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源興醫(yī)療

標(biāo)題: 醫(yī)療器械臨床試驗(yàn)常見問題解答 [打印本頁]
作者: test4    時(shí)間: 2018-5-28 10:03
標(biāo)題: 醫(yī)療器械臨床試驗(yàn)常見問題解答
　　在《醫(yī)療器械注冊管理辦法》相關(guān)條例中規(guī)定，除了被列入免于進(jìn)行臨床試驗(yàn)的醫(yī)療器械目錄的產(chǎn)品外，申請第二類、第三類醫(yī)療器械注冊，應(yīng)當(dāng)進(jìn)行臨床試驗(yàn)。下面，我們就醫(yī)療器械臨床試驗(yàn)的常見問題進(jìn)行解答，希望對大家有所幫助！

　　開展平行對照臨床試驗(yàn)時(shí)，如因合理理由不能采用已上市同類產(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：開展平行對照臨床試驗(yàn)時(shí)，如因合理理由不能采用已上市同類產(chǎn)品作為對照產(chǎn)品，可綜合考慮產(chǎn)品設(shè)計(jì)特征、臨床試驗(yàn)前研究結(jié)果、風(fēng)險(xiǎn)受益分析、臨床試驗(yàn)?zāi)康摹⑴R床試驗(yàn)評價(jià)指標(biāo)和隨訪時(shí)間等因素，考慮選擇療效和安全性已得到公認(rèn)、適用范圍與試驗(yàn)器械相同、臨床試驗(yàn)設(shè)定的評價(jià)指標(biāo)與試驗(yàn)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(yī)療器械臨床試驗(yàn)數(shù)據(jù)的產(chǎn)品，如境內(nèi)也有已發(fā)布的相應(yīng)產(chǎn)品的臨床試驗(yàn)指導(dǎo)原則，此時(shí)產(chǎn)品境外臨床試驗(yàn)數(shù)據(jù)是否必須完全滿足境內(nèi)相應(yīng)指導(dǎo)原則要求？

　　答：境外進(jìn)行的臨床試驗(yàn)可能符合試驗(yàn)開展所在國家（地區(qū)）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(yàn)設(shè)計(jì)時(shí)，有些國家僅要求臨床試驗(yàn)?zāi)軌虻贸銎餍敌阅苓_(dá)到某一觀察終點(diǎn)的結(jié)論。但在我國申報(bào)注冊時(shí)，可能要求該器械性能達(dá)到多個(gè)觀察終點(diǎn)才可確認(rèn)其有效性，且醫(yī)療器械的安全性有適當(dāng)?shù)淖C據(jù)支持。若國家藥品監(jiān)督管理局發(fā)布特定醫(yī)療器械的技術(shù)審評指導(dǎo)原則中含有對其臨床試驗(yàn)的相關(guān)要求，該器械境外臨床試驗(yàn)應(yīng)考慮有關(guān)要求，存在不一致時(shí)，應(yīng)提供充分、合理的理由和依據(jù)。

　　接受境外醫(yī)療器械臨床試驗(yàn)數(shù)據(jù)時(shí)，是否境外臨床試驗(yàn)數(shù)據(jù)中一定需要包括華人試驗(yàn)數(shù)據(jù)？

　　答：接受境外醫(yī)療器械臨床試驗(yàn)數(shù)據(jù)時(shí)，境外臨床試驗(yàn)數(shù)據(jù)中不一定需要包括華人試驗(yàn)數(shù)據(jù)。根據(jù)《接受醫(yī)療器械境外臨床試驗(yàn)數(shù)據(jù)指導(dǎo)原則》，可能對臨床試驗(yàn)結(jié)果產(chǎn)生影響的因素不僅限于人種差異，需根據(jù)產(chǎn)品特性綜合考慮受試人群差異、臨床試驗(yàn)條件差異等的影響。雖然已知這些因素客觀存在并會(huì)對臨床試驗(yàn)產(chǎn)生一定的影響，但對各因素影響程度的判定還應(yīng)結(jié)合擬申報(bào)器械的特性、臨床試驗(yàn)?zāi)康牡冗M(jìn)行。根據(jù)醫(yī)療器械發(fā)展現(xiàn)狀、臨床使用經(jīng)驗(yàn)、以及對相關(guān)疾病和診療方法的認(rèn)知，能夠?qū)Υ蟛糠轴t(yī)療器械的臨床試驗(yàn)數(shù)據(jù)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(yàn)數(shù)據(jù)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(yàn)數(shù)據(jù)是否產(chǎn)生有臨床意義的影響時(shí)，申請人應(yīng)闡明降低或消除各項(xiàng)差異影響所采用的方法，如可根據(jù)需要考慮進(jìn)行對受試人群進(jìn)行亞組設(shè)計(jì)，或?qū)σ延械呐R床試驗(yàn)數(shù)據(jù)進(jìn)行亞組分析。

