What type of participants are typically involved in Phase 3 clinical trials?

Phase 3 clinical trials are designed to further assess the effectiveness, safety, and side effects of a new treatment or intervention in a larger population. At this stage, the trials typically involve a large group of patients who have the specific condition that the treatment aims to address. This extensive participant base is essential for gathering meaningful data on how well the treatment works across a diverse demographic, ensuring that the results can be generalized to the broader population that may use the treatment if it receives approval.

Involving patients suffering from the condition allows researchers to evaluate real-world applications of the treatment and to identify any potential variations in efficacy or safety among different subgroups. This comprehensive testing phase is crucial for securing regulatory approval, as it provides substantial evidence of the new treatment's benefits compared to existing therapies or placebo.

Other participant types mentioned, such as healthy volunteers, healthcare professionals, or regulatory officials, do not align with the primary goals of Phase 3 trials, as those populations either do not experience the condition being treated or are involved in different aspects of the clinical trial process.