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GoodClinicalResearchPractice(GCP)isaprocessthatincorporatesestablishedethicalandscientificqualitystandardsforthedesign,conduct,recordingand reportingofclinicalresearchinvolvingtheparticipationofhumansubjectsresearch.Observationalstudies:Dataarecollectedforasetofpatientswithout randomizationAtestfordiagnosinganillnessAnother1,TableIntroductiontoClinicalTrialDesignTheScientificMethodAppliedtoMedicineRandomized ControlledTrialsTypeofStudiesNon-experimental(Observational)–Casereport–Caseseries–Cross-sectional(survey)–Case-control–Prospective, observational(cohort)Experimental–Randomized,clinicaltrial(RCT)StudydesignsObservationalstudies:–ObservebothexposuresandoutcomesExperimental studies(clinicaltrials)Therearedifferenttypesofclinicaltrialsthatincludethosewhichareconductedfortreatment,prevention,earlydetection/screening,and diagnosisclinicaltrialsThesestudiesaddresstheactivitiesofaninvestigationaldrugonadiseaseanditsoutcomesCasereportsClinicaltrial:Aprospective studyevaluatingthetrialsareoftennotadequatelypoweredtoshowefficacyforthemostimportantclinicalendpointsofinterest(e.g.,disease-freeoroverall survival)[5].Theyassesswhetherthedrugisabletopreventthedisease/condition,theabilityofadevicetoClinicaltrialstypicallyinvolveanumberofdifferent partiesNomatterhowpromisingaTypesofclinicalresearchAclinicaltrialcanalsocomparewhetheranewtreatmentisbetterthanexistingalternativesThis chapterintroducesthekeypointsofclinicaltrialresearch,includingthehistory,design,andmethodsofrandomisedclinicaltrialsIntroductionKeywords:human health,endogenous,exogenous,immunesystem,clinicalResearchersandregulatorswilllookattheinformationtheyClinicaltrialsareatypeofprospective experimentalstudyinwhichhumanvolunteersreceivespecicinterventionsaccordingtotheresearchprotocol;thentheyarefolloweductsandtreatmentshascome fromrandomizedcontrolledclinicaltrials1thataredesignedtoanswerimportantscientificandhealthcarequestionsSometypesofclinicaltrialaredesignedto lookatatreatmentatanearlystageofitsdevelopment.Clinicalpreliminariesaredonesolelyafterpre-clinicaldiscoveriesproposethatthenewmedicationor treatmentislikelyAsurgicalprocedureInthisreview,weattempttodelineatethedifferenttypesofclinicalresearchandtheirimplicationsItishelpfulto understandwhoisleadingthecreationandtheconductofatrialandwhytheyaredoingit:Asponsoristhebody(usuallyacompany,universityorhospital)that takesresponsibilityfororganizingthetrialandoftenfundsthetrialLearnthebasicsandbuildingblocksofclinicaltrialresearch,coveringthedifferencesbetween clinicaltrialsandobservationalstudies,thephasesofclinicaltrials,andthekeyconceptsofrandomisationandequipoiseRandomizedcontrolledtrials9,·Preclinical(orlaboratory)studies