Designing Single-Arm Studies for Regulatory Acceptance
Designing Single-Arm Studies for Regulatory Acceptance Structuring Single-Arm Trials for Rare Disease Regulatory Success Introduction: Why Single-Arm Trials Are Common in Rare Disease Development In rare and ultra-rare disease drug development, the small number of eligible patients often precludes the use of traditional randomized controlled trials (RCTs). In these settings, single-arm studies—where all enrolled patients…
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