- Types:
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phase I, phase I clinical trial
a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained
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phase II, phase II clinical trial
a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored
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phase III, phase III clinical trial
a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA
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phase IV, phase IV clinical trial
sometimes the FDA approves a drug for general use but requires the manufacturer to continue to monitor its effects; during this phase the drug may be tried on slightly different patient populations than those studied in earlier trials
