Training on

International Conference of Harmonisation (ICH)

Good Clinical Practice (GCP)
By: Sangeet Kumar

15-Mar-15

Training on
International Conference of Harmonisation (ICH)
Good Clinical Practice (GCP)
By: Sangeet Kumar

15-Mar-15

Goals and Objectives

To understand:
The affect of Good Clinical Practices on
organizations conducting Clinical Research
To discuss:
What is ICH and What is GCP
The history of Good Clinical Practices
Objective and Basic principles
Practices and strategy for staying compliant
with Good Clinical Practices

15-Mar-15

What happens in a Clinical Trial?

The trials (remember its a trial) are conducted in 4
phases:
Phase 1 trials are for determining dosing,
document how a drug is metabolized and identify
side effects.
Phase 2 trials gather further safety data and
evidence of the drug's efficacy.
Phase 3 further tests the product's effectiveness
on a greater number of participants, and monitors
side effects.
Phase 4 trials can be conducted after a product is
already approved and on the market to find out
more about the treatment's long-term risks
15-Mar-15

What actually happens in a Clinical

Trial?
Its a fact and estimated that only 5 in 5,000
compounds that enter preclinical testing make it
to human testing, and only 1 of those 5 may be
safe and effective enough to reach pharmacy
shelves
the rights, safety,
and well So the Ensure
need
regulations
to
Ensure
rights, safety, and
being ofthe
participants

well-being
of participants
How, Who, When?
Scientific Integrity of data
How, Who, When?

15-Mar-15

History of Good Clinical Practice

Prior to an actual set of guidelines to follow for good clinical practice,
clinical studies were dangerous and could result in serous disease, or
possibly death
The Nuremburg Code of 1947
Experiments performed in Germany during WWII opened the eyes of the
world for guidance for clinical testing on humans.
The code did set ethical guidelines, but it lacked legislation to back it up.

Declaration of Helsinki
In 1964, the World Medical Association established recommendations
guiding medical doctors in biomedical research involving human subjects.
These guidelines influenced national legislation, but there was no set
standard between nations

The formation of the International Conference on Harmonization (ICH) led

to the creation of the Consolidated Guidance on GCP
The ICH consisted of the governments of the United States, EU and Japan
coming together to develop common regulations for the pharmaceutical
markets among member countries
15-Mar-15

ICH GCP Consolidated Guideline E6

Glossary
Principles of ICH GCP
Information regarding:
IRB/IEC
Investigator
Sponsor
Protocol
Investigators Brochure
Essential Documents

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15-Mar-15

Objectives of ICH guidelines

Provide a unified standard

EU; US; Japan
To facilitate mutual acceptance of clinical data
Developed in accordance with existing standards in
US, EU, Japan, Australia, Canada, Nordic Countries,
and WHO

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15-Mar-15

Good Clinical Practice Guidelines - overview

Are mainly focused on the protection of human rights in clinical

trial.
Provide assurance of the safety of the newly developed
compounds.
Provide standards on how clinical trials should be conducted.
Define the roles and responsibilities of clinical sponsors, clinical
research investigators, Clinical Research Associates, and
monitors
GCPs are generally accepted, international best practices for
conducting clinical trials and device studies
They are defined as an international ethical and scientific
standard for designing, conducting, recording and reporting
trials that involve the participation of human subjects
Compliance with GCPs provide public assurance that the
rights and safety of participants in human subject research
are protected and that the data that arises from the study is
credible
15-Mar-15

Principles of ICH GCP

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
Use qualified support staff
Obtain informed consent
Record information appropriately
Protect confidentiality
Handle investigational products appropriately
Implement quality systems
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15-Mar-15

Summary of GCP

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
requirements
Before a trial is initiated, foreseeable risks and inconveniences
should be weighed against the anticipated benefit for the individual
trial subject and society. A trial should be initiated and continued
only if the anticipated benefits justify the risks
The rights, safety, and well-being of the trial subjects are the most
important considerations and should prevail over interests of
science and society
The available non clinical and clinical information on an
investigational product should be adequate to support the proposed
clinical trial
Clinical trials should be scientifically sound, and described in a
clear, detailed protocol
A trial should be conducted in compliance with the protocol that has
received prior institutional review board (IRB)/independent ethics
committee (IEC) approval/favorable opinion
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
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Under GCP, the Regulators requires

that..

The study involves research of an unproven drug, so the

main purpose of the research should be very clear
How long the participant will be expected to participate in
the study
What will happen in the study
Possible risks/benefits to the participant
Participation is voluntary and that participants can quit the
study at any time without penalty or loss of benefits to
which they are otherwise entitled
Mission is to be compliant to
GCPs
Protocol
International and Local
regulations

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Thank you!

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