Re: [新聞] 韓國宣布放寬新冠疫苗三期試驗法規已回收

看板Gossiping作者forevergood (敝姓李)時間4年前 (2021/08/06 15:26)推噓1(3推 2噓 7→)

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只能說你英文有點不好，翻譯解釋不完全正確，但是我稍微看完，韓國食藥署的目的，就是降低疫苗開發的時間、與成本，提高廠商疫苗研發的意願，這個跟生物統計的信賴區間有關，台灣可以參考依循，降地成本與研發時間韓國如何發展成為生技大國的案例。 ※ 引述《permoon (有志難伸優質寫手ㄉㄉ)》之銘言： : http://www.koreaherald.com/view.php?ud=20210630001048 : S. Korea eases rules for phase 3 clinical trial of new COVID-19 vaccine : 韓國先驅報，記者 Shim Woo-hyun : South Korea’s COVID-19 vaccine candidates can be evaluated through : comparison with previously authorized vaccines. This means domestic vaccine : developers will no longer have to recruit large control groups for a phase 3 : clinical trial. : 韓國的COVID-19疫苗可以與現有的疫苗進行免疫橋接對照實驗， : 這代表未來韓國的疫苗不須招募大量的受試者進行第三期對照實驗。他這段是說：「國內在臨床第三期的疫苗研發，不再需要招募大量控制組人數來做比對。」並不是指完全不需要招募大量受試者做比對！！！！！ : : According to the Ministry of Food and Drug Safety on Wednesday, the : government has revised guidelines for phase 3 clinical trials in a bid to : accelerate the development of homegrown vaccines against COVID-19. : : 韓國食藥署周三宣布，修改第三期實驗的指導方針來加快國產疫苗開發。 : : Under the new rules, drugmakers would need just 4,000 volunteers to conduct a : phase 3 clinical study of a vaccine candidate. Based on the findings, they : can compare the immunogenicity of an already authorized vaccine with one : under development to prove its efficacy. : : 修改後只需要4,000名受試者就可以了。(對照台灣，高端擴大二期收案數=3,700) 這段意思是：「針對候選疫苗，只需要4000受試者就可以執行三期臨床試驗。」 : : Cross-platform comparisons between already authorized vaccines and a : candidate of a different type are also allowed. : : 允許與現有的疫苗進行免疫橋接對照比較。這段意思是：「允許現有核可上市的疫苗，與其他不同種類的疫苗做(校標關聯效度)的比較，來了解疫苗對新冠肺炎的有效性。」 (目前世界授權的三種新冠疫苗，分別採用以下三種技術： 1.去活疫苗/ 2.mRNA疫苗/ 3.次單位蛋白疫苗 ) : : Several South Korean firms are developing vaccines now, including Genexine, : which is developing a DNA vaccine against the novel coronavirus. There are : currently no DNA-based COVID-19 vaccines anywhere, meaning that Genexine has : no authorized DNA vaccine that the company can compare with its vaccine : candidate. : : 這段講的是韓國選擇的DNA疫苗技術，世界上沒有同樣技術的疫苗可以比較。 : (台灣鍵盤疫苗專家鄉民：為什麼不選腺病毒跟mRNA呢? 幹嘛不學中國做減毒呢?) 這段在講：「一些韓國公司(如Genexine)正在研發疫苗，而他們正在研發的疫苗是DNA疫苗，現在DNA疫苗沒有任何與其他疫苗比較的資料，意思是Genexine所生產的疫苗與其他已授權的DNA疫苗做比較的資料」 : : The Health Ministry said vaccine developers should consult with the ministry : when designing cross-platform comparisons to decide the proper vaccine for : comparison. : The minimum number of participants needed for a phase 3 clinical study was : previously 10,000. 這段意思是：「以前韓國食藥署針對不同種技術的疫苗做臨床三期的比較，需要至少10000名受試者」 : In terms of a cross-platform comparison, vaccine developers will need to : secure 3,000 subjects to be administered with a new vaccine and 1,000 : subjects who have been already vaccinated with an existing vaccine, according : to the ministry. 這段意思是：「現在韓國改成只需要4000人參與新疫苗的臨床三期，其中3000人當試驗組接種正在臨床試驗的新疫苗； 1000人當控制組，接種目前已在市面上授權的疫苗。」 : The revision is expected to help local pharmaceutical companies speed up : development of COVID-19 vaccines and ease difficulties in securing : placebo-controlled subjects who have not been vaccinated, the ministry : expected. : Domestic firms have experienced difficulties in recruiting enough test : subjects, particularly placebo-controlled subjects, as more and more people : are getting vaccinated these days. : The ministry expects that the new guideline will also help local firms save : on spending for their clinical studies. 這段意思是：「這個新的臨床研究案修正，希望節省疫苗在臨床研究的開銷。」 : Meanwhile, the Health Ministry has also set up new articles in the guideline : that allow for vaccine developers to be able to test their vaccines against : COVID-19 variants. : : 剩下的不太重要了，主要是韓國政府希望幫國產疫苗廠商減少開支。 : (台灣鄉民：叭叭叭叭!!炒股!!圖利!!割韭菜!!!) : : BTW其實日本也快通過免疫橋接取代原本的大規模收案的三期了， : 台灣有沒有領先世界窩補知道，但一定是領先日韓的， : 至於他們的國民有沒有跳出來說政府屠殺人民或割韭菜，我就不知道了， : 等各位國際觀滿分的八卦版鄉民教育我。 -- ※ 發信站: 批踢踢實業坊(ptt.cc), 來自: 61.230.12.209 (臺灣) ※ 文章網址: https://www.ptt.cc/bbs/Gossiping/M.1628234797.A.747.html

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