GHTF SG5 PostMarket Clinical FollowUp Studies英Word文档格式.docx
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Date:
February18,2010
Dr.LarryKelly,GHTFChair
ThedocumenthereinwasproducedbytheGlobalHarmonizationTaskForce,whichiscomprisedofrepresentativesfrommedicaldeviceregulatoryagenciesandtheregulatedindustry.Thedocumentisintendedtoprovidenon-bindingguidanceforuseintheregulationofmedicaldevices,andhasbeensubjecttoconsultationthroughoutitsdevelopment.
Therearenorestrictionsonthereproduction,distributionoruseofthisdocument;
however,incorporationofthisdocument,inpartorinwhole,intoanyotherdocument,oritstranslationintolanguagesotherthanEnglish,doesnotconveyorrepresentanendorsementofanykindbytheGlobalHarmonizationTaskForce.
Copyright©
2010bytheGlobalHarmonizationTaskForce
CONTENTS
Preface3
1.Introduction4
2.Scope4
3.References5
4.Definitions6
5.CircumstancesWhereAPost-MarketClinicalFollow-UpStudyIsIndicated7
6.ElementsOfAPost-MarketClinicalFollow-UpStudy8
7.TheUseOfStudyInformation10
Preface
ThedocumenthereinwasproducedbytheGlobalHarmonizationTaskForce,avoluntarygroupofrepresentativesfrommedicaldeviceregulatoryagenciesandtheregulatedindustry.Thedocumentisintendedtoprovidenon-bindingguidanceforuseintheregulationofmedicaldevices,andhasbeensubjecttoconsultationthroughoutitsdevelopment.
1.INTRODUCTION
WhileclinicalevidenceisanessentialelementofthepremarketconformityassessmentprocesstodemonstrateconformitytoEssentialPrinciples,itisimportanttorecognisethattheremaybelimitationsintheclinicaldataavailableinthepre-marketphase.Suchlimitationsmaybedueto,forexample,thedurationofpre-marketclinicalinvestigations,thenumberofsubjectsinvolvedinaninvestigation,therelativehomogeneityofsubjectsandinvestigatorsandthecontrolofvariablesinthesettingofaclinicalinvestigationversususeinthefullrangeofconditionsencounteredingeneralmedicalpractice.
ItisappropriatetoplaceaproductonthemarketonceconformitytotherelevantEssentialPrinciples,includingafavourablerisk/benefitratio,hasbeendemonstrated.Completecharacterizationofallrisksmaynotalwaysbepossibleorpracticableinthepre-marketphase.Therefore,theremaybequestionsregardingresidualrisksthatshouldbeansweredinthepostmarketphasethroughtheuseofoneormoresystematicpost-marketclinicalfollow-upstudies.Post-marketclinicalstudiesarenotintendedtoreplacethepre-marketdatanecessarytomakethedecisionastoapprovethedevice.
Post-marketclinicalfollow-upstudiesareoneofseveraloptionsavailableinapost-marketsurveillanceprogramme(seeGHTFSG2N47)andcontributetotheriskmanagementprocess.
2.SCOPE
Thisdocumentisintendedtoprovideguidanceonpost-marketclinicalfollow-upstudiesdevelopedspecificallyforissuesofresidualrisk(includingthosemandatedbyregulation).However,theprinciplespresentedmaybeapplicabletopost-marketclinicalfollow-upstudiesconductedforotherpurposes.
Thisdocumentdoesnotimposenewregulatoryrequirementsbutisintendedtoprovideguidanceontheappropriateuseandconductofpostmarketclinicalfollow-upstudies.
Thisdocumentprovidesguidanceinrelationto:
i)thecircumstanceswhereapost-marketclinicalfollow-upstudyisindicated;
ii)thegeneralprinciplesofpost-marketclinicalfollow-upstudiesinvolvingmedicaldevices;
and
iii)theuseofstudyinformation,including,forexample,toprovideinformationtoupdatelabelling.
Thisdocumentdoesnotapplytoinvitrodiagnosticdevices.
3.REFERENCES
GHTFFinalDocuments:
SG1/N41:
2005EssentialPrinciplesofSafety&
PerformanceofMedicalDevices
SG1/N44:
2008TheRoleofStandardsintheAssessmentofMedicalDevices
SG2/N47:
2005ReviewofCurrentRequirementsonPost-MarketSurveillance
SG5/N1:
2007ClinicalEvidence–KeyDefinitionsandConcepts
SG5/N2:
2007ClinicalEvaluation
SG5/N3:
2010ClinicalInvestigations
GHTFProposedDocuments:
SG1(WD)N065RegistrationofManufacturersandOtherPartiesandListingofMedicalDevices
InternationalStandards:
ISO14155-1:
2003Clinicalinvestigationofmedicaldevicesforhumansubjects–Part1Generalrequirements
ISO14155-2:
2003Clinicalinvestigationofmedicaldevicesforhumansubjects–Part2Clinicalinvestigationplans
ISO14971:
2007Applicationofriskmanagementtomedicaldevices
Others:
AgencyforHealthcareResearchandQualityRegistriesforEvaluatingPatientOutcomes:
AUser’sGuide
4.DEFINITIONS
ClinicalData:
Safetyand/orperformanceinformationthataregeneratedfromtheclinicaluseofamedicaldevice.
