Clinical research determines the safety and effectiveness of medications, devices, and diagnostic products by conducting trials in human subjects. There are four phases of clinical trials. Phase I trials involve a small group of healthy volunteers to evaluate safety and dosing. Phase II trials provide preliminary efficacy data and further evaluate safety in patients. Phase III trials confirm efficacy and monitor safety in a large patient population across multiple clinical sites. Phase IV trials study a drug's risks and benefits after marketing approval in an even larger population. The overall goal is to provide evidence for regulatory approval and optimize treatment of diseases.

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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