Alberto Aimo, Vincenzo Castiglione, Iacopo Fabiani, Paolo Morfino, Michele Emdin, Roberto Ferrari, Luigi Tavazzi, Aldo Pietro Maggioni, Claudio Rapezzi
{"title":"[Critical reading of cardiovascular trials with neutral or negative findings].","authors":"Alberto Aimo, Vincenzo Castiglione, Iacopo Fabiani, Paolo Morfino, Michele Emdin, Roberto Ferrari, Luigi Tavazzi, Aldo Pietro Maggioni, Claudio Rapezzi","doi":"10.1714/4100.40982","DOIUrl":null,"url":null,"abstract":"<p><p>Randomized controlled trials showing a significant benefit are met with enthusiasm because they may change the standard of care for patients who share the clinical and pathophysiologic characteristics of trial participants. Nonetheless, a well-designed and fully executed trial with neutral or negative findings also represents a critically important investigation deserving careful scientific scrutiny. In this paper we propose a 10-step approach to the interpretation of neutral or negative trials to exclude important methodological issues before concluding that the treatment really does not work. We will discuss this approach using the most classic trials of the past and some notable examples among superiority trials (mostly phase 3 trials) published over the last years.</p>","PeriodicalId":12510,"journal":{"name":"Giornale italiano di cardiologia","volume":"24 10","pages":"818-826"},"PeriodicalIF":0.7000,"publicationDate":"2023-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Giornale italiano di cardiologia","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1714/4100.40982","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
引用次数: 0
Abstract
Randomized controlled trials showing a significant benefit are met with enthusiasm because they may change the standard of care for patients who share the clinical and pathophysiologic characteristics of trial participants. Nonetheless, a well-designed and fully executed trial with neutral or negative findings also represents a critically important investigation deserving careful scientific scrutiny. In this paper we propose a 10-step approach to the interpretation of neutral or negative trials to exclude important methodological issues before concluding that the treatment really does not work. We will discuss this approach using the most classic trials of the past and some notable examples among superiority trials (mostly phase 3 trials) published over the last years.