{"title":"When the Alpha is the Omega: <i>P</i>-Values, \"Substantial Evidence,\" and the 0.05 Standard at FDA.","authors":"Lee Kennedy-Shaffer","doi":"","DOIUrl":null,"url":null,"abstract":"<p><p>A prominent feature of statistical reasoning for nearly a century, the <i>p</i>-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 <i>p</i>-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.</p>","PeriodicalId":12282,"journal":{"name":"Food and drug law journal","volume":null,"pages":null},"PeriodicalIF":0.3000,"publicationDate":"2017-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6169785/pdf/nihms-987338.pdf","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Food and drug law journal","FirstCategoryId":"97","ListUrlMain":"","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"FOOD SCIENCE & TECHNOLOGY","Score":null,"Total":0}
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.
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.