Publication: BioSpace
Abstract
The FDA recently stated they will now accept a single pivotal clinical trial to support drug approval. This BioSpace article explores how the shift away from the traditional two-trial model is changing drug development strategy.
Rather than lowering the bar, a single pivotal trial concentrates risk and demands stronger planning, tighter data controls and more comprehensive evidence. This article highlights how companies are adapting by investing in risk-based quality management, real-time data monitoring, and advanced analytics tools, including artificial intelligence.
Published: March 10, 2026
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