Quality of Reporting of Bioequivalence Trials Comparing Generic to Brand Name Drugs A Methodological Systematic Review 英文参考文献.docVIP

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Quality of Reporting of Bioequivalence Trials Comparing Generic to Brand Name Drugs A Methodological Systematic Review 英文参考文献.doc

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Quality of Reporting of Bioequivalence Trials Comparing Generic to Brand Name Drugs A Methodological Systematic Review 英文参考文献

QualityofReportingofBioequivalenceTrialsComparing GenerictoBrandNameDrugs:AMethodological SystematicReview Ame′lievanderMeersch1,2,3,Agne`sDechartres1,2,3*,PhilippeRavaud1,2,3 1INSERM,U738,Paris,France,2AP-HP(AssistancePubliquedesHo?pitauxdeParis),Ho?pitalHo?telDieu,Centred9E′pide′miologieClinique,Paris,France,3Universite′ Paris Descartes,SorbonneParisCite′, Faculte′ deMe′decine,Paris,France Abstract Background: Generic drugs are used by millions of patients for economic reasons, so their evaluation must be highly transparent. Objective:Toassessthequalityofreportingofbioequivalencetrialscomparinggenerictobrand-namedrugs. Methodology/Principal Findings: PubMedwassearchedforreportsofbioequivalencetrialscomparinggenerictobrand- namedrugsbetweenJanuary2005andDecember2008.Articleswereincludediftheaimofthestudywastoassessthe bioequivalencyofgenericandbrand-namedrugs.Weexcludedcasestudies,pharmaco-economicevaluations,andvalidation dosageassaysofdrugs.Weevaluatedwhetherimportantinformationaboutfunding,methodology,locationoftrials,and participantswerereported.WealsoassessedwhetherthecriteriarequiredbytheFoodandDrugAdministration(FDA)andthe EuropeanMedicineAgency(EMA)toconcludebioequivalencewerereportedandthattheconclusionswereinagreement withtheresults.Weidentified134potentiallyrelevantarticlesbuteliminated55becausethebrand-nameorgenericdrug statusofthereferencedrugwasunknown.Thus,weevaluated79articles.Thefundingsourceandlocationofthetrialwere reportedin 41% and56% of articles,respectively.Thetype ofstatistical analysiswasreportedin 94% of articles,butthe methodstogeneratetherandomizationsequenceandtoconcealallocationwerereportedinonly15%and5%,respectively. Intotal,65articlesofsingle-dosetrials(89%)concludedbioequivalence.Ofthese,20(31%)didnotreportthe3criteriawithin thelimitsrequiredbytheFDAand11(17%)didnotreportthe2criteriawithinthelimitsrequiredbytheEMA. Conclusions/Significance: Important information to judge the validity and relevance of results are freq