撰寫醫(yī)療器械臨床試驗方案需要包含哪些內(nèi)容？

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　　眾所周知，通過臨床試驗獲得有效數(shù)據(jù)是評價醫(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，未列入免于進行臨床試驗目錄的第二類、第三類醫(yī)療器械產(chǎn)品申請注冊，應(yīng)當進行臨床試驗。食品藥品監(jiān)督管理總局指出，未在境內(nèi)外批準上市的新產(chǎn)品，安全性以及性能尚未經(jīng)醫(yī)學證實的，臨床試驗方案設(shè)計時應(yīng)當先進行小樣本可行性試驗，待初步確認其安全性后，再根據(jù)統(tǒng)計學要求確定樣本量開展后續(xù)臨床試驗。

　　因此，在開展醫(yī)療器械臨床試驗前，申辦者需要按照試驗用醫(yī)療器械的類別、風險、預期用途等組織制定科學、合理的臨床試驗方案。那么，應(yīng)當如何撰寫臨床試驗方案，需要包含哪些內(nèi)容呢？

　　在醫(yī)療器械臨床試驗質(zhì)量管理規(guī)范中，規(guī)定醫(yī)療器械臨床試驗方案應(yīng)當包括一般信息、臨床試驗的背景資料、試驗目的、試驗設(shè)計、安全性評價方法、有效性評價方法、統(tǒng)計學考慮、對臨床試驗方案修正的規(guī)定、對不良事件和器械缺陷報告的規(guī)定、直接訪問源數(shù)據(jù)或文件、臨床試驗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、財務(wù)和保險、試驗結(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)；臨床試驗機構(gòu)的具體信息、試驗結(jié)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(guī)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(gòu)中同期進行，那么這個試驗方案的設(shè)計和實施應(yīng)當至少包括以下內(nèi)容：

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

　　2.協(xié)調(diào)研究者負責臨床試驗過程中各臨床試驗機構(gòu)間的工作協(xié)調(diào)，在臨床試驗前期、中期和后期組織研究者會議，并與申辦者共同對整個試驗的實施負責；

　　3.各臨床試驗機構(gòu)原則上應(yīng)當同期開展和結(jié)束臨床試驗；

　　4.各臨床試驗機構(gòu)試驗樣本量以及分配、符合統(tǒng)計分析要求的理由；

　　5.申辦者和臨床試驗機構(gòu)對試驗培訓的計劃與培訓記錄要求；

　　6.建立試驗數(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機構(gòu)試驗數(shù)據(jù)有關(guān)資料應(yīng)當由牽頭單位集中管理與分析；

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

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