International Conference of Harmonization Good Clinical Practice ICH GCP

1. ICH-GCP
Tamer Hifnawy. MD. Dr (PH)
Associate Professor of Public health
Faculty of Medicine, Beni Suef
University, Egypt
College of Dentistry, Taibah University, KSA
Acting Vice Dean for Quality and Development
Certified Trainer in International Research
Ethics

2.  Research is a systematic investigation
designed to discover or contribute to a
body of generalisable knowledge.
What is research?

3. It is important at this point to draw the
line between “research” and
“practice”.

6. ONE
WEEK
LATER

8. The Brilliant Idea
GCP

9. Good
Cooking
Practice
GCP

10. GCP, Our Story

11. Good Clinical Practice
 An international ethical and scientific
quality standard for
designing, conducting, recording and
reporting trials that involve the
participation of human subjects.
 Clinical Data are credible.=
 the Rights, Safety and well-being of
Trial Subjects are Protected=
Quality Data
Ethics
Quality Data + Ethics = GCP

12. Can GCP be trained?
Knowledge transfer through Involvement
ICH GCP
Benjamin Franklin: Father of the Bifocal

13. GCP involve from first to last
 Clinical Trial process is
like
building a bridge
 We can’t afford to
deviate
from ICH-GCP

14. Design
Conduct
Performance
Monitoring
Auditing
Analysis
Reporting
What does GCP Cover?

15. Course 4 Introduction to
ICH-GCP Slide no 15
30
Jan
201
0
What is GCP?

16. ICH GCP
The History & Development
1536 Ambroise Paré , Wound healing
1747 James Lind , Scurvy treatment
( Perhaps the first ever clinical trial was James Lin’s demonstration that
citrus fruits cure scurvy .He compared the effects of various different acidic
substances, ranging from vinegar to cider, on groups of afflicted
sailors, and found that the group who were given oranges and lemons had
largely recovered from scurvy after 6 days.)
1894 Placebo control
1931 Flip of a coin randomisation

17. ICH GCP
The History & Development
The Disasters
1937 100 patients died, due to diethylene in sulpha
preparation
1950 Aplastic anaemia on Chloramphenicol
1961 Softenon (thalidomide) catastrophe in Europe
March 2006 The drug TGN1412 caused catastrophic
systemic failures in the subjects during its first
human clinical trials (phase I). Following this, an
Expert Group on Phase in One Clinical Trials
published a report.

18. ICH – GCP : Evolution
1980s - EC
◦ Pioneered harmonization of regulatory requirements
◦ Develop single market for medicinal products
◦ Demonstrated feasibility of harmonization
1989, Paris - WHO Conference of Drug Regulatory Authorities
◦ IFPMA – discuss joint regulatory-industry initiative
◦ ICH conceived
Apr, 1990, Brussels – EFPIA
◦ Birth of ICH
◦ ICH Steering Committee established

19. Need to Harmonize
 Awareness on critical evaluation of medicinal products
 Medical tragedies
 1960-70: rapid increase in laws, regulations & guidelines on
medicinal products
 Widening market opportunities for Pharma industry
 Duplication of work
 Raising cost of health care
 Timely Access of Patients to Safe & Effective “New Drugs”
 Need to meet public expectation

20. ICH GCP
1990/91 Guidelines on GCP in Europe
1996 ICH GCP conference
1997 All clinical trials in Europe must
comply to the ICH /GCP guidelines

21. The Objectives of ICH GCP
Main goals
Protect the patient
To provide a unified standard for the European Union (EU), Japan &
United States to facilitate mutual acceptance of clinical data by the
authorities in these jurisdictions
Facilitate the mutual acceptance of clinical data across ICH GCP
regions
Avoid trial duplication (saving time, money, resource)
Facilitate global submissions through mutual acceptance of data
Technical requirements for medicinal products containing new drugs

22. ICH- GCP

23. ICH Born
 April 1990 Brussels meeting European
Federation of Pharmaceutical Industries
Association (EFPIA)
 Representatives of regulatory agencies and
industry form EU, Japan, and USA

24. ICH – Aim
 The International Conference on Harmonization (ICH) is a joint
initiative involving both regulators and industry in the scientific
and technical discussions of procedures which are required
to ensure and assess the safety, quality and efficacy of
medicines.
 The focus of ICH has been on the technical requirements for
medicinal products containing new drugs.
 Scope on registrations in the 3 regions.
 One single Marketing Authorisation Application worldwide.

