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7/27/2019 Lecture Slides-cvt Lec0b Charron Coursera
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Vaccine Trials in the Context of Ethical and
Regulatory Guidelines
Amber Bickford Cox, MPHJohns Hopkins University
Copyright © 2012 Johns Hopkins University. All Rights Reserved.
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Vaccine Development Process
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Good Clinical Practice (GCP)
A standard for the design, conduct, performance,
monitoring, auditing, recording, analysis and reporting of
clinical trials
Assures
- Credibility and accuracy of data and reported results
- Protection of the rights, integrity, and condentiality of volunteers
ICH GCP 1.24
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Good Laboratory Practice (GLP)
Embodies a set of principles that provides a framework within
which laboratory studies are planned, performed,
monitored, recorded, reported, and archived
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Good Manufacturing Practice (GMP)
The part of quality assurance which ensures that products are
consistently produced and controlled to quality standards
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Why …
Use clinical trials to develop vaccines?
Follow regulations?
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Purpose of the Clinical Trial
Hallmark of the scientic method
Basic question
- Is the response or outcome diff erent dependent on the
presence or absence of an intervention (i.e., drug,
program, vaccine)?
In the overall scheme, saves lives, time, and money
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Why Were Research Standards Needed?
U.S. (1930s)
- Tragedy in formulation of a children’s syrup
Japan (1950s)
- Registration of all medicinal products for sale
Germany (1940s)
- Doctors’ Trial (Nuremberg Trials) Europe (1960s)
- Thalidomide tragedy
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Protection of the Clinical Trial Volunteer
Entrusted with human lives
Nuremberg Code (1947)
Declaration of Helsinki (1964)
Regulatory and Ethical Guidelines: Good Clinical Practice
“In medical research on human
subjects, considerations related to the
well-being of the human subjectshould take precedence over the
interests of science and society .” (Helsinki A5)
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Development of U.S. Regulations
1981: U.S. adopted laws that evolved into the Code of
Federal Regulations (CFR) applies to US government funded
trials or trials evaluated through the US FDA
Specic titles applicable to clinical trials
- 45 CFR 46: ”Common Rule”
- 21 CFR 11: Electronic records- 21 CFR 17: Financial disclosure
- 21 CFR 50: Informed consent
- 21 CFR 56: IRB Regulations
- 21 CFR 312: Investigational new drug application
- 21 CFR 314: Application for licensure
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Development of International Regulations: ICH
GCP
1990: Birth of the International Conference on
Harmonisation (ICH)
Representatives from the US, European Union and Japan
1996: ICH GCP nalized
ICH Section E6: Good Clinical Practice (GCP)
- International GCP standard- Origins in the Declaration of Helsinki
“ The rights, safety, and well-being of the trial
subjects are the most important considerationsand should prevail over interests of science andsociety.” (ICH GCP 2.3)
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Development of International Regulations
2003: the European Union (EU) made ICH guidelines into law
The World Health Organization (WHO) incorporated GLP, GCP,
GMP, and promoted their use globally
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ICH GCP Strengths
Standardized clinical trials
Adopted by many countries
Accepted by most drug companies
Faster global access to products
Multi-country acceptance of products
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Limitations
Insufficient representation from other regions outside of the
EU, Japan, and United States
Eff ectiveness compromised in many countries
- No regulatory agencies in place to enforce
- Guidelines adopted “as is”
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Practical Applications
How is GCP practically applied in the
context of a vaccine trial?
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GCP Affects all Aspects of Clinical Trials