ABSTRACT
Objective:Taking into account of the current situation that domestic laws and regulations of medical technology ethics review are not perfect, we put forward practical suggestions on ethical review supervision of the clinical application of new medical technologies from the perspective of standardization.Methods:Referring to the relevant laws, regulations and specific implementation guidelines of ethical review of clinical research, combined with the practical experience of the ethics committee of the host Hospital, this paper systematically summarizes the concept and characteristics and existing problems of new clinical applied medical technology, optimizes the working steps of technology access and ethical review, and establishes an ethical continuing review model.Results:A series of measurements are proposed, which including formulate the access process, improve the management system, optimize ethical review methods, etc. At the same time, pay more attention to the annual continuing review, adverse event report review, suspension/termination of approved research, closure report review, as well as site visit to improve the initiative and efficiency of ethical review. At last, it ensures the continuing of ethical review.Conclusions:It is very important to regulate new medical technology project entry and ethical review supervision in the practice. On one hand, it can effectively make up for the possible shortcomings of current laws and regulations and promote the introduction of new regulatory requirement. On the other hand, it can effectively reduce the medical technology risks and build good medical quality management, improve the system to better safeguard people′s health rights and interests.
ABSTRACT
Objective:Through the analysis of the risk factors of clinical scientific research project, risk assessment theory was brought in to develop risk assessment procedures, at the same time, to explore possible applications of risk assessment theories and methodologies in clinical scientific research projects, which might empower the research project administration.Methods:Through literature review and the author's scientific research management daily practice, the characteristics of risks involved in clinical scientific research projects were systematically summarized, relevant standards and models were used for reference to develop relevant working procedures, fatherly, methodologies of project risk assessment were discussed.Results:There are risks at different stages of scientific research project that including compliance, safety, research topic selection, research design, executive ability and risk-control. A proposal regarding to the implementation of project risk assessment covers three main steps which including preliminary preparation, implementation of risk assessment (risk identification, risk analysis and risk assessment) and risk-response proposal.Conclusions:The risk assessment of clinical scientific research projects is crucial. It is necessary to promote the development of risk assessment and improve the capacity building by improving awareness, establishing system, clarifying structure and improving technology.
ABSTRACT
Objective:To strengthen the quality management of drug clinical trials to ensure that the clinical trial data obtained is true, accurate, complete and standardized.Methods:By review literatures and the data published in NMPA and survey the problems in the drug clinical trials in some hospitals, etc, we summarized the common problems of drug clinical trials in China.At the same time, using PDCA cycle theory, we sorted out the problems in the drug clinical trials in Taizhou People's Hospital, conducted root-cause analysis of the problems, put forward suggestions and measures on how to strengthen the quality management of drug clinical trials.Results:The incidence of quality problems in clinical trials was significantly reduced from 105.6% to 37.4% by formulating relevant incentive policies, strengthening training, strengthening the supervision function of institutions to researchers, and improving the awareness of GCP of researchers.Conclusions:The implementation of PDCA cycle quality management model can effectively improve the quality of drug clinical trials.
ABSTRACT
Clinical residual biological specimens are invaluable for medical research and can be reused for medical research. This paper expounded the possibility, necessity and applied range of the medical research reuse of clinical residual biological specimens and put forward some suggestions on how to standardly supervise clinical residual biological specimens for medical research reuse. The authors raised four aspects of concern: how to strengthen the management of ethical review; how to establish strict privacy protection and information confidentiality system; how to keep samples reasonably to ensure clinical examination; and how to ensure the compliance treatment of residual biological specimens after reuse, so as to promote clinical residual biological specimens more normatively and effectively used in medical research.