　　列入《需進(jìn)行臨床試驗(yàn)審批的第三類醫(yī)療器械目錄》的醫(yī)療器械是否必須在境內(nèi)開展臨床試驗(yàn)？

　　答：根據(jù)《接受醫(yī)療器械境外臨床試驗(yàn)數(shù)據(jù)技術(shù)指導(dǎo)原則》，列入《需進(jìn)行臨床試驗(yàn)審批的第三類醫(yī)療器械目錄》的醫(yī)療器械，可以根據(jù)本指導(dǎo)原則提交境外臨床試驗(yàn)數(shù)據(jù)。在遵循倫理原則、依法原則和科學(xué)原則的基礎(chǔ)上，境外臨床試驗(yàn)數(shù)據(jù)如符合我國注冊相關(guān)技術(shù)要求，數(shù)據(jù)科學(xué)、完整、充分，可不在境內(nèi)開展臨床試驗(yàn)。

　　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型號開展臨床試驗(yàn)？

　　答：可以選取典型型號A開展臨床試驗(yàn)，對于未開展臨床試驗(yàn)的型號B,應(yīng)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(yàn)中如采用核酸序列測定、GC-MS/MS等實(shí)驗(yàn)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(yàn)？

　　答：對于某些目前臨床上尚不存在明確的臨床診斷“金標(biāo)準(zhǔn)”，亦無可比的同類產(chǎn)品上市的體外診斷試劑，臨床試驗(yàn)研究者應(yīng)依據(jù)現(xiàn)有臨床實(shí)踐和理論基礎(chǔ)，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(yàn)中采用核酸序列測定、GC-MS/MS等實(shí)驗(yàn)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(guī)檢測技術(shù)，需要專門的設(shè)備儀器和試驗(yàn)條件，且臨床試驗(yàn)機(jī)構(gòu)可能不具備相關(guān)檢測條件。對于此類情況，申請人應(yīng)盡可能選擇具備相應(yīng)條件的臨床試驗(yàn)機(jī)構(gòu)開展臨床試驗(yàn)，確無檢測條件的部分臨床試驗(yàn)機(jī)構(gòu)可將此部分測試委托給專門的測序機(jī)構(gòu)、具備一定檢測資質(zhì)的實(shí)驗(yàn)室進(jìn)行檢測，并對檢測結(jié)果進(jìn)行認(rèn)可。提交臨床試驗(yàn)機(jī)構(gòu)與受委托機(jī)構(gòu)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(yàn)器械臨床試驗(yàn)設(shè)計(jì)中計(jì)算樣本量時(shí)，是否可以參照《醫(yī)療器械臨床試驗(yàn)設(shè)計(jì)指導(dǎo)原則》？

　　答：可以，《醫(yī)療器械臨床試驗(yàn)設(shè)計(jì)指導(dǎo)原則》適用范圍明確本指導(dǎo)原則適用于產(chǎn)品組成、設(shè)計(jì)和性能已定型的醫(yī)療器械，包括治療類產(chǎn)品、診斷類產(chǎn)品，不包括體外診斷試劑。因此，臨床檢驗(yàn)器械在臨床試驗(yàn)設(shè)計(jì)計(jì)算樣本量時(shí)可以參照該指導(dǎo)原則相關(guān)要求。
　　通過同品種醫(yī)療器械臨床數(shù)據(jù)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(yī)療器械進(jìn)行對比，生產(chǎn)工藝、臨床數(shù)據(jù)等資料需不需要獲取同品種醫(yī)療器械注冊人的授權(quán)？

