Evidence in the Wild

Evidence in the Wild

Because the real world didn’t read your protocol

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Latest Articles

10
Feb
4 min read

Science Is Not Neutral, and That’s the Point

In September 2016, the FDA approved eteplirsen for Duchenne muscular dystrophy. The advisory committee had voted 7 to 6 against accelerated approval. The FDA's own review team recommended against it. The clinical program consisted of 12 boys, and western blot analysis showed a dystrophin increase of 0.93%

05
Feb
4 min read

The Post-Hoc Problem: Why Bayesian Pre-Specification Matters More Than the Philosophy

The Bayesian vs. frequentist debate usually centers on philosophy. Priors are subjective! No, they formalize existing knowledge! You're smuggling in assumptions! You're ignoring relevant information! It's a fun argument. It's also the wrong one, at least for regulatory decision-making. The real value

03
Feb
5 min read

What FDA’s Recent Rare Disease Approvals Teach Us About Single‑Arm Trial Design

Between late 2024 and late 2025, FDA approved six rare-disease therapies supported primarily by single-arm trials. None of these sponsors ran randomized controlled trials. All received traditional or accelerated approval. What separated success from rejection wasn’t luck or regulatory leniency. It was understanding what evidence compensates for the absence