ABSTRACT
Risk assessment of clinical trials is of great significance to improve the quality of clinical trials. Through systematic comparative analysis of risk assessment tools for clinical trials in Britain, Germany and France, this paper found that the three countries’ risk assessment tools were consistent in terms of legal system guarantee and assessment process, but there were obvious differences in the basic risk classification and risk grading standards of clinical trials. Based on the experience of Britain, France and Germany, this paper proposed to improve the relevant regulations and documents of clinical trial risk management in China from the perspective of Chinese national conditions, further explore the factors affecting clinical trial risk, and develop and design clinical trial risk assessment tools with different discipline characteristics according to the specialties of the discipline to improve the quality and level of clinical trials.
ABSTRACT
The passing of ethical review is a necessary conditions and prerequisite for the development of life science and medical research involving humans. At present, some medical and health institutions have no or insufficient ethical review capabilities. The lack of ethical review ability has become a bottleneck restricting the development of life science and medical research involving humans. According to documents such as Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Pharmaceutical and Medical Devices, Opinions on Strengthening the Ethical Governance of Science and Technology, institutions can entrust competent institutional ethics review committees or regional ethics review committees in writing to conduct ethical review. Entrustment ethical review provides a viable solution for institutions that need to carry out life science and medical research involving humans but do not have an ethics (review) committee or the ethics (review) committee is not competent to review. To conduct the entrustment ethical review, the entrustment between the principal and the trustee is required. According to The Measures for Ethical Review of Life Sciences and Medical Research Involving Humans, if medical and health institutions and their ethical review committees do not accept the formal entrustment to provide the ethical review opinions for other institutions, the local health authorities at or above the county level will impose administrative penalties and sanctions on the relevant institutions and personnel in accordance with the law. Signing the entrustment ethical review contract, implementing legal compliance entrusted ethical review to protect the rights and interests of the trustee and the principal, and protect the research participants.
ABSTRACT
【Objective:】 To sort out the influencing factors of drug clinical trial risks and improve the risk management level of drug clinical trials in China. 【Methods:】 The literature analysis method was used to sort out the literature related to the risk management of drug clinical trials in China, and the text analysis method was used to summarize and refine the influencing factors of drug clinical trial risks. 【Results:】 The risk categories of drug clinical trials were divided into 5 parts, namely drug clinical trial institution management, ethics committee management, clinical trial designs, researchers, and subjects, involving 13 main risk influencing factors and 21 specific risk points. 【Conclusion:】 By strengthening the construction of drug clinical trial institutions and ethical management capabilities, optimizing research protocol design, enhancing researchers’ awareness and ability, and establishing a subject management system to improve the quality of drug clinical trials.
ABSTRACT
【Objective:】 To deeply understand the current situation and hotspots of drug clinical trials risk management in China. 【Methods:】 Co-word analysis and social network analysis were used to sort out the study results of risk management in drug clinical trials in China. 【Results:】 The trend of risk research of drug clinical trials in China was generally on the rise. The research hotspots focused on four areas: drug supervision and pharmacovigilance, risk management of drug clinical trial institutions, ethical review of drug clinical trials, and risk management of drug clinical trials. 【Conclusion:】 In the future, China should gradually improve the risk management system and supervision system of drug clinical trials, explore to establish a risk-based quality management and ethical review system of drug clinical trials, and enhance the risk assessment and coping ability of institutions.
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Objective:To understand the status quo of basic research projects on respiratory diseases in China.Methods:Descriptive statistical methods were used to review the project number, funding input, funding categories and distribution of National Natural Science Foundation of China (NSFC) respiratory disease funding projects from 2009 to 2019.Results:according to the research, the number of NSFC respiratory projects and funding increased significantly, which promoted the development of respiratory science. However, due to the heavy burden of respiratory diseases, it is still necessary to increase the investment in respiratory diseases.Conclusions:taking into account of the importance of respiratory science, this paper suggests that NSFC should increase investment and support for respiratory diseases projects, strengthen the development of existing respiratory advantages, encourage cross-cutting and frontier research on respiration, cultivate a group of internationally influential scientists and research teams, and promote academic innovation in respiratory science.
