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Objective To explore ways and means to improve the investigator compliance through the evaluation and analysis of the investigator compliance of TCM clinical research projects of chronic diseases. Methods Totally 28 studies from the project Chinese medicine clinical study on prevention and treatment of chronic disease started in 2010 or 2011 and ended in 2015 were collected. The investigator compliance was analyzed by the evaluation form, which were drafted by quality control core team of TCM projects of chronic diseases, as research method performance, compliance of subjects inclusion and exclusion, integrity, accuracy and normalization of case report form in final quality evaluation for TCM clinical research on chronic diseases. Results There were 19 excellent studies according to investigator compliance, accounting for 67.9%, including 3 studies with ten score, accounting for 10.7%. There were 8 good studies according to investigator compliance, accounting for 28.6%. There was 1 study up to standard, accounting for 3.6%. 11 studies included unreasonable changes in the record during the process of implementation. 12 studies included missing in the filling of research records during the process of implementation. Conclusion In general, 28 studies of TCM linical research projects for chronic diseases show high investigator compliance. The existing problems are mainly found in the integrity and normalization of research records.
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This paper was aimed to analyze the correlation between quality evaluation and whole complete quality assessment in traditional Chinese medicine (TCM) clinical research progress,in order to discuss key steps and strategies in the clinical research progress.In accordance with the quality control indexes,all projects of Prevention and Treatment of Chronic Disease of TCM were given a research progress evaluation and complete condition.The scores were described with radar map method.The influence of research progress to whole complete quality was analyzed with correlation methods.The results showed that there was a significant correlation between research progress (including included cases and completed cases) and the total score of quality control (P ＜ 0.05).It was concluded that research progress was a key step to influence the entire clinical research level.It is necessary to strengthen the supervision on research progress to guarantee the whole research level.
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ObjectiveTo investigate and analyze the current primary quality management situation in TCM clinical studies.Methods One sub-center unit from 39 projects of “Prevention and Treatment of Difficult and Complicated Disease of TCM” plan of the“11th Five-year National Key Technology R&D Program” was chosen. Executive condition of the primary quality control of each unit was under field investigation, and quality control quantitative evaluation indexes were used to conduct quantitative evaluation.Results Results were shown as the forms of statistical description and radar map. The average and median scores of primary quality management were 5.05 and 5.2, respectively. The best and preferable proportions of 39 units were 25.64% and 28.21%. Other 46.15% of these units performed poor. The problem mainly manifested on insufficient frequency and bad normalization of primary quality management, such as comprehensiveness and integrity of inspection contents, cases, problem recordings and problems timely feedback.ConclusionAlthough the primary quality management is widely conducted in TCM clinical studies, there are still some problems to be settled and improved.
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According to the common standard of ethic review for clinical research , it is equal to each kind of research program whether western medicine or Traditional Chinese Medicine .It should be reviewed the ethic and scientific issues in the same time .However, on account of the two majority characteristics of Traditional Chinese Medicine , it would be concerned more evidence , such as the safety data before clinic , the syndrome differentiation and treatment of target disease , drug combination , dosage and course of treatment , the methods of outcome meas-urement, admixture of the drug, the selection of control drug including placebo and so on .
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Abstract: Beginning with 4-level quality control measures of clinical research in traditional Chinese medicine (TCM), we elaborated the implementation process and demands of quality control measures of each level, including quality control, monitoring, auditing, and inspection. On the basis of joint inspection experience of 41 projects of the "Prevention and Treatment of Difficult and Complicated Diseases of TCM" plan of the "11th Five-year National Key Technology R&D Program", we analyzed the ensuring effect of 4-level quality control system and joint inspection model, and then pointed out the existing problems in the executing process of quality control system at different levels and joint inspection model. Finally we investigated what should be revised in the quality control system and joint inspection model, thus providing the theoretical support for quality inspection improvement of TCM clinical research.
