Skip to main content
. 2016 May;4(9):181. doi: 10.21037/atm.2016.04.10

Table 1. Classification of clinical trials.

Stage Primary goal No. of subjects
Preclinical Analysis in non-human subjects, to preliminary evaluate efficacy, toxicity and pharmacokinetics –
Phase 0 Preliminary evaluation of efficacy, effectiveness and safety in healthy volunteers 10–20
Phase I Preliminary evaluation of efficacy, effectiveness and safety in healthy volunteers 20–100
Phase II Evaluation of efficacy, effectiveness and safety in patients 100–300
Phase III Evaluation of efficacy, effectiveness and safety in patients >300
Phase IV Postmarketing surveillance All subjects