Track 16: Phase I-IV Clinical Trials

Overview: Phase I–IV Clinical Trials

Clinical trials are typically conducted in four sequential phases (Phase I–IV) to evaluate the safety, efficacy, dosage, and long-term effects of new drugs, biologics, or medical interventions in human subjects.

Phase I – Safety and Dosage

• Purpose: To assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of a new drug.

• Participants: Small group (20–100) of healthy volunteers or patients.

• Focus: Determine safe dosage range, identify side effects, and understand how the drug is metabolized and excreted.

Phase II – Efficacy and Side Effects

• Purpose: To evaluate the efficacy of the drug for a particular condition and further assess safety.

• Participants: Larger group (100–300) of patients with the target condition.

• Focus: Optimize dosage, monitor adverse effects, and gather preliminary data on effectiveness.

Phase III – Confirmation and Comparison

• Purpose: To confirm effectiveness, monitor side effects, and compare the new intervention to standard treatments or placebo.

• Participants: Large-scale (300–3,000 or more) involving diverse patient populations.

• Focus: Provide the robust evidence needed for regulatory approval (e.g., FDA, EMA).

Phase IV – Post-Marketing Surveillance

• Purpose: To track the drug’s long-term effectiveness, rare side effects, and real-world safety after approval.

• Participants: General population using the approved drug.

• Focus: Pharmacovigilance, risk management, and identification of new indications or populations.