撰寫(xiě)醫療器械臨床試驗方案需要包含哪些內容？

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　　眾所周知，通過(guò)臨床試驗獲得有效數據是評價(jià)醫療器械是否安全有效的重要方式之一。根據醫療器械注冊管理辦法中的相關(guān)規定，未列入免于進(jìn)行臨床試驗目錄的第二類(lèi)、第三類(lèi)醫療器械產(chǎn)品申請注冊，應當進(jìn)行臨床試驗。食品藥品監督管理總局指出，未在境內外批準上市的新產(chǎn)品，安全性以及性能尚未經(jīng)醫學(xué)證實(shí)的，臨床試驗方案設計時(shí)應當先進(jìn)行小樣本可行性試驗，待初步確認其安全性后，再根據統計學(xué)要求確定樣本量開(kāi)展后續臨床試驗。

　　因此，在開(kāi)展醫療器械臨床試驗前，申辦者需要按照試驗用醫療器械的類(lèi)別、風(fēng)險、預期用途等組織制定科學(xué)、合理的臨床試驗方案。那么，應當如何撰寫(xiě)臨床試驗方案，需要包含哪些內容呢？

　　在醫療器械臨床試驗質(zhì)量管理規范中，規定醫療器械臨床試驗方案應當包括一般信息、臨床試驗的背景資料、試驗目的、試驗設計、安全性評價(jià)方法、有效性評價(jià)方法、統計學(xué)考慮、對臨床試驗方案修正的規定、對不良事件和器械缺陷報告的規定、直接訪(fǎng)問(wèn)源數據或文件、臨床試驗涉及的倫理問(wèn)題和說(shuō)明以及知情同意書(shū)文本、數據處理與記錄保存、財務(wù)和保險、試驗結果發(fā)表約定等內容。其中，部分內容可以包括在方案的其他相關(guān)文件中(比如研究者手冊)；臨床試驗機構的具體信息、試驗結果發(fā)表約定、財務(wù)和保險可以在試驗方案中表述，也可以另行制定協(xié)議加以規定。

　　如果多中心臨床試驗由多位研究者按照同一試驗方案在不同的臨床試驗機構中同期進(jìn)行，那么這個(gè)試驗方案的設計和實(shí)施應當至少包括以下內容：

　　1.試驗方案由申辦者組織制定并經(jīng)各臨床試驗機構以及研究者共同討論認定，且明確牽頭單位臨床試驗機構的研究者為協(xié)調研究者；

　　2.協(xié)調研究者負責臨床試驗過(guò)程中各臨床試驗機構間的工作協(xié)調，在臨床試驗前期、中期和后期組織研究者會(huì )議，并與申辦者共同對整個(gè)試驗的實(shí)施負責；

　　3.各臨床試驗機構原則上應當同期開(kāi)展和結束臨床試驗；

　　4.各臨床試驗機構試驗樣本量以及分配、符合統計分析要求的理由；

　　5.申辦者和臨床試驗機構對試驗培訓的計劃與培訓記錄要求；

　　6.建立試驗數據傳遞、管理、核查與查詢(xún)程序，尤其明確要求各臨床試驗機構試驗數據有關(guān)資料應當由牽頭單位集中管理與分析；

　　7.多中心臨床試驗結束后，各臨床試驗機構研究者應當分別出具臨床試驗小結，連同病歷報告表按規定經(jīng)審核后交由協(xié)調研究者匯總完成總結報告。

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