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 ResearchConceptsPostapproval 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. FoodDisease
2004
Differences, disparities, and biases: clarifying racial variations in health care use.
Rathore SS, Krumholz HM. Differences, disparities, and biases: clarifying racial variations in health care use. Annals Of Internal Medicine 2004, 141: 635-8. PMID: 15492343, DOI: 10.7326/0003-4819-141-8-200410190-00011.Peer-Reviewed Original ResearchConceptsHealth care useCare useRacial variationRacial differencesHealth care system factorsAdverse consequencesClinical factorsClinical contraindicationsTreatment eligibilityPatient preferencesObservational studyEvidence of differencesMedical literatureRacial disparitiesHealth careInitial reportSystem factorsDifferent causesTreatmentReports of variationReportDisparitiesContraindicationsDifferencesCare