Objectives To discuss the methodology of evaluation of traditional Chinese medicine (TCM) placebo simulation effects and the problems of blind implementation and so as to improve the quality of double-blind clinical trials of TCM. Methods Focusing on case of placebo preparation of TCM investigational new drug, simulation effects of the placebo were evaluated in terms of shape, color, taste and smell. The possibility of placebo be a drug and the similarity between placebo and drug were tested. Results There was no significant difference between placebo and investigational new drug to be judged as a drug (P>0.05). As for the similarity between placebo and drug, there was no significantly difference of the shape (P>0.05), for which the similarity was 100%. The color, taste and smell were significant different between placebo and drug (P<0.05), for which the similarity were 50%, 10% and 15% respectively. Conclusions It is very difficult to simulate TCM based on its certain color, taste or smell. Therefore, the subjects and the investigators’ compliance should be kept to avoid breaking the blind intentionally in the process of the trial and the influence of unblinding should be estimated at the end of the trial.
Master protocol with adaptive design is a new complex innovative trial design that combines an adaptive treatment strategy and master protocol. It is more flexible and adjustable. In the complex clinical trial environment, the dynamics emphasized in this design are consistent with the idea of traditional Chinese medicine (TCM) syndrome differentiation and treatment. In this study, we summarized its concept, characteristics and advantages, and we also discussed its application in TCM clinical research. We hope this paper can provide more thinking and suggestions for TCM clinical trials.
Adverse drug reactions (ADR) are one important type of safety data for investigational products and post-market drugs. Standardized coding is beneficial to normative ADR analysis and reporting. However, terms peculiar to traditional Chinese medicine (TCM) are not included in the widely used international adverse reaction terminologies. This paper briefly introduced the differences of World Health Organization adverse reaction terminology (WHOART) and medical dictionary for regulatory activities (MedDRA) which was developed by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). Based on the existing development of TCM terminologies for coding ADRs, basic path for developing internationally recognized TCM terminologies was proposed in this paper.
There is huge clinical value in real world data from traditional Chinese medicine (TCM), but the real world study of TCM faces many challenges, because of its diverse data types, different standards, and serious data island phenomenon. Data governance is the key to transforming real world data into real world evidence. As the last step of data governance, data transformation has not been standardized. The key technologies and methods of data transformation, including data classification, natural language processing, standardization, data system construction, and derivative variables, will be discussed in this article based on the characteristics of real world data of TCM and the current development status of data transformation technology. At the same time, the suggestions of safety control and quality control of data transformation are put forward, and the data transformation system of real world study of TCM is preliminarily constructed, combined with the characteristics of TCM data. It is hoped that this paper can provide references for future real world studies of TCM.