Good Clinical Practice 101: Good Clinical Practice 101: An Introduction An Introduction Presented by: Lester “Jao” Lacorte, MD Presented by: Lester “Jao” Lacorte, MD Medical Officer – Commissioner’s Fellow Medical Officer – Commissioner’s Fellow Division of Bioresearch Monitoring Division of Bioresearch Monitoring Office of Compliance Office of Compliance Center for Devices and Radiological Health Center for Devices and Radiological Health 1 1
Objectives: Objectives: � Define Good Clinical Practice (GCP) � Define Good Clinical Practice (GCP) � Outline the goals of GCP � Outline the goals of GCP � Provide a historical perspective on GCP � Provide a historical perspective on GCP � Outline FDA regulations relating to GCP � Outline FDA regulations relating to GCP in medical device research in medical device research 2 2
What is Good Clinical Practice (GCP)? What is Good Clinical Practice (GCP)? � GCP is defined as a � GCP is defined as a standard for the standard for the design, conduct, design, conduct, performance, performance, monitoring, auditing, monitoring, auditing, recording, analysis recording, analysis and reporting of and reporting of clinical trials or clinical trials or studies studies 3 3
Additional terms defined: Additional terms defined: � Clinical Investigation � Clinical Investigation � Clinical Investigator � Clinical Investigator � Human Subject � Human Subject � Institutional Review Board � Institutional Review Board 4 4
Why is GCP important? Why is GCP important? � GCP compliance � GCP compliance provides public provides public assurance that the assurance that the rights, safety and rights, safety and well-being of human well-being of human subjects involved in subjects involved in research are research are protected protected 5 5
What are the goals of GCP? What are the goals of GCP? � To protect the rights, safety and welfare of � To protect the rights, safety and welfare of humans participating in research humans participating in research � To assure the quality, reliability and integrity � To assure the quality, reliability and integrity of data collected of data collected � To provide standards and guidelines for the � To provide standards and guidelines for the conduct of clinical research conduct of clinical research � Good Clinical Practice = Ethics + Quality Data � Good Clinical Practice = Ethics + Quality Data 6 6
What are the foundations for the What are the foundations for the ethical conduct of clinical research? ethical conduct of clinical research? � The Nuremberg Code (1947) � The Nuremberg Code (1947) � The Declaration of Helsinki (1964) � The Declaration of Helsinki (1964) � The Belmont Report (1979) � The Belmont Report (1979) � International Conference on Harmonisation � International Conference on Harmonisation (ICH-GCP) (ICH-GCP) � International Standards Organization 14155 � International Standards Organization 14155 � Code of Federal Regulations � Code of Federal Regulations 7 7
GCP: A Historical Perspective GCP: A Historical Perspective � Nuremberg Code � Nuremberg Code (1947) (1947) – Voluntary – Voluntary participation participation – Informed Consent – Informed Consent – Minimization of risk – Minimization of risk 8 8
GCP: A Historical Perspective GCP: A Historical Perspective � Declaration of � Declaration of Helsinki (1964) Helsinki (1964) – Well-being of subject – Well-being of subject takes precedence takes precedence – Respect for persons – Respect for persons – Protection of – Protection of subjects health and subjects health and rights rights – Special protection for – Special protection for vulnerable vulnerable populations populations 9 9
GCP: A Historical Perspective GCP: A Historical Perspective � Belmont Report � Belmont Report Ethical Principles Ethical Principles (1979) (1979) – Respect for Persons – Respect for Persons • Informed consent • Informed consent • Protection of • Protection of vulnerable vulnerable populations populations – Beneficence – Beneficence • Non-malfeasance • Non-malfeasance – Justice – Justice • Fairness • Fairness 10 10
