Re: [新聞] 韓國宣布放寬新冠疫苗三期試驗法規

※ 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。
:
: 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 conducta
: 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)
:
: 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。
:
: 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?)
:
: 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.
: 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.
: 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.
: 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。

我就問一句

二期解盲過了嗎？

二期解盲沒過就要硬上

系勒衝三小

幹 別人的囝仔死袂了

--