资源描述：
《globalization and clinical research in latin america》由会员上传分享，免费在线阅读，更多相关内容在工程资料-天天文库。
1、Chapter3GlobalizationandClinicalResearchinLatinAmericaNuriaHomedesandAntonioUgaldeTheglobalizationofpharmaceuticalclinicaltrialslagsbehindthatofotherindustriesbecause,untilrelativelyrecently,low-andmiddle-incomecountriesdidnothavethesafeguardstheindustryneeded.Traditionally,clinicalt
2、rialstookplaceinhigh-incomecountries(UnitedStates,Europe,JapanandAustralia)andthepharmaceuticalindustry,beforegatheringclinicaltrialdatainothercountries,hadtoensurethattheregulatoryagenciesofthecountrieswhere80%ofthepharmaceuticalsareconsumed(UnitedStates,EuropeandJapan)wouldacceptth
3、etrialresultsfromlow-andmiddle-incomecountries(EasternEurope,LatinAmerica,Asia)includedintheapplicationsformarketauthorization.Anotherrequirementwastheexistenceofadequatesystemstoensuretheintegrityoftheresearchandtheprotectionofintellectualproperty.TheapprovaloftheguidelinesfromtheIn
4、ternationalConferenceonHarmonizationofTechnicalRequirementsforRegistrationofPharmaceuticalsforHumanUse(ICHGCP)in1996(ICH1996)andtheadoptionoftheAgreementonTrade-RelatedAspectsofIntellectualPropertyRights(WTO1994)(Virk2009;Glickmanetal.2009)satisfiedtheneedsofresearchsponsors.Clinicalt
5、rialsnowtakeplaceanywhereintheworld,anditisexpectedthatthenumberoftrialsconductedinlow-andmiddle-incomecountrieswillincreasesignificantlyinthenearfuture.Thischapterwilldescribetheneedforglobalizedrecruitment,thedevelopmentofclinicaltrialsinLatinAmericaandthefactorscontributingtotheexp
6、ansionofclinicaltrialsintheregion,andfinallytheconsequencesthatthisprocessmayhaveforthecountriesandfortheparticipantswillbediscussed.N.Homedes(*)SchoolofPublicHealth,DivisionofManagementPolicyandCommunityHealth,UniversityofTexasHoustonHealthScienceCenter,ElPaso,TX,USAe-mail:nhomedes@u
7、tep.eduA.UgaldeDepartmentofSociology,UniversityofTexas,Austin,TX,USAN.HomedesandA.Ugalde(eds.),ClinicalTrialsinLatinAmerica:WhereEthics55andBusinessClash,ResearchEthicsForum2,DOI10.1007/978-3-319-01363-3_3,©SpringerInternationalPublishingSwitzerland201456N.HomedesandA.Ugalde3.1TheNee
8、dandExtendof
