如何设定医疗器械临床试验的目的？

test4

　　为贯彻落实中共中央办公厅、国务院办公厅关于深化审评审批制度改革鼓励药品医疗器械创新的意见，加强医疗器械产品注册工作的管理，进一步提高注册审查质量，鼓励医疗器械研发创新，国家食品药品监督管理总局组织制定了医疗器械临床试验设计指导原则。

　　依据医疗器械临床试验设计指导原则的相关规定，临床试验需设定明确、具体的试验目的。申请人可综合分析试验器械特征、非临床研究情况、已在中国境内上市同类产品的临床数据等因素，设定临床试验目的。临床试验目的决定了临床试验各设计要素，包括主要评价指标、试验设计类型、对照试验的比较类型等，进而影响临床试验样本量。

　　一、当通过临床试验确认试验器械在其预期用途下的安全有效性时，若更关注试验器械的疗效是否可满足临床使用的需要，其临床试验目的可设定为确认试验器械的有效性是否优于或等效于或非劣于已上市同类产品，同时确认试验器械的安全性。此时，临床试验的主要评价指标为有效性指标。

　　二、当通过临床试验确认试验器械在其预期用途下的安全有效性时，若更关注试验器械的安全性是否可满足临床使用的需要，其临床试验目的可设定为确认试验器械的安全性是否优于或等效于或非劣于已上市同类产品，同时确认试验器械的有效性。此时，临床试验的主要评价指标为安全性指标，以ru房植入体为例，临床试验通常选择并发症发生率（如包膜挛缩率、植入体破裂率）作为主要评价指标。

　　三、对于已上市产品增加适应症的情形，临床试验目的可设定为确认试验器械对新增适应症的安全有效性。例如，止血类产品在已批准适用范围（如普通外科、妇产科）的基础上，增加眼科、神经外科、泌尿外科使用的适应症。

　　四、当已上市器械适用人群发生变化时，临床试验目的可设定为确认试验器械对新增适用人群的安全有效性。例如膜式氧合器产品，在原批准适用范围的基础上新增体重小于或等于10千克的适用人群；又如治疗类呼吸机在已批准的适用于成ren的基础上新增适用于儿童的适用范围。

　　五、当已上市器械发生重大设计变更时，可根据变更涉及的范围设定试验目的。例如冠状动脉药物洗脱支架平台花纹设计发生改变时，临床试验目的可设定为确认变化部分对于产品安全有效性的影响。

　　六、当已上市器械的使用环境或使用方法发生重大改变时，试验目的可设定为确认产品在特定使用环境和使用方法下的安全有效性。例如：已上市的植入式心脏起搏器通常不能兼容核磁共振检查，如申请兼容核磁共振检查，其临床试验目的可设置为对兼容核磁共振检查相关的安全有效性进行确认。

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