CommentaryCreative and innovative good practice in traditional Chinese medicine clinical studies: Strategies for sustainable development
Section snippets
SRs and meta-analyses
In view that many TCM SRs are often filled with mistrust, the GP-TCM RA aims to provide a strategic direction for future SRs. There is a special interest in “answering creative and urgent questions”. For example, we have noted that toxicity profiles have often been ignored in many studies, and it is believed by European and Chinese TCM practitioners that very few species used in TCM herbal preparations in the EU give rise to safety concerns and that in China, only a few toxic species are
Stratified randomized controlled trials
To achieve the ideal of personalized medicine and to adapt to the personalized features of TCM, scientific evaluation of the efficacy of TCM treatment should focus on specific subgroups of patients with specific diseases and on specific herbal preparations with clinically proven effectiveness. In TCM clinical practice, TCM pattern classification is an important route to personalized medicine. Further classification into specific TCM and modern diagnostic categories, including omics-based
Methodology research
Although the methodological quality of RCTs has been improving in recent years, several problems persist (Tang et al., 1999, Mao et al., 2007, CONSORT Group for Traditional Chinese Medicine, 2007). A key consideration is that TCM clinical studies involve low-trust and high-concern situations (Vickers et al., 1998, He et al., 2011, Ernst, 2013). Therefore, in uncertain and high-risk situations, building credibility among researchers is a critical aspect of a methodological research plan. The
Communications network
Communications in TCM clinical studies depend on an interactive process of exchange of information involving clinical data, literature assessments, expert opinion and professional opinions. Collaborations through multi-national clinical trial units can contribute expertise in trial design, support practitioners in standard CHMs supply and expand clinical data access and thus, are important. The goal of CSIG is to provide timely, thoughtful, solution-oriented, and collaborative information.
Conclusions: ability to make development of TCM clinical studies sustainable
The conclusions of this commentary are three-fold: meaningful questions; proper procedures; and inspired collaborations.
Construction of a “Design, Measurement and Evaluation Platform for TCM Research” is highly recommended to assist investigators in determining whether a SR is suitable for a certain purpose and whether a trial is properly designed and clinically meaningful.
We also aim to expand clinical data access to researchers to enable future discoveries of links between omics and
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