The presentation introduces clinical trials and its phases in a brief manner.

1. Introduction to
Clinical Research
Dr. Rajendra Dhande

2. What is Clinical Research?
• Branch of healthcare science
• Determines the safety and effectiveness (efficacy)
• Evaluate medication, devices and diagnostic
products
• Conducted in humans at clinical setups
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3. Types of Clinical Research
• Treatment Research
• Prevention Research
• Screening Research
• Quality of Life Research
• Genetic studies
• Epidemiological studies
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4. Phases of Clinical Trials
Safety
Phase I
n=20-80
Safety and
Efficacy
Phase III
n=300-3000
Post
Approval
Surveillance
Phase IV
n >10000
Safety and
Dosing
Phase II
n=100-300
Drug submitted
for FDA approval
Drug approved for
testing in human
F
D
A
R
e
v
i
e
w
Drug
approved
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5. Phases of Clinical Trials: Phase I
• First time NCE administered in human
• Conducted in healthy volunteers
• Included small group of volunteers
• Primary objective is safety and kinetics
• Safe dose and adverse effect identified
• Many NCEs/ molecules evaluated
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6. Phases of Clinical Trials: Phase II
• Efficacy tested in diseased subjects (patients)
• Large number of subjects included
• Number of NCEs are limited
• Further evaluation of safety
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7. Phases of Clinical Trials: Phase III
• Confirmation of efficacy and safety
• Treatment administered in large population
• Compared the effect and side effect
• This phase is multi-centric trial
• Various ethnic groups are studied
• Special population studies are conducted
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8. Phases of Clinical Trials: Phase IV
• Post-marketing studies
• Conducted after drug approved for use
• Provide additional information about drug
• Risks/ benefits studied in huge population
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9. Thanking you…
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