The International Conference on The International Conference on Harmonisation (ICH-GCP) Harmonisation (ICH-GCP) � GCP is an international quality standard that is � GCP is an international quality standard that is provided by the International Conference on provided by the International Conference on Harmonisation (ICH) Harmonisation (ICH) � Goals: Harmonize technical procedures and � Goals: Harmonize technical procedures and standards; improve quality; speed time to market standards; improve quality; speed time to market � In 1997, the FDA endorsed the GCP Guidelines � In 1997, the FDA endorsed the GCP Guidelines developed by ICH developed by ICH � ICH guidelines have been adopted into law in several � ICH guidelines have been adopted into law in several countries, but used as guidance for the FDA in the countries, but used as guidance for the FDA in the form of GCP form of GCP 11 11
What are the 13 principles of ICH-GCP? What are the 13 principles of ICH-GCP? � Ethics: � Ethics: 1. Ethical conduct of clinical trials 1. Ethical conduct of clinical trials 2. Benefits justify risks 2. Benefits justify risks 3. Rights, safety, and well-being of subjects prevail 3. Rights, safety, and well-being of subjects prevail � Protocol and science: � Protocol and science: 4. Nonclinical and clinical information supports the trial 4. Nonclinical and clinical information supports the trial 5. Compliance with a scientifically sound, detailed 5. Compliance with a scientifically sound, detailed protocol protocol 12 12
What are the 13 principles of ICH-GCP? (cont.) What are the 13 principles of ICH-GCP? (cont.) � Responsibilities: � Responsibilities: 6. IRB/IEC approval prior to initiation 6. IRB/IEC approval prior to initiation 7. Medical care/decisions by qualified physician 7. Medical care/decisions by qualified physician 8. Each individual is qualified (education, 8. Each individual is qualified (education, training, experience) to perform his/her tasks training, experience) to perform his/her tasks � Informed Consent: � Informed Consent: 9. Freely given from every subject prior to 9. Freely given from every subject prior to participation participation 13 13
What are the 13 principles of ICH-GCP? (cont.) What are the 13 principles of ICH-GCP? (cont.) Data quality and integrity: � Data quality and integrity: � 10. Accurate reporting, interpretation, and 10. Accurate reporting, interpretation, and verification verification 11. Protects confidentiality of records 11. Protects confidentiality of records Investigational Products � Investigational Products � 12. Conform to GMP’s and used per protocol 12. Conform to GMP’s and used per protocol Quality Control/Quality Assurance � Quality Control/Quality Assurance � 13. Systems with procedures to ensure quality of 13. Systems with procedures to ensure quality of every aspect of the trial every aspect of the trial 14 14
A Comparison A Comparison ICH-GCP: ICH-GCP: DECLARATION OF HELSINKI: DECLARATION OF HELSINKI: • Broader principles e.g. • Broader principles e.g. • Ethical principles • Ethical principles ethical, scientific & ethical, scientific & e.g. ethical and scientific e.g. ethical and scientific operational for operational for designing, conducting, designing, conducting, reporting & recording reporting & recording trials trials • Focus: Physicians in • Focus: Physicians in • Focus: Drug sponsors, • Focus: Drug sponsors, research research investigators & IRB investigators & IRB • World Medical Assembly- • World Medical Assembly- • Representatives from • Representatives from International medical International medical industry and public industry and public societies societies health health • Guidance with broad • Guidance with broad • Guidance document but • Guidance document but recommendations recommendations has the effect of law has the effect of law when put into Regulation when put into Regulation 15 15
International Standards Organization International Standards Organization � ISO 14155: Clinical Investigation of � ISO 14155: Clinical Investigation of Medical Devices for Human Subjects Medical Devices for Human Subjects – Assists sponsors, monitors, and clinical – Assists sponsors, monitors, and clinical investigators in the design and conduct of investigators in the design and conduct of device clinical investigations device clinical investigations – Assists regulatory bodies and ethics – Assists regulatory bodies and ethics committees in their roles of reviewing committees in their roles of reviewing clinical investigational plans clinical investigational plans 16 16
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