1 / 4

What is a clinical trial

Clariwell Global Services offers a Clinical Research Courses that incorporates a totally uncommon and certain perspective of learning, with a course structure that sorts out how to introduce you all around things of information into the business correspondingly as enables Associate in nursing energy for innovative work. The course needs the opportunity to have a strong put together or establishment in Life sciences since it are at the legitimization social occasion of the course, with its astoundingly arranged exchange specialists United Nations office give consistent, field experiential going

ramanaj
Download Presentation

What is a clinical trial

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Whatisaclinicaltrial? Clinicaltrialsinvolveresearchconductedonhumansthatisdesignedtoevaluatetheeffectivenessofadrugortreatmentandaddtomedicalknowledge.AspertheNationalInstitutesofHealth(NIH),“Clinicaltrialsareresearchstudiesthatexplorewhetheramedicalstrategy,treatment,ordeviceissafeandeffectiveforhumans.Thesestudiesalsomayshowwhichmedicalapproachesworkbestforcertainillnessesorgroupsofpeople.” Clinical Research Training studiesarealwaysinneedofvolunteers.Withoutthesevolunteers,medicationsandtreatmentscannotbeapprovedbytheconcernedauthoritiesandthuscannotreachthepatients.Apartfromgainingaccesstoapotentialtreatmentforaparticulardisease,otherperksincludereceivingcareatthetopmostfacilities,helpingscience,andmakingapotentialimpactonallthoselivinginthatparticularcondition.Thesestudiesgenerallyoffergenerouscompensationforyourparticipation. Clinicaltrialsareusuallymedicalorclinicalstudiesinwhichhumanvolunteersparticipateincarefullyconductedinvestigationsaccordingtoapre-determinedresearchprotocol.Theclinicaltrialprogramisalongdrawnprocesstakingupto5-7yearsormoretocomplete.Aclinicaltrialisusuallyconductedasthefinalstepofanextendedresearchprocess.First,anewmedicalstrategy,drug,treatment,ordeviceisdevelopedinthelab,thenitistestedonanimals,andfinallytestedonhumanstoseehowsafeoreffectiveitis. Typesofclinicaltrials

  2. Broadlyspeaking,clinicaltrialscanbeoftwotypes: Interventional:Inthiskindoftrial,specifictreatmentsorinterventionsaregiventotheparticipantsbytheinvestigators.Theoutcomesarethencomparedtoagroupthathasbeengivenadifferenttreatmentornotreatment. Observational:Inobservationalstudies,theinvestigatorsortheresearchersobservethetreatmentsormanagementtechniquesthataregiventoagroupofpatientsandnotetheoutcomes.However,theresearchersdonotgivetheinterventions. Basedonthepurposeofthestudy,theNIHhasclassifiedclinicaltrialsintothefollowingtypes: Treatmenttrials:Thesearedesignedtotestnewtreatments,newcombinationsofdrugs,newsurgicalapproaches,orradiationtherapy. Preventiontrials:Theobjectiveofthesetrialsistofindwaystopreventadiseasefromoccurringorrelapsing.Theseoftenincludemedicines,vaccination,orlifestylechanges. Screeningtrials:Thistypeofstudyteststhebestwaytodetectspecificdiseasesorhealthconditions. Diagnostictrials:Thesestudiesaimtocomeupwithbettertestsorproceduresfordiagnosingadiseaseorhealthcondition.

  3. Qualityoflifetrials:Alsoknownassupportivecaretrials,thesestudiesexplorewaystoimprovethecomfortandqualityoflifeofpeoplewithachronicillness.Qualityoflifetrials:Alsoknownassupportivecaretrials,thesestudiesexplorewaystoimprovethecomfortandqualityoflifeofpeoplewithachronicillness. Registrationofclinicaltrials TheDeclarationofHelsinkistatesthat"Everyclinicaltrialmustberegisteredinapubliclyaccessibledatabasebeforerecruitmentofthefirstsubject.” OrganizationslikeWorldHealthOrganization(WHO)andtheInternationalCommitteeofMedicalJournalEditors(ICMJE)arestrongadvocatesofclinicaltrialregistration.AlljournalslistedontheICMJEwebsiterequireregistrationofclinicaltrialsinapublictrialsregistrybeforethefirstpatientisenrolledasaconditionofconsiderationforpublication.ClinicalTrials.govrunbytheUnitedStatesNationalLibraryofMedicine(NLM)istheworld’slargestandmostwidelyusedclinicaltrialsregistry.TheWHOmaintainsaclinicaltrialsregistrynetwork.TheICMJEacceptsregistrationinClinicalTrials.govorinanyprimaryregistryoftheWHOInternationalClinicalTrialsRegistryPlatform(ICTRP).Oncetheclinicaltrialisover,theresultsdatashouldbesubmittedtotheregistry.WhiletheICMJEencouragessubmissionofresultsasagoodpractice,thisisnotmandatory. Casereportformforclinicaltrials Acasereportform(CRF)isapaperorelectronicquestionnaireusedinclinicaltrialresearchtorecordallprotocol-requiredinformationoneachsubject/participatingpatientinthestudy.Casereportformscontaindataobtainedduringthepatient'sparticipationintheclinicaltrial.AccordingtotheInternationalConferenceonHarmonizationGuidelinesforGoodClinicalPractice,aCRFis“Aprinted,opticalorelectronicarchive

  4. intendedtorecordthegreaterpartoftheprotocol– expecteddatatopresenttothesponsoroneverytrialsubject.” Itencompassestheentiremedicalhistoryincludingadverseeventsfromthepatientandiscollectedoveraperiodofweeksormonths. TheCRFshouldaccuratelyrepresenttheprotocoloftheclinicaltrial,aswellasmanagingitsproduction,monitoringthedatacollectionandauditingthecontentofthefilled-inCRFs.TheCRFassistsinobtainingthecomplete,comprehensiveandstandardizeddatacollectionthatpromotesefficientprocessing,analysis,andreportingofinformation,aswellastheexchangeofdataacrosssites.ThedatafromtheCRFisfurtherusedbyclinicalresearchcoordinators,biostatisticians,investigators,datamanagersoraprogrammer. ThemainpurposeofaCRFistogathercompleteandaccuratedatainaclinicaltrialandtosmoothlytranscribethedatafromthesourcedocumenttoaretrievableform.Inotherwords,aCRFpreservesandmaintainsthequalityandintegrityofdatafromaclinicaltrial.ThestructuringoftheCRFshouldenabledatacollectionofthehighestquality.Thesponsor/pharmacompanyusuallydesignsaCRF.ThesponsorshouldensurethattheCRFrepresentsthetrialprotocol;additionally,thesponsorisalsoresponsibleformanagementoftheproduction,monitoringofthedatacollectionandtheauditingthecontentoftheCRFs.However,thepatient’snameandmedicalrecordnumberareusuallyde-identifiedbeforesendingthedetailstothesponsoringagency.

More Related