醫療器械臨床試驗常見(jiàn)問(wèn)題解答

test4 · 發(fā)表于 2018-5-28 10:03:11

　　在《醫療器械注冊管理辦法》相關(guān)條例中規定，除了被列入免于進(jìn)行臨床試驗的醫療器械目錄的產(chǎn)品外，申請第二類(lèi)、第三類(lèi)醫療器械注冊，應當進(jìn)行臨床試驗。下面，我們就醫療器械臨床試驗的常見(jiàn)問(wèn)題進(jìn)行解答，希望對大家有所幫助！

　　開(kāi)展平行對照臨床試驗時(shí)，如因合理理由不能采用已上市同類(lèi)產(chǎn)品作為對照產(chǎn)品，是否可選擇相似產(chǎn)品作為對照產(chǎn)品？

　　答：開(kāi)展平行對照臨床試驗時(shí)，如因合理理由不能采用已上市同類(lèi)產(chǎn)品作為對照產(chǎn)品，可綜合考慮產(chǎn)品設計特征、臨床試驗前研究結果、風(fēng)險受益分析、臨床試驗目的、臨床試驗評價(jià)指標和隨訪(fǎng)時(shí)間等因素，考慮選擇療效和安全性已得到公認、適用范圍與試驗器械相同、臨床試驗設定的評價(jià)指標與試驗器械具有可比性的已上市相似產(chǎn)品作為對照產(chǎn)品。

　　已有境外醫療器械臨床試驗數據的產(chǎn)品，如境內也有已發(fā)布的相應產(chǎn)品的臨床試驗指導原則，此時(shí)產(chǎn)品境外臨床試驗數據是否必須完全滿(mǎn)足境內相應指導原則要求？

　　答：境外進(jìn)行的臨床試驗可能符合試驗開(kāi)展所在國家（地區）的技術(shù)審評要求，但不一定完全符合我國相關(guān)審評要求。例如進(jìn)行臨床試驗設計時(shí)，有些國家僅要求臨床試驗能夠得出器械性能達到某一觀(guān)察終點(diǎn)的結論。但在我國申報注冊時(shí)，可能要求該器械性能達到多個(gè)觀(guān)察終點(diǎn)才可確認其有效性，且醫療器械的安全性有適當的證據支持。若國家藥品監督管理局發(fā)布特定醫療器械的技術(shù)審評指導原則中含有對其臨床試驗的相關(guān)要求，該器械境外臨床試驗應考慮有關(guān)要求，存在不一致時(shí)，應提供充分、合理的理由和依據。

　　接受境外醫療器械臨床試驗數據時(shí)，是否境外臨床試驗數據中一定需要包括華人試驗數據？

　　答：接受境外醫療器械臨床試驗數據時(shí)，境外臨床試驗數據中不一定需要包括華人試驗數據。根據《接受醫療器械境外臨床試驗數據指導原則》，可能對臨床試驗結果產(chǎn)生影響的因素不僅限于人種差異，需根據產(chǎn)品特性綜合考慮受試人群差異、臨床試驗條件差異等的影響。雖然已知這些因素客觀(guān)存在并會(huì )對臨床試驗產(chǎn)生一定的影響，但對各因素影響程度的判定還應結合擬申報器械的特性、臨床試驗目的等進(jìn)行。根據醫療器械發(fā)展現狀、臨床使用經(jīng)驗、以及對相關(guān)疾病和診療方法的認知，能夠對大部分醫療器械的臨床試驗數據所產(chǎn)生的影響判定出不具有實(shí)際臨床意義時(shí)，可不要求逐一證明。能夠確定某些因素對臨床試驗數據產(chǎn)生有臨床意義的影響時(shí)，或難以判定某些因素對臨床試驗數據是否產(chǎn)生有臨床意義的影響時(shí)，申請人應闡明降低或消除各項差異影響所采用的方法，如可根據需要考慮進(jìn)行對受試人群進(jìn)行亞組設計，或對已有的臨床試驗數據進(jìn)行亞組分析。

　　列入《需進(jìn)行臨床試驗審批的第三類(lèi)醫療器械目錄》的醫療器械是否必須在境內開(kāi)展臨床試驗？

　　答：根據《接受醫療器械境外臨床試驗數據技術(shù)指導原則》，列入《需進(jìn)行臨床試驗審批的第三類(lèi)醫療器械目錄》的醫療器械，可以根據本指導原則提交境外臨床試驗數據。在遵循倫理原則、依法原則和科學(xué)原則的基礎上，境外臨床試驗數據如符合我國注冊相關(guān)技術(shù)要求，數據科學(xué)、完整、充分，可不在境內開(kāi)展臨床試驗。

