scholarly journals Factors influencing the quality of clinical trials on traditional Chinese medicine—Qualitative interviews with trial auditors, clinicians and academic researchers

2019 ◽  
Vol 37 ◽  
pp. 109-114
Author(s):  
Xue-yan Han ◽  
Xun Li ◽  
Ning Liang ◽  
Yu-qian Yan ◽  
Ying Wang ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Qualitative Interviews ◽  
Factors Influencing ◽  
Academic Researchers

scholarly journals Calling for improved quality in the registration of traditional Chinese medicine during the public health emergency: a survey of trial registries for COVID-19, H1N1, and SARS

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Zhuoran Kuang ◽  
◽  
Xiaoyan Li ◽  
Jianxiong Cai ◽  
Yaolong Chen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Secondary Outcome ◽  
Specific Information ◽  
Clinical Trial Registry ◽  
Data Set ◽  
Diagnosis Criteria

Abstract Objective To assess the registration quality of traditional Chinese medicine (TCM) clinical trials for COVID-19, H1N1, and SARS. Method We searched for clinical trial registrations of TCM in the WHO International Clinical Trials Registry Platform (ICTRP) and Chinese Clinical Trial Registry (ChiCTR) on April 30, 2020. The registration quality assessment is based on the WHO Trial Registration Data Set (Version 1.3.1) and extra items for TCM information, including TCM background, theoretical origin, specific diagnosis criteria, description of intervention, and outcomes. Results A total of 136 records were examined, including 129 severe acute respiratory syndrome coronavirus 2 (COVID-19) and 7 H1N1 influenza (H1N1) patients. The deficiencies in the registration of TCM clinical trials (CTs) mainly focus on a low percentage reporting detailed information about interventions (46.6%), primary outcome(s) (37.7%), and key secondary outcome(s) (18.4%) and a lack of summary result (0%). For the TCM items, none of the clinical trial registrations reported the TCM background and rationale; only 6.6% provided the TCM diagnosis criteria or a description of the TCM intervention; and 27.9% provided TCM outcome(s). Conclusion Overall, although the number of registrations of TCM CTs increased, the registration quality was low. The registration quality of TCM CTs should be improved by more detailed reporting of interventions and outcomes, TCM-specific information, and sharing of the result data.

scholarly journals Quality assessment of clinical trial registration with traditional Chinese medicine in WHO registries

BMJ Open ◽  
2019 ◽  
Vol 9 (2) ◽  
pp. e025218 ◽  
Author(s):  
Xuan Zhang ◽  
Ran Tian ◽  
Zhen Yang ◽  
Chen Zhao ◽  
Liang Yao ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Reporting Quality ◽  
Reporting Rate ◽  
Trial Registration ◽  
Clinical Trial Registration ◽  
Data Set

ObjectiveThis study aimed to assess the registration quality of clinical trials (CTs) with traditional Chinese medicine (TCM) in the WHO International Clinical Trials Registry Platform (ICTRP) and identify the common problems if any.MethodsThe ICTRP database was searched for all TCM CTs that were registered up to 31 December 2017. Registered information of each trial was collected from specific registry involved in ICTRP through hyperlink. The primary analysis was to assess the reporting quality of registered trials with TCM interventions, which is based on the minimum 20 items of WHO Trial Registration Data Set (TRDS, V.1.2.1) plus optional additional three items recommended by ICTRP, and some specific items for TCM information (including TCM intervention, diagnosis, outcome and rationale). Descriptive statistics were additionally used to analyse the baseline characteristics of TCM trial registrations.ResultsA total of 3339 records in 15 registries were examined. The number of TCM registered trials has increased rapidly after the requirement of mandatory trial registration proposed by International Committee of Medical Journal Editors on 1 July 2005, and the top two registries were Chinese Clinical Trial Registry and ClincialTrials.gov. Of 3339 trials, 61% were prospective registration and 12.8% shared resultant publications. There were 2955 interventional trials but none of them had a 100% reporting rate of the minimum 20 items and additional three items. The reporting quality of these 23 items was not optimal due to 11 of them had a lower reporting rate (<65%). For TCM details, 49.2% lacked information on description of TCM intervention(s), 85.9% did not contain TCM diagnosis criteria, 92.6% did not use TCM outcome(s) and 67.1% lacked information on TCM background and rationale.ConclusionThe registration quality of TCM CTs should be improved by prospective registration, full completion of WHO TRDS, full reporting of TCM information and results sharing. Further full set of trial registration items for TCM trials should be developed thus to standardise the content of TCM trial registration.

scholarly journals Systematic Review of the Registered Clinical Trials of Coronavirus Disease 2019 (COVID-19)

2020 ◽  
Author(s):  
Rui-fang Zhu ◽  
Yu-lu Gao ◽  
Sue-Ho Robert ◽  
Jin-ping Gao ◽  
Shi-gui Yang ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Sample Size ◽  
Western Medicine ◽  
Observational Studies ◽  
Small Sample Size ◽  
Small Sample

