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Clinical trial: phases
Clinical trial: phases
Clinical trials are commonly classified into 4 phases;| Phase | Goal | Notes |
|---|---|---|
| 0 | Exploratory studies | Involves a very small number of participants and aim to assess how a drug behaves in the human body. Used to assess pharmacokinetics and pharmacodynamics. Phase 0 trials help in determining whether it is feasible to move on to further phases. |
| I | Safety assessment | Determines side-effects prior to larger studies. Conducted on healthy volunteers |
| II | Assess efficacy | Involves small number of patients affected by particular disease May be subdivided into
|
| III | Assess effectiveness | Typically involves 100-1000's of people, often as part of a randomised controlled trial, comparing new treatment with established treatments |
| IV | Postmarketing surveillance | Monitors for long-term effectiveness and side-effects |
+PassMedicine Notes
Clinical trials are commonly classified into 4 phases;
Phase _ Goal _ Notes | 0 _ Exploratory studies _ Involves a very small number of participants and aim to assess how a drug behaves in the human body. Used to assess pharmacokinetics and pharmacodynamics. Phase 0 trials help in determining whether it is feasible to move on to further phases. | I _ Safety assessment _Determines side-effects prior to larger studies. Conducted on healthy volunteers| II _ Assess efficacy _ Involves small number of patients affected by particular disease May be subdivided into- IIa - assesses optimal dosing
- IIb - assesses efficacy |