ClinicalEvaluation:
Theassessmentandanalysisofclinicaldatapertainingtoamedicaldevicetoverifytheclinicalsafetyandperformanceofthedevicewhenusedasintendedbythemanufacturer.
ClinicalEvidence:
Theclinicaldataandtheclinicalevaluationreportpertainingtoamedicaldevice.
ClinicalInvestigation:
Anysystematicinvestigationorstudyinorononeormorehumansubjects,undertakentoassessthesafetyand/orperformanceofamedicaldevice.
DeviceRegistry:
Anorganizedsystemthatusesobservationalstudymethodstocollectdefinedclinicaldataundernormalconditionsofuserelatingtooneormoredevicestoevaluatespecifiedoutcomesforapopulationdefinedbyaparticulardisease,condition,orexposureandthatserves(a)predeterminedscientific,clinicalorpolicypurpose(s).(AgencyforHealthcareResearchandQuality,“RegistriesforEvaluatingPatientOutcomes:
AUser’sGuide”,modified)
Note:
Theterm“deviceregistry”asusedhereshouldnotbeconfusedwiththeconceptofdeviceregistrationandlisting.(SeeGHTFSG1N065)
Post-marketclinicalfollow-upstudy:
Astudycarriedoutfollowingmarketingapprovalintendedtoanswerspecificquestionsrelatingtoclinicalsafetyorperformance(i.e.residualrisks)ofadevicewhenusedinaccordancewithitsapprovedlabelling.Thesemayexamineissuessuchaslong-termperformance,theappearanceofclinicalevents(suchasdelayedhypersensitivityreactionsorthrombosis),eventsspecifictodefinedpatientpopulations,ortheperformanceofthedeviceinamorerepresentativepopulationofprovidersandpatients.
ResidualRisk:
Riskremainingafterriskcontrolmeasureshavebeentaken(ISO14971)(e.g.knownoremergingrisks,orpotentialrisksduetostatisticallimitations).
5.CircumstancesWhereAPost-MarketClinicalFollow-UpStudyIsIndicated
Theneedforpost-marketclinicalfollow-upstudiesshouldbedeterminedfromtheidentificationofresidualrisksthatmayimpacttherisk/benefitratio.
Circumstancesthatmayresultintheneedforpost-marketclinicalfollow-upstudiesinclude,forexample:
∙innovation,e.g.,wherethedesignofthedevice,thematerials,theprinciplesofoperation,thetechnologyorthemedicalindicationsarenovel;
∙anewindicationorclaimhasbeenapproved;
∙significantchangestodevicedesignorlabelling;
∙higherriskclassification;
∙higherriskanatomicallocations;
∙severityofdisease/treatmentchallenges;
∙questionsofabilitytogeneraliseclinicalinvestigationresults;
∙unansweredquestionsoflong-termsafetyandperformance;
∙resultsofanypreviousclinicalinvestigationincludingadverseeventsidentifiedorfrompostmarketsurveillanceactivities;
∙identificationofpreviouslyunstudiedpopulations;
∙discrepancybetweenthepremarketfollow-uptimescalesandtheexpectedlifeoftheproduct;
∙risksidentifiedfromtheliteratureorotherdatasourcesforsimilarmarketeddevices;
∙sensitivityoftargetpopulation;
∙interactionwithothermedicalproductsortreatments;
∙training/learningcurveissues;
∙emergenceofnewinformationrelatingtosafetyorperformance;
Post-marketclinicalfollow-upstudiesmaynotberequiredincaseswherethemedium/long-termsafetyandclinicalperformancearealreadyknownfromprevioususeofthedeviceorwhereotherappropriatepost-marketsurveillanceactivitieswouldprovidesufficientdatatoaddresstherisks.
6.ElementsofAPost-MarketClinicalFollow-UpStudy
Postmarketclinicalfollow-upstudiesareperformedonadevicewithinitsintendeduse/purpose(s)accordingtotheinstructionsforuse.Itisimportanttonotethatpost-marketclinicalfollow-upstudiesmustbeconductedaccordingtoapplicablelawsandregulations,andshouldfollowappropriateguidanceandstandards.
Theelementsofapost-marketclinicalfollow-upstudyinclude:
∙(a)clearlystatedobjective(s);
∙ascientificallysounddesignwithanappropriaterationaleandstatisticalanalysisplan;
∙astudyplan;
∙implementationofthestudyaccordingtotheplan,ananalysisofthedataandappropriateconclusion(s)
Theobjective(s)ofpost-marketclinicalfollow-upstudies
Theobjective(s)ofthestudyshouldbestatedclearlyandshouldaddresstheresidualrisk(s)identifiedandbeformulatedtoaddressoneormorespecificquestionsrelatingtotheclinicalsafetyorperformanceofthedevice.Aformalhypothesisshouldbeclearlyexpressed.
Thedesignofpostmarketclinicalfollow-upstudies
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