2022
Consistency between trials presented at conferences, their subsequent publications and press releases
Rowhani-Farid A, Hong K, Grewal M, Reynolds J, Zhang A, Wallach J, Ross J. Consistency between trials presented at conferences, their subsequent publications and press releases. BMJ Evidence-Based Medicine 2022, 28: 95-102. PMID: 36357160, PMCID: PMC10086295, DOI: 10.1136/bmjebm-2022-111989.Peer-Reviewed Original ResearchConceptsClinical trialsConference abstractsTrial resultsEndpoint definitionsPrimary efficacy end pointEnd pointEfficacy end pointPrimary efficacy endpointClinical Trials RegistryMedical conferencesMultiple logistic regressionCross-sectional analysisSafety endpointEfficacy endpointPeer-reviewed journalsTrial abstractsTrials RegistryTrial characteristicsConsistency of reportingSample sizePrimary analysisSecondary analysisInternational medical conferencesLogistic regressionStudy designProtocol for the development of SPIRIT and CONSORT extensions for randomised controlled trials with surrogate primary endpoints: SPIRIT-SURROGATE and CONSORT-SURROGATE
Manyara AM, Davies P, Stewart D, Weir CJ, Young A, Butcher NJ, Bujkiewicz S, Chan AW, Collins GS, Dawoud D, Offringa M, Ouwens M, Ross JS, Taylor RS, Ciani O. Protocol for the development of SPIRIT and CONSORT extensions for randomised controlled trials with surrogate primary endpoints: SPIRIT-SURROGATE and CONSORT-SURROGATE. BMJ Open 2022, 12: e064304. PMID: 36220321, PMCID: PMC9557267, DOI: 10.1136/bmjopen-2022-064304.Peer-Reviewed Original ResearchMeSH KeywordsConsensusHumansPublicationsRandomized Controlled Trials as TopicResearch DesignResearch ReportTreatment OutcomeConceptsSurrogate endpointsPeer-reviewed publicationsSurrogate primary endpointOpen-access peer-reviewed publicationPATIENTS/PARTICIPANTSCompleteness of reportingTranslation of effectsPhase 1Primary endpointPrimary outcomeTrial findingsEthical approvalCONSORT extensionSuch trialsEthics CommitteeEndpointHealth benefitsTrialsPhase 3Final outcomePhase 2Transparent reportingOutcomesPhase 4Additional items
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 devicesTransparency of Regulatory Data across the European Medicines Agency, Health Canada, and US Food and Drug Administration.
Egilman AC, Kapczynski A, McCarthy ME, Luxkaranayagam AT, Morten CJ, Herder M, Wallach JD, Ross JS. Transparency of Regulatory Data across the European Medicines Agency, Health Canada, and US Food and Drug Administration. The Journal Of Law, Medicine & Ethics 2021, 49: 456-485. PMID: 34665102, DOI: 10.1017/jme.2021.67.Peer-Reviewed Original ResearchGuidelines for Reporting Trial Protocols and Completed Trials Modified Due to the COVID-19 Pandemic and Other Extenuating Circumstances
Orkin AM, Gill PJ, Ghersi D, Campbell L, Sugarman J, Emsley R, Steg PG, Weijer C, Simes J, Rombey T, Williams HC, Wittes J, Moher D, Richards DP, Kasamon Y, Getz K, Hopewell S, Dickersin K, Wu T, Ayala AP, Schulz KF, Calleja S, Boutron I, Ross JS, Golub RM, Khan KM, Mulrow C, Siegfried N, Heber J, Lee N, Kearney PR, Wanyenze RK, Hróbjartsson A, Williams R, Bhandari N, Jüni P, Chan AW, Orkin A, Gill P, Ghersi D, Campbell L, Sugarman J, Emsley R, Steg P, Weijer C, Simes J, Rombey T, Williams H, Wittes J, Moher D, Richards D, Kasamon Y, Getz K, Hopewell S, Dickersin K, Wu T, Ayala A, Schulz K, Calleja S, Boutron I, Ross J, Golub R, Khan K, Mulrow C, Siegfried N, Heber J, Lee N, Kearney P, Wanyenze R, Hróbjartsson A, Williams R, Bhandari N, Jüni P, Chan A, Kiermer V, Corrigan-Curay J, Concato J. Guidelines for Reporting Trial Protocols and Completed Trials Modified Due to the COVID-19 Pandemic and Other Extenuating Circumstances. JAMA 2021, 326: 257-265. PMID: 34152382, DOI: 10.1001/jama.2021.9941.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus Statements
