学习CDER如何推进监管科学以保护公众健康(二)

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学习CDER如何推进监管科学以保护公众健康（二）
摘自微信公众号 药品注册英语学习平台

Learn how CDER is advancing regulatory science to protect public health.
学习 CDER如何推进监管科学以保护公众健康

CDER Researchers – In Their Own Words
CDER研究者 – 用他们自己的话说

CDER的监管科学-来自Lisa LaVange , Ph.D. 的播客

Dr. Lisa LaVange explains how CDER’s Office of Biostatistics examines evidence in pre-and post-market settings to help provide safe and effective medicines to patients.
Lisa LaVange博士解释了CDER的生物统计学办公室是如何检查上市前和上市后环境中的证据，来为病人提供安全有效的药物。

CDER监管科学Lisa博士
来自药品注册英语学习平台


Dr. LaVange: The statistics here, they’re very challenging. The data packages are complex. The protocol designs are complex. The analyses we run are complex. So, you are challenged. What you get here that you can’t get anywhere else is the public health impact.
统计学在这里非常具有挑战性。数据包是复杂的，协议设计是复杂的，我们运行的分析也是复杂的。因此，你被挑战了。你在这里得到而在其他任何地方无法得到的东西就是对公众健康影响力！

Lisa LaVange, Ph.D. 博士
Director 主任
Office of Biostatistics 生物统计学办公室
Office of Translational Sciences 转化科学办公室

Dr. LaVange: The Office of Biostatistics is the resource for statistical expertise and knowledge in CDER. We work in the pre-market setting to examine evidence of whether drugs work and whether they’re safe.
生物统计学办公室是CDER统计学专家和知识资源。我们在上市前的环境下检查药物是否有效和是否安全的证据。

We work in a post-market setting to continue to monitor the safety of drugs once they’re on the market and being taken by a much larger and more heterogeneous population of patients, and we also support the non-clinical side of drug development with animal studies and other types of non-clinical studies, and we support the Office of Generic Drugs.
一旦药物上市被更大量和更多种群的人所使用，我们在上市后的环境下持续监测药物的安全性。我们也会支持使用动物试验的药物开发和其他类型的非临床研究，我们支持仿制药办公室。

The statistics that we do helps to provide safe and effective medicines to people who need them. We have a direct impact to the public health, both the US and globally. That’s our strength and that’s our expertise.
我们的统计学工作有助于向需要的病人提供安全有效的药物。我们对美国和全球的公共卫生产生直接影响，这是我们的实力，这是我们的专长。

With the advent of more powerful computing platforms, trial designs have gotten more sophisticated. Our statisticians need to be up on these trial designs. We need to be experienced in them. We need to understand them. We need to have state of the art statistical and computing skills.
随着更加强大的计算平台的出现，试验设计变得更加复杂。我们的统计学家需要熟悉这些试验设计，我们需要从中获得经验，我们需要理解它们，我们需要先进的统计和计算能力。

One particular place in post-market, the post-marketing setting we’re working right now is the opioid epidemic and trying to determine if when we approve one of the newly formulated opioids, formulated to not be so easy to abuse, whether that’s actually making a difference in the epidemiological data, the data of overdose reports for example. And the data sources are complex and the statistical issues are complex.
一个特别的地方是在上市后,我们现在工作的上市后环境是阿片类药物流行病。如果当我们试图确定批准一个阿片类药物新制剂,制剂不那么容易滥用,那么这实际上是否给流行病学数据,例如过量使用报告的数据方面带来不同。数据源是复杂的，统计的问题也是复杂的。

Master protocols are an innovation that we’re particularly excited about right now. These are coordinated efforts to answer more than one question at a time regarding whether drugs work. They involve multiple drugs coming from different pharmaceutical sponsors who have to coordinate.
主协议是我们现在特别兴奋的一项创新。这些都是协调努力，以一次回答多个关于药物是否工作的问题。它们涉及来自不同药物赞助商必须协调的多种药物。

So, you get a better use of patients, much more quick recruitment, and you end up with a powerful infrastructure, lots of trials being run at the same time; answers about drugs are available more efficiently and sooner.
所以，你可以更好地利用病人，更快的招募，最终你会得到一个强大的基础设施，同时进行大量的试验;关于药物的答案更有效，更快速得到。

I think biostatisticians play a very important role in CDER. We’re trained to find the truth in the data, or the evidence that the data can bring, and to assess that evidence and to make sure it’s sturdy.
我认为生物统计学家在CDER扮演着十分重要的角色。我们经过培训在数据中找到真相，或数据能带来的证据，以及对数据进行评估以确保证据可靠。

We have an important role to play in determining whether drugs are safe and effective. We also try to impact the speed of development and the efficiency of development. We then are responsible for getting drugs into the hands of the patients that need them, and this is a real reason to get up and come to work in the morning.
在决定药物是否安全有效方面，我们需要扮演重要角色。我们同样努力影响药物开发的速度和效率。然后我们对药物到达需要它们的病人手上负责，这便是每天早上起床去工作的真正原因。


日积月累

challenging 挑战性的;
challenged 受到挑战的;
protocol 草案; 协议; 科学实验报告;
public health 公共卫生，公共卫生设施
Biostatistics 生物统计学
statistical 统计的; 统计学的
statistic 统计，统计学
expertise 专门知识或技能;
setting 环境;  背景;
examine 检查，调查;

monitor 监测仪;监测
on the market 出售；上市
heterogeneous population 异质性群体
effective 有效的;
direct impact 直接影响;
globally 全球的
strength 力量; 优点，长处;
advent 出现; 到来; 基督降临节
computing 计算;
sophisticated 复杂的; 精致的; 富有经验的;

statistician 统计学家，统计员
be up on 精通，熟悉
state of the art 技术发展最新水平
right now 此时; 立即;
opioid 阿片类物质;
epidemiological 流行病学
overdose 过量用药; 用药过量;
data sources 数据来源
coordinated 协调的; 协调; 协同;
involve 包含; 牵涉;

pharmaceutical 制药的，配药的; 药物
coordinate 使协调，使调和;
recruitment 募集;
end up with 以…结束
infrastructure 基础设施;
trials 测试; 试验;
sturdy 坚定的; 强壮的，健全的; 坚固的
determine 确定; 决定;

胜利者

共产主义理想一定能实现

syhorchid

可以当做学习外语的材料