Clinical trials

Phase 3

Definition

Large confirmatory trials, usually randomised and controlled, that form the basis of an approval application.

Hundreds to thousands of participants across many sites. Phase 3 results are what an NDA or BLA is built on.

Phase 2Mid-stage testing for preliminary efficacy and further safety in several hundred patients with the target condition.Definition Phase 4Post-marketing studies conducted after approval to monitor long-term safety and real-world effectiveness.Definition New Drug Application (NDA)The application through which a sponsor seeks FDA approval to market a new brand-name drug.Definition

More in Clinical trials

Exclusion criteria Expanded access Inclusion criteria Investigational New Drug (IND)NCT number Phase 1 Primary endpoint Recruiting status

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