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In our study,we adopted a schedule plan management of the Project Management Body of Knowledge(PMBOK)in the management practice of the experimental research on "The Research in Teaching and Inheritance of Experience of Famous and Veteran Doctors of TCM " which was supported by "tenth five years" plan of national science and technology as a key program.We tried to establish a project planning based on the special features of TCM and the characters of the project.This planning played a significant support role in the top project design and ensuring the smooth implementation of the research.
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In our study, we adopted a schedule plan management of the Project Management Body of Knowledge(PMBOK)in the management practice of the expefimental research on "The Research in Teaching and Inheritance of Experience of Famous and Veteran Doctors of TCM "which was supposed by " tenth five years "plan of national science and technology as a key program. We tried to establish a project planning based on the special features of TCM and the characters of the project. This planning played a significant support role in the top project design and ensuring the smooth implementation of the research.
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Background Traditional Chinese medicine (TCM), especially herbal medicine, has been widely used in China and now is also being increasingly used in other countries for the treatment of cardiovascular diseases. Although many studies have demonstrated that certain Chinese herbal products are effective and safe for the treatment of cardiovascular diseases, most of these lack sufficient quality. Therefore, large randomized clinical trials and further scientific research to determine its safety, effectiveness are necessary.QiShen YiQi Dripping Pills (QSYQDP) is a herbal preparation clinically used in the treatment and prevention of coronary artery disease. Preliminary observations have shown its safety and effectiveness. Methods/Design This randomized, controlled trial will recruit 3600 patients with a history of myocardial infarction. Patients will be randomized into two groups by a Centr-Randomized System. One group receives QSYQDP, the other group receive aspirin. This trial protocol will describe eligibility criteria, detailed information on the treatment definition, blinding, endpoints, statistical methods, sample size determination, data management, legal aspects, and the current status of the trial. Discussion This trial is one of the first randomized, controlled clinical trial to evaluate the efficacy and safety of traditional Chinese herbal medicine in the treatment and secondary prevention of coronary artery disease. The results of this study should help to define the role of TCM in modern medical care, as well as to provide the management strategy for CAD patients in China and other countries.
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Conducting quality monitoring to multi-center clinical research is an effective measure of quality control.This study explored the optimization of some key links of quality monitoring of TCM clinical research,i.e.optimization of CRA appointment,optimization of monitoring preparation,optimization of monitoring items,and optimization of monitoring feedback.For monitoring items,this study emphasized on research progress,protocol compliance,original data conservation,medication management,validity,CRF fill-in,informed consent singing and acquisition,EDC,traceability of lab examination,(severe) adverse event reporting in detail,thus providing the theoretical support for quality monitoring improvement of TCM clinical research.
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Statistical analysis plan (SAP) is an important guidance document in clinical research which is intended to be a comprehensive and detailed description of the methods and presentation of data analyses proposed for a clinical research. The analysis plan will be completed after finalising the protocol and should be finalised before treatment unblinding, to provide full details, even to the extent of including templates of tables, listings and figures to be presented in the statistical report. Any changes between the methods in the protocol and analysis plan will be explained in the analysis plan. In order to improve the quality of TCM clinical research, it is need to optimize the SAP. Considerations in optimizing the SAP include: determine the analysis sets and analysis variables, select analysis methods and statistical software.
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TCM clinical research should attach importance on ethical issues,as it takes the human for the research subjects and the clinical research activities definitely involve the benefits and risks to the subjects.Ethics optimization on the basis of safety and scientificity is necessary.This study explores the optimization of some key links of ethics of TCM clinical research,i.e.optimization of ethics committee membership,optimization of ethical review of study protocol,optimization of informed consent process,and optimization of protection and compensation of the subject,thus providing the theoretical support for ethics improvement of TCM clinical research.
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Start with common problems in the quality control process of TCM clinical research,we summarize the problems in protocol execution,CRF fill-in,ICF signature,medication management,EDC management,lab examination and AE report; meanwhile we analyze the reasons and put forward the countermeasures for the optimization of TCM quality control.
