Basic Concepts in Small Doses

6

Weam Banjar; BDS., MS.

Disclosure

• None

• Basic concepts in small doses highlights basic

concepts in research particularly in areas of concerns

for health care professionals

Banjar WM

Phases of Clinical Trial

Banjar WM

Phase I

• New investigational drug

• Sample size: small ( ~ 50-100)

• Healthy volunteer

• Objective: assess safety, determine safe dose range,

identify adverse events

Banjar WM

Phase II

• Controlled clinical trial

• Sample size: several hundreds

• Objective: assess effectiveness and further assess

safety

Banjar WM

Phase III

• Randomized clinical trial

• Sample size: several thousands

• Objective: assess effectiveness, monitor side effects,

compare efficacy to current standard of care

Banjar WM

Phase IV

Banjar WM

• Post-marketing surveillance

• Collect information on long term effect of marketed drug

Good Luck

Banjar WM