JIN Qiubai, ZHANG Ying, JIANG Feng, et al. The Key Elements of Response Adaptive Randomization and Its Application in Clinical Researches of Traditional Chinese Medicine[J]. Journal of Traditional Chinese Medicine2021, 62(17): 1478-1483.
JIN Qiubai, ZHANG Ying, JIANG Feng, et al. The Key Elements of Response Adaptive Randomization and Its Application in Clinical Researches of Traditional Chinese Medicine[J]. Journal of Traditional Chinese Medicine2021, 62(17): 1478-1483.DOI: 10.13288/j.11-2166/r.2021.17.002.
Compared with traditional randomized controlled trials
response adaptive randomization(RAR) could not only balance between scientific inference and research ethics
but also maximize the benefits of the subjects. Through systematically reviewing the publications which ever used or will use RAR
and considering the characteristics of clinical trials in traditional Chinese medicine(TCM)
this study discussed the application conditions
implementation key elements
advantages
and limitations of RAR. The many advantages of using RAR in TCM clinical trials are mainly reflected as screening of different TCM prescriptions for the same disease and syndrome; screening of the superior dosage(s) for the same prescription; selecting the most promising treatment from potential drug candidates when confronted with the outbreak of new diseases. Simultaneously
challenges such as higher technical difficulty
increasing research cost
determination of the main outcome(s) and the representativeness of the subjects are faced by RAR to be dealt with.