History and Principles of Good Clinical Practice
History and Principles of Good Clinical Practice
History and Principles of Good Clinical Practice
GCP:
Good Clinical Practices
History of GCP
Background
• Need for safe and efficacious products for various health
problems
• Drug development is expensive and time consuming
• Need for efficient quality systems
• Global drug market
• Existence of national laws and regulations for drug
development
History of GCP
Purpose
• To harmonize the regulations and guidelines for
drug development
Participants
• Regulatory agency/industry representatives from
Europe, Japan and US
Organization
n Europe
pa
United States
Ja
1978 USA – The FDA GCP established 2005 EU – “The GCP Directive”
1986 UK – The ABPI Guidelines issued 2005 WHO - Handbook for GCP Guidance
for implementation
1989 Nordic – GCP Guidelines established
Declaration of Helsinki * – Principles
• Research must conform to scientific principles
• Protocol and independent ethics committees
• Supervision and conduct of trial by suitably
qualified persons
• Objectives and possible benefits balanced against
risk to subjects
• Privacy respected and minimal physical and mental
impact
on the subject
• Informed consent * (1996, 2000, 2002 and 2004)
ICH GCP
• “International Conference on Harmonisation of Technical
Requirements for Registration of Pharmaceuticals for Human
Use”
• Tripartite: USA, EU and Japan
(plus Australia, Canada, the Nordic countries & WHO)
• The Good Clinical Practice guideline is Topic E6
• Adopted:
– 17 January, 1997 in the EU (guideline, as CPMP / ICH /
135/95)
– 1 April, 1997 in Japan (law)
– 9 May, 1997 in the USA (guideline, in the federal register)
Good Clinical Practice (GCP)
An international ethical and scientific quality standard for
designing, conducting, recording, and reporting trials that
involve the participation of human subjects
Public assurance that the rights, safety, and well-being of
trial subjects are protected
• Results in credible data
• Consistent with the Declaration of Helsinki
Objectives of ICH GCP
• Provide a unified standard for Europe, Japan, US
• To facilitate the mutual acceptance of clinical data
• Developed in accordance with existing standards in US,
Europe, Japan Australia, Canada, Nordic countries and
WHO
ICH GCP PRINCIPLES
• Conduct trials according to GCP
• Weigh risks vs benefits
• Protect the subjects
• Have adequate information to justify trial
• Write a sound protocol
• Receive IRB/IEC approval
• Use qualified physicians
ICH GCP PRINCIPLES
• Use qualified support staff
• Obtain informed consent
• Record information appropriately
• Protect confidentiality
• Handle investigational products appropriately
• Implement quality systems
GCP Design Standards
• Written protocol
• Investigator brochure
• Scientific soundness
• Feasibility
• Adequate resources
• Randomization / blinding
GCP Conduct Standards
• IRB & Regulatory approval
• Compliance with protocol
• Informed consent
• Confidentiality of data
• Medical management of adverse events
• Product accountability
• Qualification & training
GCP Recording Standards
• CRF completion
• Data handling
• Security maintenance
• Audit requirements
• Product accountability
• Management of study files/essential
documents
GCP Reporting Standards
To
• Sponsors
• IRB/IEC
• Regulatory authorities
• Other investigators
• Adverse events
• Interim reviews
• Progress reports
• Final reports
• Monitoring / audit reports
Responsibilities
GCP