我国14所儿科临床试验机构质量管理现状调查研究

[摘要]目的：了解儿科临床试验机构质量管理情况，为进一步提升儿科临床试验质量提供优化建议。方法：对中国儿科人群药物临床试验协作网内14所儿科临床试验机构进行问卷调查，结果导出至Excel 2016进行统计，分析各机构临床试验质量管理模式、人员设置、质控内容、质控标准制定等情况。结果：共发放调查问卷14份，回收有效问卷14份，有效回收率为100%。被调查的14所临床试验机构均能够在质量管理方面履行相应的职责，但仍存在需要加强的方面。结论：在儿科临床试验质量管理中积极应用科学质量管理方法、合理人员配置、完善机构办公室质控，同时，在儿科人群临床试验协作网范围内制定统一质控标准将利于进一步提升项目质量。

Investigation on Current Status of Quality Management in 14 Pediatric Clinical Trial Institutions in China

[Abstract] Objective: To investigate the quality management of pediatric clinical trial institutions, so as to provide optimization suggestions for further improving the quality of pediatric clinical trials. Methods: Questionnaire survey was performed on 14 pediatric clinical trial institutions in the pediatric clinical trial collaboration network in China, and the results were exported to Excel 2016 for statistics. The quality management mode, allocation of clinical trial quality management personnel, content of quality control and development of quality control standards of each institution were analyzed. Results: A total of 14 questionnaires were distributed, 14 valid questionnaires were recovered, and the effective recovery rate was 100%. All of the 14 clinical trial institutions surveyed were all able to perform the corresponding responsibilities in quality management, but there were still areas that need to be strengthened. Conclusions: For quality management of pediatric clinical trials, scientific quality management methods should be actively applied, proper staffing and quality control in institutional offices should be improved. Meanwhile, unified quality control standards should be established within the scope of pediatric clinical trial collaboration network. All of these measures will be conducived to further improvement of project quality.