The Fundamentals of International The Fundamentals of International Clinical Research Clinical Research ICH and GOOD CLINICAL PRACTICES ICH and GOOD CLINICAL PRACTICES Lila Schweins Lila Schweins Family Health International Family Health International
25
Embed
The Fundamentals of International Clinical Research - … Presentations/05 ICH GCP.pdf · The Fundamentals of International Clinical Research ... Qualifications + Training. 15 ...
This document is posted to help you gain knowledge. Please leave a comment to let me know what you think about it! Share it to your friends and learn new things together.
Transcript
The Fundamentals of International The Fundamentals of International Clinical ResearchClinical Research
ICH and GOOD CLINICAL PRACTICESICH and GOOD CLINICAL PRACTICESLila SchweinsLila Schweins
Family Health InternationalFamily Health International
22
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?
--
33
ICHICHInternational Conference on HarmonizationInternational Conference on Harmonization
Background:Background:Drug development Drug development globalglobal, , Regulation Regulation nationalnational
Purpose:Purpose:to harmonize very detailed to harmonize very detailed technical requirementstechnical requirements
Participants:Participants:Regulatory agencies/ industry fromRegulatory agencies/ industry fromEU, Japan, USEU, Japan, US
55
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 for Public expectation of little delay for
Remove redundancy / duplication in Remove redundancy / duplication in development and review processdevelopment and review processFor new medicinal products, single set of For new medicinal products, single set of data should demonstrate:data should demonstrate:–– SafetySafety
–– QualityQuality
–– EfficacyEfficacy
77
ICH ProcessesICH Processes
ICH members develop ICH members develop guidelinesguidelinesthrough stepthrough step--wise processwise processApplicable to:Applicable to:–– DrugsDrugs–– BiologicsBiologics–– Medical devices (test articles)Medical devices (test articles)
Approved by ICH members, Approved by ICH members, then adopted by National Regulatory then adopted by National Regulatory AuthoritiesAuthorities
88
ICH TopicsICH Topics
Safety [S] Safety [S] -- in vitroin vitro & & in vivoin vivo preclinical testing preclinical testing
E2: Clinical Safety E2: Clinical Safety (includes data management)(includes data management)
E3: Study Reports E3: Study Reports E4: Dose Response StudiesE4: Dose Response Studies
E5: Ethnic Factors E5: Ethnic Factors (acceptability of foreign data)(acceptability of foreign data)
E6: Good Clinical Practices (GCP)E6: Good Clinical Practices (GCP)E7/11: Special Populations E7/11: Special Populations E8/9/10: Clinical Trials Design (E8/9/10: Clinical Trials Design (includes biostatisticsincludes biostatistics))E12: Therapeutic CategoriesE12: Therapeutic Categories
1010
ICH ICH Good Clinical PracticesGood Clinical Practices (GCP)(GCP)
Accepted for Accepted for generating clinical generating clinical trial data intended for trial data intended for submission to submission to regulatory agenciesregulatory agencies
Principles can apply to other Principles 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 Award NIAID Clinical Terms of Award
Governs all clinical research supported Governs all clinical research supported by extramural funds by extramural funds
1212
ICH GCPICH GCPSSTANDARDSTANDARDS
International ethical and International ethical and scientific quality standard for:scientific quality standard for:
–– Professional qualifications and agreementsProfessional qualifications and agreements–– Adequate resourcesAdequate resources–– Medical care of trial subjectsMedical care of trial subjects–– IRB communicationIRB communication–– Protocol complianceProtocol compliance–– Investigational productInvestigational product
–– Randomization + Randomization + unblindingunblinding–– Informed consent of trial subjectsInformed consent of trial subjects–– Records + reportsRecords + reports–– Study conductStudy conduct
Safety reportingSafety reportingPremature trial termination or suspensionPremature trial termination or suspension
2121
GCP Essential Documents: GCP Essential Documents: Permit evaluation of trial Permit evaluation of trial conduct and data qualityconduct and data quality
Phase of trial:Phase of trial:–– Before startBefore start–– During conduct During conduct –– After completionAfter completion
2222
ComplianceCompliance with GCPwith GCP provides provides public assurance of:public assurance of:
Protection of Protection of subjectsubject’’s rights, s rights, safety, wellsafety, well--being being Consistence with Consistence with Helsinki DeclarationHelsinki DeclarationCredible DataCredible Data
2323
SUMMARYSUMMARY
ICHICH = International Conference on = International Conference on HarmonizationHarmonization
–– ICH sets international standards for ICH sets international standards for technical requirements to license technical requirements to license new drugsnew drugs
–– Issues guidelines Issues guidelines –– DMID follows ICH guidelines DMID follows ICH guidelines for clinical
research conduct and oversight
2424
SUMMARYSUMMARY
GCPGCP = Good Clinical Practices (ICH E6)= Good Clinical Practices (ICH E6)
–– Covers design, conduct, recording and Covers design, conduct, recording and reporting of clinical research reporting of clinical research
–– Designed to ensure:Designed to ensure:
Ethical research, Ethical research,
High quality, credible dataHigh quality, credible data
2525
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