clinical trials in latin america conclusion

clinical trials in latin america conclusion

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时间:2018-02-10

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1、Chapter13ConclusionAntonioUgaldeandNuriaHomedesThecollectionofarticlesincludedinthisbookprovideanoverviewoftheevolutionoftheregulatoryframeworkthatguidestheimplementationofclinicaltrialsinfiveLatinAmericancountriesand,throughthedescriptionandanalysisofseveralcasesstu

2、dies,highlightsthemainethicalissuesthathavearisenduringtheimplementa-tionofthetrials.Morethan80%ofallclinicaltrialsthattakeplaceintheregionareconductedinArgentina,Brazil,CostaRica,MexicoandPeru;therefore,whatisdescribedinthisbookcanbeconsideredrepresentativeofwhatoc

3、cursintheregion.Thelackoftransparencythatsurroundsclinicaltrialsprecludesusfromhavinganaccuratepictureofthemagnitudeoftheproblemsthathavebeendescribedinthisvolume.Theauthorsofthedifferentchaptersonlyhadaccesstolegislativeandcourtdocuments,afewthesisanddissertations,

4、informationdiscoveredafterahumantragedyoccurredduringtheimplementationofatrialandreportsfrominvestigativereportersthattookthetimetostudycomplainsfromphysiciansandotherhealthcareproviderswhoreportedabuses.Wecanonlyassumethatthecasespresentedarenotisolatedexamples.Oft

5、hefivecountriesincludedinthebook,CostaRicaandArgentinahaveastrongtraditionofinvestigativereportsanditisforthisreasonthatthereismoreinformationabouttrialsinthesecountriesthanelsewhere.Wehavetokeepinmindthatittookalmost40yearstouncoverbyincrediblechancetheclinicaltrial

6、sabuses/atrocitiesthatUSAresearcherswiththeassistanceoflocalphysicianscommittedinGuatemala.Perhapsoneday,iffilesoftheindustryandthearchivesofgovernmentsareopened,researcherswillbeabletoestablishtheextentoftheproblemwithgreateraccuracy.Inthisclosingchapter,wewillprese

7、ntthemainsimilaritiesanddifferencesregard-ingtheregulatoryprocessandtheimplementationofclinicaltrialsthathavebeenA.UgaldeDepartmentofSociology,UniversityofTexas,Austin,TX,USAN.Homedes(*)SchoolofPublicHealth,DivisionofManagementPolicyandCommunityHealth,UniversityofTe

8、xasHoustonHealthScienceCenter,ElPaso,TX,USAe-mail:nhomedes@utep.eduN.HomedesandA.Ugalde(eds.),ClinicalTrialsinLatinAmerica:WhereEthics275a

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