INTRODUCTION TO

CLINICAL RESEARCH

Pharma Instinct
 “CLINICAL” means:
“Treatment of patients”

CLINICAL
RESEARCH

“RESEARCH” means:
“Systematic investigation &
study in order to establish
facts & reach new
conclusions”
 What is Clinical Research?

A systematic observational and experimental

biomedical studies performed in human subjects to
test new drugs or combination of drugs or devices
or biologics for its safety and therapeutics uses or
new approaches to surgery or radiotherapy or
procedures to improve the diagnosis of disease and
the quality life of the patient.
 Purpose of Research
Intended to increase knowledge about how well a
diagnostic test or treatment works in a particular patient
population.

To test hypothesis formulated from observations and or

intuition

Ultimately to understand better one’s world and make

“Sense of it”.
TYPES OF CLINICAL RESEARCH (TRIALS)

Based on
researchers
behave

Observational Interventional
Study Study
 Prevention trials

Compassionate use
Screening trials
trials

Based on
the purpose
Quality of life Diagnostic trials

Treatment trials
 Phases of Clinical Trial

Phase Phase Phase

0 II IV

Phase Phase
I III
 Phase 0

Also called Human Micro-

dosing studies

Small number of subjects- 10

to 15

Very small dose of medication

is given to subjects
Phase I

Provide
First stage of Establish PK and
preliminary safety
testing in humans PD profiles of the
and tolerability
subjects (20-100) drug
evaluation
 Phase II
Therapeutic Secondary
Primary objective:-
Exploratory Trial objective:- safety
Efficacy in patients
(20-300 Subjects) issues

Optimum dose
finding

Phase II A:
Phase II :- Phase II Designed to assess Phase II B:
A and Phase II B dosing Designed to study
requirements efficacy
Phase III

To establish efficacy of
Therapeutic confirmatory the drug against
trials (300-3000 subjects) existing therapy in
larger number of
patients, method of
usage etc..

Phase III B: allows

Phase III A: to get patients to continue the
Subtypes:
sufficient and treatment, label
significant data expansion, additional
safety data
 Phase IV
Also called Post Marketing Studies (PMS)

Conducted after marketing approval of drug

Involves safety surveillance

Determine behavior of drug in real life situations

Evaluate action of drug in a situation of missed dosage or

over dosage
Major players in Research team
Investigator
Clinical
Research
Associate and
Regulatory body
Clinical
Research
Coordinator

IRB/IEC Data Manager

Patients Statistician
 Regulatory bodies (Guidelines)

Drugs and New Clinical Indian

ICMR WHO ICH-GCP
cosmetics Trial Rules & GCP
guidelines guidelines guidelines
act 1940 Regulations guidelines
Co-investigator
Principal InvestigatorInvestigators
Who conducts the clinical trial?
Who Participates In The Trial

Subjects

Healthy
Human
Patients
Volunteer
s
Key documents in Clinical research

Clinical Investigator
study report s brochure

Source Study
documents protocol

Informed
Case report
consent
form
form
Why Career in Clinical Research

Fastest growing segment in the healthcare/pharmaceutical industry

Excellent opportunity to develop combination of technical and
management skill development

Wider job horizon

Higher salaries

Higher job satisfaction

Continuous training opportunities

 Types of Employers

Contract
Pharmaceutical Non-Government
Research Hospitals WHO
Companies Organization
Organization
Types of Jobs
 Clinical research coordinators
 Clinical research associate
 Clinical monitors
 Drug safety personnel
 Medical monitors
 Regulatory affairs monitors
 Quality control/assurance
 Data management personnel
 Statisticians
 Scientists
 Medical writers
 Lab personnel
 Management and support personnel
Thank You