Evaluating the Efficacy and Safety of Novel Therapeutic in Phase 3 Clinical Trial

Author(s): Angelica Merlot

Phase 3 clinical trials are a critical and pivotal stage in the drug development process, aimed at evaluating the safety and efficacy of a new medical intervention in a large and diverse patient population. These trials follow the successful completion of Phase 1 and Phase 2 studies, which assessed the investigational product’s safety profile, dosage range, and initial efficacy. Phase 3 trials are designed to provide substantial evidence to support the regulatory approval of the new drug or medical intervention and are considered the last step before potential market release.