Administration and quality control of large-scale clinical trials of traditional Chinese medicine

2007 ◽  
Vol 5 (1) ◽  
pp. 1-4 ◽  
Author(s):  
Hongcai Shang
Keyword(s):  
Quality Control ◽  
Clinical Trials ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Large Scale

scholarly journals The Reporting Quality Assessment of Complex Interventions’ Articles in Traditional Chinese Medicine

2013 ◽  
Vol 2013 ◽  
pp. 1-8
Author(s):  
Meng Wu ◽  
Jingqing Hu ◽  
Biaoyan Liu
Keyword(s):  
Quality Control ◽  
Clinical Trials ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Complex Interventions ◽  
Reporting Quality ◽  
Chinese Journal ◽  
Inform Consent ◽  
Ethical Approval ◽  
Selection Of

Objective.To realize the current situation and problems of complex interventions’ clinical trials.Methods.Searching at Chinese Journal Integrated Traditional and Western Medicine and Journal of Traditional Chinese Medicine from 2007 to 2012 by hand, we identified complex interventions’ articles, and then we used the proposed criteria of complex interventions and CONSORT FOR TCM to evaluate.Results.All data is presented as counts with percentages and details in tables.Conclusion.Our evaluation presented that complex interventions have many defects: the selection of the intervention’s components lacks rationale, complex interventions were short of fundamental researches, components’ interactions were ambiguous, and the advantages of complex interventions were not mentioned. Furthermore, explanation of sample size, blind, quality control, ethical approval, and inform consent were neglected in different degrees.

scholarly journals Predicting the Drug Safety for Traditional Chinese Medicine through a Comparative Analysis of Withdrawn Drugs Using Pharmacological Network

2013 ◽  
Vol 2013 ◽  
pp. 1-11 ◽  
Author(s):  
Mengzhu Xue ◽  
Shoude Zhang ◽  
Chaoqian Cai ◽  
Xiaojuan Yu ◽  
Lei Shan ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Natural Products ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Drug Safety ◽  
Large Scale ◽  
Drug Candidate ◽  
Topology Analysis ◽  
Drug Safety Surveillance ◽  
Approved Drugs

As the major issue to limit the use of drugs, drug safety leads to the attrition or failure in clinical trials of drugs. Therefore, it would be more efficient to minimize therapeutic risks if it could be predicted before large-scale clinical trials. Here, we integrated a network topology analysis with cheminformatics measurements on drug information from the DrugBank database to detect the discrepancies between approved drugs and withdrawn drugs and give drug safety indications. Thus, 47 approved drugs were unfolded with higher similarity measurements to withdrawn ones by the same target and confirmed to be already withdrawn or discontinued in certain countries or regions in subsequent investigations. Accordingly, with the 2D chemical fingerprint similarity calculation as a medium, the method was applied to predict pharmacovigilance for natural products from an in-house traditional Chinese medicine (TCM) database. Among them, Silibinin was highlighted for the high similarity to the withdrawn drug Plicamycin although it was regarded as a promising drug candidate with a lower toxicity in existing reports. In summary, the network approach integrated with cheminformatics could provide drug safety indications effectively, especially for compounds with unknown targets or mechanisms like natural products. It would be helpful for drug safety surveillance in all phases of drug development.

scholarly journals Improving Participant Adherence in Clinical Research of Traditional Chinese Medicine

2014 ◽  
Vol 2014 ◽  
pp. 1-5 ◽  
Author(s):  
Wenke Zheng ◽  
Bai Chang ◽  
Jing Chen
Keyword(s):  
Clinical Trials ◽  
Chinese Medicine ◽  
Traditional Chinese Medicine ◽  
Clinical Research ◽  
Large Scale ◽  
Patient Adherence ◽  
Internal Validity ◽  
Poor Adherence ◽  
Trial Protocol ◽  
Past Experiences

Ensuring good participant adherence in clinical trials plays an important role in that poor adherence may jeopardize the internal validity of the trial. Improving adherence in clinical trials on traditional Chinese medicine (TCM) has long been a concern for Chinese researchers who are conducting clinical trials. Drawing on from our past experiences in managing patient adherence in large-scale clinical trials, we identified factors that influence adherence and categorized them by sources into factors with respect to the trial protocol, on the part of the patients and the investigators. On this basis, we developed a series of ways to improve participants’ adherence, while taking into account the characteristics of TCM trials, in the hope of providing reference for peer clinical 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.

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