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NAPSRX CHAPTER 11 (CLINICAL TRIAL) QUESTIONS AND ANSWERS WITH SOLUTIONS 2024
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NAPSRX CHAPTER 11 (CLINICAL TRIAL) QUESTIONS AND ANSWERS WITH SOLUTIONS 2024
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NAPSRX CHAPTER 11 (CLINICAL TRIAL)QUESTIONS AND ANSWERS WITH
SOLUTIONS 2024
ClinicalFTrialF-
FANSWERFAFstudyFofFhumanFsubjectsFthatFisFintendedFtoFascertainFanFinvestigationalFproduct'sFsafetyFandF
efficacyFbyFanalyzingFits...
-clinical
-pharmacologicalFand/orFotherFpharmacodynamicFeffects
-absorption
-distribution
-metabolism
-excretion
-adverseFreactions
EthicalFConsiderationsF-FANSWERF1.)FSocialFValue
2.)FScientificFValidity
3.)FFairFSubjectFSelection
4.)FInformedFConsent
5.)FFavorableFRisk-BenefitFRatio
6.)FIndependentFReviewFBoard/IndependentFEthicsFCommitteeF(IRB/IEB)
7.)FRespectFforFHumanFSubjects
,SocialFValueF-
FANSWERFClinicalFtrialFisFjustifiedFbasedFonFscientificFresearch,FandFwillFresultFinFimprovementsFinFhealthFor
FadvancementFofFscientificFknowledge
-FThisFrequirementFhelpsFensureFresourcesFareFnotFdirectedFatFnon-
meaningfulFclinicalFresearchFandFthatFhumanFsubjectsFareFnotFexploited
ScientificFValidityF-
FANSWERFtheFclinicalFtrialFshouldFbeFconductedFmethodicallyFwithFclearFobjectivesFandFoutcomesFthatFareF
statisticallyFverifiable
-
theFpreclinicalFandFtoxicologicalFdataFshouldFhaveFbeenFcarefullyFanalyzedFandFshouldFconfirmFtheFscientifi
cFfinding
-theFtrialFshouldFnotFbeFbiased,FandFshouldFbeFexecutedFwithoutFunreasonableFcaveatsFandFconditions
FairFSubjectFSelectionF-
FANSWERFsubjectsFshouldFbeFselectedFbasedFonFscientificFobjectivesFandFnotFonFwhetherFtheFsubjectFisFpri
vilegedForFvulnerable,ForFbecauseFofFconvenience
-inclusionFandFexclusionFcriteriaFareFwellFthoughtFoutFandFdesignedFtoFsatisfyFtheFscientificFdataF
-mustFbeFdocumentedFevidenceFtoFsupportFtheFchoiceFofFselectionFcriteria
InformedFConsentF-
FANSWERFsubjectsFshouldFbeFinformedFaboutFtheFaims,Fmethods,Frisks,FandFbenefitsFofFtheFtrial
-theFavailableFalternativesFshouldFbeFexplained
-subjectsFshouldFnotFbeFpressuredFtoFenrollingFinFtrial,FandFshouldFbeFallowedFtoFleave
-forFyoungFandFincapacitatedFpeople,FproxyFdecisionFfromFtheirFrepresentativesFmustFbeFobtained
FavorableFRisk-BenefitFRatioF-
FANSWERFwhetherFpossibleFclinicalFtrialFsubjectsFshouldFbeFsubjectedFtoFminimalFriskFandFmaximalFbenefit
,-shouldFbeFbasedFonFprovenFscientificFdataFgatheredFfromFpre-clinicalFstage
-shouldFnotFbeFconductedFifFthereFisFanyFdoubtFaboutFtheFrisk-benefitFration
IndependentFReviewFBoard/IndependentFEthicsFCommitteeF(IRB/IEC)F-
FANSWERFinsuresFthatFtheFindependentFpartyFassessesFtheFclinicalFtrialFtoFaddressFtheFquestionFofFconflictFi
nterests
-
