2018
Comparison of treatment effect sizes from pivotal and postapproval trials of novel therapeutics approved by the FDA based on surrogate markers of disease: a meta-epidemiological study
Wallach JD, Ciani O, Pease AM, Gonsalves GS, Krumholz HM, Taylor RS, Ross JS. Comparison of treatment effect sizes from pivotal and postapproval trials of novel therapeutics approved by the FDA based on surrogate markers of disease: a meta-epidemiological study. BMC Medicine 2018, 16: 45. PMID: 29562926, PMCID: PMC5863466, DOI: 10.1186/s12916-018-1023-9.Peer-Reviewed Original ResearchMeSH KeywordsBiomarkersDrug ApprovalEpidemiologic StudiesHumansTreatment OutcomeUnited StatesUnited States Food and Drug AdministrationConceptsPostapproval trialsPivotal trialsActual clinical effectSurrogate markerTrial endpointsLarge treatment effectsPrimary endpointNovel therapeuticsNovel drugsTreatment effectsFDA approvalPatient-relevant outcomesMeta-epidemiological studyStandardized mean differenceTreatment effect sizeClinical effectsResultsBetween 2005Odds ratioDrug trialsSame indicationDrug AdministrationEvidence of differencesMean differenceU.S. FoodDiseaseLarge-Scale Epidemiologic Studies of Cardiovascular Diseases in China Need for Improved Data Collection, Methods, Transparency, and Documentation
Qu H, Lu Y, Gudbranson E, Bucholz EM, Xuan S, Masoudi FA, Spertus JA, Zheng X, Li J, Krumholz HM. Large-Scale Epidemiologic Studies of Cardiovascular Diseases in China Need for Improved Data Collection, Methods, Transparency, and Documentation. Global Heart 2018, 13: 3-12.e4. PMID: 29248362, DOI: 10.1016/j.gheart.2017.07.002.Peer-Reviewed Original Research
2003
Effect of ibuprofen on cardioprotective effect of aspirin
Curtis JP, Krumholz HM. Effect of ibuprofen on cardioprotective effect of aspirin. The Lancet 2003, 361: 1560. PMID: 12737890, DOI: 10.1016/s0140-6736(03)13193-5.Peer-Reviewed Original Research