　　答：根據(jù)《醫(yī)療器械臨床評價(jià)技術(shù)指導(dǎo)原則》（總局通告2015年第14號），對于通過同品種醫(yī)療器械臨床數(shù)據(jù)進(jìn)行分析評價(jià)的要求中，明確數(shù)據(jù)應(yīng)是合法獲得的相應(yīng)數(shù)據(jù)�！妒称匪幤繁O(jiān)管總局關(guān)于執(zhí)行醫(yī)療器械和體外診斷試劑注冊管理辦法有關(guān)問題的通知》（食藥監(jiān)[2015] 247號）基于數(shù)據(jù)應(yīng)合法獲得，規(guī)定依據(jù)《導(dǎo)則》第六條開展臨床評價(jià)的，如使用了同品種醫(yī)療器械的生產(chǎn)工藝、臨床數(shù)據(jù)等資料，申請人應(yīng)提交同品種醫(yī)療器械生產(chǎn)工藝、臨床數(shù)據(jù)等資料的使用授權(quán)書。《醫(yī)療器械注冊管理法規(guī)解讀之五》對于醫(yī)療器械臨床評價(jià)數(shù)據(jù)授權(quán)要求進(jìn)行了進(jìn)一步解讀，對于擬使用的同品種醫(yī)療器械非公開數(shù)據(jù)等提出授權(quán)要求，以保證數(shù)據(jù)來源的合法性；使用公開發(fā)表的數(shù)據(jù)，如公開發(fā)表的文獻(xiàn)、數(shù)據(jù)、信息等，不需取得授權(quán)。因此，通過同品種醫(yī)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(yī)療器械，數(shù)據(jù)如果來自公開數(shù)據(jù)、試驗(yàn)測量、行業(yè)共識(shí)等，可不要求提供數(shù)據(jù)使用授權(quán)書。

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

　　答：《醫(yī)療器械臨床評價(jià)技術(shù)指導(dǎo)原則》中提到“與每一個(gè)同品種醫(yī)療器械進(jìn)行對比的項(xiàng)目均應(yīng)包括但不限于附2列舉的項(xiàng)目”同時(shí)指出“若存在不適用的項(xiàng)目，應(yīng)說明不適用的理由”，附錄2列舉了包括基本原理、安全性標(biāo)準(zhǔn)、符合的國家標(biāo)準(zhǔn)、行業(yè)標(biāo)準(zhǔn)、適用范圍等項(xiàng)目。申請人在進(jìn)行對比時(shí)，應(yīng)充分考慮產(chǎn)品的設(shè)計(jì)特點(diǎn)、關(guān)鍵技術(shù)、適用范圍和風(fēng)險(xiǎn)程度等，選擇對比項(xiàng)目并闡述理由，例如超聲理療設(shè)備比對應(yīng)重點(diǎn)考慮設(shè)備的結(jié)構(gòu)組成、基本原理、主要性能指標(biāo)、關(guān)鍵部件（主要指探頭或治療頭）、預(yù)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其他項(xiàng)目的對比進(jìn)行評價(jià)，使用方法對于同類產(chǎn)品基本相似，可不進(jìn)行對比。

　　某產(chǎn)品從II類升到III類，類別調(diào)整后的產(chǎn)品可采用自身臨床數(shù)據(jù)作為同品種臨床數(shù)據(jù)進(jìn)行臨床評價(jià)嗎？

　　答：可以，但應(yīng)充分收集其作為II類產(chǎn)品時(shí)的上市前和上市后數(shù)據(jù)，進(jìn)行合理地總結(jié)和分析。主要關(guān)注申報(bào)產(chǎn)品是否在正常使用條件下，產(chǎn)品可達(dá)到預(yù)期性能；與預(yù)期受益相比較，產(chǎn)品的風(fēng)險(xiǎn)是否可接受；產(chǎn)品的臨床性能和安全性是否均有適當(dāng)?shù)淖C據(jù)支持。