2020
Non-inferiority trials using a surrogate marker as the primary endpoint: An increasing phenotype in cardiovascular trials
Bikdeli B, Caraballo C, Welsh J, Ross JS, Kaul S, Stone GW, Krumholz HM. Non-inferiority trials using a surrogate marker as the primary endpoint: An increasing phenotype in cardiovascular trials. Clinical Trials 2020, 17: 723-728. PMID: 32838556, PMCID: PMC8088773, DOI: 10.1177/1740774520949157.Peer-Reviewed Original ResearchConceptsNon-inferiority trialPrimary endpointClinical outcome trialsNon-inferiority marginSurrogate markerNon-inferiority designCardiovascular trialsOutcome trialsClinical outcomesDefinitive clinical outcome trialsNon-inferiority criteriaStudy protocolSurrogate outcomesBACKGROUND/Median numberSurrogate endpointsPrimary analysisCardiovascular interventionsCardiovascular medicineTrialsEndpointClinical interpretationOutcomesMarkersInterventionConsistency of trial reporting between ClinicalTrials.gov and corresponding publications: one decade after FDAAA
Talebi R, Redberg RF, Ross JS. Consistency of trial reporting between ClinicalTrials.gov and corresponding publications: one decade after FDAAA. Trials 2020, 21: 675. PMID: 32703252, PMCID: PMC7376878, DOI: 10.1186/s13063-020-04603-9.Peer-Reviewed Original Research
2017
Measuring clinical trial transparency: an empirical analysis of newly approved drugs and large pharmaceutical companies
Miller JE, Wilenzick M, Ritcey N, Ross JS, Mello MM. Measuring clinical trial transparency: an empirical analysis of newly approved drugs and large pharmaceutical companies. BMJ Open 2017, 7: e017917. PMID: 29208616, PMCID: PMC5728266, DOI: 10.1136/bmjopen-2017-017917.Peer-Reviewed Original Research
2016
Compliance with prospective trial registration guidance remained low in high-impact journals and has implications for primary end point reporting
Dal-Ré R, Ross JS, Marušić A. Compliance with prospective trial registration guidance remained low in high-impact journals and has implications for primary end point reporting. Journal Of Clinical Epidemiology 2016, 75: 100-107. PMID: 26820559, DOI: 10.1016/j.jclinepi.2016.01.017.Commentaries, Editorials and LettersConceptsPrimary end pointInterim analysisTRIAL REGISTRATIONEnd pointHigh-impact general medicine journalsICMJE policyMain outcome measuresPublic trials registryPredictors of complianceProspective trial registrationTrials of FDACross-sectional analysisPercent of trialsTrials RegistryGeneral medicine journalsProspective registrationOutcome measuresClinical researchStudy designTrial resultsHigh-impact journalsRetrospective registrationTrialsAscertainmentMedicine journals
2015
Clinical trial registration, reporting, publication and FDAAA compliance: a cross-sectional analysis and ranking of new drugs approved by the FDA in 2012
Miller JE, Korn D, Ross JS. Clinical trial registration, reporting, publication and FDAAA compliance: a cross-sectional analysis and ranking of new drugs approved by the FDA in 2012. BMJ Open 2015, 5: e009758. PMID: 26563214, PMCID: PMC4654354, DOI: 10.1136/bmjopen-2015-009758.Peer-Reviewed Original Research
2013
Time to Publication Among Completed Clinical Trials
Ross JS, Mocanu M, Lampropulos JF, Tse T, Krumholz HM. Time to Publication Among Completed Clinical Trials. JAMA Internal Medicine 2013, 173: 825-828. PMID: 23460252, PMCID: PMC3691813, DOI: 10.1001/jamainternmed.2013.136.Peer-Reviewed Original Research