Abstract 17838: Discordance Between Findings in Publications and FDA Reviews for New Drug Approvals in Cardiovascular Disease and Diabetes, 2005-2013

The US Food and Drug Administration (FDA) approves new drugs based on studies that demonstrate safety and efficacy. Selective publication and outcome reporting was previously described but not evaluated since the 2007 FDA Amendment Act (FDAAA) mandated registration and reporting of all clinical studies included in applications for FDA approval. Our objective was to determine publication status and ClinicalTrials.gov registration for studies submitted to the FDA in support of new drug approvals from 2005-2013 in cardiovascular disease and diabetes, and compare outcome reporting in the FDA reviews with those in the published literature. A publicly available FDA database was searched to identify all new drug approvals. For each study used to support efficacy, we searched PubMed and ClinicalTrials.gov to determine publication and registration status, respectively, and calculated overall rates and stratified these rates by study characteristics. For all published studies, we compared FDA and peer-reviewed publ...