Healthcare Economist April 26, 2022
When new drugs are approved, FDA limits their on-label use to the treatment of specific diseases. A key question is whether the definition of a disease should be narrower or broader. Make the disease definition too broad, then there may not be strong evidence from the clinical trial to support its use among these types of patients; make the disease definition too narrow, however, patients who could benefit from the treatment may not be able to receive it.
One common way that FDA extrapolates the trial results is that not all of the clinical trial inclusion criteria are applied to the FDA label. For instance, if a clinical trial is undertaken in oncology, the trial may exclude patients with serious...
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