目的 分析降糖药临床试验中违背方案事件的特点,探讨违背方案事件的管理策略.方法 采用根原因分析法,对某医院内分泌科近几年承接的降糖药临床试验进行回顾性分析,统计试验实施过程中违背方案事件的类别、发生率和影响因素.结果 降糖药临床试验发生的265例次违背方案事件,93.58%为轻度违背,重度违背仅占6.42%.所有违背中,以未按照中心实验室的要求管理生物样本、未执行已批准的研究程序和未按照试验方案用药发生率最高.结论 申办者和研究团队可引入基于风险的质量管理体系,通过早期识别、定期监测和评估关键风险并制定防控措施加强降糖药临床试验的质量管理,减少临床试验不依从/违背方案事件的发生.

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.

Objective:By strengthening the management of external provision of data generated by clinical trials in medical institutions, to improve the effectiveness of supervision of human genetic resource information, and to promote the legal sharing and effective use of data.Methods:Analyzed problems identified in filing human genetic resource information in clinical trials since July 1, 2019, put forward possible solutions and suggestions.Results:Main problems were identified in external provision of human genetic resource information, including the specification and time limit of external provision of information, the information recipient, the storage location and the final disposal method of information.Conclusions:Hospital and regulatory authority need to carry out more tailored training, optimize management systems and procedures in order to strengthen the management of the external provision of human genetic resources information.

Patent ductus arteriosus(PDA) has high morbidity in the newborns.The risk is higher in the premature,especially in the low birth weight infants.Several co-morbidities(i.e.,necrotizing enter colitis,intracranial hemorrhage,respiratory distress syndrome,and bronchopulmonary dysplasia) could be caused if the treatment is not in time.However,considered the wide adverse drug reactions of indomethacin,ibuprofen is also used in the treatment of PDA with 73.0% ～ 95.5% PDA closure rate.The side effects of ibuprofen are less than indomethacin,especially on the effect on the renal blood flow.Due to off-label use,more researches on the efficacy and safety of ibuprofen for the treatment of PDA are needed.This paper reviewed the mechanism and clinical use of ibuprofen for the treatment of PDA.