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In order to understand the existing problems in the management of medical ethical review,this paper summed up related domestic literature published in 2001 to 2015 with the method of literature analysis.There existed several problems in the construction and management,the ability of ethical review,external supervision,and other aspects of the current medical ethics committee.It suggests that strengthening external continuous supervision,strengthening the ethics committee itself construction and management and participating in standardized certification can help medical ethics committee to solve the above problems and have important significance for the standardized development.
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Taking CRA as the research object,and using the method of questionnaire investigation to collect the evaluation results of CRA to the operation status of the hospital ethics committee,this paper found that the review efficiency of ethics committee and the professional level of ethics staffs existed insufficiency.Aiming at this,this paper put forward to strengthen the connotation construction from the perspectives of information disclosure,system construction,committee training,improvement of staff internal quality and professional level and so on,in order to improve the efficiency and quality of ethical review.
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Objective In this paper,we analyzed the initial review projects of clinical research during past five years in a hospital,which aims to summarize the experience and analysis existent problems,in order to provide a reference for the future hospital ethics review.Methods Summarizing and analyzing the meeting records during past five years,which were also in the field of the initial review projects of clinical research.Results Clinical trials of drug and divice,and clinical research projects exist in varying degrees of problems,which express in these two aspects:research design and ethical rational.Conclusions Ethics Committee should stengthen review the following two parts,the scientific of research project and the informed consent form.Improve their own system constantly,and ensure the efficient operation of the Ethics Committee.
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Objective To construct and assess the competency scale for emergency physicians in our country. Methods Learning from the milestone project in America, we developed the scale through Delphi method . The application effect was evaluated among 81 emergency physicians by questionnaire survey. Excel was used to do data entry. SPSS 20.0 was adopted to do data analysis. Factor analysis method was employed to verify the structure validity of the scale. Results The competency scale comprises six dimensions and 13 items. The scale of total Cronbach's alpha coefficient was 0.98 and the split half reliability was 0.95. Two factors were extracted by principal component analysis with cumulative contribution rate of 86.5%. The differ-ences of competency score on six aspects of different ages, titles, working years and training situation were tested and all had statistically significant differ-ence (P<0.01). Conclusion The scale developed in our study can reflect the growth stage of the emergency physicians and serve the purpose as an evaluation tool for the competency of emergency physicians in our country.
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By means of literature review,expert interviews and experts sorting,the authors identified three approaches of medical humanities care,and applied them to three clinical departments of top ten incidence of medical disputes of the hospital in 2012.These departments have similar number of beds,and covered both internal medicine and surgery departments.The purposes of the study are to evaluate the effects of medical humanities care measures in clinical departments,and to make relevant thoughts and suggestions.
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Using the method of semi -structure interviews to pre-interview 6 experts and officially interview10 experts , then the record of the interview was compiled into the paper .Using the grounded theory method to encode material of the interview , a summary was made for each case base on data collation and analysis .This paper ana-lyzed the humanities concern the connotation of the application in the construction of a harmonious doctor -patient relationship and the specific measures .On the basis of the application of humanistic care in the construction of a harmonious doctor -patient relationship , significance and limitation is discussed .
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Objective To build a competency-based indicator system for emergency physicians in their career stages.Methods We conducted expert consultations which were guided by Delphi method,and analyze the data collected from the experts using professional statistic software such as Excel and SPSS.Results The evaluating indicator system for emergency specialists at primary,intermediate and senior level was constructed base on experts' view.Conclusion The indicators illustrate the required competencies of emergency specialists in different stages comprehensively,which help to evaluate and classify the career stages of emergency physicians effectively.