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Objective:The authenticity and accuracy of medical device related clinical trial data is crucial for the efficacy and safety of tested products. This article analyzed issues identified during previous data inspections of medical device clinical trials in our hospital, summarized experiences and findings, and proposed solutions.Methods:According to the " Medical Device Clinical Trial Inspection Points and Judgment Principles" , this study retrospectively analyzed the data inspection of medical device clinical trials in our hospital since 2016, summarized and analyzed the common issues identified.Results:A total number of six data inspections on medical device clinical trials were carried out in our hospital, during which 30 findings were identified. These findings include 4 items of pre-trial preparation, 2 items of patient rights protection, 7 items of trial processes, 12 items of records and reporting, as well as 5 items of experimental medical device management.Conclusions:The completeness, accuracy and consistency of clinical trial records in clinical trials of devices in our hospital have a lot space for improvement. And there is still room for improvement in the compliance to the protocol and the management of medical devices during the trial process. Based on the common findings, our drug clinical trial center will strengthen training and quality control, improve informatization and centralized management, and emphasize the importance of records. Through that the accuracy and authenticity of trial data for medical devices, and the credibility and objectiveness of trial results would be assured.
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Objective:The particularity of drugs determines the particularity of drug patents. From the legal perspective, this means that special terms should be included designed in the patent law system.The interests of patent holders are not fully protected currently, although some drug related provisions have been set in the current patent law. Along with the many reforms that China has implemented in the field of new drug research and development, there are some problems related to drugs that need to be resolved in the patent system, This article will explore this issue.Methods:Based on the particularity of drug patents, this paper analyzes the necessity of improving the relevant provisions of the patent law for the research and development of new drugs, and proposes suggestions for improving the terms of drug patents.Results:There is still space for improvement in terms of balancing the interests of the innovator, the generic maker and the public.Conclusions:The necessary improvements and adjustments to the drug provisions in the patent laws and regulations need to be made in order to further enhance the patent system’s role in promoting the research and development of new drugs.
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Objective The funding management of drug clinical trials is one of the most important step in the management of clinical trials.Strengthening the management of clinical trial funds can improve the efficiency of fund utilization and ensure the smooth implementation of clinical trials.Methods This paper summarizes the problems of clinical trial fund management,proposes some main strategies for fund management based on root cause analysis.Results Through the establishment and improvement of the drug clinical trial fund management system in our hospital,the management of funds is strengthened,the trial carry out more smoothly and the result is more accurate.Conclusions Improving the management system of drug clinical trial funds and standardizing the management of clinical trials is of great significance to ensure the quality of clinical trials.Also it will improve the clinical trial management level of our hospital.
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Objective To strengthen human genetic resource management in clinical trials.Methods This article analyzes the common problems in the process of reviewing human genetic resources application by the drug clinical trial institute in our hospital,and proposes solutions for solving the problems.Results Common questions are also the key points for future review of human genetic resources applications,including the collection of sample and consistency with clinical trial plan,ethical review and informed consent,intellectual property rights etc.Conclusions Strictly reviewing applications of human genetic resources,as well as strengthen the management of human genetic resources in clinical trials,are not only make traceability of human genetic resources traceable,but also have important significance for the authenticity and scientific validity of trial results.
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Objective To discuss our drug clinical trial institution's experience and findings during the process of establishing drug clinical trial central pharmacy.Methods Analyze the previous key issues identified during the drug management under different modes,discuss the necessity and feasibility of establishing drug clinical trial central pharmacy.Meanwhile,discuss the planning and construction of hardware including location site of the central pharmacy,equipment and facilities,staff,as well as software such as electronic management system and standard operation procedures.Results After the adoption of central trial pharmacy,space and energy are saved,manpower and material resources are saved,the quality of clinical trials also improved.Conclusions Standardized and unified management of investigational drugs through establishing drug clinical trial central pharmacy,is the strong guarantee for the drug safety of human subject,as well as the accuracy and scientificity of trial results.
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Objective To improve the quality of medical device clinical trial.Methods To analyze medical device clinical trials conducted in our hospital from 2006 to 2010,and proposed the strategy to strengthen medical device clinical trial management.Results Most of the medical devices clinical trials were class Ⅲ medical devices clinical validation in our hospital,Surgical departments undertook most of the clinical trials.Until July 2013,49 trials were done only 56％ of undertake the project.96％ of completed trials were approved for medical device registration certificate.Conclusions The quality of clinical trials must be improved,andthe quality control process in medical device clinical trial should be reinforced.