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FDA Clinical Trial Imaging Endpoint Process Standards Guidance for Industry

蒋千琴 12/12/2021 浏览 142 FDA 美国

标准简介

Clinical Trial Imaging Endpoint Process Standards Guidance for Industry[附网盘链接]是FDA于过去发布的FDA标准，适用于美国。

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Clinical Trial Imaging Endpoint Process Standards Guidance for Industry[附网盘链接]
Clinical Trial Imaging Endpoint Process Standards Guidance for Industry[附网盘链接](截图)

 

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标准文档类型为Clinical Trial Imaging Endpoint Process Standards Guidance for Industry[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。

标准部分原文

Clinical Trial Imaging Endpoint Process Standards 1

Guidance for Industry This guidance represents 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. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page. I. INTRODUCTION The purpose of this guidance is to assist sponsors in optimizing the quality of imaging data 2

obtained in clinical trials intended to support approval of drugs and biological products. This guidance focuses on imaging acquisition, display, archiving, and interpretation process standards that we regard as important when imaging is used to assess a trial’s primary endpoint or a component of that endpoint. Considerable standardization already exists in clinical imaging. There are a variety of sources, including picture archiving and communication systems and the Digital Imaging and Communications in Medicine (DICOM) formats for the handling and transmission of clinical imaging information that describe the standards generally employed by clinical practitioners. This guidance recommends additional imaging endpoint process standards that are more specific to clinical trials. Imaging process standards help sponsors ensure that imaging data are obtained in a manner that complies with a trial’s protocol, that the quality of imaging data is maintained within and among clinical sites, and that a verifiable record of the imaging process is created. Minimization of imaging process variability may importantly enhance a clinical trial’s ability to detect drug treatment effects. Standardization, while important for all clinically used measures, becomes essential for an imaging endpoint used in a clinical trial to reduce variability and to ensure interpretability of the results. The extent of trial-specific standardization may vary depending upon how standardized the local imaging procedures are (e.g., routine bone X-rays (relatively standardized) versus bone mineral density (more variability across sites)). This guidance does not address approaches for 1

This guidance has been prepared by the Division of Medical Imaging Products in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research at the Food and Drug Administration. 2

For the purposes of this guidance, all references to drugs include both human drugs and biological products unless otherwise specified.

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