Sandbox gc
Summary of clinical trial phases | ||||
---|---|---|---|---|
Phase | Primary goal | Dose | Patient monitor | Typical number of participants |
Preclinical | Testing of drug in non-human subjects, to gather efficacy, toxicity and pharmacokinetic information | unrestricted | scientific researcher | not applicable (in vitro and in vivo only) |
Phase 0 | Pharmacokinetics; particularly, oral bioavailability and half-life of the drug | very small, subtherapeutic | clinical researcher | 10 people |
Phase I | Testing of drug on healthy volunteers for dose-ranging | often subtherapeutic, but with ascending doses | clinical researcher | 20–100 normal healthy volunteers (or for cancer drugs, cancer patients) |
Phase II | Testing of drug on patients to assess efficacy and side effects | therapeutic dose | clinical researcher | 100–300 patients with specific diseases |
Phase III | Testing of drug on patients to assess efficacy, effectiveness and safety | therapeutic dose | clinical researcher and personal physician | 300–3,000 patients with specific diseases |
Phase IV | Postmarketing surveillance – watching drug use in public | therapeutic dose | personal physician | anyone seeking treatment from their physician |