{
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  "path": "/t/fda-draft-guidance-use-of-bayesian-methodology-in-clinical-trials-of-drug-and-biological-products/28598#post_11",
  "publishedAt": "2026-03-02T12:44:10.000Z",
  "site": "https://discourse.datamethods.org",
  "tags": [
    "@Stephen"
  ],
  "textContent": "Great post by @Stephen . It is up to all of us Bayesians to respect experimental design principles and to allow the use of extra-study data only when justifications are extreme and unavoidable. But even with very rare diseases, patients are ill-served when concurrent controls are not part of the design. Non-study data may possibly be used to augment the concurrent controls, but seldom to replace them.",
  "title": "FDA Draft Guidance: Use of Bayesian Methodology in Clinical Trials of Drug and Biological Products"
}