临床试验的E20适应性设计_中英文

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多多猪 2025-11-06 3 1.54MB 72 页

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E20 Adaptive Designs for

Clinical Trials

This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration

(FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or

the public. Yo u can use an alternative approach if it satisfies the requirements of the applicable statutes and

regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed

on the title page. The draft guidance has been left in the original International Council for Harmonisation

format. The final guidance will be reformatted and edited to conform with FDA’s good guidance practice

regulation and style.

For questions regarding this draft document, contact (CDER) Gregory Levin, 301-796-4228 or

(CBER) Phillip Kurs, 240-402-7911.

E20临床试验的自适应设计

本指南草案在最终确定后，将体现美国食品药品监督管理局（FDA）的最新观点。（FDA或相关机

构）关于此主题。该声明不赋予任何个人权利，且对FDA或公众。如果替代方案符合相关法规的要

求，您可采用该方案。法规。如需讨论替代方案，请联系FDA负责本指南的工作人员（具体名单见

后）。标题页上。该草案指南已保留在原版国际协调委员会文件中。最终指南将重新排版并编

辑，以符合FDA的良好指南实践。关于规章和风格。

如对本草案文件有疑问，请联系（CDER）Gregory Levin，301-796-4228或（CBER）Phillip Ku-

rs，240-402-7911。

FOREWORD

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals

for Human Use (ICH) has the mission of achieving greater regulatory harmonization

worldwide to ensure that safe, effective, and high-quality medicines are developed,

registered, and maintained in the most resource-efficient manner. By harmonizing the

regulatory expectations in regions around the world, ICH guidelines have substantially

reduced duplicative clinical studies, prevented unnecessary animal studies, standardized

safety reporting and marketing application submissions, and contributed to many other

improvements in the quality of global drug development and manufacturing and the products

available to patients.

ICH is a consensus-driven process that involves technical experts from regulatory authorities

and industry parties in detailed technical and science-based harmonization work that results

in the development of ICH guidelines. The commitment to consistent adoption of these

consensus-based guidelines by regulators around the globe is critical to realizing the benefits

of safe, effective, and high-quality medicines for patients as well as for industry. As a

Founding Regulatory Member of ICH, the Food and Drug Administration (FDA) plays a

major role in the development of each of the ICH guidelines, which FDA then adopts and

issues as guidance to industry.

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标签： #临床试验 #中英文 #E20适应性设计

摘要：

E20AdaptiveDesignsforClinicalTrialsThisdraftguidance,whenfinalized,willrepresentthecurrentthinkingoftheFoodandDrugAdministration(FDAorAgency)onthistopic.ItdoesnotestablishanyrightsforanypersonandisnotbindingonFDAorthepublic.Youcanuseanalternativeapproachifitsatisfiestherequirementsoftheapplicablesta...

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