新聞翻譯-FDA海外臨床試驗(yàn)新法規(guī)

1、http:/product- nical-trials-fda-vs-industry/ A U.S.Food and Drug Administration proposal entitled“Human Subject Protection: Acceptance of Data From Clinical Studies for Medical Devices”is inciting the medical device industrys top trade group,along with several major manufacturers. If enacted,the pro

2、posed rule would require that clinical studies involving medical devices conducted outside the United States“be conducted in accordance with good clinical practice(GCP,which includes obtaining and documenting the review and approval of the study by an independent ethics committee(IECand obtaining an

3、d documenting freely given informed consent of study subjects.”美國(guó)食品和藥品監(jiān)督管理局建議,題為“人類主題保護(hù):接受”醫(yī)療器械臨床研究的數(shù)據(jù)來源是煽動(dòng)醫(yī)療器械行業(yè)的貿(mào)易集團(tuán),隨著幾大廠商。如果獲得通過,擬議的規(guī)則將要求在美國(guó)以外進(jìn)行的涉及醫(yī)療器械的臨床研究“進(jìn)行良好的臨床管理規(guī)范(GCP,其中包括獲得和記錄由一個(gè)獨(dú)立的倫理委員會(huì)的審查和批準(zhǔn)本研究根據(jù)(IEC和自由獲取和記錄受試者的知情同意?！癡arious players in the medical device industry have taken issue with t

4、he FDAs actions,outlining their grievances in written comments to the rule.First,the industry has taken issue with some of the documents cited in the proposed rule, arguing that they have no application to medical devices.In its“Reasons for Proposing to Revise the Regulations,”the FDA references the

5、 International Conference on Harmonisation(ICHof Technical Requirements for Registration of Pharmaceuticals for Human Uses document entitled“Good Clinical Practice: Consolidated Guideline”as one of”several notable documents”that identifies “ethical and other principles that provide assurance of the

6、quality and integrity of clinical data and adequate protection of human subjects.”The ICHs guideline defines good clinical practice(GCPas“a standard for the design,conduct, performance,monitoring,auditing,recording,analyses,and reporting of clinical trials that provides assurance that the data and r

7、eported results are credible and accurate,and that the rights,integrity,and confidentiality of trial subjects are protected.”According to the Advanced Medical Technology Association(“AdvaMed” and the medical device companies who commented on the rule,the ICH guidelines do not provide any guidance fo

8、r medical devices,and thus should not be used as support for the rule.廠商在醫(yī)療器械行業(yè)已采取各種問題與FDA的行動(dòng)規(guī)則的書面意見中,概述了他們的不滿。首先,該行業(yè)已采取一些擬議的規(guī)則中引用的文件的問題,爭(zhēng)辯說,他們沒有醫(yī)療設(shè)備的應(yīng)用程序。在其“理由,提議修訂”條例“,”FDA引用的人類使用的文檔藥品注冊(cè)技術(shù)要求國(guó)際協(xié)調(diào)會(huì)議(ICH題為“良好的臨床實(shí)踐:綜合指引”為一體的“幾個(gè)顯著的文檔“標(biāo)識(shí)”提供保證的質(zhì)量和誠(chéng)信的臨床數(shù)據(jù)和充分保護(hù)人類受試者的道德和其他原則?！癐CH的指導(dǎo)方針定義為”標(biāo)準(zhǔn)的設(shè)計(jì),行為,性能良好的臨床實(shí)踐(

9、GCP,監(jiān)控,稽查,記錄,分析和報(bào)告臨床試驗(yàn)的數(shù)據(jù)和報(bào)告的結(jié)果是可信的,準(zhǔn)確的,并提供保證受試者的權(quán)利,完整性和保密性得到保障?！案鶕?jù)先進(jìn)醫(yī)療技術(shù)協(xié)會(huì)(先進(jìn)醫(yī)療技術(shù)協(xié)會(huì)“和醫(yī)療設(shè)備公司評(píng)論規(guī)則,ICH指導(dǎo)原則不提供任何指導(dǎo)的醫(yī)療設(shè)備,因此不應(yīng)該被用來作為規(guī)則的支持。Second,AdvaMed expressed its concern that the non-U.S.regulatory and clinical community could present serious barriers to the FDA rule,making it difficult or impossibl

10、e for medical device companies to conduct business in that environment. In other words,not all foreign nations would permit disclosure of the very information that is needed to make the assurances required by the FDA rule.二,先進(jìn)醫(yī)療技術(shù)協(xié)會(huì)表示關(guān)注非美的法規(guī)和臨床社群可能會(huì)和FDA的規(guī)則之間出現(xiàn)嚴(yán)重的障礙,將會(huì)使得醫(yī)療設(shè)備公司開展業(yè)務(wù)更加的困難。換句話說,并不是所有的外國(guó)國(guó)

11、家允許揭露FDA需要的訊息披露。Boston Scientific Corp.echoed AdvaMeds concerns,pointing out that the proposed regulation sets out requirements for clinical studies conducted outside the U.S., without any corresponding explicit support from foreign regulators.Many of the medical device companies,including Indiana-b

