When the Alpha is the Omega: P-Values, "Substantial Evidence," and the 0.05 Standard at FDA.

IF 0.3 4区医学 Q4 FOOD SCIENCE & TECHNOLOGY

Food and drug law journal Pub Date : 2017-01-01

Lee Kennedy-Shaffer

引用次数: 0

Abstract

A prominent feature of statistical reasoning for nearly a century, the p-value plays an especially vital role in the clinical testing of new drugs. Over the last fifty years, the U.S. Food and Drug Administration (FDA) has relied on p-values and significance testing to demonstrate the efficacy of new drugs in the premarket approval process. This article seeks to illuminate the history of this statistic and explain how the statistical significance threshold of 0.05, commonly decried as an arbitrary cutoff, is a useful tool that came to be the cornerstone of FDA decision-making.

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当Alpha是Omega: p值，“实质性证据”和FDA的0.05标准。

p值是近一个世纪以来统计推理的一个突出特征，在新药的临床试验中起着特别重要的作用。在过去的50年里，美国食品和药物管理局(FDA)一直依靠p值和显著性检验来证明新药在上市前批准过程中的有效性。本文试图阐明这一统计数据的历史，并解释0.05的统计显著性阈值是如何成为FDA决策基石的有用工具的，该阈值通常被谴责为任意截止。

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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来源期刊

Food and drug law journal 医学-食品科技

CiteScore

0.20

自引率

50.00%

发文量

审稿时长

>36 weeks

期刊介绍： The Food and Drug Law Journal is a peer-reviewed quarterly devoted to the analysis of legislation, regulations, court decisions, and public policies affecting industries regulated by the U.S. Food and Drug Administration (FDA) and related agencies and authorities, including the development, manufacture, marketing, and use of drugs, medical devices, biologics, food, dietary supplements, cosmetics, veterinary, tobacco, and cannabis-derived products. Building on more than 70 years of scholarly discourse, since 2015, the Journal is published in partnership with the Georgetown University Law Center and the O’Neill Institute for National & Global Health Law. All members can access the Journal online. Each member organization and most individual memberships (except for government, student, and Emeritus members) receive one subscription to the print Journal.