presentation on good clinical practice

1. Presented by:
Kabir Ahmad

2. Contents
 Foundation of GCP
 Event and Tragedies
 What does ICH stands for?
 What is ICH?
 Purpose of ICH
 Need to Harmonize
 When did it begin
 ICH structure
 ICH topics
 Good Clinical practice
 Principles of ICH-GCP
 Conclusion
 Reference

3. Foundation of GCPDevelopment of Good Clinical Practice historically has been reactive to
events or tragedies.

4. Event And Tragidies
- Nuremberg trials (1945-1946)- Nuremberg code ( 1947)
- Thalidomide Tragedy (1957-61)- The Kefauver Harris Amendment
(1962)
- Declaration of Helsinki (1964)
- Tuskegee Syphilis Study (1932-71)- Belmont Report (1979)

5. What does ICH stands for?
- The ICH stands for “ International Conference on Harmonisation of
technical requirements for registration of pharmaceuticals for human
use”.

6. What is ICH ?
 ICH is a joint initiative involving both regulators and research based
industry representative of the Europian Union, Japan and the USA in
scientific and technical discussions of the testing procedures required
to assess and ensure the safety,quality and efficacy of medicines.

7. Purpose of ICH
 Harmonization of technical requirements
 Ensure safety, efficacy and quality of medicines
 Prevent duplication of clinical trials in humans
 Minimize the use of animal testing without compromising safety and
effectiveness

8. Need to Harmonize?
 industry become global
 Duplicate test procedures
- Time consuming
- Expensive
 Increasing R&D costs
 Meeting public demand

9. When did it begin?
 1st conference in 1990 in Brussels
3 regions participated
Industry
Academia
. Representative from
Ministry of Health

10. ICH Structure
Region Regulatory Body Research Based
Industry
Japan MHLW JPMA
Europe EU EFPIA
U.S FDA PhRMA

11. Observer
 WHO
 Europian free trade association (EFTA)
 Canada
 IFPMA ( International federation of pharmaceutical manufactures
association) representative

12. ICH Topics
S- Safety ( 24 guidelines)- related to the chemical & pharmaceutical
quality assurance
E- Efficacy (15 guidelines)- related to pre clinical studies
Q- Quality (18 guidelines)- related to clinical research in
human subject
M- Multidisciplinary (5 guidelines)- i.e Medical Terminology
(MedDRA)

13. Safety Topics
. S1; Carcinogenicity
. S2; Genotoxicity
. S3; Kinetics
. S4; Toxicity testing
. S5; Reproductive toxicity
.S6; Biotech safety
. S7; Pharmacology
. S8; Immunotoxicology

14. Efficacy Topics
 E1; Clinical Safety E9; Statistical principels
 E2; Clinical Safety E10; Choice of control group
 E3; Study Report E11; Pediatric studies
 E4; Dose Response E12;Therapeutic evaluations
 E5; Ethnic factor E14; QT/QTc prolongation
 E6; GCP E15; Pharmacogenomics
 E7; Special populations
 E8; General Consideration

15. Multidisciplinary
 M1; MedDRA
 M2; Electronic Standards
 M3; Timining of preclinical studies
 M4; CTD
 M5; Drug Dictionaries

16. Good Clinical Practice- E6
 Applies to clinical data intended to be submitted to regulatory
authorities
 Also applies to clinical interventions and obervational studies
Purpose
 Protect the rights of the research subjects (volunteers or patients)
 To ensure credibility of the data

17. Why GCP
 GCP guidelines carry the authority of Law
 GCP guidelines are endorsed and followed by the regulators
 Requirement as per newly amended ‘ Schedule Y’ (2005)
 Compliance with the GCP standard provides public assurance that
rights,well-being, and confidentiality of clinical participants are
observed and consistently protected

18. The End Product of Clinical
Research
Protocol
Data
Collection
Data
Management
Data Analysis Study Report

19. Introduction
1. Glossary
2. The principles of ICH-GCP
3. Institutional review board/Independent ethics committee
4. Investigator
5. Sponsor
6. Clinical trial protocol and protocol amendment
7. Investigator’s brochure
8. Essential documents for the conduct of a clinical trial

20. 13 Principles of ICH-GCP
1- Clinical trials should be conducted in accordance with the ethical principles
that have their origin in the Declaration of Helsinki, and that are consistent
with GCP and the applicable regulatory requirement(s).
2- Before a trial is initiated,foreseeable risk and inconveniences should be
weighted against the anticipated benefits for the individual trial subject and
society. A trial should be initiated and continued only if the anticipated
benefits justify the risks.
3- the rights,safety and well being of the trial subjects are the most important
considerations and should prevail over interests of science and society.
4- The available non clinical and clinical information on an investigational
product should be adequate to support the proposed clinical trial.

21. Continuing..
5- Clinical trials should be scientifically sound , and described in a clear,
detailed protocol.
6- A trial should be conducted in compliance with the protocol that has
received prior Institutional review board(IRB)/independent ethics
committee(IEC) approval/favourable opinion.
7- The medical care given to, and medical decisions made on behalf of,
subjects should always be the responsibility of a qualified physician or,
when appropriate, of a qualified dentist.
8- Each individual involved in conducting a trial should be qualified by
education, training and experience to perform his or her respective tasks.
9- Freely given informed consent should be obtained from every subject prior
to clinical trial participation.

22. 10- All clinical trial information should be recorded,handled, and stored in a
way that allows its accurate reporting, interpretation and verification
11- The confidentiality of records that could identify subjects should be
protected, respecting the privacy and confidentiality rules in accordance
with the applicable regulatory requirement(s).
12- Investigational products should be manufactured, handled, and stored in
accordance with applicable good manufacture practice (GMP). They
should be used in accordance with the approved protocol.
13- Systems with procedures that assure the quality of every subject of the
trial should be implemented.
Continued..

23. Conclusion
The importance of GCP lies in the question ‘ why’ and ‘how’ GCP trials
came about. To know the answer to this, we have to look to the
historical background that led to the formulation of GCP guidelines in
the U.S and Europe and also to the formation of ICH.The events that
led up to the culmination of the ICH-GCP guidelines brought forth
public awareness that there was a need to control and regulate clinical
trials dealing with drugs and human subjects.The violation of human
rights played a large role in the evolution of ICH-GCP. The ICH_GCP
guidelines have become a global law which safeguards humanity as we
know today.

24. Reference
 www.ich.org
 http://illingworthresearch.com
 http://en.m.wikipedia.org
 www.ncbi.nlm.nih