药学专业英语视听说教程课件视听说下篇 lecture 4 Clinical Research.pptx

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药学专业英语视听说教程课件视听说下篇 lecture 4 Clinical Research.pptx

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Lecture4ClinicalResearch

relapsebiomarkerfollow-upinformedconsentendpoint

subjectblindingprotocolbiasretrospective

testnewtreatmentsormedicaldevicesinpeopleitisshowntobesafeinpeopleandworkswell20to100participantswithorwithoutthedisease Learnaboutsafety,howthetreatmentworksinthehumanbody,andthebestamounttotake Lessthanayear

About300participantswiththedisease Learnmoreaboutsafetybylookingatsideeffectsandotherproblems Afewmonthsto2years Hundredsorthousandsofparticipantswiththedisease Seehowwellthetreatmentworksandlearnmoreaboutsideeffects 1–3years Thousandsofparticipantswiththedisease Continuetolookatthetreatment’sbenefitforpeople Manyyears protectthesafetyofparticipants

1.Whatisblindinginclinicaltrials?Blindingisaprocedureinwhichoneormorepartiesinatrialarekeptunawareoftreatmentarmallocationofparticipants.2.Whocanbeblindedinclinicaltrials?Dependingonthetypeofthetrialthefollowingcanbeblinded,participantsbeingtreated,clinicalstafforinvestigatoradministeringtreatment,teamcollectingoutcomedataordataanalysts.

3.Whatisanopen-labeltrial?Andwhenisitused?Allthepeopleinvolvedinthetrialwillbeawareofthetreatmentgroupassignmentofstudyparticipants.Itisusedwhenethicalconsiderationsdonotpermitblindingandifnocontrolgroupcanbeused.4.Whatisasingle-blindedtrial?Andwhenisitused?Usuallythesubjectreceivingtheinterventionisblinded.Itisusedwhendoubleblindingisnotpossible,andwhentheexperimentalmedicineandcontrolcannotbemanufacturedidentically.

5.Whatisadoubleblindedtrial?Andwhenisitused?Usually,theinvestigatorsaswellasthestudyparticipantsareblindedtothetreatmentallocation.Doubleblindingshouldbeusedwheneverpossiblebecauseitisthebestcontroltrialdesignwithdecreasedtenseofobservationalbias

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药学专业英语视听说教程课件视听说下篇 lecture 4 Clinical Research.pptx