Special population considerations and regulatory affairs for clinical research.

Kristin N Grimsrud, Catherine M T Sherwin, Jonathan E Constance, Casey Tak, Athena F Zuppa, Michael G Spigarelli, Nicole L Mihalopoulos
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Abstract

Special populations, including women (non-pregnant and pregnant), pediatrics, and the elderly, require additional consideration with regard to clinical research. There are very specific regulatory laws, which protect these special populations, that need to be understood and adhered to in order to perform clinical research. This review provides a broad overview of some of the physiological differences in special populations and discusses how these differences may affect study design and regulatory considerations. These various special populations, with respect to regulatory affairs, are clearly defined within the Code of Federal Regulations. The definition of "special population" exists to provide enhanced awareness of their vulnerabilities, thereby allowing the creation of regulatory guidance aimed to decrease injury or outright harm. Currently, progress is being made to be more inclusive of special populations in clinical trials. This reflects changing attitudes towards drug information, with it being more representative of those patients that will ultimately be prescribed or exposed to the therapy. However, all research undertaken in these populations should be performed in a manner that ensures all protections of each participant are upheld.

Abstract Image

特殊人群考虑因素和临床研究监管事务。
特殊人群,包括妇女(非孕妇和孕妇)、儿科和老年人,在临床研究方面需要额外考虑。要开展临床研究,必须了解并遵守保护这些特殊人群的非常具体的监管法律。本综述概述了特殊人群的一些生理差异,并讨论了这些差异会如何影响研究设计和监管考虑。在监管事务方面,《联邦法规》对各种特殊人群有明确的定义。定义 "特殊人群 "是为了更好地了解他们的脆弱性,从而制定监管指南,减少伤害或直接伤害。目前,在临床试验中更加包容特殊人群的工作正在取得进展。这反映了人们对药物信息的态度正在发生变化,药物信息更能代表那些最终会被处方或接受治疗的患者。但是,在这些人群中开展的所有研究都应确保对每位参与者的所有保护措施得到维护。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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