Re: [新闻] 韩国宣布放宽新冠疫苗三期试验法规

楼主: forevergood (李弟兄)   2021-08-06 15:26:35
只能说你英文有点不好,翻译解释不完全正确,
但是我稍微看完,韩国食药署的目的,
就是降低疫苗开发的时间、与成本,
提高厂商疫苗研发的意愿,
这个跟生物统计的信赖区间有关,
台湾可以参考依循,降地成本与研发时间
韩国如何发展成为生技大国的案例。
※ 引述《permoon (有志难伸优质写手ㄉㄉ)》之铭言:
: http://www.koreaherald.com/view.php?ud=20210630001048
: S. Korea eases rules for phase 3 clinical trial of new COVID-19 vaccine
: 韩国先驱报,记者 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.
: 韩国的COVID-19疫苗可以与现有的疫苗进行免疫桥接对照实验,
: 这代表未来韩国的疫苗不须招募大量的受试者进行第三期对照实验。
他这段是说:“国内在临床第三期的疫苗研发,
不再需要招募大量控制组人数来做比对。”
并不是指完全不需要招募大量受试者做比对!!!!!
:
: 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.
:
: 韩国食药署周三宣布,修改第三期实验的指导方针来加快国产疫苗开发。
:
: 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.
:
: 修改后只需要4,000名受试者就可以了。(对照台湾,高端扩大二期收案数=3,700)
这段意思是:“针对候选疫苗,
只需要4000受试者就可以执行三期临床试验。”
:
: Cross-platform comparisons between already authorized vaccines and a
: candidate of a different type are also allowed.
:
: 允许与现有的疫苗进行免疫桥接对照比较。
这段意思是:“允许现有核可上市的疫苗,
与其他不同种类的疫苗做(校标关联效度)的比较,
来了解疫苗对新冠肺炎的有效性。”
(目前世界授权的三种新冠疫苗,分别采用以下三种技术:
1.去活疫苗/ 2.mRNA疫苗/ 3.次单位蛋白疫苗 )
:
: 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.
:
: 这段讲的是韩国选择的DNA疫苗技术,世界上没有同样技术的疫苗可以比较。
: (台湾键盘疫苗专家乡民:为什么不选腺病毒跟mRNA呢? 干嘛不学中国做减毒呢?)
这段在讲:“一些韩国公司(如Genexine)正在研发疫苗,
而他们正在研发的疫苗是DNA疫苗,
现在DNA疫苗没有任何与其他疫苗比较的资料,
意思是Genexine所生产的疫苗与其他已授权的DNA疫苗做比较的资料”
:
: 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.
这段意思是:“以前韩国食药署针对不同种技术的疫苗做临床三期的比较,
需要至少10000名受试者”
: 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.
这段意思是:“现在韩国改成只需要4000人参与新疫苗的临床三期,
其中3000人当试验组接种正在临床试验的新疫苗;
1000人当控制组,接种目前已在市面上授权的疫苗。”
: 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.
这段意思是:“这个新的临床研究案修正,
希望节省疫苗在临床研究的开销。”
: 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,主要是韩国政府希望帮国产疫苗厂商减少开支。
: (台湾乡民:叭叭叭叭!!炒股!!图利!!割韭菜!!!)
:
: BTW其实日本也快通过免疫桥接取代原本的大规模收案的三期了,
: 台湾有没有领先世界窝补知道,但一定是领先日韩的,
: 至于他们的国民有没有跳出来说政府屠杀人民或割韭菜,我就不知道了,
: 等各位国际观满分的八卦版乡民教育我。

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