载药医疗器械临床试验质量控制要点

载药医疗器械临床试验是该类器械上市前最重要的考核指标之一,作为药物和器械的组合产品,要求研究者所掌握的专业知识和操作技能较普通医疗器械更高,试验质量直接关系到产品上市后的安全性和有效性。通过分析医疗器械临床试验和载药医疗器械临床试验的质控要点,总结经验,提出针对医疗器械临床试验领域的相关建议。目前载药医疗器械临床试验在法规、人才培养、机构监管等层面存在一些不足之处,需在实践过程中不断改进,以提升临床试验质量。

Key points of quality control for clinical trials of drug-loaded medical devices

The drug-loaded medical device clinical trial is one of the most important evaluation indices for such devices before coming into the market. As a combination of drugs and devices, it requires investigators to master more professional knowledge and operating skills than medical apparatus, and trial quality is directly related to the safety and effectiveness of the products after they are marketed. Some relevant suggestions were proposed in the field of medical device clinical trials with summarizing experiences through analyzing the key points of quality control for clinical trials of medical instruments and those with medicines. There were still some deficiencies in the regulations, talent cultivation and site supervision of clinical trials for medical equipment containing drugs, which was necessary to be continuously improved in the practice of clinical trials, and improving the quality of clinical trials.