The application of single-arm clinical trials with objective performance criteria in clinical research of traditional Chinese medicine / 中国中西医结合杂志

ABSTRACT

Clinical research of Chinese medicine, due to its own features, is not suitable to be studied by randomized controlled trial methods in some cases. The single-arm clinical trials with objective performance criteria could be taken as a more ideal alternative method. In this paper the basic principles of single-arm clinical trials with objective performance criteria was introduced. Correlated problems of the selection of therapeutic efficacy index, the target identification, case standards, sample size calculation, statistical inference, and interpretation of results were also addressed. This method was scientific and feasible. It can partially solve some problems in the clinical research of Chinese medicine. It has better application prospect.