如何設(shè)定醫(yī)療器械臨床試驗(yàn)的目的？

test4

　　為貫徹落實(shí)中共中央辦公廳、國務(wù)院辦公廳關(guān)于深化審評(píng)審批制度改革鼓勵(lì)藥品醫(yī)療器械創(chuàng)新的意見，加強(qiáng)醫(yī)療器械產(chǎn)品注冊(cè)工作的管理，進(jìn)一步提高注冊(cè)審查質(zhì)量，鼓勵(lì)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(yàn)設(shè)計(jì)指導(dǎo)原則。

　　依據(jù)醫(yī)療器械臨床試驗(yàn)設(shè)計(jì)指導(dǎo)原則的相關(guān)規(guī)定，臨床試驗(yàn)需設(shè)定明確、具體的試驗(yàn)?zāi)康�。申�?qǐng)人可綜合分析試驗(yàn)器械特征、非臨床研究情況、已在中國境內(nèi)上市同類產(chǎn)品的臨床數(shù)據(jù)等因素，設(shè)定臨床試驗(yàn)?zāi)康摹ＥR床試驗(yàn)?zāi)康臎Q定了臨床試驗(yàn)各設(shè)計(jì)要素，包括主要評(píng)價(jià)指標(biāo)、試驗(yàn)設(shè)計(jì)類型、對(duì)照試驗(yàn)的比較類型等，進(jìn)而影響臨床試驗(yàn)樣本量。

　　一、當(dāng)通過臨床試驗(yàn)確認(rèn)試驗(yàn)器械在其預(yù)期用途下的安全有效性時(shí)，若更關(guān)注試驗(yàn)器械的療效是否可滿足臨床使用的需要，其臨床試驗(yàn)?zāi)康目稍O(shè)定為確認(rèn)試驗(yàn)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(shí)確認(rèn)試驗(yàn)器械的安全性。此時(shí)，臨床試驗(yàn)的主要評(píng)價(jià)指標(biāo)為有效性指標(biāo)。

　　二、當(dāng)通過臨床試驗(yàn)確認(rèn)試驗(yàn)器械在其預(yù)期用途下的安全有效性時(shí)，若更關(guān)注試驗(yàn)器械的安全性是否可滿足臨床使用的需要，其臨床試驗(yàn)?zāi)康目稍O(shè)定為確認(rèn)試驗(yàn)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(shí)確認(rèn)試驗(yàn)器械的有效性。此時(shí)，臨床試驗(yàn)的主要評(píng)價(jià)指標(biāo)為安全性指標(biāo)，以ru房植入體為例，臨床試驗(yàn)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(píng)價(jià)指標(biāo)。

　　三、對(duì)于已上市產(chǎn)品增加適應(yīng)癥的情形，臨床試驗(yàn)?zāi)康目稍O(shè)定為確認(rèn)試驗(yàn)器械對(duì)新增適應(yīng)癥的安全有效性。例如，止血類產(chǎn)品在已批準(zhǔn)適用范圍（如普通外科、婦產(chǎn)科）的基礎(chǔ)上，增加眼科、神經(jīng)外科、泌尿外科使用的適應(yīng)癥。

　　四、當(dāng)已上市器械適用人群發(fā)生變化時(shí)，臨床試驗(yàn)?zāi)康目稍O(shè)定為確認(rèn)試驗(yàn)器械對(duì)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(zhǔn)適用范圍的基礎(chǔ)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(jī)在已批準(zhǔn)的適用于成ren的基礎(chǔ)上新增適用于兒童的適用范圍。

　　五、當(dāng)已上市器械發(fā)生重大設(shè)計(jì)變更時(shí)，可根據(jù)變更涉及的范圍設(shè)定試驗(yàn)?zāi)康�。例如冠狀�?dòng)脈藥物洗脫支架平臺(tái)花紋設(shè)計(jì)發(fā)生改變時(shí)，臨床試驗(yàn)?zāi)康目稍O(shè)定為確認(rèn)變化部分對(duì)于產(chǎn)品安全有效性的影響。

　　六、當(dāng)已上市器械的使用環(huán)境或使用方法發(fā)生重大改變時(shí)，試驗(yàn)?zāi)康目稍O(shè)定為確認(rèn)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(qǐng)兼容核磁共振檢查，其臨床試驗(yàn)?zāi)康目稍O(shè)置為對(duì)兼容核磁共振檢查相關(guān)的安全有效性進(jìn)行確認(rèn)。

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