　　按照同品種醫(yī)療器械臨床數(shù)據(jù)進(jìn)行臨床評價(jià)時(shí)，如檢索不到同品種醫(yī)療器械的臨床文獻(xiàn)怎么辦？

　　答：同品種醫(yī)療器械臨床數(shù)據(jù)的收集、分析與評價(jià)，根據(jù)申報(bào)產(chǎn)品設(shè)計(jì)特點(diǎn)、關(guān)鍵技術(shù)、適用范圍和風(fēng)險(xiǎn)程度的不同，具有不同作用，包括確認(rèn)同品種醫(yī)療器械的安全有效性是否已得到臨床公認(rèn)，風(fēng)險(xiǎn)受益是否在可接受范圍內(nèi)；充分識(shí)別同品種醫(yī)療器械的臨床使用風(fēng)險(xiǎn)，為申報(bào)產(chǎn)品的風(fēng)險(xiǎn)受益分析提供信息；通過臨床數(shù)據(jù)確認(rèn)非臨床研究的剩余風(fēng)險(xiǎn)；為部分非臨床研究（如臺(tái)架試驗(yàn)）測試結(jié)果的評價(jià)提供臨床數(shù)據(jù)等。

　　同品種產(chǎn)品臨床數(shù)據(jù)除了臨床文獻(xiàn)數(shù)據(jù)，還包括臨床經(jīng)驗(yàn)數(shù)據(jù)和臨床試驗(yàn)數(shù)據(jù)，臨床經(jīng)驗(yàn)數(shù)據(jù)包括已完成的臨床研究數(shù)據(jù)集、不良事件數(shù)據(jù)集和與臨床風(fēng)險(xiǎn)相關(guān)的糾正措施數(shù)據(jù)集，其中不良事件數(shù)據(jù)集可以通過監(jiān)管機(jī)構(gòu)上市后的投訴、不良事件公開獲取。

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


作者: 遼寧生活網(wǎng)n    時(shí)間: 2018-5-31 19:16
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作者: youyou    時(shí)間: 2018-6-4 14:49
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作者: 重慶生活網(wǎng)r    時(shí)間: 2018-6-6 11:56
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作者: youyou    時(shí)間: 2018-6-7 16:44
作者: np雅宇公司    時(shí)間: 2018-8-8 19:13
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作者: 余君海430    時(shí)間: 2018-8-10 00:58
謝謝哦，辛苦辛苦！













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作者: d咔油    時(shí)間: 2018-8-10 04:21
又看了一次













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作者: iujlb04.com    時(shí)間: 2018-9-4 04:07

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作者: admck    時(shí)間: 2018-9-4 21:18
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作者: fsdylkj    時(shí)間: 2018-9-25 14:04
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作者: kfvxw    時(shí)間: 2018-11-20 12:23
頂而不懈，遇到好貼決不能放過












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作者: 香港社區(qū)網(wǎng)    時(shí)間: 2018-12-17 15:36
繼續(xù)關(guān)注一下這方面的信息
作者: 香港社區(qū)網(wǎng)    時(shí)間: 2018-12-21 12:34
好,應(yīng)該頂，今后繼續(xù)努力
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作者: vvsqw    時(shí)間: 2019-1-13 00:50
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作者: gvgwe    時(shí)間: 2019-1-15 13:02
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作者: o拼多多券商城k    時(shí)間: 2019-1-17 08:15
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作者: gvgwe    時(shí)間: 2019-1-22 19:46
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作者: gvgwe    時(shí)間: 2019-1-25 05:41
參考參考，我認(rèn)為很好，大家說說
作者: ohnfb    時(shí)間: 2019-1-29 03:47
有空一起交流一下
作者: 徐劍聯(lián)844    時(shí)間: 2019-3-26 10:45
真是好東西，頂��！













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作者: 徐劍聯(lián)844    時(shí)間: 2019-4-5 03:22
就看看，不說話。













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作者: avmwz    時(shí)間: 2019-5-11 00:33
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作者: gqtmr    時(shí)間: 2019-5-13 18:46
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