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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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In order to encourage the development of traditional Chinese medicine (TCM), the state has set up a spe-cial project and funds to construct the National TCM Clinical Research Base. The goal is to establish a regular line with the development of TCM clinical research and innovation platform gradually. Ensuring the project proceeds suc-cessfully, we have taken a series of initiatives that include the personnel training, the establishment of the network center, medical diagnostic centre, imaging centre, ethical platform and the laboratory. Also, we have explored the operation mode which matches the construction. During the process of construction, we have found that four elements are particularly important for the base development, which are top-level design, leadershipˊs attention, financial sup-port, solidarity and cooperation.
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Intellectual property protection is an indispensable management measure in the process of knowledge innovation in the National Traditional Chinese Medicine (TCM) Clinical Research Bases. Longhua Hospital, a National TCM Clinical Research Base , has actively participated in studies and construction of TCM intellectual property policy , laws and regulations , and endeavored to enhance international research cooperation and broaden the international repercussions of TCM . Longhua Hospital made great efforts to strengthen management on intel-lectual property management team and measures, advocacy training, property rights formation and transactions. Intellectual property protection played an important role in the construction of the National TCM Clinical Re-search Base in Longhua Hospital .
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This article elaborated the connotation and characteristics of research-oriented hospital as well as its inner connection with the development of key disciplines , based on the system dynamics model data analysis of the National TCM Clinical Research Base . It gave suggestions in increasing discipline input , strengthening personnel training , and improving achievement output to research-oriented hospital construction in order to promote the construction of research-oriented hospitals .
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This article was aimed to introduce progresses in fields of high-level research team training and re-lated technological and management platform construction , such as the Clinic and Scientific Sharing Platform , Database of Jaundice Literature , Academic Inheritance of TCM Senior Experts , and the Standardized Manage-ment of Clinical Practice and Scientific Research , Collaborative Innovative Mode Construction , and Key Disease Research . This article emphasized on the key step in the construction of the national clinical research base is the long-term construction of the base and the construction of talented personnel team.
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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.