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Sample size design is to determine the minimum number of observed cases in the case of ensuring the reliability of research conclusions.The reliability of sample size estimation mainly related to the reliability of the basis of sample size calculation.Some things are essential,such as the emphasis on pre-test quality,extensive collection of relevant literature and research materials and accurate analysis.Estimation of sample size is first to determine the value of ?,?,or 1-? and effect indicators and their types,the effect indicators predictive value of each comparison group,the emphasis on sources and requirements of the effect indicators predictive value(the basis of calculation),besides,should pay close attention to study design and comparison of types,each group allocation ratio,the expected rate of lost to follow,the level of expected treatment compliance,the choice of some main effect indicators in outcome evaluation.An introduction and explaining with examples to estimation method and estimation of sample size formula,such as design of randomized controlled trials,cohort studies and case-control study commonly used in the clinical validation study of TCM,and study design commonly used in the clinical exploratory study of TCM,case analysis and so on.
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TCM clinical research covers different design types on basis of objective of the study. For exploratory research of TCM, cross-sectional study and descriptive research (e.g. case report and case analysis) is suitable. For hypothesis-testing research, RCT design is commonly adopted. RCT is most commonly used in activity or prevention therapy research, when using randomized cross-over design, the influence of sequence effects should be considered, and double-blind method is the best choice. Cohort study includes various intervention measures, as it doesn’t involve randomized allocation and blinding. Case-control study is widely applicable, but it may bring about bias. Cross-sectional study is much used in syndrome investigation of TCM clinical research. Descriptive research is available for summarization of TCM clinical experience and TCM exploratory research. Third party-central randomization system is recommended, as the randomization is not easy to be damaged. Randomization concealment should also be attached importance to. When blinding is impossible, blindness testing could reduce measurement bias, positive control should be supported high-level evidence. Placebo application could improve the level of evidence-based medicine.
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TCM clinical investigators should attach importance to buildup of research basis in order to ensure the feasibility and normalization of clinical regimen,definite curative effect of treatment regimen and enhance consistency among different researchers and repeatability of clinical regimen.Syndrome,therapeutic method and prescription should be consistent,the addition or subtraction of the medicinal or the dosage should be reasonable.Reduce the use of rare or invaluable medicinal to avoid the restrictions of herb resource,drug cost and animal protection.When transforming decoction to capsule,granule,dripping pill and compound granule,the preliminary test in clinic to recur the curative effect of the decoction is necessary.The application of a single medicinal,the single target area of a medicinal or active ingredient of a single medicinal in a prescription should be based on the preliminary work experience.Meanwhile the county-level producing area of the processed medicinal should be explicit,in order to ensure the quality and efficacy of the processed medicinal.This article also discussed the key point of treatment regimen optimization of acupuncture and massage.
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The principle of TCM diagnosis standard is communicational convenience, and the international universal standard recommended by WHO should also be paid attention to. When there’s no corresponding standard, inferior standard is available, but self made standard is generally not accepted. It’s suggested to apply the same standard for one program. The standards include international standard, regional standard, domestic standard, industrial standard, provincial standard and enterprise standard, the hierarchies and levels of these standards reduce successively. It’s thought that medical standard consists of international standard (issued by WHO or set by international academic conference), domestic standard (set by government authorities, national academic organization and conference), diagnosis standard set by provincial academic organization and textbook standard by universities and colleges. A lot of literature network database, as well as ICD-10, therapy guide, professional periodicals, professional society website, and books could be used for searching. TCM clinical trials also cover syndrome diagnosis standard. The conclusion standard and exclusion standard setting and influence of improper standard setting is also discussed in this article.
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Optimization of Traditional Chinese Medicine (TCM) clinical trials as philosophy, process and method, is extremely necessary and can be applied in different levels. Optimization of TCM clinical trials should follow some principles and procedures, and be executed in two ways. Optimization of treatment plan should be supported by the research basis and literature experience, and be perfected by research group and experts argumentation. Optimization of design plan is modified and accomplished by expert discussion and repeated consulting multi-disciplinary experts. Specific research objective, exact target population definition, proper design plan selection, valid calculation of sample size, precise and appropriate main outcome measures, data management system, medical ethics and statistical analysis are the focuses.