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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