FDA’s One-trial Default: Key Factors Shaping Drug Development

Brigid DeCoursey Bondoc spoke to Lexology PRO about the U.S. Federal Drug Administration's (FDA) recently announced plans to shift away from its longstanding two-trial standard toward a single-trial standard in an effort to speed up the the availability of new medicines and allow greater flexibility in demonstrating drug performance. Specifically, Brigid discussed how this shift will affect clinical development planning, particularly during Phase 2.

Brigid stated, "Sponsors should evaluate whether their data demonstrates a clear, clinically meaningful signal with sufficient consistency and durability to anchor a single study. The strength of the Phase 2 package will influence whether a one-trial approach is realistic or whether additional trials will be prudent."

She also spoke to how regulatory engagement with the FDA may shift in single-trials, stating, "Under a one-trial policy, the cost of misalignment is higher, so proactive engagement at key inflection points – particularly before finalising pivotal trial design – will be essential."

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