Good Clinical PracticeGood Clinical PracticeGCP overviewGCP 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:– Capacity to receive information– Sufficient time– Without coercion– Benefits (procedures/treatments)– Risks– Proxy consent– Witness for oral consent