　　若注冊產(chǎn)品中包括A和B兩個(gè)型號，申辦者是否可選擇典型型號A型號開(kāi)展臨床試驗？

　　答：可以選取典型型號A開(kāi)展臨床試驗，對于未開(kāi)展臨床試驗的型號B,應詳述B型號與A型號的相同性和差異性，評價(jià)差異性是否對產(chǎn)品的安全有效性產(chǎn)生不利影響。

　　體外診斷試劑臨床試驗中如采用核酸序列測定、GC-MS/MS等實(shí)驗室檢測參考方法作為對比方法進(jìn)行比較研究,是否可以委托檢驗？

　　答：對于某些目前臨床上尚不存在明確的臨床診斷“金標準”，亦無(wú)可比的同類(lèi)產(chǎn)品上市的體外診斷試劑，臨床試驗研究者應依據現有臨床實(shí)踐和理論基礎，建立合理的方法，進(jìn)行比較研究。對于部分體外診斷試劑，臨床試驗中采用核酸序列測定、GC-MS/MS等實(shí)驗室檢測參考方法作為對比方法進(jìn)行比較研究，這些方法非臨床常規檢測技術(shù)，需要專(zhuān)門(mén)的設備儀器和試驗條件，且臨床試驗機構可能不具備相關(guān)檢測條件。對于此類(lèi)情況，申請人應盡可能選擇具備相應條件的臨床試驗機構開(kāi)展臨床試驗，確無(wú)檢測條件的部分臨床試驗機構可將此部分測試委托給專(zhuān)門(mén)的測序機構、具備一定檢測資質(zhì)的實(shí)驗室進(jìn)行檢測，并對檢測結果進(jìn)行認可。提交臨床試驗機構與受委托機構的委托證明文件，并評價(jià)對比方法的方法學(xué)研究和整體質(zhì)量。

　　臨床檢驗器械臨床試驗設計中計算樣本量時(shí)，是否可以參照《醫療器械臨床試驗設計指導原則》？

　　答：可以，《醫療器械臨床試驗設計指導原則》適用范圍明確本指導原則適用于產(chǎn)品組成、設計和性能已定型的醫療器械，包括治療類(lèi)產(chǎn)品、診斷類(lèi)產(chǎn)品，不包括體外診斷試劑。因此，臨床檢驗器械在臨床試驗設計計算樣本量時(shí)可以參照該指導原則相關(guān)要求。
　　通過(guò)同品種醫療器械臨床數據進(jìn)行臨床評價(jià)時(shí)，如果選取其他注冊人的產(chǎn)品作為同品種醫療器械進(jìn)行對比，生產(chǎn)工藝、臨床數據等資料需不需要獲取同品種醫療器械注冊人的授權？

　　答：根據《醫療器械臨床評價(jià)技術(shù)指導原則》（總局通告2015年第14號），對于通過(guò)同品種醫療器械臨床數據進(jìn)行分析評價(jià)的要求中，明確數據應是合法獲得的相應數據�！妒称匪幤繁O管總局關(guān)于執行醫療器械和體外診斷試劑注冊管理辦法有關(guān)問(wèn)題的通知》（食藥監[2015] 247號）基于數據應合法獲得，規定依據《導則》第六條開(kāi)展臨床評價(jià)的，如使用了同品種醫療器械的生產(chǎn)工藝、臨床數據等資料，申請人應提交同品種醫療器械生產(chǎn)工藝、臨床數據等資料的使用授權書(shū)�！夺t療器械注冊管理法規解讀之五》對于醫療器械臨床評價(jià)數據授權要求進(jìn)行了進(jìn)一步解讀，對于擬使用的同品種醫療器械非公開(kāi)數據等提出授權要求，以保證數據來(lái)源的合法性；使用公開(kāi)發(fā)表的數據，如公開(kāi)發(fā)表的文獻、數據、信息等，不需取得授權。因此，通過(guò)同品種醫療器械對比進(jìn)行臨床評價(jià)時(shí)，若選取其他注冊人的產(chǎn)品作為同品種醫療器械，數據如果來(lái)自公開(kāi)數據、試驗測量、行業(yè)共識等，可不要求提供數據使用授權書(shū)。