actsFasFaFthirdFpartyFtoFoverseeFwelfareFofFtheFtrialFsubjectsFandFensureFtrialFisFconductedFinFaccordanceFtoF
theFstudy
-hasFaFrightFtoFstopFtrialForFrequireFproceduresFandFmethodsFbeFchanged
-members:Fclinicians,Fscientists,Flawyers,FreligiousFpeople,FandFlayFpeople
RespectFforFHumanFSubjectsF-
FANSWERFsubjectsFshouldFbeFprotected,FtheirFprogressFinFtheFtrialFmonitoredFcloselyFandFprovidedFwithFap
propriateFtreatment
-
newFdevelopmentsFinFtheFtrialFmushFbeFrelayedFtoFsubjectsFwithoutFprejudice,FandFsubjectsFdecisionsFsho
uldFbeFhonored
-outcomesFmustFbeFcommunicatedFtoFtheFsubjectsFpromptlyFandFinFanFunbiasedFway
PhaseF1F-FANSWERFtheFfirstFexperimentFinFwhichFaFdrugFisFtestedFonFtheFhumanFbody
-primaryFaimFisFtoFassessFtheFsafetyFofFtheFnewFdrug,Fpharmacokinetics,FandFpharmocodynamics
-10-100FhealthyFvolunteersFrecruited
-dosesFincreasedFasFtrialFprogresses,FmonitoredFcloselyFtoFcheckFtheirFtoleranceFandFsideFeffects
-samplesFtakenFtoFevaluateFabsorption,Fdistribution,Fmetabolism,FandFevaluation
-observationsFonFhowFtheyFfeel,FvitalFsigns,FandFbehavioralFmatters
PhaseF2F-FANSWERFexaminesFtheFsafetyFandFeffectivenessFofFtheFdrugFinFaFtargetedFdiseaseFgroup
-50-500Fpeople,F1-2Fyears
-hasFaFcontrolFgroup,FrandomizedFandFblindedFtoFsubjects
, -helpsFdetermineFeffectiveFdoseFandFtheFdosingFregimenFofFfrequencyFandFduration
-specificFclinicalFendpointsForFmarkersF(definitiveF&Fsurrogate)FassessFinteractionFofFdrugFandFdisease
-
statisticalFanalysisFconductedFtoFevaluateFtheFinfluenceFofFtheFdrugFonFdifferentFpatientFgroupsFandFdeter
mineFoptimumFconditions
PhaseF3F-FANSWERFconfirmsFtheFefficacyFofFtheFdrugFinFaFmushFlargerFpatientFgroup
-severalFhundredFtoFtensFofFthousandsFofFpeople,F2-5Fyears
-multi-siteFtrial:FconductedFinFseveralFlocations
-pivotalFtrial:FitsFresultsFdetermineFtheFeffectivenessFofFtheFdrug
-theseFresultsFhelpFsetFdrug'sFdosage,FtreatmentFfrequency,Fduration,FandFtargetFpatientFgroup
-resultsFsubmittedFtoFregulatoryFauthoritiesFtoFseeFapprovalFtoFmarketFtheFdrug
PhaseF4F-FANSWERFpost-
marketingFapprovalFtrialsFtoFmonitorFefficacyFandFsideFeffectsFofFtheFdrugFinFanFuncontrolledFreal-
lifeFsituationF
-collectFinformationFtoFobserveFdrugsFefficacy,FsideFeffects,FpatientsFqualityFofFlife,FandFcost-effectiveness
InvestigatorF-FANSWERFTheFpersonFwhoFconductsFtheFtrial
-FIfFthereFisFaFteam,FthenFthereFisFaFPrincipalFInvestigator
-
FResponsibilityFisFtoFensureFthatFGCPFisFbeingFimplementedFinFtheFcourseFofFtheFtrial,FthatFtheFsubject'sFrigh
tsFandFwelfareFareFrespected,FthatFtheFstudy'sFtransparencyFisFmaintained,FandFthatFthereFareFnoFconflictsF
ofFinterest
-
FShouldFbeFableFtoFmaintainFimpartiality,FmeaningFthatFtheyFshouldFbeFneitherFemployedFbyFtheFSponsor,Fn
orFotherwiseFexpectedFtoFbenefitFfinanciallyFfromFtheFdrug'sFsuccess
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