Clinical trials for new drugs involve 4 phases - Phase I studies assess safety with small groups of healthy volunteers. Phase II explores effectiveness in hundreds of patients. Phase III tests efficacy versus standard treatments in thousands of patients. Phase IV monitors long-term safety after market approval. The document provides a brief overview of the basic concepts in clinical research phases for healthcare professionals.

1. Basic Concepts in Small Doses
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Weam Banjar; BDS., MS.

2. Disclosure
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None
Basic concepts in small doses highlights basic
concepts in research particularly in areas of concerns
for health care professionals
Banjar WM

3. Phases of Clinical Trial
Banjar WM

4. Phase I
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New investigational drug
Sample size: small ( ~ 50-100)
Healthy volunteer
Objective: assess safety, determine safe dose range,
identify adverse events
Banjar WM

5. Phase II
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Controlled clinical trial
Sample size: several hundreds
Objective: assess effectiveness and further assess
safety
Banjar WM

6. Phase III
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Randomized clinical trial
Sample size: several thousands
Objective: assess effectiveness, monitor side effects,
compare efficacy to current standard of care
Banjar WM

7. Phase IV
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Post-marketing surveillance
Collect information on long term effect of marketed drug
Banjar WM

8. Good Luck
Banjar WM