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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

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