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1、CancerClinicalTrialsIn-DepthInformationTheDrugDevelopmentandApprovalProcess1.Earlyresearchandpreclinicaltesting2.INDapplicationfiledwithFDA3.Clinicaltrials(phases1,2,and3)4.NDAfiledwithFDA5.FDAvalidatesclaimandapprovesdrug2PhasesofClinicalTrialsPhase1:15-3
2、0peopleWhatdosageissafe?Howshouldtreatmentbegiven?Howdoestreatmentaffectthebody?Phase2:Lessthan100peopleDoestreatmentdowhatitissupposedto?Howdoestreatmentaffectthebody?3PhasesofClinicalTrialsPhase3:From100tothousandsofpeopleComparenewtreatmentwithcurrentst
3、andardPhase4:FromhundredstothousandsofpeopleUsuallytakesplaceafterdrugisapprovedUsedtofurtherevaluatelong-termsafetyandeffectivenessofnewtreatment4TypesofClinicalTrialsTreatmentPreventionScreeningandearlydetectionDiagnosticGeneticsQuality-of-life/supportiv
4、ecare5TreatmentTrialsTestsafetyandeffectiveness ofnewagentsorinterventions inpeoplewithcancerPossiblebenefit:EarlyaccesstonewtreatmentsPossiblerisk:Occurrenceofunknownsideeffects6PreventionTrialsForpeopleatriskof developingcancerActionstudiesvs.agentstudie
5、sPossiblebenefit:EarlyaccesstonewinterventionsPossiblerisk:Unknownsideeffectsandeffectiveness7ScreeningandEarly-DetectionTrialsAssessnewmeansofdetectingcancerearlierinhealthypeoplePossiblebenefit:Detectingdiseaseatanearlierstage,resultinginimprovedoutcomes
6、Possiblerisks:DiscomfortandinconvenienceIfimagingtechniqueisstudied,exposuretox-raysorradioactivesubstances8DiagnosticTrialsDevelopbettertoolsforclassifyingtypesandphasesofcancerandmanagingpatientcarePossiblebenefits:Newtechnologymaybebetterandlessinvasive
7、EarlierdetectionofrecurrencesPossiblerisk:Mayrequirepeopletotakemultipletests9GeneticsTrialsThesetrialsseekto:Determinehowone’sgeneticmakeupcaninfluencedetection,diagnosis,prognosis,andtreatmentBroadenunderstandingofcausesofcancerDeveloptargetedtreatmentsb
8、asedonthegeneticsofatumor10Quality-of-Life/SupportiveCareTrialsAimtoimprovequalityoflifeforpatientsandtheirfamiliesPossiblebenefit:EarlyaccesstonewtreatmentPossiblerisk:Maynotbenefitfromparticipation11Clinica