　　《醫療器械臨床評價(jià)技術(shù)指導原則》中關(guān)于同品種醫療器械的判定，提出十六項對比項目，需要逐項對比嗎？

　　答：《醫療器械臨床評價(jià)技術(shù)指導原則》中提到“與每一個(gè)同品種醫療器械進(jìn)行對比的項目均應包括但不限于附2列舉的項目”同時(shí)指出“若存在不適用的項目，應說(shuō)明不適用的理由”，附錄2列舉了包括基本原理、安全性標準、符合的國家標準、行業(yè)標準、適用范圍等項目。申請人在進(jìn)行對比時(shí)，應充分考慮產(chǎn)品的設計特點(diǎn)、關(guān)鍵技術(shù)、適用范圍和風(fēng)險程度等，選擇對比項目并闡述理由，例如超聲理療設備比對應重點(diǎn)考慮設備的結構組成、基本原理、主要性能指標、關(guān)鍵部件（主要指探頭或治療頭）、預期用途等，對于生產(chǎn)工藝、使用方法等，由于生產(chǎn)工藝對該產(chǎn)品的安全有效性的影響可通過(guò)其他項目的對比進(jìn)行評價(jià)，使用方法對于同類(lèi)產(chǎn)品基本相似，可不進(jìn)行對比。

　　某產(chǎn)品從II類(lèi)升到III類(lèi)，類(lèi)別調整后的產(chǎn)品可采用自身臨床數據作為同品種臨床數據進(jìn)行臨床評價(jià)嗎？

　　答：可以，但應充分收集其作為II類(lèi)產(chǎn)品時(shí)的上市前和上市后數據，進(jìn)行合理地總結和分析。主要關(guān)注申報產(chǎn)品是否在正常使用條件下，產(chǎn)品可達到預期性能；與預期受益相比較，產(chǎn)品的風(fēng)險是否可接受；產(chǎn)品的臨床性能和安全性是否均有適當的證據支持。

　　按照同品種醫療器械臨床數據進(jìn)行臨床評價(jià)時(shí)，如檢索不到同品種醫療器械的臨床文獻怎么辦？

　　答：同品種醫療器械臨床數據的收集、分析與評價(jià)，根據申報產(chǎn)品設計特點(diǎn)、關(guān)鍵技術(shù)、適用范圍和風(fēng)險程度的不同，具有不同作用，包括確認同品種醫療器械的安全有效性是否已得到臨床公認，風(fēng)險受益是否在可接受范圍內；充分識別同品種醫療器械的臨床使用風(fēng)險，為申報產(chǎn)品的風(fēng)險受益分析提供信息；通過(guò)臨床數據確認非臨床研究的剩余風(fēng)險；為部分非臨床研究（如臺架試驗）測試結果的評價(jià)提供臨床數據等。

　　同品種產(chǎn)品臨床數據除了臨床文獻數據，還包括臨床經(jīng)驗數據和臨床試驗數據，臨床經(jīng)驗數據包括已完成的臨床研究數據集、不良事件數據集和與臨床風(fēng)險相關(guān)的糾正措施數據集，其中不良事件數據集可以通過(guò)監管機構上市后的投訴、不良事件公開(kāi)獲取。

　　此外，申請人還需確認選取的同品種產(chǎn)品是否為同類(lèi)產(chǎn)品中臨床關(guān)注度較高的、安全有效性已得到公認的產(chǎn)品，以及文獻檢索策略是否恰當，能否保證檢索的全面性。

gqtmr · 發(fā)表于 2019-5-13 18:46:56

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avmwz · 發(fā)表于 2019-5-11 00:33:21

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徐劍聯(lián)844 · 發(fā)表于 2019-4-5 03:22:22

就看看，不說(shuō)話(huà)。

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徐劍聯(lián)844 · 發(fā)表于 2019-3-26 10:45:42

真是好東西，頂��！

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ohnfb · 發(fā)表于 2019-1-29 03:47:59

有空一起交流一下

gvgwe · 發(fā)表于 2019-1-25 05:41:37

參考參考，我認為很好，大家說(shuō)說(shuō)

gvgwe · 發(fā)表于 2019-1-22 19:46:32

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gvgwe · 發(fā)表于 2019-1-15 13:02:46

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