What are the phases in clinical data management ? Explain each phase in detail ?

Question

Accepted Answer

Four phases in a clinical trials
Phase-0:-introduce very small drug dose in to limited number of healthy volunteers
Sample size:-10-15
This is a microdosing phase
Phase-1:- safety is primary aim secondary aim is Tolerability
Pharmacokinetic and pharmacodynamic drug dose
Phase-1A:- single ascending dose
Phase-1B:- multiple ascending dose
Sample size:- 20 to 100
Alternatively name:-Dose escalation studies
Phase-2:-efficacy is primary aim, safety is secondary aim
Sample size:-20 to 300
Alternative name :- Therapeutic exploratory studies
Phase-3:-efficacy of the drug against large number of patient
Sample size:-300 to 3000
Alternative name:- multicentric trials
Phase-4:-involve safety survivaliance.Determine behavior of drug in real life situations
Sample size :- thousands of subjects

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