In a new draft guidance issued on January 14, 2026, the FDA discussed the use of a modern statistical methodology in clinical trials designed to show the effectiveness of a new drug. The guidance, ...
Consistent with the Food and Drug Administration’s (FDA) commitment to streamlining the prescription drug and biologics approval processes by adopting innovative approaches to clinical trial design, ...
Cluster randomized trials (CRTs) represent a pivotal design in evaluating public health and clinical interventions where individuals are grouped into clusters (such as schools, hospitals or ...
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