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Sample translations submitted: 1
English: 随机对照试验为与对照用医疗器械进行实验 General field: Medical Detailed field: Engineering (general)
Source text - English Randomized controlled trials (RCTS) are 1:1 trials of not less than 200 pairs with luminal loss at least 12 months as the primary endpoint compared with control devices, which are considered to have better efficacy. At present, coronary drug-eluting stents with metal platforms can be used as control devices. With the development of bioabsorbable coronary drug-eluting stent technology, it is suggested to select the bioabsorbable coronary drug-eluting stent with the same main function principle as the test product as the control medical device.
The primary endpoint of the single-arm trial is the failure rate of target lesions for at least 12 months, and the sample size should not be less than 1000 cases, some of which may be from the randomized controlled trial group. The total sample size should be no less than 1200 on a statistically significant basis. The hypotheses of both clinical trials need to be established.
When applying for registration of domestic products, the applicant shall submit the clinical follow-up results of 36 months of randomized controlled subjects.
Translation - English 随机对照试验为与对照用医疗器械进行的以至少12个月晚期管腔丢失为主要研究终点的1:1的不少于200对的试验，对照用医疗器械应选择公认疗效较好的对照用医疗器械。目前可采用平台为金属的冠状动脉药物洗脱支架作为对照用医疗器械。随着生物可吸收冠状动脉药物洗脱支架技术的发展，建议选用与受试产品主要功能原理一致的生物可吸收冠状动脉药物洗脱支架作为对照用医疗器械。
单臂试验以至少12个月靶病变失败率为主要研究终点，样本量应不少于1000例，其中部分病例可来源于随机对照试验的试验组。试验总样本量应在具有统计学意义基础上不少于1200例。两个临床试验的研究假设均需成立。
境内产品注册申报时，申请人应提交随机对照部分受试者36个月临床随访结果。
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Years of experience: 12. Registered at ProZ.com: Aug 2021.
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I'm a freelance translator/interpreter,
native English, with more than 9 years of experience translating law, IT&
internet, medical, Engineering, telecom, etc. presently looking to expand
my pool of potential clients for long term cooperation, I have a license
in translation; I translate mainly from English into Chinese(Simplified or
Traditional) and vice versa, I've always got positive feedback so far,
being fast and delivering good quality translations,
I use MS Office and CAT tools( SDL
Trados Studio, Memsource, and MemoQ).
Here I am glad to offer you my
translation, transcription, and caption service. Attached please find my CV.
Best rate per word: 0.06USD/preferred:0.07 USD, I look forward to working with you in the near future!
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