2023
Press Releases of Drug-Related Randomized Trial Results Prior to Publication in High-Impact Journals: an Observational Study
Purohit U, Sacks C, Raissi A, Hughes E, Boctor M, Manzoor S, Hodzic-Santor B, Zhu K, Raudanskis A, Ross J, Fralick M. Press Releases of Drug-Related Randomized Trial Results Prior to Publication in High-Impact Journals: an Observational Study. Journal Of General Internal Medicine 2023, 38: 3107-3114. PMID: 37532876, PMCID: PMC10651612, DOI: 10.1007/s11606-023-08313-1.Peer-Reviewed Original Research
2022
Comparison of Clinical Study Results Reported in medRxiv Preprints vs Peer-reviewed Journal Articles
Janda G, Khetpal V, Shi X, Ross J, Wallach J. Comparison of Clinical Study Results Reported in medRxiv Preprints vs Peer-reviewed Journal Articles. JAMA Network Open 2022, 5: e2245847. PMID: 36484989, PMCID: PMC9856222, DOI: 10.1001/jamanetworkopen.2022.45847.Peer-Reviewed Original ResearchConceptsPrimary end pointPrimary end point resultsPeer-reviewed journalsClinical studiesEnd pointClinical trialsObservational studyStudy characteristicsEnd point resultsClinical study resultsMost clinical studiesCross-sectional studyHealth-related outcomesSample sizeMAIN OUTCOMEPeer-reviewed publicationsMedRxivEffect estimatesStudy interpretationDiscordant pairsCOVID-19Trials
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 ResearchMeSH KeywordsDrug ApprovalHumansPeer ReviewPubMedResearch ReportUnited StatesUnited States Food and Drug AdministrationConceptsHigh-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
2018
Will research preprints improve healthcare for patients?
Krumholz HM, Ross JS, Otto CM. Will research preprints improve healthcare for patients? The BMJ 2018, 362: k3628. PMID: 30249719, DOI: 10.1136/bmj.k3628.Commentaries, Editorials and Letters