25. What and Who does GCP apply to?
GCP applies to clinical trials in humans for drugs, biologicals
and devices
GCP applies to every one and anyone involved in the
conduct of a clinical trial
- Sponsors
- Research site staff
- IRB/ ethics committees
- CROs
- Patients

26. Structure of ICH - Parties
Participants
Six Parties: EU, EFPIA, FDA,MHLW, JPMA, PhRMA
Three Observers: WHO, EFTA “European Free Trade Association”, Canada
 European Commission - European Union (EU)
 European Federation of Pharmaceutical Industries and
Associations (EFPIA)
 US Food and Drug Administration (FDA)
 Ministry of Health, Labor and Welfare, Japan (MHLW)
 Japan Pharmaceutical Manufacturers Association (JPMA)
 Pharmaceutical Research and Manufacturers of America
(PhRMA)

27. Definition of GCP
(Good Clinical Practice)
Definition of ICH-GCP
“ICH GCP is an international ethical and scientific quality
standard for designing, conducting, recording and reporting
trials that involve the participation of human subjects .
Compliance with this standard provides public assurance that
the rights , safety and well being of the trial subjects are
protected, consistent with the principles that have their origin
in the Declaration of Helsinki and that the clinical trial data are
credible”
A standard for the
design, conduct, performance, monitoring, auditing, recording,
analysis, and reporting of clinical trials that provides
assurances that the data and reported results are credible and
accurate and that the rights, integrity, and confidentiality of
trial subjects are protected. ”

28. Declaration of Helsinki - 1964
Developed to guide physicians in biochemical research
involving human subjects
Requires:
 All physicians to conform to accepted scientific principles
 A research protocol to be reviewed by an independent
committee
 Research performed by “clinically competent person”
 Objective proportional to risk
 Rights of patients protected
 Participants to be fully informed, and to consent to take part

30. Copyright 2007 ACRP 30
E6: Good Clinical Practice
 Guideline is one of the major
achievements of ICH
 Led to regulatory changes in the 3
regions

31. Principals of ICH GCP
 Before the trial is initiated
◦ Risk Vs. Benefit
◦ Right; Safety and well being of trial
subjects
◦ Clear and scientific protocol
◦ Trials should have REC approval
◦ Medical care is the responsibility of a
qualified Physician.
◦ Research Physicians should be qualified

32. Principals of ICH GCP
 During the trial
◦ Patients should freely give their Consent
◦ Appropriate and careful recording and
storage of trial information.
◦ Confidentiality
◦ GMP
◦ Applicable Systems and procedures

33. 30 Jan 2010
13 Principles of GCP

35. 13 Principles of GCP
( A set of standard principles for the initiation and conduct of clinical trials)
Clinical trials should be conducted in accordance with ethical
principles and applicable regulatory requirements
Risk versus benefits should be assessed
Rights, Safety and the well being of the trial subjects are the
most important considerations
Preclinical and clinical information on an investigational
product should support the proposed clinical trial
Clinical trials should be scientifically sound and described in a
clearly detailed protocol

36. 13 Principles of GCP
( A set of standard principles for the initiation and conduct of clinical trials)
A trial should be conducted in compliance with the approved protocol
Qualified Physician Is Responsible for medical care and medical
decisions made on behalf of subjects
Each individual involved in conducting a clinical trial should be
qualified by education, training, and experience to perform his/her
respective tasks
Freely given, informed consent should be obtained from every subject
prior to clinical trial participation
All clinical trial information should be recorded, handled, and stored in
a way that allows its accurate reporting, interpretation, and verification

37. 13 Principles of GCP
( A set of standard principles for the initiation and conduct of clinical trials)
Confidentiality of records that could identify subjects should be protected
Investigational products should be manufactured, handled, and stored in
accordance with applicable Good Manufacturing Practices
Systems and procedures that ensure the quality of every aspect of the trial
should be implemented, which is generally the responsibility of the
sponsor

38. Efficacy Guidelines
(Important guidelines)
E 1: Exposure – to assess clinical safety
E 2: Clinical Safety Data Management
E 3: Study Reports
E 6: Good Clinical Practice (GCP)
E 8: Clinical Trials Design

39. Present as well as future
 It is the protection for today and
tomorrow

40. Essence of ICH-GCP guideline in Clinical Trial
 What will happen if
trial is not conducted
with ICH-GCP
guideline?

41. 5/12/2014 Prof. Maha Hegazi, Alex. Univeristy 41