FDA Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products

标准简介

Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products[附网盘链接]是FDA发布的FDA标准，适用于美国。

标准截图

 

标准文档说明

标准文档类型为Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products[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

Enrichment Strategies for Clinical Trials to Support Determination of Effectiveness of Human Drugs and Biological Products 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 industry in developing enrichment strategies that can be used in clinical investigations intended to demonstrate the effectiveness of drug and biological products. Enrichment is the prospective use of any patient characteristic to select a study population in which detection of a drug effect (if one is in fact present) is more likely than it would be in an unselected population. Although this guidance focuses on enrichment directed at improving the ability of a study to detect a drug’s effectiveness, similar strategies can be used in safety assessments. The enrichment strategies described in this guidance are intended to increase the efficiency of drug development and support precision medicine, i.e., tailoring treatments to those patients who will benefit based on clinical laboratory, genomic, and proteomic factors. This guidance also discusses design options for enrichment strategies and discusses the interpretation of the results of studies that use enrichment strategies. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required. 1

This guidance was developed by the Center for Drug Evaluation and Research in coordination with the Center for Biologics Evaluation and Research at the Food and Drug Administration. Although the principles and examples discussed in this guidance relate primarily to the safety and effectiveness of drugs and biologic products many of these principles also apply to studies for other medical products, including devices. FDA encourages a sponsor that is considering applying these principles to the study of a device to discuss such a proposal with the Center for Devices and Radiological Health, specifically with the organizational unit responsible for that product area.

网盘链接

百度网盘：https://pan.baidu.com/s/1unFMvADrsGnF2-XXl5JlMw
提取码：r4na