2022
Protocol 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
Assessment of Concordance and Discordance Among Clinical Studies Posted as Preprints and Subsequently Published in High-Impact Journals
Shi X, Ross JS, Amancharla N, Niforatos JD, Krumholz HM, Wallach JD. Assessment of Concordance and Discordance Among Clinical Studies Posted as Preprints and Subsequently Published in High-Impact Journals. JAMA Network Open 2021, 4: e212110. PMID: 33734411, PMCID: PMC7974637, DOI: 10.1001/jamanetworkopen.2021.2110.Peer-Reviewed Original ResearchPublishing at any cost: a cross-sectional study of the amount that medical researchers spend on open access publishing each year
Ellingson MK, Shi X, Skydel JJ, Nyhan K, Lehman R, Ross JS, Wallach JD. Publishing at any cost: a cross-sectional study of the amount that medical researchers spend on open access publishing each year. BMJ Open 2021, 11: e047107. PMID: 33526505, PMCID: PMC7852964, DOI: 10.1136/bmjopen-2020-047107.Peer-Reviewed Original Research
2019
Digital medicine systems: an evergreening strategy or an advance in medication management?
Egilman AC, Ross JS. Digital medicine systems: an evergreening strategy or an advance in medication management? BMJ Evidence-Based Medicine 2019, 24: 203. PMID: 31754072, DOI: 10.1136/bmjebm-2019-111265.Commentaries, Editorials and Letters
2018
Postmarket studies required by the US Food and Drug Administration for new drugs and biologics approved between 2009 and 2012: cross sectional analysis
Wallach JD, Egilman AC, Dhruva SS, McCarthy ME, Miller JE, Woloshin S, Schwartz LM, Ross JS. Postmarket studies required by the US Food and Drug Administration for new drugs and biologics approved between 2009 and 2012: cross sectional analysis. The BMJ 2018, 361: k2031. PMID: 29794072, PMCID: PMC5967364, DOI: 10.1136/bmj.k2031.Peer-Reviewed Original ResearchConceptsProspective cohort studyCohort studyClinical trialsPostmarketing requirementsTimeliness of registrationNew drugsUS FoodDrug AdministrationFDA approvalStudy designNumber of patientsSectional analysisPostmarket studiesFirst approvalRegistrySecondary analysisTrialsBiologicsDrugsComparator typeAdministrationApprovalFDAFDA's authority
2017
Merits of Data Sharing The Digitalis Investigation Group Trial
Angraal S, Ross JS, Dhruva SS, Desai NR, Welsh JW, Krumholz HM. Merits of Data Sharing The Digitalis Investigation Group Trial. Journal Of The American College Of Cardiology 2017, 70: 1825-1827. PMID: 28958337, DOI: 10.1016/j.jacc.2017.07.786.Peer-Reviewed Original Research
2016
Clinical research data sharing: what an open science world means for researchers involved in evidence synthesis
Ross JS. Clinical research data sharing: what an open science world means for researchers involved in evidence synthesis. Systematic Reviews 2016, 5: 159. PMID: 27649796, PMCID: PMC5029013, DOI: 10.1186/s13643-016-0334-1.Commentaries, Editorials and Letters
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
2011
Promoting transparency in pharmaceutical industry-sponsored research.
Ross JS, Gross CP, Krumholz HM. Promoting transparency in pharmaceutical industry-sponsored research. American Journal Of Public Health 2011, 102: 72-80. PMID: 22095335, PMCID: PMC3319748, DOI: 10.2105/ajph.2011.300187.Commentaries, Editorials and LettersConceptsClinical trial researchTrial researchIndividual clinical decisionsGuideline recommendationsEvidence-based practiceTRIAL REGISTRATIONSystematic reviewClinical decisionInvestigator contributionsTrial outcomesMedical literaturePublic healthSelective publicationClinical trial data analysisHealthTrial data analysisIndustry-sponsored researchPatientsPhysicians