12、ased Cook Group Inc.,argued that the data required by the FDA to demonstrate compliance will be unable to be supplied, based on the standards of good clinical practice or the laws of different countries or regions.In its comment to the rule,Cook argued that the FDA“has no statutory authority to regu

13、late the conduct of studies conducted outside the United States.”波士頓科學(xué)公司贊同先進(jìn)醫(yī)療技術(shù)協(xié)會(huì)的關(guān)注(即上述的規(guī)定,指出在擬議規(guī)例在美國(guó)境外進(jìn)行的臨床研究中,沒有任何外國(guó)監(jiān)管機(jī)構(gòu)相應(yīng)的明確的支持要求。很多的醫(yī)療器械公司,包括印第安納州的庫(kù)克集團(tuán)股份有限公司,爭(zhēng)辯,以證明符合FDA要求的數(shù)據(jù)將無法提供,基于良好的臨床實(shí)踐的標(biāo)準(zhǔn)或不同國(guó)家或地區(qū)的法律。在其注釋的規(guī)則,庫(kù)克認(rèn)為,美國(guó)FDA“沒有法定權(quán)力,規(guī)范的行為在美國(guó)以外進(jìn)行的研究?！盠astly,device companies complained that the FDA

14、s requirement that they vet an ethics committee abroad goes beyond whats expected of them domestically.Johnson &Johnson also noted that foreign committees may not wish or be able to provide thenecessary information required for the vetting process,such as qualifications of the ethics committee m

15、embers.最后,設(shè)備公司抱怨說,FDA的要求,他們的獸醫(yī)國(guó)外倫理委員會(huì)超越他們的預(yù)期。強(qiáng)生(Johnson&Johnson也指出,外國(guó)委員會(huì)未必愿意或能夠提供審批過程中所需的必要信息,如倫理委員會(huì)成員的資格。AdvaMed recommends that,in order to avoid these pitfalls,the FDA should broker agreements with other countries in advance in order to authorize the proposed framework for clinical trials.By

16、convening a group of international regulators and industry officials,AdvaMed says,the FDA could”fast track”harmonized guidelines that all relevant players agree upon.This way,according to the trade group, sovereign nations outside the U.S.would not view the FDA as unilaterally imposing its own stand

17、ards on international device regulators.先進(jìn)醫(yī)療技術(shù)協(xié)會(huì)建議,為了避免這些缺陷,使用本品時(shí)應(yīng)與其他國(guó)家提前經(jīng)紀(jì)協(xié)議授權(quán)的擬議框架進(jìn)行臨床試驗(yàn)。通過召集一個(gè)國(guó)際監(jiān)管機(jī)構(gòu)和行業(yè)官員,先進(jìn)醫(yī)療技術(shù)協(xié)會(huì)說,FDA可以“快速跟蹤”所有相關(guān)的參與者商定的統(tǒng)一準(zhǔn)則。通過這種方式,根據(jù)該貿(mào)易團(tuán)體,在美國(guó)以外的主權(quán)國(guó)家不會(huì)查看FDA單方面制定自己的標(biāo)準(zhǔn),國(guó)際設(shè)備監(jiān)管。For its part,the FDA explains in its proposed rule that it is aiming to streamline oversight by bringing

18、 all types of device approval applications under one common standard for conducting clinical trials outside the U.S.As of now,clinical trials supporting premarket approval applications for potentially risky devices must be conducted in accordance with the laws of the country where theyre conducted,o

19、r with the Declaration of Helsinki(a set of international ethical principles established in1964.This means that studies involving multiple countries can face a mix of standards,creating uncertainty and delays.Thus,the FDA says,the aim of the proposed rule is to actually decrease the regulatory burde

20、n for device makers, while providing greater protection of patients participating in clinical trials.對(duì)于它的一部分,FDA在其擬議的規(guī)則解釋,它的目標(biāo)是簡(jiǎn)化監(jiān)督,使一個(gè)共同的標(biāo)準(zhǔn)下,所有類型的設(shè)備核準(zhǔn)申請(qǐng)進(jìn)行臨床試驗(yàn),截至目前,臨床試驗(yàn)在美國(guó)以外的支持潛在風(fēng)險(xiǎn)的上市前批準(zhǔn)申請(qǐng)?jiān)O(shè)備必須按照他們進(jìn)行所在國(guó)的法律,或與赫爾辛基宣言“(成立于1964年的國(guó)際倫理原則進(jìn)行。這意味著,涉及多個(gè)國(guó)家的研究可以面對(duì)標(biāo)準(zhǔn)的混合,創(chuàng)造的不確定性和拖延。因此,FDA表示,擬議的規(guī)則的目的,實(shí)際上是降低設(shè)備制造商的監(jiān)管負(fù)擔(dān),同時(shí)參加臨床試驗(yàn)的患者提供更大的保護(hù)。Given how many medical device companies rely on clinical trials conducted abroad, the final version of this rule will have a significant impact on the medical device industry.Depending on the requirements outlined in the final rule,device companies may cho