Phase III trials typically enroll numbers in which range?

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Phase III trials are designed to confirm whether a treatment works in a broad patient population and to monitor safety across diverse groups. To reliably detect a meaningful difference between the new treatment and the control, these studies are planned with enough participants to achieve adequate statistical power, considering the expected effect size, variability, and chosen endpoints. Because of this need for robust power and generalizability, enrollments typically fall in the hundreds to thousands. Smaller numbers (dozens) are characteristic of earlier-phase studies focused on safety and dosing, while extremely large studies (tens of thousands) are less common and often driven by specific circumstances. Therefore, hundreds to thousands best matches the typical Phase III enrollment range.