Most noninferiority trials were not designed to preserve active comparator treatment effects.
Sign Up to like & getrecommendations! Published in 2019 at "Journal of clinical epidemiology"
DOI: 10.1016/j.jclinepi.2019.03.003
Abstract: OBJECTIVES To evaluate whether noninferiority trials are designed to adequately preserve the historical treatment effect of their active comparators. STUDY DESIGN AND SETTING We reviewed 162 noninferiority trials published in high-impact medical journals. We assessed… read more here.
Keywords: active comparator; treatment; trials designed; noninferiority trials ... See more keywords
Active comparator restricted disproportionality analysis for pharmacovigilance signal detection studies of chronic disease medications: An example using sodium/glucose cotransporter 2 (SGLT2) inhibitors.
Sign Up to like & getrecommendations! Published in 2021 at "British journal of clinical pharmacology"
DOI: 10.1111/bcp.15178
Abstract: INTRODUCTION Disproportionality analysis is a common pharmacovigilance tool to detect safety signals of type 2 diabetes medications from spontaneous drug reporting databases. OBJECTIVE To demonstrate the impact of using the active-comparator restricted disproportionality analysis (ACR-DA),… read more here.
Keywords: disproportionality analysis; comparator; sglt2 inhibitors; aror ... See more keywords