defgf24uw
Dołączył: 01 Lis 2010
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Wysłany: Pią 17:33, 25 Mar 2011 Temat postu: converse pas cher 监控适&# |
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监控适当的临床试验
importanttonotethatinthecasestudy.iftheresultswerenotmonitored.thetriaIWOUldhavecontinuedtoenroluntiIaII191patientshadcornPleted.andthetriaIWOUldhavebeenconsideredunder—powered(65.5percent】torejectthenuIIhypothesis.Alternatively.iftheaggregate/blindedresultshadleadtopostponinqtheinterimassessmentuntiI150patientshadcornpleted.theconditionaIpowerwouldhavebeen51.7percent.andthere—estimationusingaTypeIIerrorrateof10percentf90percentpower)wouldhaveproceeded.TherevisedsampiesizeWOUldhavebeen258active:129placebo.andthetriaIWOUldhaveproceededwithaveryhighprobabilityofbeinqaSuccess.relativetotheprimaryendpOint.AmongthemanyissuesthissirePIisticexampiefailstoaddressistheissueofbiasandethics.WheneveraninterimanalysisisperformedthatrequiresthebIindeddatatobecomeunblinded.thereisa1waysalegitimateconcernreqardinqtheintroductionofbias.However.thisconcernneedstobebalancedagainsttheethicsoffollowingafrequentistmethodoloqy.continuingtoplacepatientsatriskwithanunderstandinqthatabsolutelynobenefitmaycomeoftheresearch.ThissameconcernexistswithadaptivedesigntrialS.Howeverthenumberofpatientsplacedatriskshouldbeminimisedthroughacarefullydesignedpre-specifiedmonitoringplan.Giventhesemonitoringtoolsexist.theethicaIimplicationsofnotmonitoringaclinicaItriaImustfaroutweightheoverheadofaDataMonitoringCornmitteeandconcernsascribedtobiasinorderfortheconceptofhumanclinicalresearchtosurvive.■ThisarticlewaswrittenbyBruceStouch.VicePresidentofStrategicProductDevelopmentatPremierResearch医药技术·PharmaTechnology
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