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8/7/2019 05 ICH GCP
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The Fundamentals of InternationalThe Fundamentals of International
Clinical ResearchClinical Research
ICH and GOOD CLINICAL PRACTICESICH and GOOD CLINICAL PRACTICES
Lila SchweinsLila Schweins
Family Health InternationalFamily Health International
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General questionsGeneral questions
What is ICH?What is ICH? What does it do?What does it do?
What is GCP?What is GCP? What is it for?What is it for?
Why should we implement GCP?Why should we implement GCP?
--
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ICHICHInternational Conference on HarmonizationInternational Conference on Harmonization
GCPGCPGood Clinical PracticesGood Clinical Practices
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ICH HistoryICH History
Background:Background:Drug developmentDrug development globalglobal,,RegulationRegulation nationalnational
Purpose:Purpose:to harmonize very detailedto harmonize very detailedtechnical requirementstechnical requirements
Participants:Participants:
Regulatory agencies/ industry fromRegulatory agencies/ industry fromEU, Japan, USEU, Japan, US
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ICH HistoryICH History
Concerns:Concerns:
Rising costs of health careRising costs of health care
Increasing costs of R+DIncreasing costs of R+D Public expectation of little delay forPublic expectation of little delay for
new, safe, efficaciousnew, safe, efficacious txtx
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ICH GoalICH Goal
Remove redundancy / duplication inRemove redundancy / duplication in
development and review processdevelopment and review processFor new medicinal products, single set ofFor new medicinal products, single set ofdata should demonstrate:data should demonstrate:
SafetySafety
QualityQuality
EfficacyEfficacy
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ICH ProcessesICH Processes
ICH members developICH members develop guidelinesguidelines
through stepthrough step--wise processwise process
Applicable to:Applicable to:
DrugsDrugsBiologicsBiologics
Medical devices (test articles)Medical devices (test articles)
Approved by ICH members,Approved by ICH members,then adopted by National Regulatorythen adopted by National RegulatoryAuthoritiesAuthorities
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ICH TopicsICH Topics
Safety [S]Safety [S] -- in vitroin vitro&& in vivoin vivopreclinical testingpreclinical testing
Quality [Q]Quality [Q] -- chemical & pharmaceutical QAchemical & pharmaceutical QA
Efficacy [E]Efficacy [E] -- clinical studies in humansclinical studies in humans
Multidisciplinary [M]Multidisciplinary [M] -- terminologyterminology
-- electronic standardselectronic standards-- common documentscommon documents
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ICHICH EfficacyEfficacy GuidelinesGuidelines
E1: ExposureE1: Exposure (to assess clinical safety)(to assess clinical safety)
E2: Clinical SafetyE2: Clinical Safety (includes data management)(includes data management)
E3: Study ReportsE3: Study Reports
E4: Dose Response StudiesE4: Dose Response Studies
E5: Ethnic FactorsE5: Ethnic Factors (acceptability of foreign data)(acceptability of foreign data)
E6: Good Clinical Practices (GCP)E6: Good Clinical Practices (GCP)E7/11: Special PopulationsE7/11: Special Populations
E8/9/10: Clinical Trials Design (E8/9/10: Clinical Trials Design (includes biostatisticsincludes biostatistics))E12: Therapeutic CategoriesE12: Therapeutic Categories
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ICHICH Good Clinical PracticesGood Clinical Practices (GCP)(GCP)
Accepted forAccepted for
generating clinicalgenerating clinicaltrial data intended fortrial data intended forsubmission tosubmission toregulatory agenciesregulatory agencies
Consist of:Consist of: Guiding PrinciplesGuiding Principles
StandardsStandards
RequirementsRequirements
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ICH GCPICH GCPPrinciples can apply to otherPrinciples can apply to other
clinical research:clinical research:
NIH Guidance on conduct of clinical researchNIH Guidance on conduct of clinical research
NIAID Clinical Terms of AwardNIAID Clinical Terms of Award
Governs all clinical research supportedGoverns all clinical research supportedby extramural fundsby extramural funds
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ICH GCPICH GCPSSTANDARDSTANDARDS
International ethical andInternational ethical andscientific quality standard for:scientific quality standard for:
DesigningDesigning
ConductingConducting
