Transcript Good Clinical Practice (GCP)

Good Clinical Practice
GCP overview
Research for Better Health
Outcomes - Workshop
March 9, 2011
Content
• Historical perspective
• Origins of ICH / GCP
• Principles of GCP
• Informed consent
Historical Perspective
• Nuremberg Code (1948)
• Kefauver-Harris Amendment (1962)
• Declaration of Helsinki (1964)
• International Conference on Harmonization (ICH)
– (1990’s)
Principles of ICH
• Aim
To increase international harmonisation, ensuring good
quality, safe and effective medicines are developed and
registered in a cost effective manner, prevention unnecessary
trials & minimising use of animals
• Guidelines
Quality, Safety, efficacy, multi-disciplinary regulatory
communications
• x12 Efficacy topics
– including E6: GCP
(http://www.ich.org/cache/compo/475-272-1.html)
ICH definition - GCP
"A standard for the design, conduct, performance,
monitoring, auditing, recording, analyses, and
reporting of clinical trials that provides
assurance that the data and reported results are
credible and accurate, and that the rights,
integrity, and confidentiality of trial subjects are
protected"
ICH E6 1.24
Good Clinical Practice - GCP
• What is GCP?
– International ethical and scientific quality standards for
designing, conducting, recording and reporting trials
that involve participation of human subjects
• Why is it needed?
– To ensure that the RIGHTS, SAFETY and WELLBEING of
the trial subjects are protected
– Ensure the CREDIBILITY of clinical trial data
• Why has it developed into formal guidelines?
– Public disasters, serious fraud and abuse of human rights
ICH/GCP in New Zealand
• NZ regulatory framework based on Europe’s system
• NZ adopts majority of European ICH/GCP guidelines
• Country specific requirements to be taken into
account (i.e. MEDSAFE, S.C.O.T.T., EC regulations)
• New guideline Clinical trials - regulatory approval
and good clinical practice requirements
• Comes into effect on 1 January, 2011
http://www.medsafe.govt.nz/hot/Consultation/GCRPGudideline.asp
Informed Consent
• A process by which a subject voluntarily confirms
his/her willingness to participate in a trial having
been informed of all aspects of the trial
• Informed consent is documented by means of a
written, signed and dated informed consent form
Informed Consent
• Process of information exchange
• Who’s responsibility
• Consent Process:
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Capacity to receive information
Sufficient time
Without coercion
Benefits (procedures/treatments)
Risks
Proxy consent
Witness for oral consent