AbstractBackgroundSince the outbreak of coronavirus disease 2019 (COVID-19), many researchers in China have immediately carried out clinical research scheme of the COVID-19. But, there is still a lack of systematic review of registered clinical trials. Therefore, we conducted a systematic review of the clinical trials of COVID-19 to summarize the characteristics of the COVID-19 registered clinical trials.MethodsThis study is based on the recommendations of the PRISMA in the Cochrane handbook. The databases from the Chinese Clinical Registration Center and the ClinicalTrials.gov were searched to collect the registered clinical trials of COVID-19. The retrieval inception date is February 9, 2020. Two researchers independently selected the literature based on inclusion and exclusion criteria, extracted data and evaluated the risk of bias.ResultsA total of 75 registered clinical trials (63 interventional studies and 12 observational studies) of COVID-19 were obtained. A majority of clinical trials were sponsored by Chinese hospitals. Only 11 trials have begun to recruit patients, and none of the registered clinical trials had been completed; 34 trials were early clinical exploratory trials or in a pre-experiment stage, 15 trials belonged to phrase III and 4 trials were phrase IV. The methods of intervention included traditional Chinese medicine involving 26 trials, Western medicine involving 30 trials, and integrated traditional Chinese medicine and Western medicine involving 19 trials. The subjects were mainly non-critical adult patients (≥ 18 years old). The median sample size of the trials was 100 (IQR: 60 - 200), and the median execute time of the trials was 179 d (IQR: 94 - 366 d). The main outcomes were clinical observation and examinations. Overall, both the methodology quality of interventional trials and observational studies were low.ConclusionsDisorderly and intensive clinical trials of COVID-19 using traditional Chinese medicine and western medicine are ongoing or will being carried out in China. However, based on the low methodology quality and small sample size and long studies execute time, we will not be able to obtain reliable, high-quality clinical evidence about COVID-19 treatment in the near future. Improving the quality of study design, prioritizing promising drugs, and using different designs and statistical methods are worth advocating and recommending for the clinical trials of COVID-19 in China.

Bibliometric Study on the Highly Cited Papers and Correlation Between Citation Frequency and Download Frequency in Chinese Medicine Journals

2021 ◽  
pp. 2153004
Author(s):  
Qinghui Qu ◽  
Xinyang Zhang
Keyword(s):  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Academic Quality ◽  
Academic Journal ◽  
Research Papers ◽  
Highly Cited Papers ◽  
Natural Medicine ◽  
Citation Frequency ◽  
Highly Cited

The purpose of this paper is to retrieve and study the highly cited papers as well as the correlation between the citation frequency and the download frequency of the 20 traditional Chinese medicine journals in China, in order to provide the guidance for improving the influence and academic quality of these journals. Bibliometric analyses were conducted on 1103 papers of 20 traditional Chinese medicine journals from 2011 to 2020 by retrieving for the China Academic Journal Network Publishing Database (CAJD) in China National Knowledge Infrastructure (CNKI). SPSS 17.0 software was used to analyze the correlation between the citation frequency and the download frequency via conducting regression fitting and establishing the mathematical models. The results showed that the total citations of the 1103 papers were 93051 times and the average citations were 84.36 times per paper. The total downloads of the 1103 papers were 2058442 times, and the average downloads were 1866.22 times per paper. China Journal of Chinese Materia Medica ranked first according to the number of papers, total citations and total downloads. The citations of Journal of Chinese Medicinal Materials ranked first based on the number of citations per paper. One of Li’s paper had been cited the most (983 times). There were 629 (57.03%) papers whose first author was from universities. The scopes of the first authors were distributed in 29 regions and 2 special administrative regions (Macao, Hong Kong) in China. The authors from Beijing published 283 (25.66%) papers, ranking number one. The number of papers supported by funds was 882 (79.96%). The research results of correlation showed that the citation frequency and the download frequency of the highly cited papers had a highly positive correlation from both journal and paper level for whether the sample data of journals was normally distributed or nonnormally distributed. The correlation coefficients of the 20 journals at journal level and that at paper level were 0.9765 and 0.6677, respectively. The correlation was better at journal level than that at paper level, while the optimal regression fitting was all cubic polynomial. Among the 1103 papers, there were 684 (62.01%) research papers and 419 (37.99%) review papers. The main citation period of the top 15 papers was from the 2nd year to the 6th year after publication, accounting for 78.39%. Papers on clinical therapeutics research, papers on the pharmacological effects and its mechanism of traditional Chinese medicine, and papers on traditional Chinese medicine and natural medicine were the main source of the highly cited papers of the traditional Chinese medicine journals. Editors of the journals should focus on the above-mentioned research areas to select manuscripts for exploiting the excellent sources extensively, while paying attention to review papers, focusing on national major or key projects, paying attention to network spreading, stabilizing authors with quality services, in order to improve the influence and the academic quality of journals.

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