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Preclinical Pharmacology and toxicology Biochemical and animal studies Phase I Basic human pharmacology Open/uncontrolled Phase II Efficacy in disease(s) Controlled trials/smallrandomised controlled trials Phase III Efficacy and comparative efficacy(for regulatory approval) Randomised controlled trialsPhase IV Problems in clinical practice/ comparison with other drugsObservational studies/ randomised controlled trialsTable 12.1 Phases of drug developmentand/or controlled, but these are rarely used in drug development studies; see the following text).
R Peto (Tue,) studied this question.