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. FoodDisease
2015
Commentary: Will 20th century patient safeguards be reversed in the 21st century?
Gonsalves G, Zuckerman D. Commentary: Will 20th century patient safeguards be reversed in the 21st century? The BMJ 2015, 350: h1500. PMID: 25814537, DOI: 10.1136/bmj.h1500.Peer-Reviewed Original ResearchAcquired Immunodeficiency SyndromeDrug DiscoveryHistory, 20th CenturyHistory, 21st CenturyHIV InfectionsHumansPatient SafetyPrescription DrugsUnited StatesUnited States Food and Drug Administration