clinical trials in specific areas of health or healthcare, which can reduce the heterogeneity of outcomes in similar clinical trials, so that much more trials can merge in systematic reviews. Meanwhile, using COS may be easy to identify potential selective reporting bias in clinical trials. The research of COS has been developed for more than 30 years in western countries. At present there are much more researchers focusing on this area in China. However the status and progress of COS remain unclear. This paper reviewed the quantity of COS, the disease distributions of COS, the geographical locations involved in the development of COS, as well as the methodological progress of COS, so as to clarify the general situation of COS.
Evidence-based Chinese medicine is a relatively new discipline which applies the concepts and methods of evidence-based medicine (EBM) to the clinical research and practice of Chinese medicine. It is not only a branch of EBM but also a natural product of the development of Chinese medicine. This paper introduces the theoretical concepts of evidence-based Chinese medicine and reviews the process of its development. It then elucidates the main characteristics of evidence-based Chinese medicine, emphasizes its holistic approach, prescription-syndrome relationship, and its human-centered approach. Research contents and status quo are also summarized to point out the challenges of the production and application of evidence. Finally, we innovatively indicate further research directions on combining individual-based research with population-based research and developing narrative EBM.