癌症临床试验（英文版）

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1、CancerClinicalTrialsIn-DepthInformationTheDrugDevelopmentandApprovalProcess1.Earlyresearchandpreclinicaltesting2.INDapplicationfiledwithFDA3.Clinicaltrials(phases1,2,and3)4.NDAfiledwithFDA5.FDAvalidatesclaimandapprovesdrug2PhasesofClinicalTrialsPhase1:15-30peo

2、pleWhatdosageissafe?Howshouldtreatmentbegiven?Howdoestreatmentaffectthebody?Phase2:Lessthan100peopleDoestreatmentdowhatitissupposedto?Howdoestreatmentaffectthebody?3PhasesofClinicalTrialsPhase3:From100tothousandsofpeopleComparenewtreatmentwithcurrentstandardPh

3、ase4:FromhundredstothousandsofpeopleUsuallytakesplaceafterdrugisapprovedUsedtofurtherevaluatelong-termsafetyandeffectivenessofnewtreatment4TypesofClinicalTrialsTreatmentPreventionScreeningandearlydetectionDiagnosticGeneticsQuality-of-life/supportivecare5Treatm

4、entTrialsTestsafetyandeffectivenessofnewagentsorinterventionsinpeoplewithcancerPossiblebenefit:EarlyaccesstonewtreatmentsPossiblerisk:Occurrenceofunknownsideeffects6PreventionTrialsForpeopleatriskofdevelopingcancerActionstudiesvs.agentstudiesPossiblebenefit

5、:EarlyaccesstonewinterventionsPossiblerisk:Unknownsideeffectsandeffectiveness7ScreeningandEarly-DetectionTrialsAssessnewmeansofdetectingcancerearlierinhealthypeoplePossiblebenefit:Detectingdiseaseatanearlierstage,resultinginimprovedoutcomesPossiblerisks:Discom

6、fortandinconvenienceIfimagingtechniqueisstudied,exposuretox-raysorradioactivesubstances8DiagnosticTrialsDevelopbettertoolsforclassifyingtypesandphasesofcancerandmanagingpatientcarePossiblebenefits:NewtechnologymaybebetterandlessinvasiveEarlierdetectionofrecurr

7、encesPossiblerisk:Mayrequirepeopletotakemultipletests9GeneticsTrialsThesetrialsseekto:Determinehowone’sgeneticmakeupcaninfluencedetection,diagnosis,prognosis,andtreatmentBroadenunderstandingofcausesofcancerDeveloptargetedtreatmentsbasedonthegeneticsofatumor10Q

8、uality-of-Life/SupportiveCareTrialsAimtoimprovequalityoflifeforpatientsandtheirfamiliesPossiblebenefit:EarlyaccesstonewtreatmentPossiblerisk:Maynotbenefitfromparticipation11Clinica