撰寫醫(yī)療器械臨床試驗(yàn)方案需要包含哪些內(nèi)容？

test4

　　眾所周知，通過臨床試驗(yàn)獲得有效數(shù)據(jù)是評(píng)價(jià)醫(yī)療器械是否安全有效的重要方式之一。根據(jù)醫(yī)療器械注冊管理辦法中的相關(guān)規(guī)定，未列入免于進(jìn)行臨床試驗(yàn)?zāi)夸浀牡诙�類、第三類醫(yī)療器械產(chǎn)品申請注冊，應(yīng)當(dāng)進(jìn)行臨床試驗(yàn)。食品藥品監(jiān)督管理總局指出，未在境內(nèi)外批準(zhǔn)上市的新產(chǎn)品，安全性以及性能尚未經(jīng)醫(yī)學(xué)證實(shí)的，臨床試驗(yàn)方案設(shè)計(jì)時(shí)應(yīng)當(dāng)先進(jìn)行小樣本可行性試驗(yàn)，待初步確認(rèn)其安全性后，再根據(jù)統(tǒng)計(jì)學(xué)要求確定樣本量開展后續(xù)臨床試驗(yàn)。

　　因此，在開展醫(yī)療器械臨床試驗(yàn)前，申辦者需要按照試驗(yàn)用醫(yī)療器械的類別、風(fēng)險(xiǎn)、預(yù)期用途等組織制定科學(xué)、合理的臨床試驗(yàn)方案。那么，應(yīng)當(dāng)如何撰寫臨床試驗(yàn)方案，需要包含哪些內(nèi)容呢？

　　在醫(yī)療器械臨床試驗(yàn)質(zhì)量管理規(guī)范中，規(guī)定醫(yī)療器械臨床試驗(yàn)方案應(yīng)當(dāng)包括一般信息、臨床試驗(yàn)的背景資料、試驗(yàn)?zāi)康�、試�?yàn)設(shè)計(jì)、安全性評(píng)價(jià)方法、有效性評(píng)價(jià)方法、統(tǒng)計(jì)學(xué)考慮、對臨床試驗(yàn)方案修正的規(guī)定、對不良事件和器械缺陷報(bào)告的規(guī)定、直接訪問源數(shù)據(jù)或文件、臨床試驗(yàn)涉及的倫理問題和說明以及知情同意書文本、數(shù)據(jù)處理與記錄保存、財(cái)務(wù)和保險(xiǎn)、試驗(yàn)結(jié)果發(fā)表約定等內(nèi)容。其中，部分內(nèi)容可以包括在方案的其他相關(guān)文件中(比如研究者手冊)；臨床試驗(yàn)機(jī)構(gòu)的具體信息、試驗(yàn)結(jié)果發(fā)表約定、財(cái)務(wù)和保險(xiǎn)可以在試驗(yàn)方案中表述，也可以另行制定協(xié)議加以規(guī)定。

　　如果多中心臨床試驗(yàn)由多位研究者按照同一試驗(yàn)方案在不同的臨床試驗(yàn)機(jī)構(gòu)中同期進(jìn)行，那么這個(gè)試驗(yàn)方案的設(shè)計(jì)和實(shí)施應(yīng)當(dāng)至少包括以下內(nèi)容：

　　1.試驗(yàn)方案由申辦者組織制定并經(jīng)各臨床試驗(yàn)機(jī)構(gòu)以及研究者共同討論認(rèn)定，且明確牽頭單位臨床試驗(yàn)機(jī)構(gòu)的研究者為協(xié)調(diào)研究者；

　　2.協(xié)調(diào)研究者負(fù)責(zé)臨床試驗(yàn)過程中各臨床試驗(yàn)機(jī)構(gòu)間的工作協(xié)調(diào)，在臨床試驗(yàn)前期、中期和后期組織研究者會(huì)議，并與申辦者共同對整個(gè)試驗(yàn)的實(shí)施負(fù)責(zé)；

　　3.各臨床試驗(yàn)機(jī)構(gòu)原則上應(yīng)當(dāng)同期開展和結(jié)束臨床試驗(yàn)；

　　4.各臨床試驗(yàn)機(jī)構(gòu)試驗(yàn)樣本量以及分配、符合統(tǒng)計(jì)分析要求的理由；

　　5.申辦者和臨床試驗(yàn)機(jī)構(gòu)對試驗(yàn)培訓(xùn)的計(jì)劃與培訓(xùn)記錄要求；

　　6.建立試驗(yàn)數(shù)據(jù)傳遞、管理、核查與查詢程序，尤其明確要求各臨床試驗(yàn)機(jī)構(gòu)試驗(yàn)數(shù)據(jù)有關(guān)資料應(yīng)當(dāng)由牽頭單位集中管理與分析；

　　7.多中心臨床試驗(yàn)結(jié)束后，各臨床試驗(yàn)機(jī)構(gòu)研究者應(yīng)當(dāng)分別出具臨床試驗(yàn)小結(jié)，連同病歷報(bào)告表按規(guī)定經(jīng)審核后交由協(xié)調(diào)研究者匯總完成總結(jié)報(bào)告。

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