Скачать или смотреть BBIU | The FDA’s Bayesian Turn as Structural Reallocation of Epistemic Power

From Hypothesis Rejection to Belief Governance under ODP–DFP Stress

For more than half a century, FDA approval has not meant that a drug was true.
It meant that disbelief could no longer be sustained.

Under the frequentist regime, regulators never asserted that a therapy worked; they merely rejected the hypothesis that it did not. This preserved legal defensibility—but it also displaced epistemic responsibility. Clinical development proceeded inside a statistical fiction where “passing” replaced “being true.”

The FDA’s January 2026 draft guidance on Bayesian methodology ends that fiction.

By authorizing Bayesian primary inference in pivotal trials, the Agency has redefined regulatory truth as a quantified belief state—a posterior probability built from biology, historical trials, external datasets, and real-world evidence. Approval is no longer an event. It is a continuously updated belief about clinical reality.

This shift is not philosophical. It is structural.

Small populations, globalized execution, China-centered trial ecosystems, and exploding real-world data volumes have made hypothesis-based validation obsolete. In response, the FDA has converted its regulatory engine from event-based adjudication to belief governance.

Whoever controls data now controls truth.

And in a Bayesian FDA, truth is no longer declared—it is computed.

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This video is part of the BioPharma Business Intelligence Unit (BBIU). We provide structured, high-density analysis on biopharma, clinical research, medical education, AI, and strategic blueprints.
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