RecordingRecording
ReportingReporting
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GCPGCP DesignDesign StandardsStandardsProtocol, Investigator Brochure contentProtocol, Investigator Brochure content
Scientifically sound, feasibleScientifically sound, feasible
Adequate resourcesAdequate resources
Randomization / blinding proceduresRandomization / blinding procedures
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GCPGCP ConductConduct StandardsStandardsRegulatory + IRB approvalsRegulatory + IRB approvals
Comply with protocolComply with protocol
Informed consent, ConfidentialityInformed consent, Confidentiality
Medical management, adverse eventsMedical management, adverse eventsProduct accountabilityProduct accountability
Qualifications + TrainingQualifications + Training
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GCPGCP RecordingRecording StandardsStandardsCRF completionCRF completion
Data handlingData handling
Security, audit trailsSecurity, audit trails
ProductProduct
AccountabilityAccountability
Study Files/ EssentialStudy Files/ Essential
DocumentsDocuments
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GCPGCP ReportingReporting StandardsStandards
Adverse Events, interim reviews,Adverse Events, interim reviews,progress reports, final reports,progress reports, final reports,monitoring/audit reports to:monitoring/audit reports to:
SponsorsSponsors
IRB/IECIRB/IEC
Regulatory authoritiesRegulatory authorities
Other investigatorsOther investigators
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ICH GCPICH GCP
REQUIREMENTSREQUIREMENTS
Requirements & responsibilitiesRequirements & responsibilitiesdelineated for:delineated for:
IRB/IECIRB/IEC
InvestigatorsInvestigators
SponsorsSponsors
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IRB/IEC Requirements &IRB/IEC Requirements &
ResponsibilitiesResponsibilities
ResponsibilitiesResponsibilities Composition, function, operationsComposition, function, operations
ProceduresProcedures
RecordsRecords
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Investigators Requirements (1):Investigators Requirements (1):
Professional qualifications and agreementsProfessional qualifications and agreementsAdequate resourcesAdequate resources
Medical care of trial subjectsMedical care of trial subjects
IRB communicationIRB communication
Protocol complianceProtocol compliance
Investigational productInvestigational product
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Investigators Requirements (2):Investigators Requirements (2):
Randomization +Randomization + unblindingunblinding
Informed consent of trial subjectsInformed consent of trial subjects
Records + reportsRecords + reports
Study conductStudy conduct
Safety reportingSafety reporting
Premature trial termination or suspensionPremature trial termination or suspension
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GCP Essential Documents:GCP Essential Documents:Permit evaluation of trialPermit evaluation of trial
conduct and data qualityconduct and data quality
Files ofFiles ofInvestigatorInvestigator
SponsorSponsor
Phase of trial:Phase of trial:Before startBefore start
During conductDuring conductAfter completionAfter completion
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ComplianceCompliance with GCPwith GCP providesprovides
public assurance of:public assurance of:
Protection ofProtection ofsubjectsubjects rights,s rights,
safety, wellsafety, well
--beingbeing
Consistence withConsistence withHelsinki DeclarationHelsinki Declaration
Credible DataCredible Data
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SUMMARYSUMMARYICHICH = International Conference on= International Conference on
HarmonizationHarmonization
ICH sets international standards forICH sets international standards for
technical requirements to licensetechnical requirements to licensenew drugsnew drugs
Issues guidelinesIssues guidelines
DMID follows ICH guidelinesDMID follows ICH guidelines for clinicalresearch conduct and oversight
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SUMMARYSUMMARYGCPGCP = Good Clinical Practices (ICH E6)= Good Clinical Practices (ICH E6)
Covers design, conduct, recording andCovers design, conduct, recording andreporting of clinical researchreporting of clinical research
Designed to ensure:Designed to ensure:
Ethical research,Ethical research,
High quality, credible dataHigh quality, credible data
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Web resources for ICH/GCPWeb resources for ICH/GCP
US FDA:US FDA: http://http://www.fda.gov/oc/ohawww.fda.gov/oc/oha
ICH Website:ICH Website:
http://www.ifpma.org/ich1.htmlhttp://www.ifpma.org/ich1.html