Characteristic analysis of clinical trials for new traditional Chinese medicines in mainland China from 2013 to 2021

Abstract

ObjectiveBased on the clinical trials registered on the platform for the registry and publicity of clinical drug trials of the National Medical Products Administration (NMPA), the registration and approval of clinical trials of traditional Chinese medicines (TCMs) in mainland China from 2013 to 2021 were reviewed.MethodsClinical trials of new TCMs published in Chinese were retrieved from the platform for the registry and publicity of clinical drug trials. The number of registered trials and approved trials, status of clinical trials, therapeutic area of clinical trials for the treatment of diseases, type of trial design, sample size, sponsors, and leading clinical trial centers were evaluated.ResultsFrom 2013 to 2021, a total of 965 clinical trials of new drugs applied in TCM were registered on the aforementioned NMPA platform, comprising 117 phase I trials, 586 phase II trials, 174 phase III trials, 40 phase IV trials, and 48 other clinical trials. The treatment fields included the respiratory system, alimentary tract and metabolism, genetic system and reproductive hormones, and cardiovascular system. Among the 760 phase II and phase III trials, 98.9% were randomized, 95.4% were double-blind, and 98.2% were parallel controlled trials, and the proportion of placebo-controlled trials increased year by year from 2013 to 2021. From 2013 to 2021, 123 new TCMs were approved in mainland China.ConclusionFrom 2015 to 2021, the number of registered clinical trials of new TCMs remained low. The approval rate was also low, but the clinical trial design was greatly improved.

Heavy Metals, Halogenated Hydrocarbons, Phthalates, Glyphosate, Cordycepin, Alcohol, Drugs, and Herbs, Assessed for Liver Injury and Mechanistic Steps

“…Problematic are plants containing 1,2unsaturated pyrrolizidine alkaloids (PAs) if they are used as traditional medicines [306]. Recognized as important issue, efficacy of medicinal herbal products is often poorly approved using RCTs [308], but efforts of continued improvements are recognizable as update of the International Society of Pharmacovigilance China Chapter [309] and quality improvement of RCT evaluations although many rele- vant publications are still only in Chinese language available [310]. While efficacy of herbal medicinal products remains an actual and largely intransparent clinical issue, adverse reactions including liver injury classified mostly as idiosyncratic and rarely as intrinsic HILI are well documented in worldwide published 12,068 RUCAM based cases [16], in addition to 11,160 RUCAM based HILI cases from the Asian region [311], for which RUCAM was used for causality assessment either in its now preferred updated version of 2016 [22] or as original of 1993 [312].…”

Analysis of Clinical Trials Using Anti-Tumor Traditional Chinese Medicine Monomers

“…Previous studies provided detailed analyses of the drug development profile in China, 13 the characteristics of clinical trials of new TCMs, 14 and the clinical trials on specific tumors. 15 , 16 However, there are few reviews worldwide summarizing the characteristics of clinical trials that used anti-tumor herbal monomers.…”

Development of clinical trials for non-small cell lung cancer drugs in China from 2005 to 2023

“…Clinical trials are the gold standard for the evaluation of the safety and efficacy of therapeutics and the generation of evidence-based knowledge in the field of medicine ( 5 , 6 ). The legitimacy of clinical trials can be ensured by informed consent, data collection of clinical trial processes, and quality assurance systems.…”