1. A randomization and trial supply management system for adaptive clinical studies of TCM and its scientific research application in recurrent tuberculosis
- Author
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Liu Baoyan, He Liyun, Lv Xiaoying, Wen Tiancai, Wang Xin, and Zhang Yanning
- Subjects
medicine.medical_specialty ,Randomization ,Tuberculosis ,business.industry ,Management efficiency ,030206 dentistry ,Traditional Chinese medicine ,medicine.disease ,law.invention ,Clinical trial ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,law ,Data quality ,Supply management ,medicine ,Medical physics ,030212 general & internal medicine ,business - Abstract
In recent years, a growing number of dynamic, double-blind and randomized trials for traditional Chinese medicine (TCM) have been designed with adaptive treatment regimens. The blind envelope or current randomization and trial supply management (RTSM) system have not met this requirement. Therefore, a more efficient platform for subject randomization and medicine dispensation was required. After we had done much research on dynamic TCM treatment trials’ protocols, a new RTSM was designed and developed, which is suitable for TCM clinical trial during randomizing the groups for subject and medicine allocation in China. In a recurrent tuberculosis study of TCM, this RTSM system was involved in the management of subjects and medicines. By this system, a suit of TCM formulas or placeboes were assigned to patients based on their TCM syndrome diagnosis results by investigators at different visit points. The new RTSM system was convenient to operate, reduced operational errors, enhanced the management efficiency, and improved the data quality.
- Published
- 2018