Adaption and Application of the Four Phase Trials to Traditional Chinese Medicines

Abstract

Four phases of trial are widely used in testing drugs, surgery, and diagnosis in Western medicine (WM). The staged testing process helps protect patients from unnecessary harms and control costs while assessing safety and efficacy. In this paper we adapt the four phase trials for traditional Chinese medicine (TCM). As TCM has been used in humans for thousands of years and there has been good preliminary clinical evidence on safety and efficacy for many of its therapies, in most cases its evaluation can start directly in humans, and preclinical laboratory research can be conducted in phase 4 trials after the efficacy is firmly demonstrated. Furthermore, unlike investigational drugs, TCM therapies are various in the certainty of their safety and efficacy and thus should not enter the evaluation process at the same stage. Unlike in WM, clarifying and refining PICO (patients, intervention, comparator, and outcome) are an important part of evaluation of newly designed TCM therapies. The incommensurability between WM and TCM causes additional difficulties in TCM trials regarding defining and choosing PICO, for which some suggestions are made. Observational studies seem to have a greater role in evaluation for TCM although the efficacy must be confirmed with randomized trials.

Reporting quality of economic evaluations of the negotiated Traditional Chinese Medicines in national reimbursement drug list of China: A systematic review

“… 11 Because of the unique characteristics of TCM, like individualization and holism, it is more challenging to evaluate the safety, efficacy, and cost-effectiveness of TCM treatments than Western Medicine protocol. 12 And there is still no consensus achieved on the health economic evaluation of TCM among academics. 13 In addition, pharmacists and clinicians performed most TCM pharmacoeconomic studies and the disconnection between real clinical practice and the pharmacoeconomic study hinders its quality and usability.…”

PRAgmatic Clinical Trial Design of Integrative MediCinE (PRACTICE): A Focus Group Series and Systematic Review on Trials of Diabetes and Kidney Disease

“…This affected the clinical utility of the evidence (18) and was contradicted with many core principles of TCIM. The efficacy-driven approach, which focuses on comparative effectiveness, has been proposed to bridge ConM and TCIM (8,(19)(20)(21)(22).…”

Clinical Research of Traditional Chinese Medicine Needs to Develop Its Own System of Core Outcome Sets

“…Clinical research in TCM has been developed relatively later. Largely due to the many existing methodological defects of TCM trials, the efficacy of TCM remains controversial [ 1 , 2 ]. All these issues have created a bottleneck in the development of TCM.…”