GCP Rocks!
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GCP Rocks! Dr Alison Richardson, B.A (Hons), M.Phil., Ph.D. Head of Medical Writing www.mediscribe.net [email protected] www.mediscribe.net 1
Transcript of GCP Rocks!
GCP Rocks!
Dr Alison Richardson, B.A (Hons), M.Phil., Ph.D.
Head of Medical Writing
www.mediscribe.net
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What caused Good Clinical Practice (GCP) to be needed?
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1945 WWIIWar Crime
TrialsBirth of the Neuremberg
Code
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u Over the years there have been many documented cases where people have suffered as a direct result of medical intervention
u WWII atrocities result in:The Nuremberg Code
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The Nuremberg Code
A Set of 10 Ethical Principles
for Experimentation
on Humans
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10 Principles1. Voluntary Consent
2. Benefit Society
3. Based on animal experimentation
4. Avoid unnecessary physical or mental suffering
5. No prior knowledge that death or disabling injury may occur
6. Degree of risk should never exceed the humanitarian importance
7. Adequate facilities and protection provided
8. Conducted only by scientifically qualifiedpersons
9. The human subject should be at liberty to withdraw at any time
10. The scientist in charge must terminate the experiment at any stage, if they have probable cause to believe a continuation of the experiment is likely to result in injury, disability or death
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Isn’t that enough?
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Unfortunately not!
u Over the years there have been a multitude of examples where The Nuremberg Code has been breached both intentionally and non-intentionally
u This has resulted in more recommendations and guidelines further defining the ethical principles which MUST be followed in human experiments 7
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So what exactly is GCP then?
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GCP is not just one document
It is a compilation of many thoughts, ideas and learnings spanning the entire world
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Declaration of Helsinki
Common Rule
Belmont Report
Word Health Organization
(WHO) Guidelines for GCP
International Conference on Harmonization
ICH GCP
FDA GCP
13 Overarching Principles of GCP1. Conducted in accordance with ethical principles
2. Initiated and continued only if the anticipated benefits justify the foreseeable risks
3. Subject’s rights, safety and well-being should prevail overinterests of science and society
4. Supported by adequate non-clinical and clinical information
5. Scientifically sound, and described in a clear, detailedprotocol
6. Conducted in compliance with the protocol, previouslyapproved by an ethical committee
7. Medical decisions and care should always be theresponsibility of a qualified physician
8. All study staff should be qualified by education, training and experience
9. Prior to participation, all study subjects should freely give informed consent to participate
10. Information should be recorded, handled and stored in a waythat allows its accurate reporting, interpretation and verification.
11. Confidentiality of subjects’ identity should be protected
12. Investigational products should be manufactured, handled, and stored in accordance with applicable good manufacturing practice and the protocol
13. Quality assurance of the trial should be implemented
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Key Stakeholders – Is the Experiment Ethical?
EVERYONE INVOLVED
Ethical Committees
Sponsors
Site Staff
Investigators
Patients and
Families
Regulatory Authorities
Clinical Research
Organisations(CROs)
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GCP is an Ever-Evolving Art
u GCP became law in the EU in 2001
u Each country developed and implemented their local guidelines
u There are new updates incorporated as new information is brought to light
u For example… 12
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Northwick Park HospitalLondon
2006Very experienced Phase I Unit
Drug – TGN1412
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Dear Diary - 13 March 2006
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“The men went down like dominoes. They began tearing their shirts off complaining of fever, then some screamed that their heads were going to explode. After that they started fainting, vomiting and writhing around in their
beds. All of them suffered multiple organ failure”
Today, 6 healthy male volunteers received an
experimental drug
Within minutes the men became violently ill
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But GCP had been followed
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All 6 men survived but with damaged immune systems, removal of feet and
fingers in some cases, and a completely uncertain future
Clearly further regulations to protect
human safety were needed
After investigation, an extra 22
recommendations have been introduced in early-stage clinical
trials
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If you would like a copy of the full slide deck, or the production of
other training materials, then please contact us
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