BASICS OF CLINICAL

RESEARCH

BY: DR. FATIMA AZIZ (RPH)

PROJECT MANAGER
(DIAKOB HEALTHCARE)
 CLINICAL RESEARCH

Clinical research is the comprehensive

study of the safety and effectiveness of
the most promising advances in patient
care.
Clinical research is different than
laboratory research.
 CLINICAL TRIAL

A clinical study involves research using human

volunteers (also called participants) that is
intended to add to medical knowledge
• Clinical trial is the main stay for bringing out new drugs
to the market.
• Clinical trials are carried out in four phases
• It takes approx. 10-12 years to bring one new drug to
market
 TRIAL STAKE HOLDERS

Stake holders of clinical trials includes:

1. Sponsors
2. CRO Clinical Research Organization
3. Clinical trial(Research) Site/ Investigators
4. Study subject
5. Regulatory authority
6. Ethics committee
 Clinical Research Site

A CRS facility should be clean, secure and designed to

ensure the proper conduct of the clinical trial as well as
participants safety, privacy and confidentiality
 Infrastructure Requirements
 Hazard free entrance area
 Reception area
 Informed consent area
 Adequately equipped examination room
 Rest area
 Treatment area
 Lab and pharmacy
 Power backup
 Data management area
 Space for storing trial documents i.e, Record Keeping
Room
 Emergency facilities
 Lockable cabinets, Fridge
 Well defined quality control standards
 Study Team At Clinical Trial Site

 Study team at trial site includes:

1. Investigator
2. Co-investigator
3. Study Co-ordinator
4. Doctors
5. Pharmacist
6. Nurses
 Delegation of Duties

Every individual in study team has been assigned specific duties.

 Counselling of patients
 Completion of consent form
 Data entry
 Storage, Dispensing and Availability of Drugs
 Completion of source document
 Reporting of SAE
 Logistic management
 Patients Visit Scheduling, Protocol compliance and Follow up
 Maintanance of Site Master File
 What is GCP?
GCP is an international ethical and scientific quality
standard for designing, conducting, recording and
reporting 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
 Background to ICH-GCP Guidelines

In 1960s a new drug was marketed for nausea in pregnancy in

Europe
The promotional materials described it “outstandingly safe”
The drug was marketed in 46 different countries
It was considered free from side effects with occasional nausea
Doctors reported side effects to the drug company and situation
continues for 05 years
Over 8,000 children across 46 countries were born without arms,
ears, legs , eyes or born dead
The drug was “Thalidomide”
 Why needed GCP?

Data and Reported Results are Credible and

Accurate (Quality Data)
Rights, Safety, Integrity and Confidentiality of Trial
Subjects are Protected (Ethics)

Quality Data + Ethics = GCP

 ICH-GCP

ICH-GCP (E6): Basic Structure (8 Chapters)

1. Glossary
2. The Principles of ICH-GCP
3. IRB/IEC
4. Investigator
5. Sponsor
6. Clinical Trial Protocol
7. Investigator’s Brochure
8. Essential Documents for Clinical Trial
Principles of ICH-GCP
Institutional Review Board/ Independent Ethics Committee

An independent body constituted of medical, scientific, and

non scientific members, whose responsibility is:

To ensure and safeguard rights, safety, and well being of

trial subjects especial attention to vulnerable subjects.

By reviewing, approving protocols and methods and

materials to be used in obtaining and documenting
informed consent of trial subjects.
 Main Objectives of IRB/IEC
An investigator may be able to obtain IRB review by submitting
the research proposal to
a community hospital,
a university/medical school,
an independent IRB,
a local or state government health agency or other
organizations
The IRB system was designed to foster open discussion and
debate at convened meetings of the full IRB membership for one
prime purpose
 Three Principles of Research Ethics
1. Respect People

 Protect Vulnerable people

 Minors
 Pregnant women
 Prisoners
 Mentally/Physically challenged
 Economically Challenged
2. Benefit Others

3. Justice for All

 Fair & equal balance of benefits & risks

 Fair & equal recruitment of people to participate