2021
Registration, publication, and outcome reporting among pivotal clinical trials that supported FDA approval of high-risk cardiovascular devices before and after FDAAA
Swanson MJ, Johnston JL, Ross JS. Registration, publication, and outcome reporting among pivotal clinical trials that supported FDA approval of high-risk cardiovascular devices before and after FDAAA. Trials 2021, 22: 817. PMID: 34789308, PMCID: PMC8597303, DOI: 10.1186/s13063-021-05790-9.Peer-Reviewed Original ResearchConceptsHigh-risk cardiovascular devicesPrimary efficacy outcomeFDA Amendments ActPivotal clinical trialsClinical trialsEfficacy outcomesFDA approvalTrial interpretationPivotal clinical studiesPrimary clinical evidenceFDA summariesPivotal trialsClinical evidenceResultsBetween 2005Clinical studiesHigh-risk medical devicesOutcome reportingUS FoodDrug AdministrationTrialsReporting of findingsInterpretation of findingsPeer-reviewed literatureOutcomesCardiovascular devices
2014
Descriptions and Interpretations of the ACCORD-Lipid Trial in the News and Biomedical Literature: A Cross-Sectional Analysis
Downing NS, Cheng T, Krumholz HM, Shah ND, Ross JS. Descriptions and Interpretations of the ACCORD-Lipid Trial in the News and Biomedical Literature: A Cross-Sectional Analysis. JAMA Internal Medicine 2014, 174: 1176-1182. PMID: 24796406, PMCID: PMC4124903, DOI: 10.1001/jamainternmed.2014.1371.Peer-Reviewed Original ResearchConceptsACCORD lipid trialACCORD-LipidFibrate useTrial interpretationImproved cardiovascular outcomesCross-sectional studyCross-sectional analysisStatin therapyCardiovascular outcomesCardiovascular riskDiabetes (ACCORD) trialDiabetes mellitusConflicts of interestTrialsPatientsFenofibrateAuthor conflictsLipid componentsMellitusTherapyPhysiciansMonths