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【drug-news】FDA发布了临床试验的行为准则

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FDA's final rule on clinical trials

The FDA has issued a final rule that clarifies what safety information must be reported during clinical trials of investigational drugs and biologics. The rule requires that certain safety information, which was previously not required to be reported to the FDA, must be reported within 15 days of becoming aware of an occurrence. These reports include:

findings from clinical or epidemiological studies that suggest a significant risk to study participants
serious suspected adverse reactions that occur at a rate higher than expected
serious adverse events from bioavailability studies, as well as bioequivalence studies in the case of generic drugs.

The FDA has also issued a draft guidance for industry and investigators that provides information and advice about the new requirements.

“This final rule will expedite FDA’s review of critical safety information and help the agency monitor the safety of investigational drugs and biologics,” Rachel Behrman, Associate Director for Medical Policy in the FDA’s Center for Drug Evaluation and Research, explained in a statement. “These changes will better protect people who are enrolled in clinical trials.”

The rule also provides examples of evidence that would suggest that an investigational product may be the cause of a safety problem. Under the current regulations, drug sponsors often report all serious adverse events, including those that are probably not related to the product. This reporting can complicate and delay the FDA’s ability to detect safety signals. The rule clarifies when a single event should be reported and when sponsors should wait for more than one occurrence. According to the FDA, the new rule also revises definitions and reporting standards to make them more consistent with the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use and the World Health Organization’s Council for International Organizations of Medical Sciences.

http://pharmtech.findpharma.com/pharmtech/News/FDAs-final-rule-on-clinical-trials/ArticleStandard/Article/detail/689042?contextCategoryId=35097

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2010-10-09 14:16 浏览 : 433 回复 : 2

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• (求大佬指点）医学专硕毕业，四证合一，在深圳找得到工作吗

ddylyk

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认领本文翻译，48小时内未提交，请其他战友认领。

2010-10-09 15:23

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• 全科医疗科诊疗范围、设置标准?全科医学专业执业范围、注册条件？

ddylyk

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FDA's final rule on clinical trials
FDA发布了临床试验的行为准则

The FDA has issued a final rule that clarifies what safety information must be reported during clinical trials of investigational drugs and biologics. The rule requires that certain safety information, which was previously not required to be reported to the FDA, must be reported within 15 days of becoming aware of an occurrence. These reports include:
FDA发布了一项准则，要求药物或生物制品临床试验过程中，必须报告其安全性信息。要求指出，一些之前并没有要求报告的安全性性信息，必须在发生后的15日内，上报FDA，包括：

findings from clinical or epidemiological studies that suggest a significant risk to study participants
临床试验或流行病学研究中，对受试者有明显风险的；

serious suspected adverse reactions that occur at a rate higher than expected
疑似严重不良反应率高于预期；

serious adverse events from bioavailability studies, as well as bioequivalence studies in the case of generic drugs.
生物利用度试验和仿制药生物等效试验中严重不良事件；

The FDA has also issued a draft guidance for industry and investigators that provides information and advice about the new requirements.
FDA还发布了一个指导原则的草案，用来咨询提供信息的药厂和研究者，对这项新要求提出意见。

“This final rule will expedite FDA’s review of critical safety information and help the agency monitor the safety of investigational drugs and biologics,” Rachel Behrman, Associate Director for Medical Policy in the FDA’s Center for Drug Evaluation and Research, explained in a statement. “These changes will better protect people who are enrolled in clinical trials.”
“这项行为准则将加快FDA对重大安全信息的审查，帮助研究用药品和生物制品的安全监管机构”，FDA药品审评中心副主任Rachel Behrman在一份声明中说到，“这个改变将保护那些参加临床试验的人群”。

The rule also provides examples of evidence that would suggest that an investigational product may be the cause of a safety problem. Under the current regulations, drug sponsors often report all serious adverse events, including those that are probably not related to the product. This reporting can complicate and delay the FDA’s ability to detect safety signals. The rule clarifies when a single event should be reported and when sponsors should wait for more than one occurrence. According to the FDA, the new rule also revises definitions and reporting standards to make them more consistent with the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use and the World Health Organization’s Council for International Organizations of Medical Sciences.
这个规定也提供了研究品可能造成安全性问题的例子。在现行的政策下，申办者需要报告全部的SAE，包括那些可能与研究品无关的SAE。这些报告使FDA鉴别安全信号复杂化，降低鉴别能力。规定清除的规定了，什么时候事件一发现就应上报，而什么事件需等到多次发生的时候在上报。根据FDA要求，这项新规定还需修改一些定义和报告标准，使得他们能更符合ICH和WHO的国际医学科学组织要求。

汇总：

FDA发布了临床试验的行为准则

FDA发布了一项准则，要求药物或生物制品临床试验过程中，必须报告其安全性信息。要求指出，一些之前并没有要求报告的安全性性信息，必须在发生后的15日内，上报FDA，包括：

临床试验或流行病学研究中，对受试者有明显风险的；

疑似严重不良反应率高于预期；

生物利用度试验和仿制药生物等效试验中严重不良事件；

FDA还发布了一个指导原则的草案，用来咨询提供信息的药厂和研究者，对这项新要求提出意见。

“这项行为准则将加快FDA对重大安全信息的审查，帮助研究用药品和生物制品的安全监管机构”，FDA药品审评中心副主任Rachel Behrman在一份声明中说到，“这个改变将保护那些参加临床试验的人群”。

这个规定也提供了研究品可能造成安全性问题的例子。在现行的政策下，申办者需要报告全部的SAE，包括那些可能与研究品无关的SAE。这些报告使FDA鉴别安全信号复杂化，降低鉴别能力。规定清除的规定了，什么时候事件一发现就应上报，而什么事件需等到多次发生的时候在上报。根据FDA要求，这项新规定还需修改一些定义和报告标准，使得他们能更符合ICH和WHO的国际医学科学组织要求。

2010-10-09 15:56

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