如何設定醫(yī)療器械臨床試驗的目的？

test4

　　為貫徹落實中共中央辦公廳、國務院辦公廳關于深化審評審批制度改革鼓勵藥品醫(yī)療器械創(chuàng)新的意見，加強醫(yī)療器械產(chǎn)品注冊工作的管理，進一步提高注冊審查質量，鼓勵醫(yī)療器械研發(fā)創(chuàng)新，國家食品藥品監(jiān)督管理總局組織制定了醫(yī)療器械臨床試驗設計指導原則。

　　依據(jù)醫(yī)療器械臨床試驗設計指導原則的相關規(guī)定，臨床試驗需設定明確、具體的試驗目的。申請人可綜合分析試驗器械特征、非臨床研究情況、已在中國境內上市同類產(chǎn)品的臨床數(shù)據(jù)等因素，設定臨床試驗目的。臨床試驗目的決定了臨床試驗各設計要素，包括主要評價指標、試驗設計類型、對照試驗的比較類型等，進而影響臨床試驗樣本量。

　　一、當通過臨床試驗確認試驗器械在其預期用途下的安全有效性時，若更關注試驗器械的療效是否可滿足臨床使用的需要，其臨床試驗目的可設定為確認試驗器械的有效性是否優(yōu)于或等效于或非劣于已上市同類產(chǎn)品，同時確認試驗器械的安全性。此時，臨床試驗的主要評價指標為有效性指標。

　　二、當通過臨床試驗確認試驗器械在其預期用途下的安全有效性時，若更關注試驗器械的安全性是否可滿足臨床使用的需要，其臨床試驗目的可設定為確認試驗器械的安全性是否優(yōu)于或等效于或非劣于已上市同類產(chǎn)品，同時確認試驗器械的有效性。此時，臨床試驗的主要評價指標為安全性指標，以ru房植入體為例，臨床試驗通常選擇并發(fā)癥發(fā)生率（如包膜攣縮率、植入體破裂率）作為主要評價指標。

　　三、對于已上市產(chǎn)品增加適應癥的情形，臨床試驗目的可設定為確認試驗器械對新增適應癥的安全有效性。例如，止血類產(chǎn)品在已批準適用范圍（如普通外科、婦產(chǎn)科）的基礎上，增加眼科、神經(jīng)外科、泌尿外科使用的適應癥。

　　四、當已上市器械適用人群發(fā)生變化時，臨床試驗目的可設定為確認試驗器械對新增適用人群的安全有效性。例如膜式氧合器產(chǎn)品，在原批準適用范圍的基礎上新增體重小于或等于10千克的適用人群；又如治療類呼吸機在已批準的適用于成ren的基礎上新增適用于兒童的適用范圍。

　　五、當已上市器械發(fā)生重大設計變更時，可根據(jù)變更涉及的范圍設定試驗目的。例如冠狀動脈藥物洗脫支架平臺花紋設計發(fā)生改變時，臨床試驗目的可設定為確認變化部分對于產(chǎn)品安全有效性的影響。

　　六、當已上市器械的使用環(huán)境或使用方法發(fā)生重大改變時，試驗目的可設定為確認產(chǎn)品在特定使用環(huán)境和使用方法下的安全有效性。例如：已上市的植入式心臟起搏器通常不能兼容核磁共振檢查，如申請兼容核磁共振檢查，其臨床試驗目的可設置為對兼容核磁共振檢查相關的安全有效性進行確認。

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